ISO 9000
The International Organization for Standardization (ISO) is an international federation of national standards involving more than 140 countries. ISO 9000 is a well-known family of guidelines and standards developed by the ISO. It has become popular worldwide for its role in setting up quality management systems within organizations.
Understanding ISO
What are Standards?
Today great emphasis is being laid on organisations following predefined levels
of standards in their processes and operation. But what are standards? How are
they useful to an organization, business performance?
Standards are documented technical specifications and other defined benchmarks. These specifications are applied as a set of regulations and procedures to ensure that the materials, products, operations and services conform to predefined requirements. Standards contribute to the enhancement of the product parameters such as quality, safety, reliability, effectiveness and interchangeability at an optimum cost.
The ISO:
The International Organisation for Standardisation (ISO) is an international
federation of national standards involving more than 140 countries. A
non-governmental organisation it was set up in 1947. The motto of ISO is to
endorse the growth of standardisation worldwide to promote international trade
and services. ISO promotes mutual collaboration between various organisations in
the scientific, technology and economic related activities.
Advantages of ISO
standards:
ISO sets up technical standards (that are voluntary) that help in enhancing
various types of organisational processes. They aid in the development,
production and delivery of products and services in a more effective, secure and
cleaner way. ISO standards also seek to safeguard customer interests.
ISO Standards are acknowledged worldwide as the means for manufacturers and service providers to bring about utmost ease and effectiveness in trading their products and services. These International Standards provide a benchmark to make the transfer of technology between suppliers and their customers possible.
The evolution of
ISO:
International standardisation was first initiated in the electro technical area.
The International Electro Technical Commission (IEC) was established in 1906.
The International Federation of the National Standardising Associations (ISA),
established in 1926, put in groundbreaking efforts in other areas. ISA focused
mainly on mechanical engineering. Its activities came to an end in 1942.
In 1946, representatives from 25 countries convened in London and decided to form a new international organisation, in order to “make possible the international coordination and integration of organisational standards". The new organisation, ISO, formally became operative on 23 February 1947.
ISO standards -The
process:
ISO has a well-defined process for incorporating standards.
First phase:
In any country a business segment puts forward the need for a standard
before its national standards institute. The latter suggests this to the ISO.
Once the necessity for an International standard has been acknowledged and
officially approved, the technological feasibility of the standard is defined.
This stage is usually performed in teams consisting of professionals from those
countries that are interested in the particular standard.
Second phase:
Once the experts reach a conclusion on the technical parameters to be
covered in the standard, the participating countries discuss in detail the
specifics pertaining to the standard. This is the consensus-building phase.
Final phase:
The final phase comprises of the endorsement of the final draft of the
International Standard. This report is subsequently made available in print as
an ISO International Standard.
Many of the standards need regular reviews. Various factors contribute to make a standard obsolete: scientific advancement, new techniques and equipment, changing trends in quality and safety procedures. To consider these issues, ISO has stipulated that all ISO standards should be evaluated every five years.
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The ISO 9000
Understanding > The
ISO 9000
The ISO 9000:
The goal of any organisation is to constantly accrue benefits through product
innovation and efficiency in the use of resources. The critical aspect to
achieve this is to attain all round quality performance. Quality is a basic
consumer requirement. A customer prefers organisations reliable as far as its
quality performance is concerned. Consistently manufacturing products and
offering services of superior quality is the need of the hour worldwide. This is
a critical aspect in sustaining customer loyalty and retaining the market base.
In order to attain
this, organisations have to comply with a set of procedures that are not only
acknowledged and accepted within a country but also internationally. ISO 9000
standards serve this purpose.
ISO 9000 is a well-known family of guidelines and standards developed by the
ISO. ISO 9000 standards for a Quality Management System handles the processes
concerned with the design, development and delivery of a product or service. The
standard stipulates specifications for the control and assessment of a process
for attaining quality performance.
The 1987 version of ISO 9000 standard, (originally published as BS5750 by the
British Standards Institute) emphasised on quality control by means of effective
checking and corrective actions. Quality control (QC) is a management function
that controls the quality of raw materials, products, components, and services
concerned with production and inspection activities. It aims to prevent defects
in the products or services.
The 1994 version of the ISO 9000 standard focused on quality assurance via
preventive actions, and stipulated the need for documented procedures. Quality
assurance (QA) comprises all measures taken to ascertain that the standards and
procedures are in conformity and that the products or services meet the
performance requirements.
An ISO 9000 certification indicates that the management is effectively
controlling the processes that are ‘critical to quality’ with respect to the
customer. ISO 9000 is not just about service or product quality; it's about
quality in management. These standards address aspects related to process
management. This requires organisations to identify, document and control
processes ranging from executive management to the production of different
items.
An organisation
could be successfully certified to ISO 9000 if it adhered to the specifications
of the standard. In order to be certified, an organisation must submit to an
accredited assessor’s examination. The assessor interviews staff members to
ensure that they are aware of their roles and responsibilities in complying with
the ISO 9000 standard. The assessor also examines the organisation's paperwork
to check on ISO 9000 compliance. When all issues are addressed, the organisation
is deemed for certification.
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The ISO 9000:94 Family
Understanding > The ISO 9000:94 family
ISO 9000:94 family is a set of international quality standards and guidelines
that have become popular worldwide for their role in setting up quality
management systems within organisations.
In
the past, organisations preferred to implement any of the three ISO 9000:94
requirement standards i.e. the ISO 9001, ISO 9002 and ISO 9003. Moreover, there
was a notion that ISO standards are applicable only in the manufacturing sector.
ISO in a move to change this perception drafted some more guidelines that cater
to the requirements of the service sector, small and medium scale industries and
software companies. Given below is a list of ISO 9000:94 guidelines and
standards.
ISO 8402, Quality management and quality assurance – Vocabulary. Defines
the essential terms used in the ISO 9000 family, which is necessary for avoiding
misinterpretations.
ISO 9000-1, Quality management and quality assurance standards – Part 1: Sets the guidelines for selection and use of specific standards. Provides the scope for understanding and selecting the appropriate standards.
ISO 9000-2, Quality management and quality assurance standards –Part 2: Provides basic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003. Helps in interpreting ISO 9001, ISO 9002 and ISO 9003.
ISO 9000-3, Quality management and quality assurance standards –Part 3: Sets guidelines for the application of ISO 9001 1994 in the development, delivery, installation, and maintenance of computer software. Also provides a specific interpretation of the requirements of ISO 9001 for computer software development applications.
ISO 9000-4, Quality management and quality assurance standards –Part 4: Provides guidance on how to plan, organise and control resources to produce reliable and sustainable products.
ISO 9001, Quality systems – Model for quality assurance in design, development, production, installation and servicing. This is a requirement standard used to ascertain the process capabilities for the design and development of the product or service, as well as for installation and servicing.
ISO
9002,
Quality systems – Model for quality assurance in production, installation and
servicing.
This standard is used to ascertain process capabilities for production,
installation and servicing (identical to ISO 9001except for design control
requirement).
ISO 9003, Quality systems – Model for quality assurance in final inspection and testing. This is a requirement standard used to control product or service through final inspection and testing.
ISO 9004-1, Quality management and quality system elements –Part 1: Guidelines for implementation. This optional standard provides guidelines to implement a quality system to satisfy the customers’ and organisational requirements.
ISO 9004-2, Quality management and quality system elements –Part 2: Sets guidelines for services. This standard is analogous to ISO 9004-1, but the guidelines are designed specifically to suit the requirements of the service sector.
ISO 9004-3, Quality management and quality system elements –Part 3: Sets guidelines for processed materials.
ISO 9004-4, Quality management and quality system elements –Part 4: Sets guidelines for quality improvement. Provides guidelines for implementing continual quality improvement within the organisation using tools and techniques based on information compilation and evaluation.
ISO 10005, Quality management –Sets guidelines for quality plans. This standard provides guidance on how to prepare quality plans for the control of specific products, and projects.
ISO 10006, Sets guidelines to quality in project management
ISO 10007, Quality management –Sets guidelines for configuration management. Provides guidelines to ensure that a complex product continues to work in the desired manner even when certain parts are modified.
ISO 10011-1, Sets guidelines for auditing quality systems – Part 1: Provides guidelines for auditing a quality system, and verifying the system’s capability to achieve set quality goals. It can be used within the organisation or for auditing the suppliers.
ISO 10011-2, Sets guidelines for auditing quality systems – Part 2: Qualification criteria for quality systems: auditors. Provides guidance on the education, training, know-how, personal traits and management capabilities needed to carry out an audit.
ISO 10011-3, Sets guidelines for auditing quality systems – Part 3: Management of audit programmes. Provides basic guidelines for managing quality system audit programmes.
ISO 10012-1, Quality assurance requirements for measuring equipment – Part 1: It is a metrological confirmation system for measuring equipment. Provides guidelines on the key characteristics of a calibration system to ensure that measurements are done with the projected accuracy.
ISO
10012-2,
Quality assurance for measuring equipment – Part 2:
Sets guidelines for control of measurement processes. Provides additional
guidance on the application of statistical process control whenever it is apt
for achieving the objectives of Part 1.
ISO 10013, Sets guidelines for developing quality manuals. Provides guidelines for the setting up, organising and controlling quality manuals customised to specific needs.
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The ISO 9000:94 Quality System Elements
Understanding > The ISO 9000:94 Quality System Elements
The ISO 9000
Quality system elements:
An ISO 9000 compliant quality assurance system includes 20 system elements. Of
the three system models (ISO 9001, 9002, and ISO 9003), ISO 9001 requires all
20-system elements whereas certain sub clauses have been omitted in ISO 9002 and
9003. The 20 system elements that ISO 9001 requires are listed below:
4.1 Management
Responsibility.
4.2 Quality System.
4.3 Contract Review.
4.4 Design Control.
4.5 Document and Data Control.
4.6 Purchasing.
4.7 Control of Customer – Supplied Product.
4.8 Product Identification and Traceability.
4.9 Process Control.
4.10 Inspection and Testing
4.11 Control of Inspection, Measuring and Test Equipment.
4.12 Inspection and Test status.
4.13 Control of Non-Conforming Product.
4.14 Corrective and Preventive Action.
4.15 Handling Storage, Packaging, Preservation, and Delivery.
4.16 Control of Quality Records.
4.17 Internal Quality Audits.
4.18 Training.
4.19 Servicing.
4.20 Statistical Techniques.
The ISO 9002 standard comprises of all the twenty clauses except Design control (clause 4.4)
The ISO 9003 standard comprises all the twenty clauses as in ISO 9000 barring Design control (4.4), Process control (4.9), Preventive action (4.14) and Servicing (4. 19)
The ISO 9000 Standard’s twenty system elements are explained in detail below.
4.1. Management Responsibility:
4.1.1. Quality policy:
4.1.2. Organisation:
4.1.2.1. Responsibility and authority:
4.1.2.2. Resources:
4.1.2.3. Management representative:
4.1.3. Management review:
4.2. Quality
System:
4.2.1. General:
4.2.2. Quality system procedures:
4.3. Contract
Review:
4.3.1. General:
4.3.2. Review:
The organisations must conduct a thorough assessment of the customer orders
before taking them up.Therefore, the management should ensure that:
4.3.3. Amendment to
contract:
Sometimes, the consumer might go for a replacement of the order or the
organisation itself could fall short of the specifications. The standard states
that:
4.3.4. Records:
Upon the assessment of the customer order, the organisation should document the
information pertaining to the order and the subsequent assessment incorporated
in it. This is to be preserved for a specific duration.
4.4. Design Control:
4.4.1. General:
The organisation needs to lay down procedures to ensure that the design of
the product suits the customer requirements.
4.4.2. Design and development planning:
The design plan must describe how the design process will be executed. It
covers the employees in various hierarchies, their interactions and design
procedures. Experts must regularly evaluate the design processes.
4.4.3. Organisational and technical interfaces:
All interfaces between the design of a product and other organisations that
design it have to be identified, communicated, and assessed periodically. The
information required for carrying out a design process within the organisation
must be gathered and incorporated within the documents.
4.4.4. Design input:
The organisation must put in place procedures to ensure that the design team
obtains the crucial information pertaining to the design parameters. The design
team must promptly explain, convey and solve discrepancies in the product
specifications.
4.4.5. Design review:
The organisation must carry out design reviews at various phases of product
evolution in order to control the design process.
4.4.6. Design output:
The output of the design process consists of documented drawings, and
tolerance specifications, materials requirements, and assembly guidelines.
4.4.7. Design verification:
Design verification states that:
4.4.8. Design
validation:
The organisation must make sure that the final product conforms to the design
parameters, which in turn suit the customer’s needs. To attain design
validation, the product must be tested in the environment it is going to be
used. This is done to ensure that the product conforms to customer's
requirements.
4.4.9. Design changes:
The course of action for making modifications in design should be
documented.
4.5. Document and
Data Control:
4.5.1. General:
All documents relevant to the ISO 9000 standard should be managed by a system
with relevant procedures laid down for document assessment, improvement,
approval and disposition. This also includes verifying documents used in design
and testing. The documents must be easily accessible.
4.5.2. Documentation approval and issue:
To meet the terms of this clause:
4.5.3. Document changes:
4.6. Purchasing:
4.6.1. General:
4.6.2. Evaluation
of subcontractors:
Assessment of a supplier must include an official documented assessment
procedure. Review of subcontractors stipulates that:
4.6.3. Purchasing
data:
Goods being purchased should be clearly specified. This consists of pinpointing
critical components and high lighting process capabilities, guidelines for
inspection and other relevant data. The purchase record must contain details of
conformity to a relevant standard.
4.6.4. Verification of purchased product:
It is the purchaser's choice to carry out a check of the product at the
supplier’s place or within the purchaser’s organisation. Product verification
proves that the information pertaining to the inspection of the product is
incorporated in the purchase record.
4.7. Control of Customer Supplied Product:
The organisation should lay down procedures to assess, stock up, utilise and
maintain the goods made available by the customer to be integrated into the
final product. Materials that are not viable should be identified, separated and
intimated to the concerned customer.
4.8. Product Identification and Traceability:
To maintain product identification and traceability:
4.9. Process
Control:
Process control can be defined as the means by which the process is designed to
be in line with the standards or specifications.
4.10. Inspection
and Testing:
4.10.1. General:
4.10.2. Receiving inspection and testing:
4.10.3. In-Process Inspection and Testing:
4.10.4 Final Inspection and Testing:
4.10.4 Inspection and Test Records:
4.11. Control of
Inspection, Measuring, and Test Equipment :
This clause defines the system established to ensure that the products meet the
quality requirements through effective inspection and testing.
4.11.1. General:
4.11.2. Control procedure:
4.12. Inspection and Test Status:
4.13. Control of
Nonconforming Product:
This clause defines the system to manage nonconforming product.
4.13.1. General:
4.13.2
Nonconforming product review and disposition:
The defective product should be assessed in compliance with the procedures laid
down. This product may be:
The products that
are fixed and modified are re-examined in compliance with the procedures laid
down.
4.14: Corrective and Preventive Action:
4.14.1General:
The organisation should implement corrective and preventive actions taking
into consideration consumer grievances, service faults, audit results and
quality documents. These measures should identify the causes of nonconformity
and establish remedial procedures to eliminate potential non-conformities. The
organisation should take measures to ascertain that all activities are executed
with efficiency.
4.14.2. Corrective Action:
The corrective action procedure must involve:
4.14.3. Preventive
Action:
The preventive action procedure must involve:
4.15. Handling,
Storage, Packaging, Preservation, and Delivery:
4.15.1. General:
The organisation should lay down procedures to process, stock, pack and deliver
products.
4.15.2. Handling:
4.15.3. Storage:
4.15.4. Packaging:
4.15.5. Preservation:
4.15.6. Delivery:
4.16. Control of
Quality Records:
The organisation should
4.17. Internal Quality Audits:
4.18: Training:
4.19. Servicing:
4.20. Statistical
Techniques:
4.20.1. Identification of need:
4.20.2. Procedures:
Implementation > Establishing ISO 9000 Quality Management System
Establishing ISO
9000 Quality Management System:
ISO 9000 family provides a basic structure to analyse and enhance organisations
key activities - that are particularly involved in establishing and maintaining
quality.
The best known of the ISO 9000 family are the ISO 9001, ISO 9002 and ISO 9003 standards - each defining standards for different aspects of an organisation.
For instance, while ISO 9001 specifies the model for quality assurance in design, development, production, installation and servicing, ISO 9002 specifies standards for production, installation and servicing, and ISO 9003 is applicable for final inspection and testing. Thus, before embarking on implementation every organisation should consider factors like
Regardless of the kind of standard adopted, organisations can go about their quality system implementation through the following steps:
Step 1: Top
management commitment:
The first step towards establishing a QMS in accordance with ISO 9000 series of
standards is the commitment of the top-management. Any measure taken towards the
development of a QMS will be productive only when the top- management is
committed towards it.
The top-management must be convinced of the benefits of certification. They should realise how certification will help them improve their systems and demonstrate a visible commitment to quality to customers.
The top management can demonstrate their commitment to the implementation and enhancement of the QMS by several methods, some of which include:
Step 2: Establish
an implementation team and allocate responsibilities:
The next step is to form an implementation team and appoint a management
representative to streamline the organisation¡¦s planning and manage the
implementation program. Care should be taken that the team members are from all
the functions in the organisation.
A management representative, is a person within the organisation who acts as an interface between organisation¡¦s management, it's employees and the ISO 9000 registrar. He should be the organisation's "quality management system champion," and should:
Step 3: Start ISO
9000 awareness programs:
Enhancement of quality performance in an organisation does not occur by itself.
The top-management should motivate and support the work force in their efforts
to achieve quality improvement.
An organisation-wide awareness program should be conducted on ISO 9000 QMS. This will help employees gain adequate knowledge of ISO 9000 quality system. They should be able to understand:
Step 4: Provide
training:
Once the above activities are performed, necessary training should be provided
for different categories of employees - senior managers, middle-level managers,
supervisors and workers. The duration may vary depending on the need but
training is a must for all. This training needs to be comprehensive enough to
include all the basic concepts of the QMS, the standards and their influence on
the planned targets of the organisation.
The management representative along with the members of the implementation team, who conduct internal audits, would need an internal auditor-training course. Training may also be necessary on writing quality manuals, procedures and work instruction, auditing principles, techniques of laboratory management, calibration, and testing procedures.
If expertise is not available to conduct the training, it may be necessary to participate in external training courses that professional training organisations conduct. Alternatively, an external training consultant could be invited to conduct in-house training courses.
Step 5: Conduct Gap
analysis:
Gap analysis is an evaluation of the organisation's current policies and
procedures to identify those that fall short of what is required by ISO 9000.
Gap analysis enables the organisation to analyse its business plan, policies and
strategies and their suitability.
Many organisations have the necessary procedures in place for a QMS but the question is whether they are in accordance with the required standards. Gap analysis assists in identifying such procedures. It also helps in identifying the need for new procedures.
A gap analysis generally uses a standard template of questions (questionnaire) on the current status of the organisation's processes. The analysis can be conducted internally i.e. by an in-house team, provided the required knowledge is available. Otherwise the services of an external consultant should be availed.
Step 6: Create a
documented implementation plan (Action plan):
Once the organisation gets a clear picture of the status of its existing quality
initiatives, all non-conformances should be managed with a documented
implementation plan (action plan). This requires identifying the non-conformance
process and modifying them to make the QMS compliant to the required standard.
Gap analysis helps to obtain information pertaining to all the activities that an organisation practices. This information should be used to develop a new implementation plan.
This implementation plan should define:
These elements need to be arranged in the form of a chart, to enable periodic reviews. This plan should define the roles and responsibilities of employees in different departments and specify the time limits for the completion of the activities.
The implementation team should approve the action plan that is developed. While a quick action is essential it should not be the only norm. The management representative should control, review and update the plan as the implementation process proceeds.
Step 7: Develop QMS
documentation:
Once the action plan is ready, the next step is documentation. Documentation is
a common area of non-conformance in organisations willing to implement quality
systems. In most organisations the documentation is either insufficient or
absent in some areas. Areas like inspection and measurement are generally
performed in every organisation, but very few document them.
Documentation of the QMS should include all the activities that have their profound impact on quality. This generally should include:
Step 8: Document
control:
Once the necessary documentation is developed, a documentation system should be
developed to control it. These control systems need to be simple and easy to
operate.
Document control should include:
Step 9:
Implementation:
After developing the necessary documentation and systems for their control, the
management representative (quality co-coordinator) needs to validate them. Then
the actual QMS implementation can be initiated.
Implementation is putting down the written systems into practice. Care should be taken that the all activities in the organisation are in accordance to the documented standards.
It would be a good idea to initially evaluate areas where the chances of a positive evaluation are high. This helps to maintain the confidence of both management and staff in the merits of implementing the QMS.
Step 10: Internal
quality audit (Phase-1 audit):
Internal quality audit can help identify the gaps in the quality system
implementation that are not yet compliant to the ISO standards.
Internal audit process should be conducted properly and thoroughly. It helps to verify that the QMS is in accordance with the:
This may require
modification of a particular system or procedure. Even after the system
stabilises and starts functioning, internal audits should be planned and
performed as part of an ongoing strategy.
Step 11: Pre-assessment audit (Phase-2 audit):
When system errors are no longer observed, it is normally time to apply for
certification. However, before doing so, arranging a pre-assessment audit though
not mandatory is advisable.
Phase - 2 audit generally conducted by an external agency could help organisations re-evaluate their QMS. This may help them identify defects that were not visible previously. Thus the organisation gets a certain a degree of confidence before going through the formal process of certification.
Generally, an independent and qualified auditor conducts the pre-assessment. In certain cases certifying agencies provide this service.
Step 12: Selecting
a certifying agency:
Some criteria that organizations can consider while evaluating a certifying
agency are:
Step 13:
Certification and registration:
The next step is the certification. The certifying agency first conducts a
document review to check for the adequacy of available documentation.
Once the documentation is found adequate, a conformity audit or a compliance audit is conducted. Such an audit is performed in accordance with the ISO 10011 auditing standard. On satisfying the conformance audit, the certifying agency grants certification.
Step 14:
Surveillance and re-certification audits:
Establishment of a QMS in accordance with the ISO 9000 series of standards is
not a one-time effort. ISO 9000 standards need to be adhered to by the QMS once
it is implemented in the organisation.
Hence, organisations need to ensure that the systems implemented are also established. Regular surveillance audits are necessary for this. They help to ensure that the organisation continuously adheres to the required quality standard. In general, the certifying agency conduct these surveillance audits.
The certification issued is valid for a period of 3 years. After which a re-certification audit is conducted.
Gap Analysis > The ‘What’ and the ‘How’ Of Gap Analysis
Gap Analysis:
Gap analysis is an evaluation of the organisation’s Quality Management System.
Purpose:
Gap analysis assists in identifying the organisation’s functions that conform to
the ISO 9000:1994 standard and the “gap” between the non-conforming functions to
the requirements of the ISO 9000 standards. Gap analysis also provides the
organisation with some suggestions to fill the identified “gaps”. Indeed such
proposals guide the implementation process.
Every organisation requires effective and efficient systems to remain competitive. Gap analysis helps to identify the range and depth of the conformance of its systems to the standards. Most organisations find documentation falling short of the standards. Similarly, internal audits (conducted by in-house employees), corrective and preventive actions and management reviews are some of the other areas that often fail to meet the standards.
Conducting the gap
analysis:
The organisation can use the services of either trained internal personnel or
external consultants to conduct the gap analysis. The gap analysis will evaluate
the system in terms of adequacy of documentation and compliance of working
system to the ISO 9000 standard requirements.
Tools:
A standard
questionnaire
is used to collect
information regarding the existing QMS. Based on the gap analysis and report
generated, the organisation can work out an appropriate implementation plan and
time schedule to meet the ISO 9000 requirements.
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Questionnaire
Gap Analysis > Questionnaire
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4.1.1 Quality policy:
4.1.2 Organisation:
4.1.2.1 Responsibility and authority:
4.1.2.2 Resources:
4.1.2.3 Management representative:
4.1.3 Management review:
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4.2.1 General:
4.2.1 Quality system procedures:
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4.3.1 General:
4.3.2 Review:
4.3.3 Amendment to a contract:
4.3.4 Records:
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4.4.1 General:
4.4.2 Design and development planning:
4.4.3 Organisational and technical interfaces:
4.4.4 Design input:
4.4.5 Design review:
4.4.6 Design verification:
4.4.7 Design validation:
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4.5.1 General:
4.5.2 Document and data approval and issue:
4.5.3 Document and data changes:
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4.6.1 General:
4.6.2 Evaluation of sub-contractor:
4.6.3 Purchasing data:
4.6.4 Verification of product purchased: 4.6.4.1 Supplier verification at subcontractor’s premise:
4.6.4.2 Customer verification of subcontractors product:
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Does it include:
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Does the organisation:
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4.10.1 General:
4.10.2 Receiving inspection and testing:
4.10.3 In-process inspection and testing:
4.10.4 Final inspection and testing:
4.10.5 Inspection and test records:
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4.11.1 General:
4.11.2 Control procedures:
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4.14.1 General:
4.14.2 Corrective action:
4.14.3 Preventive action:
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4.15.1 General:
4.15.2 Handling:
4.15.3 Storage:
4.15.4 Packaging:
4.15.5 Preservation:
4.15.6 Delivery:
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Documentation > Documentation of ISO 9000:1994
Documentation:
Documentation can help an organisation to
Documentation is the most common area of non-conformance within organisations implementing ISO 9000:1994 quality management systems. In most organisations the documentation is either insufficient or absent in many areas.
ISO 9000:1994 standards necessitate an organisation’s quality management system to be documented and controlled. But most organisations fall short of their defined goals and objectives due to improper planning i.e. lack of an organised approach.
The 1994 version of ISO 9000 unlike the 1987 version included a new clause-Quality planning. This requires preparation of quality plans showing how the requirements of quality are going to be met.
Thus, before embarking on documentation an organisation should first analyse what to document and what is already documented. Mere documentation is not sufficient. Documentation will be effective only if it is properly planned and managed in stages.
Common problems:
Given below are
some guidelines for developing the documentation for a QMS
1. Provide a structure for documentation:
ISO 9000:1994 standards do not address the details of the quality system.
Instead, they specify that an organisation must have defined processes for areas
such as quality, process documentation, and verification.
Therefore, organisations need to first identify the processes that impact the quality of their products or services. Then, a basic approach is to be developed involving all these processes and their interrelationship. These processes generally include
Once the processes are identified, a model, which acts as the base for the documentation is to be outlined. ISO 9000:1994 follows a three-tier model - quality manual, process guides and work instruction respectively.
2. Check the clauses of ISO 9000:
After outlining the model for documentation, organisations need to check all
the clauses of ISO 9000:1994 standards.
The family of ISO 9000:1994 series specify three different standards, namely ISO 9001, ISO 9002 and ISO 9003- each specifying standards for different aspects of the business.
Hence, organisations (before preparing the quality manual or process guides) initially need to verify the standard appropriate to them. This requires an extensive clause-by-clause inspection of the elements in the organisation. Check lists are used for this purpose. These checklists present a clear picture of the organisation’s existing quality system and ensure that there is nothing overlooked.
3. Review the
process map:
This forms the most crucial stage of the entire documentation process. Many
organisations view the quality system as the responsibility of the quality
manager alone. However, the quality system is the responsibility of the entire
organisation.
Thus, top-management needs to first evaluate their process map and analyse existing systems and those planned for the future. Employees’ viewpoints need to be considered to make the documentation more effective.
4. Write Quality
manual:
Once the inadequate processes are identified, they need to be rectified and new
documents prepared. There is no standard format for writing a quality manual but
it is essential to keep it simple.
If the organisation consist of complex processes, it may even be necessary to create functional manuals (defining every function). The criteria should not be the style and size but the needs of the users of the manual.
Document control:
Some tips to maintain an effective document control system are explained below:
Keep It Simple:
Documentation should be comprehensive, short and user-friendly. It should be
simple so that everyone can comprehend it easily. It should be precise and
adequate enough to cover all the necessary activities.
Have the right
amount of documentation:
Too much documentation may prove burdensome while too little could prove
insufficient and ineffective.
Other tips:
Measurement, Analysis and Improvement > Elements Included
Quality of products or service is the major factor that determines the success or failure of any organisation. Therefore, organisations must assure customers of their high standards in product quality. For this organisations need to initially implement strong and effective techniques for measurement, analysis and improvement of the quality related activities.
ISO 9000 series of standards defines certain specifications for this purpose. Measurement, analysis and improvement are an important part of both quality control and quality assurance systems. These initiatives are directly related to product quality, where they take the form of testing or inspection measurements (ISO 9001 requirement 4.10), or relate indirectly to initiatives that affect product quality, taking the form of process control measurements. (ISO 9000 requirement 4.9).
How
can quality be measured and improved?
ISO 9000:1994 has some defined clauses to measure, analyse and
improve the quality related activities in an organisation. In most
organisations, it is the quality manager who evaluates these measurement,
analysis and improvement techniques.
The various clauses defined in ISO 9000:1994 for measurement, analysis and improvement are:
The
above clauses and the processes relevant to these clauses are explained below.
4.9 Process Control:
The purpose of process control is to ensure that all the processes in the
organisation that directly impact quality are identified, planned and carried
out under controlled conditions. This identification requires organisation’s to
measure and analyse their quality related activities.
Some of the activities defined in this clause that involve measurement and analysis directly or indirectly are:
“In the 2000 version, process control is integrated along with the statistical techniques in the measurement and monitoring of processes(Clause 8.2.3).The additional requirement in the 2000 version is continuous improvement of these processes.”
4.10
Inspection and testing:
“Inspection and testing” necessitates organisations to have a
detailed inspection and testing system to ensure that the processes conform to
the required standard. In order to ensure this conformance, organisations need
to continuously measure and analyse their existing processes.
The clause “Inspection and testing” requires organisations to carry out inspection and testing at three different stages of the production process as below:
This specifies that the inputs received are not used or processed until they have been verified and conformance to the necessary requirements certified.
Inspection at this stage is carried out on steps that are involved in the production of output. It is aimed at preventing the production of defective output.
This
requires organisations to conduct inspection and testing on output that has been
produced. This is to prevent output that does not meet the quality
specifications from reaching customers.
“In the 2000 version, there was no significant change
in this, but monitoring, analysis and improvement, and the use of appropriate
statistical techniques were introduced.”
4.13
Control of non-conforming products:
The purpose of this element is to ensure that products that do
not conform to required standards are prevented from unintended use. This
prevention, initially, requires organisations to identify the non-conforming
product, which requires measurement and analysis.
Control of non-conformance product thus directly or indirectly requires organisations to maintain defined procedures for measurement and evaluation of the non-conforming products. Some aspects in this clause that relate to measurement and analysis are:
Clause 4.13.1 specifies that the organisation need to identify and evaluate the non-conforming product.
Clause 4.13.2 specifies that the defective product should be assessed in compliance with the procedures laid down. These products may be:
It
also specifies that the products fixed and modified are re-examined in
compliance with the laid down procedures. Measurement, analysis and improvement
are the basic functions involved in this.
“2000 version has no major change from this except that
the production terms such as rework or repair are removed.”
4.14 Corrective and preventive action:
Corrective action refers to the initiatives taken to identify the causes of non-conforming products or services and establishing necessary measures to reduce these occurrences.
Preventive action refers to the precautionary measures taken to prevent the occurrence of a problem or to reduce its effect.
Both corrective and preventive actions are intended to improve the existing organisations quality processes.
Some of the aspects in this clause that relate to measurement, analysis or improvement are:
Clause 4.14.2 Corrective action requires that the organisation
Clause 4.14.3 Preventive action involves
“2000 version has focussed much more on “improvement” and has made it a continual process. Additional clauses such as planning for continual improvement were added”.
4.17 Internal quality audits:
The purpose of this element is to help management determine if the implemented quality system is effective in achieving required quality objectives. This is an evaluation technique organisations use to verify processes.
They
collect the data from a variety of sources and crosscheck them for the purpose
of Internal quality audits. This data is analysed and loopholes identified.
Management is required to take the necessary action on the loop holes discovered
and implement the suggestions of the audit team.
Some aspects of this clause that relate to measurement, analysis and improvement
are:
“The 2000 version of this clause is similar to 1994 version, but it allows employees who have the responsibility and who actually carry out the activity to conduct auditing. It necessitated that the procedure included the requirements for ensuring the autonomy of the audit.”
4.20 Statistical techniques:
Statistical techniques involve measurement, analysis and improvement techniques. They ensure that systematic approaches are used in quality improvement and control.
These techniques range from analysis of the markets to the measurement of the level of the follow-up service. The analysis techniques must be appropriate to the situation and the data collected effectively utilised.
Aspects defined in this clause that relate to measurement, analysis or improvement are
Clause 4.20.1 Identification of need requires organisations to evaluate their systems to verify their appropriateness (measurement and analysis).
Clause 4.20.2 Procedures are essential for ascertaining the proper application of the tools (improvement).
“In the 2000 version, statistical techniques are included in the measurement and monitoring of processes (Clause 8.2.3) that require the processes to be continually improving”.
Tools Deployed > ISO 9000:1994 Tools
The tools applicable in the various stages of the ISO 9000:94 implementation process are :
Gap Analysis:
Quality policy establishment:
Document control:
Planning:
Awareness and Training:
Process Control:
Problem identification and rectification:
Design and development of a product:
Delegation of responsibilities:
Monitoring and Measurement:
Corrective and Preventive action:
Quality Tools > Brainstorming
Brainstorming is a process wherein a group of people focus on an issue/ problem and then come up with several radical solutions. They bring out ideas as they think of them, regardless of the content of the ideas, such that each of the participants has the opportunity to build on the ideas of others. No discussion, evaluation, or criticism of ideas is allowed until the brainstorming session is complete. Every brainstorming session should have a facilitator assigned to record all ideas.
An American advertising executive Alex Osborn developed this technique in the 1940s.
Types of Brainstorming:
For effective brainstorming:
What is it?
Fagan Inspection is a well-defined procedure for thoroughly
evaluating documents (especially those pertaining to designing and
implementing projects). This evaluation is done by a team that
includes the person who has designed the project/programme and, if
possible, the customer. Fagan Inspection helps eliminate conceptual
errors in the early stages of the documentation.
Implementation Process:
Advantages:
Early defect detection in a document through
inspection enhances its quality and reduces subsequent
modifications.
Quality Tools > Document Management System
What
is it?
Document Management System (DMS) is a software solution that enables
organisations to better manage their documents that are in electronic or digital
format. The objective of a DMS is to manage documents from their conception to
the phase out. It includes storing documents at identifiable locations and to be
able to recover them swiftly and easily.
Implementation process:
The accumulation of unnecessary and irrelevant documents may negatively affect the working of the DMS. Identifying and separating the documents pertinent to the organisational requirements is an important step towards the setting up of an efficient document management system.
Scanning and OCR (Optical Character Recognition) technology is required to transform and integrate the paper document into the organisation’s document management system.
The organisation must make sure that the OCR device has fine accuracy and identification rate. it must also monitor the indexing and searching abilities of the product closely.
Advantages:
DMS can simplify the organisation’s need for managing documents.
The system is especially useful in managing management systems such as EMS
Review.
Quality Tools > Activity Network Diagram/ PERT/CPM
What
is it?
Activity Network Diagram is the graphical display of the sequence
in which actions have to be performed to complete a project.
Activity Network Diagram is applicable to those projects where the tasks (actions to be performed) are known in advance. It enables the team to implement the most efficient path/sequence.
Some of the other versions of this method are Arrow diagram, PERT Chart, CPM chart.
Programme Evaluation Review Technique (PERT):
What is it?
Program Evaluation Review Technique is an organised network based
method used for planning complex processes.
Network diagram is the essential element of network based planning approach. Network diagram is an outline drawing that indicates all the activities in a sequence (i.e. the order in which they need to be accomplished to finish the project) signifying their correlation.
PERT is an effective tool in the area of Project Management. This technique helps planning the duration of the project and the various resources required.
Implementation Process:
An activity can be a critical activity or a non-critical activity. A critical activity is one that if delayed can delay the project. The delay of a non-critical activity does not affect the project’s deadlines/completion.
Advantages:
PERT is an effective technique to determine where interruptions
(that lead to increase in project duration) in the project implementation are
likely to take place and the resulting consequences on the entire project.
Quality Tools > Critical Path Analysis
What
is it?
Critical path analysis is an effective tool to plan the most optimum and cost
effective sequence of activities to complete a project. Critical path analysis
is a deterministic model with familiar operation times taken into consideration
through past experience.
Implementation Process:
Advantages:
Critical path analysis is best applied for recurring projects wherein cost
effectiveness is given priority. This ensures efficient use of resources.
Quality Tools > Gantt Charts
What
is it?
A Gantt chart is an effective tool used for planning and implementing complex
projects.
It enables the project team to evaluate the total time needed to accomplish a project, estimate the resources required and outline the sequence in which activities will have to be accomplished.
Implementation Process:
A complex project can be broken down into its individual
activities.
Some of these activities can be started only when certain other activities are completed first. These activities contingent on one another should be carried out emphasising the need to complete a task before starting the next one. These activities are called sequential activities.
Some activities can be carried out at any time during the implementation of the project. They do not rely on the completion of other activities and can be performed independent of other project activities. These activities are called parallel activities.
Calculate approximately the time required to accomplish each activity and the dates indicating its beginning and its completion.
Drawing a Gantt chart:
The Gantt chart is created with the horizontal axis indicating
the total duration of the project, broken down into increments (days, weeks, or
months) and the vertical axis representing the various activities that
constitute the project.
Each activity in the Gantt chart is signified using horizontal bars connecting the starting date and the date of completion of each activity. These bars are also known as activity bars. Above the activity bars, specify the time taken to complete them.
Parallel horizontal bars should represent the parallel activities and horizontal bars in sequence indicating the sequential activities.
Schedule the sequential activities. The path traced by each set of sequential activities is called a critical path.
Schedule the parallel activities such that they do not disturb the way of the critical path.
Determine the optimum amount of resources to be allocated for each activity. Carefully assess the project advancement making use of the Gantt chart.
Advantages:
The Gantt chart has certain options that assist the project team such that:
Additional reading:
1. This article explains how to create a Gantt chart using MS
Excel.
http://www.me.umn.edu/courses/me4054/assignments/gantt.html
2. This article presents the application of Gantt charts in daily life.
http://www.smartdraw.com/resources/examples/business/gantt.htm
Quality Tools >
Skills Gap Analysis Technique
What is it?
The skills gap-analysis is a valuable technique to evaluate training
requirements. It helps to provide personalised training.
Implementation process:
An in-depth analysis of the job of each employee is conducted to identify
the variety of skills set needed to accomplish the task successfully. The
employees’ individual skills have to be compared against the skills required to
perform the individual jobs. Training has to be imparted wherever the skills of
the employees fall short.
In this context it is important to understand the various skills that are
involved. These skills can be classified into two broad categories.
Technical skills: These include requisite knowledge to perform
the tasks/jobs, occupational knowledge i.e. skills to operate various
equipments, familiarity of various processes etc.
Personal skills: The soft skills and personal skills such as
communication skills or teamwork that improve the capability to perform or
accomplish the required job.
The people with identical roles or responsibilities or those needing similar
skill sets in their job, have to be grouped together. Key training objectives
for each group has to then be identified and common training modules developed.
Advantages:
The technique enables the organisation to methodically assess the training
requirements of its employees and develop effective training strategies.
Quality Tools > Process Analysis
What is it?
The process analysis technique is used to assess processes or
operations in order to make improvements. Processes can be assessed for their
effectiveness, efficiency or impact on external environment.
Implementation:
Advantages:
Process analysis helps understand a process and develop ways to
improve those activities that fall short of the set requirements.
Best
Practices > Constructing on a Good Foundation
ABC Ltd.
is one of the first building contractors in Singapore to be registered to the
ISO 9002 standards. From the time of its registering to the standards in 1994,
ABC had been committed to providing superior quality services while
constantly enhancing its quality system.
Introduction:
ISO 9000:1994 has defined quality as ``totality of characteristics of a
product, process, organisation, person, activity or system that influence them
to satisfy stated or implied needs’’. In this context
quality in construction can be defined as conformity to the needs
of all the people involved in construction, satisfying the needs of the client,
legal and regulatory compliances and needs of the society.
ISO 9000 in construction was the key: to attaining reliable performance levels, enhanced effectiveness and output, and gaining a competitive advantage. ISO 9000 compliance was a prerequisite for companies in search of international construction contracts.
Case
study:
The present study explains how ABC Ltd. applied ISO 9000 QA standards
aptly and minimised the generic human related defects classified in three sub
systems. These sub systems can be classified as Technical, Human Resource, and
Management sub systems.
ABC Ltd. is one of the first building contractors in Singapore to be registered to the ISO 9002 standards. From the time of its registering to the standards in 1994, ABC had been committed to providing superior quality services while constantly enhancing its quality system.
Quality system:
The organisation’s quality system stipulated responsibilities for
each organisational unit and employee, in order to attain quality within the
scope of the organisation. It also controlled the operations among various
departments to make sure that the construction and civil engineering activities
were carried out efficiently.
Even before the organisation got certified to ISO 9002 in 1994, the organisation established a quality improvement programme called the ‘quality recipe’. It was a set of values and viewpoints that focus on modifying and enhancing the mind-set of the workforce towards quality. ABC also emphasised on the PDCA (Plan-Do-Check-Act) cycle. Along with it is the Methods-Materials-Steps-Sequence programme that was personally created by the Managing Director to remind his employees to get involved in planning, monitoring and assessment so that a most favourable means to achieve quality was put in place.
Soon after the ISO 9002 registration, all the quality management programmes initiated by ABC were amalgamated into a single action plan towards quality improvement, structured in line with the ISO 9000 QMS.
External quality management experts guided the initial phase of the ISO 9000 implementation process. For the other phases i.e. planning and documentation the top management delegated the responsibilities to its employees. Employees involved in the implementation of the quality system were allowed to undergo training in this aspect. This would enable them to educate the remaining staff on the quality system.
The half yearly assessment of the documents on quality management enabled ABC to identify defects in its operations. Certain innovative features in the newly taken up projects were promptly incorporated.
The organisation had established comprehensive procedures to efficiently carry out the various aspects relating to the three sub systems within the scope of ISO 9000 QMS. This was primarily done to minimise the defects in the construction. Some of these are presented in detail.
Technical sub-system analysis:
This sub system consists of those elements that are concerned with procurement
of projects and the ensuing implementation process.
Procurement:
The top management made the choice of clients. This was complemented with the
suggestions of the contract’s manager. To ensure that building being constructed
was of high quality and that the project was completed within the scheduled
duration and costs, the management utilised the documented procedures at each
crucial phase of the project.
It
was the motto of the organisation, to be dedicated to satisfying the client’s
requirements for a venture and construct a structure of high quality. In order
to accomplish this, ABC introduced new techniques, novel practices and
sophisticated design features into building construction.
ABC also had in place additional design options within the scope of each
project. Though it did not have the resources for designing the buildings it
managed to form business related associations with architectural and design
experts to establish alternative designs. Procedures for these were documented
and incorporated into the quality system maintained as per the requirements of
the ISO 9002 standards.
Project planning:
Planning for all construction projects the organisation had taken
up, was an elaborate procedure. Often the project director and the managing
director personally participated.
The key employees of the organisation visited the location where the building was to be constructed to evaluate the necessity of additional machinery, and workforce. The duration required to carry out the project was determined taking into consideration the assessment at the site. Problems identified were brainstormed. If the employees were not able to come up with effective remedial measures, experts’ opinion was solicited.
Viable options for carrying out the project were put forward in order to consider the opinion of the client. Any inconsistencies in the contract documents were communicated to the clients.
The complete construction procedure was established and the ease of use of the resources was established. The project manager devised a quality plan with the help of his employees who were responsible for the on site operations. Pertinent data for any new procedure or machinery to be used was collected and incorporated into the document for future reference.
Execution and control of works:
Once a contract was authorised, the preparatory work done was assessed and
modified as required. The resources were assembled and organised with the help
of a checklist to ensure every aspect is taken into consideration. If a group of
contractors had to carry out the project then care was taken to assign the
phases of the project to individual contractors appropriately. Moreover,
emphasis was laid on harmonising the activities of various contractors.
The entire process from placing the order to buying raw materials and storing them was executed in agreement with the set procedures. Key staff members directed their entire operation to ensure the material was not damaged. The sites wherein the material was to be stocked were identified keeping in view how tasks were done, by whom, in what order and how quickly. The possible impacts of the current processes were also used to determine the storage sites.
The organisation did not encourage overstocking of materials and made use of the JIT concept for the purpose. This minimised the threat of damage to the materials. JIT (Just in time) is a concept in inventory management that ensure raw materials are supplied to an organisation precisely when needed. This implies that the fresh stock must reach the site just before the process actually starts. The purpose of JIT is to drastically reduce the storage of raw materials thus avoiding the accumulation of the stock.
Once the building was completed, safety measures were implemented until the client took over the building. A team proficient in more than one technique carried out the project. This was a consequence of the organisation’s principle to consistently upgrade its employees’ abilities. With a view to generate an output high in quality ABC shuns contracting out a part of its responsibilities to an external entity except when inevitable. ABC shoulders the responsibility for the results of the projects it handles.
Supervisors and engineers were required to put in place a set of measurements within a process so the outcome of the process adhered to the relevant specifications. This was especially done for the ‘critical to quality’ components of the building ABC had identified through the evaluation of the projects it had executed previously.
Checklists for various phases of the project were utilised for evaluation during internal site quality audits. Procedures for identifying the tasks that were not meeting the requirements, the subsequent correction done, re assessment, and the analysis of the causes of non conformance were structured in the form of flowcharts for better know-how.
The management of the organisation extensively encourages the application of Value Engineering methodology. Value Engineering in the context of construction was the assessment of construction procedures and/or materials to identify those processes that can be performed by reducing unnecessary costs while conforming to the specifications, the design features, the performance standards and safety criteria.
Human
resource sub-system analysis:
In ABC this sub-system covers aspects such as the enhancement of the
knowledge levels of the staff, and providing constant encouragement and support
to the staff.
Employing the staff:
The guidelines for recruitment were based on in -sourcing before out-sourcing.
Every time there was a requirement of staff internal candidates were considered
first. The organisation’s policy was to make every employee proficient in
various skills. In addition to monetarily benefiting the organisation enhances
the employee know-how thus enhancing his worth in the organisation. The
management resorted to out-sourcing as a last resort.
The recruitment of prospective employees was done on the basis of pre-determined criteria. The interview procedure consists of filling up of forms to evaluate in detail the competency of each candidate for the post. These evaluation sheets were integrated into the documented procedures on quality and enable the personnel to execute the interviews efficiently.
Training and Development:
The managing director personally focused on the training aspect of the
employees. It was the policy of the organisation to constantly impart training
in order to upgrade employees’ skills. This also helps the employees to attain
job competencies. The training programme necessitates a systematic collection of
information pertaining to the employees or the requirements of the organisation.
A good appraisal by the top management included a study of the extent to which
the organisation was able to meet certain specific requirements; the skill set
the employees must possess to achieve these requirements and the manner in which
the training was to be imparted.
Senior employees and sometimes outside agencies conducted the training classes. The training emphasised on imparting the knowledge of the three ISO management systems implemented. So that employees could go for training without any difficulty the classes were held at the place where the project was being carried out. Technical skills training was imparted by allowing the employees to get trained in certified training institutions.
ABC sponsors employees in the executive category aspiring to continue their higher studies. Provisions were set up to enable them to handle their job and learning responsibilities. These employees are even sent for short-term courses to develop specific skills as and when the need arose. This includes attending international symposiums on the innovative practices in the area of construction engineering and management. Trips abroad to gain knowledge and expertise from world-renowned contractors had been arranged earlier.
The employees who had attended these programmes were needed to present their learning to the top management. They were also required to convey their opinions on the effectiveness of these programmes. This enabled the organisation to assess the efficiency of the training programmes and implement improvements in its procedures wherever necessary.
Encouragement and support
Motivating the employees was a high priority in ABC.
Events such as get-together of employees and their families were held regularly
to foster better relations between the employees. Employees were encouraged to
express any problems they encountered in their work by utilising the forms
allocated for this purpose.
Management sub-system analysis
The important aspects covered in this sub-system are documentation management
and generating awareness of crucial information in the employees.
Comprehensive documented procedures
ABC’s policy to cope with ineffective communication across various
departments was to prepare comprehensive documents for all relevant procedures.
The details of the employee performing the documentation and the location of the
document were incorporated within. Sets of flowcharts were drawn to describe the
relevant procedures for various processes. The employees who personally perform
a process indicated the process flow in a flow chart, providing information
critical to the quality wherever necessary.
Checklists were used to identify the defects in the documents. The QES department of the organisation routinely checks those procedures and checklists that were widely used in the entire organisation. A few modifications that may result from the suggestions put forward by the clients are promptly noted, rectifications made and sent to the concerned clients.
To
generate knowledge
The organisation regularly updated its employees on the accessibility to the
information that was relevant and critical for performing their jobs. A chart
that contained crucial information on individual projects was put up in the
premises of the main office and at strategic places where projects were being
executed.
Also each division of the organisation and every location where a project was being carried out possessed the latest copy of the organisation’s quality system documents. These included the quality manual, procedures and work instructions. A quick recourse to the documents as and when required was thus possible.
Conclusion:
It is thus obvious that the ISO 9002 QMS ABC had
implemented was successful. It ensured that quality was sustained in the
construction. A holistic approach had been adopted towards the understanding and
accomplishment of the needs of the ISO 9000 standards to incorporate the other
quality programmes. This had resulted in the development of a wide range of
policies, programs and procedures to ascertain the effectiveness and efficiency
of all its operations.
Continue:
Moving Up The Ranks
Best practices > Moving Up The Ranks
Asset Recovery Business (ARB) of Dell is a model for this approach of process innovation to make the utmost use of the ISO 9000:1994 QMS.
In this modern world, initiatives specifying the steps for controlling quality or inspection are inadequate for organisations to remain competitive. Business Success largely depends on the entrepreneurs who have the ability and vision to implement and enhance their processes.
This case study highlights the method of using the ISO 9000:1994 quality management system, as a tool for developing a culture for constant improvement.
Dell Computers:
“Dell” is the world number-1 PC manufacturer and seller. It is
known for its direct selling and build-to-order business model. Dell’s
understanding of its customers and the strategies it tailors for them
are the key factors for its success. Dell is an example of how effective
leadership can bring about changes in an organisation.
Dell has a unique business culture that helps it to be the No 1 in the computer industry. Special features of Dell’s business culture:
Employee performance assessment is conducted in Dell only if it reflects in the enhancement of the business performance. Training is deemed as a day- to day activity but not as one that interrupts work. Risk is encouraged at every stage of the process because of the shared vision of the organisation. Roadblocks are viewed as opportunities and coped with bold and systematic effort.
With all such existing initiatives, in 1995 Dell accomplished ISO 9002 certification. However, the “ISO process” was not looked as a performance enhancement tool. Most of its business units viewed it as a structure to evaluate and enhance their existing processes and ensuring conformance to international standards.
Case under study:
The Asset Recovery Business (ARB)
of Dell computers at AUSTIN, USA is an
internal division of Dell computers and sells renovated computers at a
nominal price.
Background:
Dell computers has a unique system in place under which any Dell product
can be returned for repayment or substitution within a month. Earlier
these returned products were used to inspect faults, renovated and sold
to retail customers at the Factory Outlet Store.
Although the errors were minimised to the maximum possible extent, due to consistent growth in sales the number of units returned each month seemed enough to keep 450 people busy everyday. Thus they developed an e-commerce site for selling the renovated computers.
However, the organisation’s main focus was not just gaining by selling these renovated products but on making this particular unit also a recognised profit centre.
Asset Recovery Business (ARB) is a model for this approach of process innovation to make the utmost use of the ISO 9000:1994 QMS.
ARB does not have defined production lines nor does it demand specialisation in its cycle. Almost every employee is made responsible for all the products that the group has to deal with. Even the issues they deal with are quite different from the issues in the typical Dell manufacturing units. They have to find out what the customer returned and why did he do so. Then the best solution for each unit is determined.
Planning used to be done in real time instead of estimates since ARB has no defined practice to predict the number of units that will be received. Even ARB’s customers were very distinct from the customers of the other Dell manufacturing units. They were more price-sensitive and precisely consistent hunters for broader technical requirements.
ARB employees work on the challenges thrown at them to improve throughput, curtail cost and essentially make this recovery unit a profit centre. When all other plants of the organisation were trying to sustain their reputation, ARB was working towards becoming the standard of productivity, novelty and business process enhancement for all of Dell.
Despite meeting such diversified requirements, instead of being recognised as the most talented and innovative division, they were perceived as the operators at the bottom line of the chain.
Blessing in disguise:
As a part of the certification process of the Dell manufacturing units,
ARB was scheduled to go through an inspection by their registrar (NSAI)
That was a time when they had the obsolete documentation of their
earlier business unit. ARB does not have the required documentation to
prove their continuous enhancement process. Thus with two months to go
before the audit they choose to implement ISO9000: 1994 not only for
preparing the essential documentation but also for using it as a tool
for enhancing their business of selling renovated computers.
A “Business Management System (BMS)” was developed on a six-week basis to help in the documentation of existing processes and assisting for transition to continuous business process enhancement.
The steps taken to ensure this include:
1. Identifying the crucial areas of the plant totalled to 49 that need to be summarised and documented.
2. Identifying the experts in each of these functional areas and assigning the responsibility of drafting a procedure encompassing activities like the method of conducting each process.
3. Developing a Business Management Systems Manual (BMSM) after interviewing each of the experts by the BMSM representative and outlining an agenda for ARB to perform its daily activities.
4. Inspection and review of the drafts prepared for approval by the respective managers.
5. Preparing a “Roles and Responsibilities” Manual.
6. Placing the manual, roles and responsibilities and 49 identified procedures on website named BMIS (Business Management Information System).
Audit:
External auditors (NSAI) were astonished to see the ARB’s drive for
continuous enhancement. Very few areas were noticed for possible
improvement contrasting the expectation of large number of
non-conformities. Thus the audit resulted in a series of reforms and
revisions instead of disciplinary remedial actions focussed at
individual performance as expected. Contradicting to the view of ARB as
the bottom line of the business chain, the unit was cited as the “Most
improved” business unit.
Conclusion:
There were no supernatural activities involved in the
two-month reformation process of the business. The success is attributed
to the visionary leaders in the plant always seeking internal and
external channels to build solutions for different business issues.
Using the concept of continuous process improvement and implementing ISO
9000:1994 as a value adding activity rather than as a non-conformance
inspection tool, helped the plant in acquiring certification.
BMS (Business Management System) developed in ARB was
thus included in every sector of the organisation as in finance, sales
and marketing, and the organisation’s operations. Dell ARB has moved
from being under the eye of suspicion to the spotlight of success. It
proved that ISO 9000:1994 can in fact be a system of business
enhancement and not just a tool for traditional quality management.
Continue:
Aiming for Consistency in Practices
Best Practices >Aiming For Consistency In Practices
An insight into the efforts of a steel maker to improve
consistency of practices through ISO 9002 implementation.
Advanced technology has helped steel makers to develop the best operating processes to melt, roll and ship steel. The full impact of these processes can be realised, only if they are performed on a daily basis without any irregularities. Companies today are working towards ensuring consistency in practices, with the aim of improving quality, productivity, customer services and profitability.
Structural Metals Inc., (SMI) is the steel-making venture of Commercial Metals Co., (CMC) of Dallas. It accounts for 53% of CMC’s annual sales of $2.25 billion. The annual production for the year 1999 was 7,50,000 tons. In order to ensure consistency in its practices, SMI’s plant at Texas decided to work for the ISO 9002 quality management certification.
SMI’s employees were initially reluctant to accept its
ISO programme, since it involved changes in procedures. Quality meetings
were conducted every week. The employees slowly but surely began to
involve themselves in the company’s programmes. Department managers and
other employees also attended the weekly meetings. Production
statistics, quality issues, customer complaints and internal problems
were discussed during these meetings. Mistakes commonly committed by the
employees were also discussed in a constructive manner. The main aim of
these meetings was to identify problems, and solve them before customers
spotted them.
At first, the mill’s quality-systems manager attended a one- week ISO
introduction class. A steering committee comprising of eight department
managers was formed to discuss the ISO process. In turn, these managers,
along with their key employees imparted ISO training to their department
workers. One of the important requirements of the ISO process was
documentation of the work instructions, procedures and practices. The
main cause of concern of the department managers was the allocation of
resources and time for documenting procedures. The shop-floor workers
and operators helped by documenting all the work instructions, which
were later compiled and stored on a computer.
Documentation helped to develop consistency in practices. Earlier, it
was observed that there were slight differences in processes due to
variations in operating procedures among workers. For example, each of
the four members of the rolling-mill department had different methods
for redirecting “red tag” or non-conforming materials. After discussing
the procedures with the four workers, a standard method was evolved and
documented. Similarly, in the melt shop, during the melting process,
different workers added alloys at different times. ISO helped to evolve
a standardised procedure, by eliminating variations from worker to
worker. Although procedures were standardised, ISO gave workers the
flexibility to incorporate changes when required. Also, they had to
record the diversions from standard procedures in their shift notes.
The results of the ISO programme were seen in the first year itself. In
the first fiscal year after starting the programme, SMI noticed that
customer complaints had reduced by 23.5% and the final-chemistry
non-conformance of its steel dipped by 14%. This was a remarkable
achievement, considering the fact that the company was still in the
process of ISO certification.
Auditing process:
SMI appointed teams to undertake the internal auditing programme. These
teams, comprising three members had to conduct audits of different
departments, and evaluate the workers with regard to their
responsibilities and functions. The leader of the audit team then wrote
a summary, which included strengths and opportunities for improvements.
If the auditors recorded any non-conformance or deviation, the concerned
departments had to take up corrective actions and document the same. The
results of the internal audits were then submitted to Steel Related
Industries (SRI), which was the external auditor. SRI also conducted
surveillance audits of SMI every six months.
The auditors were allowed to evaluate people from other departments, and
this gave scope to cross-functional learning. The internal audits helped
team members to learn about procedures and functions of other
departments. This enhanced communication between departments.
The 17-member in-house team, which undertook the ISO 9002 Internal
Auditing task for SMI, received the first “Steelworkers of the Year”
award from New Steel. This award honours the services of a team of plant
floor steelworkers whose quality, productivity, safety, profitability
and problem-solving skills are a model for the entire steel industry.
Within two years of starting the ISO process, SMI found that external
customer complaints had dropped by an amazing 74%, and the
final-chemistry non-conformance of its steel had reduced by 80%.
The ISO programme has also helped SMI in providing enhanced training to
new employees. During the training process, new employees study the ISO
procedures stored on the computer and understand their job
responsibilities. They also gain a good understanding about the
functions and procedures in individual departments.
ISO also brought about functional improvements in SMI’s sales
department. Earlier, the sales department would communicate only with a
few departments to check if new customer requirements could be
fulfilled. The introduction of ISO brought in a stringent rule, that all
department managers must be consulted while considering a new customer’s
request.
Being a paperless system, ISO enabled SMI’s workers to become more
computer-literate. All the instructions, work rules and procedures are
now maintained on Lotus Notes software. This eliminated paper work.
SMI not only used ISO to improve consistency of its processes, but also
for improving safety at the workplace. The analyses of job safety, along
with instructions to perform jobs safely are also documented and stored
on the Lotus software. In consequence, the number of shop-floor
accidents at SMI has dipped to almost zero. Thus, ISO served as a
platform for developing consistency, improving quality, productivity and
safety.
Case
Studies > A Healthy QMS
The present case study outlines the implementation of ISO
9001 standards in a healthcare centre highlighting the need for it. It
thereby establishes that ISO 9001 can be implemented in any organisation
irrespective of the services it caters to.
Introduction:
Many organisations have got the ISO 9001 registration, which is a
quality system standard implemented by organisations worldwide. It is
considered a good alternative to the other quality management systems.
ISO 9001standard is broad and flexible making it possible for each
certificant to customise and adopt these standards according to his
requirements. Even health care institutes can register for ISO 9001
standards. They can thereby generate effective practices in the design
and health care services they provide. ISO 9000:1994 standards emphasis
on documenting the critical to quality procedures. This implies that
hospitals can establish and document innovative procedures to guarantee
quality in their services.
CCJR (Cleveland Centre for Joint Reconstruction):
CCJR (Cleveland Centre for Joint Reconstruction) is one of the seven
units in the Cleveland Orthopaedic and Spine department that
provides treatment for bone and joint problems. This department is a
part of Lutheran hospital in Cleveland, Ohio.
In May 1995, CCJR achieved ISO 9001certification. This initiative helped CCJR to effectively manage its operations and to provide enhanced services to its customers.
CCJR (Cleveland Centre for Joint Reconstruction) is the first medical entity in United States to achieve ISO 9001 registration. CCJR earns $2 million every year to the hospital and employs only 10 personnel.
Need for
QMS:
Between 1992-1994 (From identifying the need for certification to
accomplishing it) there was no formal quality management system in CCJR.
Hence, the centre had to begin the process of developing the quality
management system from the scratch. This did not mean that the centre
was providing ineffective service to its customers. The unit had some
effective practices in place to ensure efficient service. The only
drawback was that the maintenance of these procedures was not
systematic.
For instance, there were no set practices to record the results of the routine activities conducted in the centre. This prevented the unit from using documented information in order to train other employees in specific areas or hold anyone responsible for not following procedures. Procedures were planned and sometimes even modified by inadequately trained employees. This led to utilising the services of more number of employees for a work that a few could do.
Thus CCJR found the need for a suitable documentation method that would assist them in regularly reviewing and revising their quality practices. Establishing a QMS was the need of the hour.
Pre-registration
CCJR emerged a pioneer when it registered its centre for
ISO 9001 certification in 1995. Few organisations had adopted ISO 9001
at that time and it was still in the initial stages, especially in the
health care industry.
Stulberg (A renowned surgeon in CCJR) initially heard of ISO 9001 system and the benefits it could bring to an organisation from his acquaintances in the manufacturing sector. Believing that it would be worthwhile to further investigate the process, he performed an extensive research and found that ISO 9001 QMS does not have any specific standards for the medical industry.
Even then, Stulberg and his colleagues in CCJR decided to adopt ISO 9001 since they were aware of the numerous benefits that could be accrued. As the employees did not have adequate exposure to ISO certification, CCJR hired a consultant (Tim Weber, who was at that time president of ICON consultants) to assist them in planning the organisations approach to certification.
Care was taken such that the consultant hired, had adequate experience in implementing ISO 9000 QMS and was significantly interested in conducting in-depth study on the registration process and in assessing its effects for a health care practice.
Steps
followed:
The initial priority of CCJR on its path to certification
was on conducting an in-depth study of the ISO 9001 QMS and setting the
standards for a health care centre.
ISO 9001 in general, is a quality system for areas likely design/development, production, installation, and servicing that are common to the manufacturing sector. Hence CCJR felt the necessity of setting the quality standards in its health care centre structured in line with that of a manufacturing sector. They realised that their QMS needed to focus on defining and executing health care plans for its customers (patients) with arthritic hips and knees.
Thus every clause in the ISO 9001 QMS (like management responsibility, document control, control of customer-supplied product, inspection and handling, storage, packaging, preservation delivery) was evaluated and structured to make it relevant for health care practice. For instance, what is viewed as delivery in the manufacturing sector is the final contentment of the patient in CCJR. Care was thus taken to structure every stage of the health care service within the scope of ISO 9001 standard. This took a lot of time and effort.
The following two activities proved to be the most significant ones among all the activities performed.
1.Developing the documentation system:
Developing the document system proved to be a complex
process. Tools like flow charts were used to simplify the task. Since
CCJR already had a defined process to evaluate its client satisfaction
after surgery, assimilating them into the system was taken care of. In
addition, the need to develop documents for the following processes was
identified and successfully implemented.
2.
Training:
Training the employees was the next major task. Efficient
training was provided to the employees to speed up the process of
implementation of ISO 9001QMS. Care was taken to ensure that the
training offered enabled the employees to understand what ISO 9001
actually is and the benefits that would accrue to CCJR and its
employees.
This enhanced the involvement of the employees in the ISO 9001 QMS implementation. They started using the process as an aid for tackling complaints and documenting the remedial actions.
As stated by an employee in the centre,
“ISO 9001 system ensures sure the staff addresses a problem and works together to find a solution”.
Checklists were maintained to ensure that the activities relating to ISO 9001 were consistently maintained. Employees were entrusted the responsibility of documenting these necessary activities. Effective communication system was developed to ensure better interaction among the employees.
Registration procedure:
BSI Inc. was selected as the ISO 9001 registrar. Phase-1 audit was
conducted in March 1995 for four days. BSI inspected for the conformance
of the activities in CCJR to ISO 9001 standards.
No major non-conformities were found. However some minor ones in document control were identified for correction.
These include:
BSI reported that on the whole, CCJR satisfied all the necessary requirements to accomplish ISO 9001 certification save a few non-conformities. These minor ones were immediately focussed upon and corrected successfully. Thus CCJR received ISO 9001 certification in May 1995.
Results:
The certification enabled CCJR to develop a comprehensive and a detailed
documentation plan for each and every aspect in its centre. This
included action plans to tackle every specific disorder their clients
complained of. All the stages of the health care service were
continuously improved.
Certification also provided for a system to evaluate the satisfaction of the patient. Allocation of crucial responsibilities to the employees made them work with enhanced dedication and motivation.
Benefits:
CCJR has been putting together the benefits of ISO 9001 certification.
Price-sensitive techniques were developed and its health care service
properly managed and made more reliable. Considerable reduction in
complaints from the customers (post surgery) was observed. CCJR observed
that it could identify problems the moment they started. Problems were
solved quickly and effectively. Above all, patients were satisfied with
the services of CCJR.
Conclusion:
Thus CCJR found ISO 9001 a useful approach to successfully accomplish
the following::
Continue:
ISO 9000 - The Other Point Of View
Case Studies > ISO 9000- the other point of view
Introduction:
The 1990’s witnessed a flurry of ISO certifications. However the
question that arises is have these certifications been useful in
improving the quality performance of organisations or have they just
been an exercise in futility. At least some seem to think so.
Due to the increased awareness of ISO 9000 and its benefits, more and
more customers are requiring organisations to become certified.
Certifying to ISO 9000 is voluntary under ISO rules, but has become
necessary for many organisations in order to retain their customers. The
certification process to ISO 9000 standards however is a costly and
time-consuming affair, especially for small organisations.
A perceived drawback of the ISO 9000:1994 standards was that while ISO
9000 registered companies are certified to have standardised quality
procedures, that in no way ensured that the organisation produced
quality products or services. ISO 9000:94 registration ensured that a
quality system is in place but provided no guarantee of customer
satisfaction or results. It did not address a company’s need for
continuous improvement, evaluation, or performance planning.
Given below is a study conducted on two organisations Tech Co, Systems
Co, and System Co to study the impact ISO 9000:94 QMS implementation had
on their organisational performance.
The issues that were common to the two organisations are discussed in
detail.
Tech.Co:
'Tech. Co.' is a retailing and distribution organisation located in
the UK. The organisation sells high technology products.
Tech. Co. decided to certify itself to ISO 9000. The registration
process was completed in three years. The main motive behind
registration was that its customers (especially the government agencies)
were insisting on the certification. Tech.Co felt that not getting
certified to the ISO standards might cause it to lose customers.
The organisation had seven product divisions and each unit had its own
order processing function. After ISO 9000 certification Tech.Co
standardised it’s the order processing procedures. Each division however
continued to process its own sales orders.
Registration to ISO 9000 led to the development of nine procedure
manuals. It had one manual for each type of product, one manual for
quality and another for the warehouse. The manuals documented what
should be done at each stage of an order, and ensured that every thing
had been taken care of.
Has ISO 9000 contributed to performance?
A tussle
between Sales and Administration:
The sales administration manager felt that sales personnel considered
themselves special. He was of the view that the sales personnel
displayed a careless attitude towards filling the forms with the
required information. He therefore felt that ISO 9000 would help control
their activities. He was of the opinion that strict adherence to the
procedures would automatically make the sales personnel fall in line.
As a result, the sales personnel were asked to perform their jobs in
strict accordance with the laid down procedures. However, the way the
sales personnel operated did not change. The differences between the
sales people and the administration remained the same and in fact got
worse. This was because the former felt that the administration was
imposing restrictions on them in the name of procedures.
Complexity in pricing:
The next issue was that of pricing. The pricing of the products was
a complex process. The sales personnel encountered customers with
different requirements. Thus they wanted the administration to be more
flexible in pricing products based on the customer requirements and
circumstances.
The administrative staff on the other hand was asked to work in
compliance with the new procedures. They therefore adhered only to those
prices and procedures that were recorded in the manual. Some of the
requirements were not available in the sales manual and therefore had to
be constantly updated. Everyone’s energy was being spent on documenting
information but the real issue was being overlooked. The administration
failed to realise that it was losing customers due to its rigid pricing.
Customer Orders:
One of the ISO 9000 conditions was to record the customer orders.
Management used these recorded manuals as evidence, in case of
differences between the customers and the organisation. This was however
a wrong way to approach a difference with the customer.
Take for instance a case when the customer wants to change his order. In
such instances, customers expect their suppliers to be kind, polite and
accomodating. They do not expect the supplier to show them a paper
document and contest their request for a change in order. If they ask
for a change in the order, it is the responsibility of the supplier as
far as possible, to make the change swiftly. However, the management at
Tech Co. seemed to think otherwise. This indifferent attitude of the
organisation towards its customers led to a decline in its customer
base.
Quarantine Procedure:
One of the ISO 9000 conditions was the handling of goods returned by
the customers. As per ISO 9000 these goods were to be quarantined till
the official paperwork permitted reuse. The organisation found that the
goods sent back in less than fifteen days were not damaged even if
subjected to unfavourable conditions.
As per ISO 9000, the storehouse in charge should verify the date on
which the goods had been returned against the date on which it was
shipped to the customer. Those products that were found to be in
condition (that were sent back in less than fifteen days) were sent to
the concerned authority for signature, as per the procedure. These
authorities were hardly found and when present did not consider signing
the forms from the storehouse as priority.
Since Tech.Co’s goods were heat and light sensitive, the quarantine only
delayed its reuse. Moreover, any re-testing done at this stage further
damaged the goods.
Actually there was no need to implement the 'quarantine' procedure.
Except for some rare occasions, the organisation had not faced any major
issue with the goods returned prior to the registration. The
organisation could in most occasions reuse the product immediately after
its return. If the organisation had worked as an integrated system, it
would have realised that customers often returned good products
because it did not meet their specifications, rather than it being
defective. Tech. Co. had established a documented procedure on the basis
of a rare occurrence, giving rise to new problems. The consequence
was losses to the organisation.
Conclusion:
ISO 9000 implementation had not improved the overall performance of
Tech Co. Tech Co. was of the wrong notion that implementing a quality
system would automatically improve the organisation’s quality
performance. The focus lay on documenting each and every procedure,
which was a time consuming, costly and tedious affair. The drawback of
the system was that the thinking level of the employees was confined to
the scope of the written procedures. The result was that ISO 9000
registration did more harm than good to Tech Co.
Systems Co:
'Systems Co' produces handling systems that are used in packaging and
manufacturing operations and sets them up on customer sites. Systems Co
got registered to ISO 9000 QMS standards.
In order to get the certification, Systems Co took the assistance of a
consultant agency. After many deliberations, it finally selected a
consultant who seemed to display an attitude that was practical and
accommodating.
The case
study focuses on the auditor’s (the consultant employed) perception of
ISO 9000 quality standard and also whether the action plans initiated by
him, really enhanced the quality performance of the organisation.
The organisation management considered the auditor a capable person and
the entire auditing procedure as a sort of backing for the various
processes.
The auditor as a part of his routine activity scrutinised several key
matters of concern and then chose to focus on the engineering and
customer service areas of the business. The auditor intended to identify
the elements that did not meet the set standards and then set a deadline
for corrective action.
Engineering:
In engineering, the auditor thoroughly examined the enquiry
document. The document consisted of the information pertaining to
consumers. The auditor wanted to investigate:
All the time the auditor was referring to the set of manuals and
procedures laid down in the document. He was blindly adhering to the
clauses laid down in the ISO 9000 quality standards. The auditor felt
that controlling the process by means of a set of procedures would
prevent the employees from committing errors. He was not interested in
finding ways to actually improve the various activities in the
department. This was contrary to the ‘quality thinking’ approach.
Quality thinking emphasises on continual enhancement that in turn
necessitates initiation of certain action plans.
ISO 9000 standard, on the other hand emphaised that a system would be in
line with the requirements, if all the employees worked in adherence to
the procedures. These procedures sometimes may not highlight issues that
are critical to quality (such as customer related issues and certain
innovative techniques etc).
The major drawback of this standard is that it doesn’t emphasise on
exploring the elements that appropriately fit into the quality model.
Blindly adhering to ISO 9000 resulted in the organisation relying on the
auditor for implementing corrective action. The auditor in turn strictly
adhered to documentation, thus relegating the very thought of quality to
the backburner. The quality approach requires that actions are
associated to the intent. If the intent of the present organisation was
quality, the procedures put in place to monitor and check this intent
should have been enough to update the management about the status of the
quality performance.
Customer service:
It was a positive turn when the auditor emphasised on the
significance of customer requirements to the organisation. This was
something novel. The auditor wanted to know the importance the
organisation gave to customer service. This implied:
The auditor
emphasised on linking the customer survey information to the quality
management system. This helped the organisation to implement corrective
actions so that the improved processes would be in line with the
customer requirements.
It would have been more helpful to the organisation if the auditor
suggested better techniques to gather customer related information.
However his focus was only on the existing procedures and identifying
loopholes, rather than improving the system .
Had ISO
9000 been beneficial?
According to the quality manager, the ISO 9000
implementation was the point for the initiating other quality
performance activities. There is no doubt that ISO 9000:94 standard
bring clarity of procedures, which in turn improves performance. But if
this required superfluous documentation and out of place controls, would
it be of much use?
The organisation had spent a large amount of valuable time dismantling those elements of ISO 9000 that failed to serve the purpose. Was it imperative to incur those extra costs and time? The answer would be no.
Systems Co claimed that the ISO 9000 registration was the driving force for the initiation of other quality related activities. Instead of this, had Systems Co focussed on its customers as an inspiration it would have improved performance in a shorter time.
Systems Co. was gradually transforming to being a customer-focused organisation. This commitment to customers would have been thwarted by the ISO 9000 registration with its focus on documentation and compliance to procedures, had the organisation not smartly evaded certain dysfunctional constraints of ISO 9000 standard.
Conclusion:
In each of the two cases we find proof of ISO 9000
registration being detrimental to the organisation’s quality
performance. In the first case, the harm done was obvious. In the second
case it is relevant to make a note of how they overlooked the
dysfunctional aspects of the Standard.
The blind
adherence to ISO 9000 quality standards had caused sub-optimisation in
these organisations. More badly, maximum efforts were diverted into
setting up the ISO 9000 Standard, which could have been utilised to
explore more feasible ways of enhancing the quality and efficiency.
It was observed that external agencies (auditors) were instrumental in
inciting the organisations to perform activities that damaged the
quality performance. Moreover, the registration to ISO 9000 involved
both time and capital.
The philosophy of ISO 9000 is one of control. “Control” of processes or
activities is done by compliance to procedures i.e. the setting up of
procedures that are presumed to influence the quality of the product.
Many organisations assume that documentation and control of procedures
will 'avert' problems. There is however no proof to support this
opinion. Such a mindset results in people giving preference to
procedures rather than intent. Thus, the certification to ISO 9000
quality standard can result in zero knowledge. Zero knowledge resulting
from the tendency to stop thinking and follow procedures.
Online Navigators > Concept and Implementation
Given below are some online links that detail the different aspects related to ISO 9000:1994
1. ISO
Online:
ISO (International Organisation For Standardisation) is a
federation of several national standards bodies working together to
facilitate international trade. This link is to the official website of
ISO. It clearly explains what ISO is, the technical committees involved
in developing the different ISO standards, duties performed by ISO, the
benefits it brings to society and the various standards it developed.
http://www.iso.ch/iso/en/ISOOnline.frontpage
2. ISO
9000 - An introduction:
ISO 9000 is a series of standards and guidelines for
establishing a QMS in any kind of organisation. This document gives a
brief insight of what ISO is, guidelines for selection and use of ISO
9000, what ISO 9000 consists of, how it can be useful for organisations
in different businesses and the flow chart for implementing ISO 9000.
http://www.isoeasy.org/selusee.pdf
3. ISO 9000
Documentation:
One of the most intimidating aspects of ISO 9000 is the
documentation. Documentation was often found inadequate or ineffective
or even absent in many organisations. This page gives a detailed
explanation of the five areas that need to be addressed by organisations
in order to develop an effective quality system, with less paper work.
The five areas included are process definition, structure, tools,
format/grammar, and flexibility.
http://www.cavendishscott.com/articles/Documentation.htm
4. ISO 9000
Process Documents:
This document is a collection of ISO 9000 process
documents. Also downloads for the documentation of the various aspects
involved in ISO 9000:1994 QMS are provided.
http://www.isoeasy.org/iso_9000_process_documents.htm
5.
Implementation:
This PDF provides an elaborate explanation of the various
steps involved in the certification process of ISO 9000:1994 standards.
http://www.dkminc.com/documents/pway_iso.pdf
6. Gap
analysis:
Gap analysis is a tool used for evaluation of the
organisation’s existing quality management system. This tool is a
template of questions that help organisations identify those
organisational functions that fall short of the required standards.
This
document provides links to two questionnaires used for the gap analysis.
The first is for a mini gap analysis while the other assists in-depth
review of the organisations systems.
http://www.realquality.com/gap.htm
7. Elements
of ISO 9000:1994:
Successful implementation of any standard depends on the
way it is understood. This site gives a clear explanation of ISO 9000
series, elements in it, the meaning, purpose and elaboration of all the
20 clauses in the series.The explanation is comprehensive and extremely
informative.
http://www.realquality.com/elements.htm
8. Benefits
of implementation of ISO 9000:
This document outlines the benefits that companies large,
medium, and small enterprises could accrue by implementing ISO 9000.
This document is prepared based on an in-depth study of a number of
Spanish organisations.
http://www.sii.org.il/WebFiles/topicsQW/m10.pdf
9. ISO 9000
Advice:
This document is a guide to ISO 9000. Questions such as
what is quality, what is quality assurance, why is it necessary? This
document is an arsenal of advice and guidance on ISO9000 and associated
registration.
http://www.quality.co.uk/isoadvic.htm
10.
Choosing a trainer:
Successful organisations have well-trained and skilled employees.
However, there are many a cases where employees do not have the required
knowledge and skills for new assignments. Thus choosing a trainer could
be a daunting task. This document could help to make a more
knowledgeable decision when trying to select the best training solution
for an organisation.
http://asia.bsi-global.com/Quality/BSI_Practical_Guide_for_Choosing_a_Trainer.pdf
11. ISO
9000 differences for businesses in the service industry:
ISO 9000 is in general, considered applicable only to manufacturing
industries. But it can be applied to the same level of efficiency in the
service industry as in the manufacturing industry. This document
explains the differences in implementation in the service industry
compared to the manufacturing industries.
http://www.dardenneassociates.com/iso9000/index.htm
12.
Purchasing ISO standards and documents:
All ISO standards and documents are copyrighted by the International ISO
organisation and must be purchased from one of the local ISO member
bodies in your country. The sale of these documents provides part of the
ISO organisation's funding. This document provides the list of all such
ISO members who sell the standards and documents.
http://www.iso.org/iso/en/aboutiso/isomembers/MemberDetailPage.MemberDetail?MEMBER=address
Continue
the tour:
Online links for Additional Reading
Online Navigator > Additional Reading
Following are some online links that could help for
Additional Reading in ISO 9000:1994.
1. ISO 9000:1994 Guidelines:
This website gives details about the various guidelines
in the ISO 9000:1994 series.
http://praxiom.com/iso-9000-1994.htm
2. ISO 9000:1994 Sample Pages:
This website provides free downloads useful in
implementing the different clauses of ISO 1994 version. It helps in the
preparation of quality manual.
http://www.iso9000commerce.com/htm/sample1994.htm
3. ISO 9000 consultants:
This page symbolises a directory of consultants
experienced in assisting organisations to develop ISO 9000 quality
management systems, and achieve ISO 9000 Registration.
http://www.isoeasy.org/Referral%20Network.htm
4. FAQ’s:
This document provides answers to the frequently asked questions and
thereby gives a clear picture of ISO 9000 series and the certification
process of various standards involved in it.
http://honeywellaircraftlandingsystems.com/working_at_als/new_hire_orientation/nhorientation/policies/ISO
9000.pdf
5. Sample quality manual:
This document provides a sample quality manual of an
organisation that has implemented ISO 9000.
http://www.quality.co.uk/example/manual.htm
6. Sample Design procedure:
The document explains at length the various activities
involved in the system design procedure of ISO 9000. A flow chart to
explain the same is also given in the document.
http://www.quality.co.uk/example/op10ades.htm
7. A model ISO 9001/ 9002/ 9002 certificate
http://www.okonite.com/certificate.html
8. Case studies
This link provides downloads for case studies relating to
different industries for various standards in the ISO 9000:1994 series.
http://www.powerwayinc.com/about/resources.asp
9. Anglia Telephones and Data Communicators:
This document provides a case study of “Anglia telephones
and data communicators” .
http://www.angliatelephones.co.uk/iso9002_approved.htm
Online Navigators > Concept and Implementation
Given below are some online links that detail the different aspects related to ISO 9000:1994