Quality system requirements

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,... 

A need to harmonize fundamental supplier quality system requirements and eliminate multiple interpretations. 

The drive for these additional requirements has come not from the suppliers but from users, such as the automotive, utilities, telecommunications, software, and aerospace industries which purchase millions of products and services used to produce the goods and services they provide to the consumer. Rather than invoke customer-specific conditions in each contract, the larger purchasers perceive real benefits from agreeing common quality system requirements for their industry sector. Quite often a supplier will be supplying more than one customer in a particular sector and hence costs increase for both the supplier and the customer if the supplier has to meet different requirements that serve the same objective. All customers desire products and services that consistently/ meet their requirements. While the physical and functional requirements for the product or service will differ, the requirements governing the manner in which their quality is to be achieved, controlled, and assured need not differ. Differences in quality system requirements may arise between industry sectors where the technology, complexity, and risks are different. 

Currently a supplier supplying customers in the USA and Europe needs to seek certification to QS-9000 and either VDA 6.1, AVSQ 94, or EAQF 94. Within Europe, certification to any one of the three European quality system requirements is, at least in theory, recognized by customers in the other countries. 

Common language to improve understanding of quality system requirements... 

These are the characteristics which need to be specified and their achievement controlled, assured, improved, managed, and demonstrated. These are the characteristics which form the subject matter of the specified requirements referred to in ISO 9000. When the value of these characteristics is quantified or qualified they are termed quality requirements or requirements for quality. ISO 8402 1994 defines requirements for quality as an expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity to enable its realization and examination. While rather verbose, this definition removes the confusion over quality requirements and technical requirements. (An additional definition is provided in Appendix A.) Technical requirements for a product or service are quality requirements. The requirements of ISO 9000 are quality system requirements. 

As stated in Chapter 1, ISO/TS 16949 harmonizes the quality system requirements of the automotive industry in the USA, Germany, France, and Italy. It does not contain all automotive quality system requirements. All participating organizations have customer-specific requirements in addition, which may be issued separately or included in individual contracts for the supply of products and services. 

The differences with the existing automotive quality system requirements need careful examination. There are additions, deletions, and movements that users of QS-9000 Third Edition, AVSQ 94, EAQF 94, and VDA 6.1 1998 need to be aware of, as they affect not only supplier quality systems but the internal and external auditing practices. As the national requirements are not similarly structured comparisons are impossible to illustrate in a single table. Readers are therefore advised to compare specific text in each to discover the actual differences. The source of the requirements is depicted in the tables that follow. A dash (-) indicates that there is no matching requirement. 

From this table one can see that all the additional requirements in ISO/TS 16949 were sourced from one or more of the four national quality system requirement documents. The location and wording of the requirements changed on incorporation into ISO/TS 16949. Many requirements from QS-9000 have been incorporated verbatim, whereas extracts from VDA, AVSQ, and EAQF were reworded so as to phrase the statements as requirements. 

In order to identify the differences in detail one would have to compare each of the four existing automotive quality system requirement documents with ISO/TS 16949. This is an exercise that forms part of the lATF Auditor Qualification Course and is not duplicated here. However, a summary of the 26 requirements that are additional to those in QS-9000 Third Edition are listed below ... 

The existing quality system requirements do have some of the above requirements but it is ISO/TS 16949 in which the full impact of their relationship is evident. It follows therefore that in making the transition from your existing system to an ISO/TS 16949 compliant system, the first step is to establish the extent to which your existing system possesses these linkages and feedback loops - a sort of coherence check to verify your system is not just a bolt-on extra. 

Most certification body auditors who are currently performing audits against one or more of the national automotive quality system requirements (QS-9000, VDA 6, AVSQ, or EAQF) will qualify. To qualify, auditors need to ... 

Existing automotive auditors must have performed at least 15 third party audits to one of the four automotive quality system requirements in the last three years at a minimum of 45 audit days with two of these as a lead auditor. 

If your organization is registered to one or more of the existing automotive quality system requirements and the scope is unchanged, the required man-days for the initial audit may be reduced by 50%, but if you decide to change certification body or have changed the scope, there will be no reduction. 

The standard requires that the supplier s management with executive responsibility appoints a member of its own management with responsibility for ensuring that quality system requirements are established, implemented, and maintained in accordance with ISO 9001, and for reporting on the performance of the quality system to management for review and as a basis for improvement of the quality system. 

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. 

Quality requirements are not the requirements contained in ISO/TS 16949. These are quality system requirements they apply to quality systems, not to products and services. A product cannot conform with ISO/TS 16949 as it contains no product requirements (see also Part 1 Chapter 2). 

A specification of the requirements which will give you an assurance of quality - this might be a simple reference to the appropriate ISO 9000 standard, but as this standard does not give you any rights you will probably need to amplify the requirements (see Subcontractor quality system requirements). 

The quality of the product can only be verified by the subcontractor during its design and manufacture. (In such cases you need to rely on what the contractor tells you and to gain sufficient confidence you can impose quality system requirements, require certain design, manufacturing, inspection, and test documents to be submitted to you for approval, and carry out periodic audit and surveillance activities. This method is usually applied for one-off systems or small quantities when the stability of a long production run cannot be achieved to resolve problems.)... 

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... 

QS-9000 Quality system requirements, 3rd edition (GM, Ford, Chrysler)... 

The QSR major new requirements are in the areas of design, management responsibility, purchasing, and servicing. It encompasses quality system requirements that apply to the entire life cycle of a device. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

Sec. 820.5 Quality System - Estabiish and maintain a quality system Subpart B Quality System Requirements... 

One of the alternative approaches under the 510(k) paradigm is Special 510(k) Device Modifications. This approach utilizes certain aspects of the Quality System Regulations (Quality System Requirements for Good Manufacturing Practices). The other alternative is the Abbreviated 510(k). This approach utilizes special controls in which standards or voluntary guidelines can facilitate 510(k) review and expedite evaluation. 

This Chapter describes outlines and discusses the regulations applicable to the QA function and unit, structure, function, charter, and application of the unit in the pharmaceutical manufacturing environment. In addition, it discusses additional quality-related responsibilities that may result when manufacturers move toward a quality systems approach to quality that incorporates current quality system models to further improve quality and harmonize with international quality system requirements. 

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