Quality system development

A system built around the organization s core processes - see ISO 9000 Quality System Development Handbookby David Hoyle (Butterworth-Heinemann, 1998). 

Other steps are no different to any quality system development and further guidance is given in Part 2 of this handbook and in the ISO 9000 Quality S /stem Development Handbook. 

The quality system developed to meet the requirements of ISO/TS 16949 is likely to be a generic system, not specific to any particular product, project, or contract other than the range of products and services which your organization supplies. By implementing the policies and procedures of the documented quality system, product, project, or contract specific plans, procedures, specifications, etc. are generated. ISO 9001 contains a series of quality system requirements, not product quality requirements. For a given product, project, or contract there will be specific product, project, or contract requirements and it is these requirements to which this clause of the standard refers. 

The standard requires suppliers to perform subcontractor quality system development with the goal of subcontractor compliance to ISO/TS 16949 or an existing customer quality system requirement... 

ISO 9000 Quality System Assessment Handbook 1996 (ISBN 0-7506-2563-5) ISO 9000 Quality System Development Handbook 1998 (ISBN 0-7506-2562-7) ISO 9000 Pocket Guide 1998 (ISBN 0-7506-4025-1)... 

A major change is the notion that the health care system is a supplier and needs to be held accountable for the value it delivers. It is strange that health quality systems developed (or failed to develop) in total isolation from the rest of the American... 

The second approach - creation of systems for non-destructive testing quality assurance in compliance with ISO standards 9000 series - considers the quality system as an assembly of organisational strueture, procedures, processes and resources necessary for overall quality management at the laboratory. This approach requires methodieal development. 

Quality System Documentation. Quahty system documentation has two aspects. One is the development of a quahty manual, which is a... 

ISO 9000 - Quality Management and Quality Assurance Standard. Guidelines for selection of Standards in the series and use of the same for the managemetit of quality systems. ISO 9001 - Model for Quality Assurance in Design or Development. Production. Installation and Servicing. 

Similarly, the aehievement of quality assuranee eertifieation, sueh as BS EN ISO 9000 (1994), is also not a guarantee of good quality produets. The quality assuranee model reeommends quality system requirements for the purpose of a supplier demonstrating its eapability, and for assessment of the eapability in terms of design, development, produetion, installation and servieing (BS EN ISO 9001,... 

Quality systems - Model for quality assurance m design, development, production, installation and servicing. Previously BS 5750 Part 1 1987... 

There are those who see the emergence of sector standards as a retrograde step, having reached the stage where we have condensed all the world s national quality system standards into one group of 20 standards. Those following the development of ISO 9000 will already be aware that the 20 standards in the ISO 9000 family are soon to be reduced to four (ISO 9000, ISO 9001, ISO 9004, and a replacement for ISO 10011). It... 

Prior to the publication of ISO 9000, several nations had developed national quality system standards, with many used only in the procurement of military equipment. With the emergence of the NATO Quality Control System standards in 1973, the Quality Panel of the UK Society of Motor Manufacturers set out to develop an equivalent standard for non-military applications. The result was BS 4891, which was published in 1972. In 1974 this was followed by BS 5179 with the title Operation and Evaluation of Quality Assurance Systems. However, BS 5179 was intended only as a guide and it was not until 1979, with the publication of BS 5750, that major purchasers in the UK had a standard that could be invoked in contracts. A certification scheme was eventually established in 1983, following the UK government s white paper on competitiveness ... 

In 1983, BSI approached the International Organization of Standardization in Geneva with a view to developing an international quality system standard and eventually a committee was formed. Using BS 5750 as its basis, the ISO 9000 series of standards was born. 

Although the UK, and in particular the UK automotive industry, had been at the forefront of the development of non-military quality system standards, harmonization within the automotive sector beyond BS 5750 was believed too difficult to achieve. Using BS 5750 as a baseline only, the UK motor manufacturers continued to develop their own supplementary standards, many of which are still in use today. BS 5750, and its successor ISO 9000, was enforced by the UK automotive industry and no further harmonization took place. 

Common quality system approach for subcontractor development... 

The typical focus for a quality system is at the operations level. ISO 9000 is seen as an initiative for work process improvement. The documentation is often developed at the work process level and focused on functions. Much of the effort is focused on the processes within the functions rather than across the functions and only involves the business level at the customer interface, as illustrated in Table 2-1. 

Manage the design, development, implementation, and evaluation of the quality system including the necessary resources (the managerial role)... 

This requirement is similar to that in clause 4.14.3 under Preventive action since the data collected for preventive action serves a similar purpose. In one case an analysis of company-level data serves to identify overall trends and predict potential failures that will affect achievement of the goals. In the preventive action case, the data serves to identify local and overall trends and predict potential failures that will affect achievement of specified requirements for the product, process, and quality system. It would be sensible to develop a data collection and analysis system that serves all levels in the organization, with criteria at each level for reporting data upwards as necessary. You should not treat this requirement separately from that for preventive action since the same data should be used. However, the explanation given in clause 4.1.5 of Operational performance does include some factors that may not be addressed in your preventive action procedures. 

Quality system design and development, addressed by clauses 4.2.1 and 4.2.2... 

The quality system you have developed should have made all the necessary provisions to enable the products and services you normally supply to conform to customer... 

Create a plan of how you intend to design, develop, introduce, and evaluate the quality system. 

Determine training needs for developing, implementing, and evaluating the quality system. 

Produce a glossary of terms covering the concepts, documents, and activities to be used in developing and implementing the quality system. 

Don t divorce the quality system documents from other documents of your business - develop an integrated system. 

To what extent do you steer the development of your subcontractors quality systems towards ISO/TS 16949 compliance ... 

The standard provides a choice as to whether you define the inspections and tests required in a quality plan or in documented procedures. You may of course need to do both. As the quality system is often designed to accommodate all products and services you supply, it may not specify inspections and tests which are needed for particular products. This is one of the roles of the quality plan. Within such a plan you should identify the verification stages during product development, production, installation, and servicing as applicable. These stages will vary depending on the product, so your quality plan will be product, contract, or project specific (see Part 2 Chapter 2). There may... 

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