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Training On HTML and Creating a Web Page |
Documentation
and Implementation of
ISO 9000 Based
Quality
Management System. |
Contents
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Preface
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1. Introduction
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2. The Key Aspects of a Quality System
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3. Quality System Documentation-Quality Manual
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4. Quality System Implementation
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Supplement
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Preface
Buyers and manufactures have traditionally relied on inspection and certification before accepting goods. And hence, a typical traditional quality management system (QMS) often relies heavily on a series of checking products to identify instances of non-conforming. The errors then corrected.
However, inspection is not a satisfactory way of giving assurance that the products will perform as desired during its life. In addition, the traditional QMS does not cover other services and administration activities such as finance, marketing or personnel, where more than half of the quality problems are believed to have been emanated.
" It is vital important to consolidate and improve upon the quality of all activities of the company- not just the product"
Dr W. Edwards Deming
These shortcomings necessitate the need for proper QMS. Fortunately, with the advent of ISO 9000 series of standards in 1987 , it is now possible to measure tangibly the effectiveness of a quality management in an enterprise.
In the last decades many organizations have come to appreciate the strategic importance of managing quality based on ISO 9000 QMS standard.
The basic philosophy of these standards is to plan every activity and to make all personnel aware of the standard procedure for carrying out their functions. It described a controlled documented system of procedure designed to ensure that only conforming products or services are released to customers.
This training is structured around the needs of quality managers and experts, production supervisors and foramen, sales and human resource managers as well as for those requiring decision-making information for a strategic approach to ISO 9000 QMS Documentation and Implementation.
1. Introduction
System Concept
A system by definition is composed of interrelated parts or elements. This is true for all systems: mechanical, biological and social. Every system has at least two elements, and these elements are interconnected.
Generally, system concept and approach provide us a basis for understanding the integration of a wide variety of specialized activities in organizations so as to achieve certain objectives.
The International Standard Organization (ISO) defines Quality System as follows:
"Organizational
structure, Procedures, Processes and Recourses,
needed to implement Quality Management."
Since the Concept of Quality System is comparatively new, most people confuse "Product Quality standard" and Quality System Standard".
The following sections give you an explanation for the difference.
Product Quality Standard
This standard specifies various technical characteristic or parameters which a product must meet if it is to conform to the product standard. Conformity of a product to its specification is ascertained by the certification body through periodic testing of products sample. Example: strength, active matter content, moisture content, conductivity, etc.
Quality system standard
The quality system standard defines the method of managing quality in a company to ensure that products conform to the quality level that it has set for itself. A quality system standard helps the company to plan and consistently achieve the requite quality standard.
The company’ quality system may be based on recognized industry, national, regional or international (ISO 9000) Quality System Standards.
However, establishing a quality system based on ISO 9000 Quality System Standard has attached numerous benefits.
Some of the distinct benefits of installing a quality system based on ISO 9000 model are listed bellow:
Ø Helps to maintain consistency in quality of products Ø Provide objective evidences to customers Ø Brings clarity and transparency of duties and responsibilities Ø Reduce cost of non- conformance Ø Provides means for documenting the company’s experiences in a structured manner and thus establishes a basis for educating and training of workers Ø Provides the means for employees to performer their tasks right the first time, every time and on time Ø Provides auditable system Ø Provides a framework for establishing continuous improvement because of its dynamic elements such as management review, internal audit, corrective and prevention actions Ø Forms the basis for applying an effective Total Quality Management program
2. The Key Aspects of a Quality System An effective Quality Management System (QMS) is a key-building blocs for Total Quality. It is, however, only one element in Total Quality management organization. It describes a controlled, documented system of procedures, designed to ensure that only conforming products or service are released to customers.
Although, a number of quality system standards have been developed to describe the requirements for an effective QMS, they have three key aspects as described in the following section. 1.
Management responsibility -Quality policy -Quality objectives -Quality responsibility and authority -Management review 2.
Personnel and material recourses 2.1 Personnel -Motivation -Training and development -Communication 2.2
Material resources -Equipment and facility -Operational needs: accommodation, transport etc -Quality assessment facilities -Operational and technical documentation 3. Quality
system structure The
quality system elements should be structured to establish adequate control
and assurance of over all operational processes affecting quality based on
quality loop. 3.1
Documentation All elements,
requirements and provisions incorporated in the quality system should be
defined and documented as part of the organizational overall documentation Appropriate
quality system documentation includes the following: -Quality manual -Quality plan -Procedures -Quality records 3.2
Document control All
documentation should be legible, dated (including revision dates) clear,
readily identifiable and carry authorization status. Methods should be
established to control the issue distribution, revision and removal. 3.3
Internal quality audit To verify the implementation and effectiveness of the quality system. 3. Quality System Documentation-Quality Manual "If it isn't written down, it does not exist" All quality
system elements require documentation and implementation of suitable
procedures. Therefore, establishing a formal quality system involves
establishing and maintaining documents in which all the elements,
requirements and provisions adopted by the company for its Quality Management
System are documented in a systematic and orderly manner in the form of
written policies and procedures. The quality system documentation is divided
into thee levels as follows: Level-A Quality Manual It states an organization's quality policy and describes it quality
system. Generally, it gives a company's profile, presents organizational
relationships and responsibilities of persons whose work affects quality and
outlines the main procedures. Click here to see a sample Quality Manual. Level-B Quality System Procedure Describes activities of individual departments of an organization. It
shows how an organization's quality policy will be implemented day to day in
each department. Click here to see a sample Quality Procedure. Level-C Work Instruction While procedures prescribe when, what and by whom an activity is
performed, work Instructions describe how a task is to be performed in
details and keyed to specific activity. Examples: forms, drawings, manufacturing
instructions, inspection and test criteria, method of packing etc There are a number of ways in implementing
a Quality System (QS). The following section presents a guideline for
implementing an ISO based QS. Step 1
Commitment from
senior management The top manger (chairman or managing director or chief executive)
should demonstrate a commitment and a determination to implement an ISO 9000
QS in the company. Step 2
Establishing a
steering committee This committee will comprise the chief executive and head of various
functional departments. They should be trained on The committee functions include the following: -Adopting the company's policy -Nominating the management representative -Overall planning and direction of the ISO project -Selecting consultant, if necessary -Allocating recourses to the project -Coordinating project work carried out by different departments on
major issues -Monitoring and controlling the project Step 3
Awareness Program ISO awareness program should be conducted to communicate to employees
the aim and advantages of the QS. Step 4
Establishing task
force A task force or project team will normally have a management
representative with the requested competence and members drawn from each
functional area. The members also shall be trained on QS. The task force will have the following responsibilities, among others: -Initial status survey (Gap- analysis) -Detail planning of the ISO project -Train employees on ISO -Selecting appropriate QS requirements -Preparing quality manual, procedures and
operating instructions -Monitoring the progress of implementation -Assisting consultants -Organizing periodic audit Step 5
Implementation To implement the procedures, it would be a good idea initially to
evaluate areas where the chance of positive evaluation will be high, but if
the company activity is not so much vast and complicated it is advisable to
implement at once. Step 6
Internal quality
audit After subjecting the new system to trial
for a few months, an internal audit should be conducted to assess the system
compliance with ISO QS. Step 7
Corrective action
Taking corrective action on non-conformance
revealed by the audit. Step 8
Pre- assessment
Audit When QS deficiencies are no longer visible, it is normally time to
apply for certification; however, before doing so, a pre-assessment audit
should be arranged with an independent and qualified auditor. The
pre-assessment audit would provide a degree of confidence for formally going
ahead with an application for certification. Step 9
Certification and
registration Arraigning formal assessment by an accredited certification or
registration body. GOOD
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