As its name suggests, this ‘Quick Reference Guide’ is intended to illustrate the general requirements of ISO 9001:2000 and comment on their application. It does not aim to cover every detail and nuance of the standard, and is certainly not intended as a substitute. Copies of national and ISO standards can be obtained from your local standards association.

ISO 9001:2000 is generic - it is not specific to a particular industry, and requires some thought to suitably apply it to an individual organisation.

ISO 9001:2000 is part of the third generation of ISO 9000 standards. Many users will be familiar with the earlier 1994 standards in particular. For their benefit, the following is a very brief summary of the major changes from the 1994 edition:

• ISO 9002 and ISO 9003 withdrawn to leave just one standard for certification - ISO 9001. Those that do not wish their quality system to cover all the clauses of ISO 9001 can exclude certain requirements.
• Less emphasis on procedures in favour of a more process-based approach. The requirement for documented procedures has been reduced, but you are expected to describe your processes and the interaction between them. Documented procedures are compulsory only for control of documents, control of records, internal audits, control of nonconformity, corrective action, preventive action.
• Closer link with ISO 9004 guidelines - now seen as part of a "matched pair" with ISO 9001.
• Your system is expected to include processes for ensuring continuous improvement.
• New requirement for employee competency introduced.
• New requirement to monitor customer satisfaction.
• New requirement to analyse data.
• Numerous clauses tightened up, or clarified. What were notes in some of the 1994 clauses have been made mandatory.
• General improvements in terminology to make the standard more readable e.g. "management with executive responsibility" becomes simply "top management"

ISO 9001:2000 contains an annex that illustrates correspondence with clauses in its 1994 edition.

Clauses 1-3 deal with the scope of the standard, terms and definitions etc. This guide therefore commences at clause 4.

You are expected to prepare statements that explain your policy and objectives for quality. The statements would normally be included in a quality manual - with additional copies on display in areas such as reception, main office etc. Your policy and objectives should not just be glib statements - but the focus of your procedures, methods and entire system.

You are expected to have a quality manual that describes your system, outlines your work processes (and interaction between them), justifies any exclusions from the requirements of the standard, and either includes or refers to your documented procedures.

It is typical to describe the structure of the documented system, and include a matrix or outline that cross-references the clauses of the standard, and procedures or methods by which they are addressed in greater detail. One or more flow charts may be appropriate to illustrate your overall work processes.

Although the standard uses the term "quality manual", a different title is sometimes used in practice e.g. "policy manual" or "business manual". This often occurs where an organisation has integrated its quality system with other business management systems e.g. safety or environmental.

A document may be defined as information and the media that carries it.

The documents to be controlled would include your manual, procedures, and original copies of forms etc. Documents may also include those of external origin - such as copies of standards. The aim is to establish controls that ensure only current, approved copies of documents are made available where they are needed - with any changes to them being controlled and identified.

Documents do not have to be on paper - they may include word-processor files, other computer files, or other forms of electronic data. Therefore, ensuring availability may include various information security measures - including back-up and safe storage of computer media.

Unlike earlier versions of the standard, this edition does not specify that a "master document list" MUST be maintained. However, that may still be a suitable tool to help control your documents.

You may find it necessary to keep copies of obsolete documents for various reasons e.g. to meet legal requirements or to preserve historical knowledge. In which case, they should be clearly identified as such (to avoid accidental use).

You should have one or more documented procedures to cover this issue.

A record is a document containing information that describes an event or provides some form of evidence about an activity or process that has taken place. As your quality system is implemented you will generate various records that need to be controlled. They should be clearly identified and indexed. They should also be stored in a manner that ensures their safekeeping, while being readily available when needed for reference.

You should have one or more documented procedures to cover this issue.

This clause requires you to establish leadership of your quality system by your top management.

This is an introductory section. It addresses the need to provide evidence of your top management's commitment to developing and improving your quality system with respect to the following:

You should ensure that your organisation has a focus on customer satisfaction and confidence. This will involve identifying what they need and expect, building those needs and expectations into overall product / service requirements, and ensuring that those requirements are satisfied.

This clause has various requirements for your quality policy, including ensuring that it is understood and adhered to throughout your organisation. Apart from a printed or electronic copy in your quality manual, additional copies may be put on display in areas such as reception, main office etc. Your policy and objectives should not just be glib statements - but the focus of your procedures, methods and entire system.

The requirement for a policy statement document is also mentioned in clause 4.2.

In a similar fashion to the above, you are required to ensure that quality objectives are established throughout your organisation. In a small business it would normally be quite adequate to have a common set of objectives. In a larger organisation, there may be overall objectives for the whole organisation, with sub-sets or supporting objectives for parts of the organisation e.g. teams/departments/individuals. For individuals, these objectives may be set out in job descriptions and / or personal development plans. For teams / departments they may be set out in service level agreements or subordinate statements of quality objectives.

The objectives should be measurable e.g. able to be confirmed whether they have been achieved or not.

Where there are any changes to your system, you need to ensure that they do not harm the integrity of it.

You need to set out the roles that various people have to play in the organisation e.g. their levels of authority, their responsibilities, and their reporting relationships. Informing personnel of their levels of authority may be achieved in job descriptions, or by circulating an overall list of 'authorisations' or 'delegations'. Informing personnel of their responsibilities is typically achieved with job descriptions, supplemented with memos, notices etc. as necessary. Reporting relationships are typically described in an organisation chart (or several charts if necessary).

A management representative(s) for quality should be appointed. The quality representative is typically referred to as the Quality Manager. In larger organisations, the Quality Manager tends to be supported by "Quality co-ordinators" that assist in the development/implementation of the system in their team, department or location.

To ensure that your quality system is fully implemented, information regarding it must be effectively communicated within your organization. This may include the use of one-to-one verbal communications, paper documents, notice boards, computer networks, an intranet, meetings / seminars / briefings etc.

To help guarantee leadership and commitment, your top management needs to perform regular reviews of your quality system. This section of the standard also specifies what issues should be addressed at these reviews (you may also choose to address other issues at the same time). You are expected to consider changes and improvements to your system, and to allocate any further actions required. Records should be kept of your reviews.

The standard does not specify how often the reviews should take place or what their format should be. However, in most organisations, they are conducted as meetings - perhaps quarterly, six-monthly or annually. In a very small organisation, the arrangements could be less formal - perhaps just recorded as a series of notes, and taking place at the same time as internal quality audits.

You should have one or more documented procedures to cover this issue.

Your personnel must be competent to perform their allocated tasks, and be aware of the effect their work has on the overall achievement of quality objectives. Requirements for competency may be specified as 'selection criteria' in job descriptions.

You should determine required levels of competency, provide the necessary training to achieve those levels, and maintain records (e.g. training records). It may be helpful to carry out 'employee performance reviews' to monitor achievement against selection criteria or other set standards, and to plan training / further development for employees.

Within your organisation you need to develop an adequate infrastructure to successfully realize the provision of your products / services on a consistent basis. This infrastructure may include the following:

• Workspace

• Tools
• Equipment
• Vehicles
• Hardware
• Software
• Support facilities

You should ensure that work takes place in a suitable environment. This seems to be primarily aimed at the physical environment needed to ensure that your product or service meets requirements. However, there would also be scope for a wider interpretation that might possibly involve consideration of HR policies to ensure a suitable human environment.

The standard uses the words 'product realization' to describe your manufacture/assembly of a product and/or provision of a service.

This is the only clause that allows you to make exclusions. Where they are not relevant to your business, you may choose not to address certain items in your quality system (e.g. if you do not carry out design, your system would be unlikely to include a method of managing the design process). If you elect to do this, you should justify the exclusion in your quality manual.

You are required to plan your work processes. This may involve:

• Establishing quality objectives, processes or plans for a specific project, product or contract;
• Considering the need to allocate particular resources for a certain task;
• Determining suitable criteria for acceptance of the product / service;
• Planning methods of measuring and monitoring;
• Determining what records are necessary to assure interested parties of your conformance with requirements.

The aim here is to ensure that there is communication and mutual understanding between you and your customer as to what their requirements are, and what you have to offer.

In determining requirements for the job or transaction, you need to consider those that the customer has explicitly made known to you, and any other implied requirements e.g. meeting legal and regulatory requirements, social / environmental obligations. You need to check your ability to meet those requirements.

You should have a process to resolve any differences between an offer you make and your customer's acceptance.

Where there are any variations to contracts, you need a process to agree these with the customer and communicate relevant details of the variation to the your personnel or other people/organisations who may be affected by them.

You should also make arrangements for receiving customer complaints and other feedback.

Of course, you need to maintain suitable records of these activities.

This section is about applying a controlled approach to the management of the design/development process. It does not specify HOW to design something. The main points are summarised as follows:

• You should prepare a plan for each design project, and update this plan as the design evolves;
• Design work should be allocated to suitably qualified people. Where there is a design team, you should plan the organisation of, and working relationships between members of the team;
• Requirements of the design (e.g. customer requirements, legal requirements, your organisation’s objectives) should be included or referred to in your plan. These requirements are referred to as 'Design inputs';
• Review these inputs for their suitability, and resolve any contradictions, ambiguities or problems that they may cause;
• Produce design output in terms that may be checked against the design inputs, refer to any acceptance criteria, and applicable legal / regulatory requirements, identify aspects of the design that are crucial to safe and proper use, handling, storage etc.;
• Carry out a recorded review of the design on completion and at other appropriate stages. On a small design project, reviews may be recorded on a ‘Design plan’ or similar checklist. On a large project with several people involved, reviews may be recorded as minutes of design meetings;
• Verify that the design does meet the input requirements (e.g. by testing, analysis or comparison with another proven design);
• Validate or prove the design (e.g. by pilot production, beta testing or trials);
• Control any changes or modifications to the design.

This section is about exercising controls to ensure that any products or services that you purchase from suppliers meet requirements. The controls should include:

• Selecting suppliers that can meet requirements.
• Ensuring that purchase orders (or other purchasing documents) clearly describe requirements, and are checked and approved by a suitably authorised person.
• Checking that the purchased items do meet your requirements. If it is planned to check purchases at the suppliers premises (e.g. witnessing factory tests or commissioning), describe or refer to these arrangements in the purchasing document.

This section addresses the management of your production and/or service processes. There are a number of methods of doing this and an organisation is likely to employ several e.g. product drawings/specifications, service level agreements, supervision, selection of appropriate staff, detailed work instructions etc.

Any tools / equipment used in these processes should be adequately maintained.

This applies where it is not possible or practical to check the output of a process before it is provided to a customer. Under those circumstances, you need other controls to ensure conformity. These might include the following:

• Specifying arrangements for pre-qualifying processes, equipment to be used, or personnel that may perform tasks.
• Specifying methods of work, and any re-checking in the event of any nonconformance.

You should keep adequate records of the application of these controls.

There are three main issues of identification, and these are as follows:

• Where appropriate, you should be able to identify the type of product.
• Where specified in a contract or otherwise necessary, individual items or batches should be provided with a means of unique identification. You should keep suitable records so that the items can be traced where and to the extent necessary.
• There should be means of identifying the status of a product or service with regard to any measurement or monitoring that has taken place. The means of identification are typically labeling, the physical location of the item, and/or associated documentation such as checklists or inspection / test sheets.

Customer property may be materials or products they have provided for inclusion in a job, physical property or real estate you are working on, documentation provided or intellectual property. You need to take good care of customer property while it is within your control. You are required to describe how due care and attention is exercised, and how you will record and report any damage or loss to the customer. In some cases, 'loss' may refer to any breach of confidence or accidental release of information relating to the customer.

This clause is aimed at avoiding damage to the product and its component parts throughout your work processes and delivery to the customer.

Processes to consider might include handling, storage, labeling, packaging, delivery etc. Any process documentation should state what precautions are to be taken.

Requirements for precautions taken during delivery should also be applied where the delivery process is outsourced.

Where measuring or monitoring devices are used to check product conformance, it is essential that they are accurate to the required degree. In order to ensure confidence about that accuracy, there are a number of issues that need to be addressed:

• An appropriate device should be selected for the purpose, and personnel instructed on its use/handling/storage.
• It should be clearly identified and safeguarded from accidental or unauthorised adjustment.
• There should be clear calibration requirements, and you should ensure that the device is calibrated in accordance with them.
• Records should be maintained of calibration.
• You should ensure that the necessary action is taken if and when a device is found to be out of calibration.

This section requires you to obtain information on levels of customer satisfaction, record and analyse that information, and use it to achieve improvement.

The information may come from a variety of sources e.g. customer feedback forms, customer surveys, statistics on sales/returns/complaints etc. At first glance, this may appear to be difficult for small business to comply with. However, obtaining some form of information should be within everyone's reach. For example, you could telephone a batch of customers shortly after providing of a product or service to them. Your information gathering can double up as after-sales service and help towards good customer relations.

If a register of customer complaints is kept, this may help to provide basic knowledge on levels of customer satisfaction.

Some would argue that this is the most important section of the standard. It requires you to establish a process of internal auditing to determine whether your quality system is effectively being used in practice.

You may choose to audit some procedures/processes more often than others (your choice being guided by the importance / status of the activities to be audited).

Your auditors should be people who have adequate ability, but are not responsible for the activity being audited.

The results should be recorded and brought to the attention of those that are responsible for the activity being audited. They are expected to take prompt action on any problems found.

You should do a follow-up check on any action planned as a result of the audit. Audit records would also normally be made available for consideration at management reviews.

A typical result of an internal audit is to find that a procedure or other document is no longer entirely relevant. Often, changing circumstances have led to a change in practice, or people have just found a better way to perform a task. Assuming that the change is for the better, the document should then be adjusted to reflect the new, improved way of doing the activity.

You should have one or more documented procedures to cover this issue.

You should check work processes to confirm their ability to effectively achieve their purpose. A variety of management tools may be used. For example, benchmarking may be helpful to compare the effectiveness of a process in one location with another or against a set standard.

This section requires you to check your products to confirm that they meet requirements.

Depending on the nature of your activities, checks may include 'objective' measuring or testing (e.g. is an item the correct height, size, weight etc.) and/or 'subjective' monitoring (e.g. does it look, sound, taste, smell, feel right).

This section addresses the issue of ensuring that an item that fails to conform to requirements is not accidentally used or provided to the customer.

You should allocate responsibility to decide what to do with a nonconforming item, and specify the options that they may choose from e.g. scrap it, redo the previous work etc.

The options that you allow will depend on the nature of your business.

You should have one or more documented procedures to cover this issue.

This section requires you to obtain and analyse data on the effectiveness of your quality system.

The data may come from a variety of sources e.g. customer surveys/feedback forms, audit records, improvement requests etc.

Various tools may also be employed for the analysis e.g. scatter diagrams to help establish whether there is a trend in nonconformances, pie charts to easily compare relative quantities, benchmarking to compare one supplier's performance against another on a range of indicators.

This section is about ensuring the continuous improvement of your quality system, and fixing the root cause(s) of both actual and potential problems. It is divided into three sub-sections that address planning, corrective action and preventive action.

In particular, you are required to identify problems, determine their causes and solutions, implement any necessary actions and maintain records of the process.

You should have one or more documented procedures to cover this issue.

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