Quality system implementation

Define roles and responsibilities the plan should clearly define the roles and responsibilities of those responsible for development and execution of the plan for quality system implementation as well as staff roles and responsibilities under the quality system. 

Any other facility considered necessary to implement the quality systems in full. 

Where a supplier has a quality system that covers the whole business, the audit plan must not include elements that are not implemented for automotive customer needs e.g. elements of Human Resources, Accounting, Finance, IT, Legal, Marketing, Sales, Public Relations may not serve automotive customers needs but company needs. 

The audit plan shall include evaluation of all supplier quality system elements for effective implementation of ISO/TS 16949 requirements as well as for effectiveness in practice. 

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

The quality system should be designed to implement the corporate quality policy and hence the operational policies need to be consistent with the corporate policy. Often the... 

In this way, a quality system can drive you forward towards world class quality. It is not a static system but a dynamic one, if properly designed and implemented. 

The term resource is often used to imply only human resources when there are in fact other types of resources. The standard is not specific although resources would normally include time, manpower, machines, materials, finance, plant, facilities in fact, any means available to the supplier for implementing the quality system. So when ISO 9001 requires that you provide adequate resources it requires that you provide all the human, finance, and material resources necessary to implement your quality system, including the allocation of sufficient time. 

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. 

Primarily, the designated person is the system designer for the quality system. This person may not produce the policies and procedures but operate as a system designer. He/she lays down the requirements needed to implement the corporate quality policy and verifies that they are being achieved. It is also necessary to have someone who can liaise with customers on quality issues, who can coordinate the assessment and subsequent surveillance visits, who can keep abreast of the state of the art in quality management. The person should be an adviser to the top management who can measure the overall performance of the company with respect to quality. 

To ensure the quality system is established, implemented, and maintained and report on... 

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

The elements of the system can be construed to be the 20 elements of ISO 9001. The components of the system are different. ISO 8402 states that a quality system is the organizational structure, procedures, processes, and resources for implementing quality management. It therefore follows that in reviewing the quality system one needs to review each of these aspects. 

While the plan itself is not auditable by third parties, it may be auditable by second parties i.e. customers. The third party or registrar is entitled to examine the plan to ascertain that it is what it proclaims to be. The particulars are of no concern except those aspects relating to quality, such as the resources, quality objectives, customer satisfaction plans, and performance metrics. Whatever is stated on these aspects, the auditors will expect to see evidence that the business plan is not merely a wish list and that provisions have been made to enable implementation through the quality system. 

Although there are only two basic requirements in ISO/TS 16949 for the establishment and maintenance of a quality system, they are perhaps the most important requirements of all. The quality system is a tool to enable you to achieve, sustain, and improve quality. It implements your quality policy and enables you to achieve your quality objectives either for control or for improvement. Quality systems, like any other system, need to be managed and so quality system management is a function of the business. This function consists of four principal processes ... 

The standard does not require you to demonstrate that you meet all the requirements of the standard. It only requires a quality system to be documented, implemented, and maintained. While clause 4.16 on quality records does in fact require you to demonstrate the effective operation of the quality system, it does not dictate how you should... 

This requirement clearly defines the purpose of a quality system, that of ensuring that products conform to specified requirements. One of the principal differences between ISO 9000 and ISO/TS 16949 is the emphasis placed on internal efficiency and effectiveness. Implementing the requirements of ISO/TS 16949 will cause the waste, errors, and internal costs to be minimized. Unlike ISO 9001, ISO/TS 16949 requires the system to enable the organization to implement its quality policy and achieve its quality objectives, which after all is its purpose. This fundamental shift in concept is also behind the changes being made to ISO 9000 in the year 2000 edition. 

Why should all this be necessary to maintain the quality system The answer can be found in ISO 8402 which defines a quality system as the organizational structure, responsibilities, procedures, processes, and resources needed to implement quality man-... 

In order to keep the system up-to-date with the needs of the business you will need to review the system when changes occur in the business. This review may be carried out at the same time as the management reviews described in Part 2 Chapter 1 however, as these reviews may be scheduled on a periodic basis, you should not allow the system to become outdated. The system should always reflect what you do and should remain ahead of actual practice rather than lag behind it. You should therefore integrate your system review with the business review so that changes in the business are implemented through the quality system rather than as an afterthought. 

Quality system procedures are a certain type of procedure. They implement the operational policies and regulate processes that produce an output, the quality of which is essential to the business. Procedures do not in fact achieve quality - it is people who do that. Procedures do not take decisions, it is people who do that. So you could have the best procedures in the world and still not achieve quality. It has to be a combination of both for you to achieve the desired quality. 

The standard requires the supplier to effectively implement the quality system and its documented procedures. 

In ensuring the effective implementation of the quality system you should continually ask ... 

If the answer is Yes your system is operating effectively. If your answer is No to any of these questions, your quality system is not being effectively implemented. 

Further guidance on implementing a quality system can be found in Part 1 Chapter 5 and the ISO 9000 Quality System Development Handbook hy David Hoyle (Butterworth-Heinemann, 1998). 

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. 

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

Create a system manual that describes your quality system and how it works and references all the procedures, standards, etc. that implement your quality policies. 

Design the quality system from the top down by analyzing your business processes and then implement from the bottom up, starting with customer complaints. 

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

How do you ensure that the documented quality system is implemented effectively ... 

The system audit to verify that the quality system complies with the appropriate part of ISO 9000. The system audit is a composite of a documentation audit and implementation audit (see below). This is now required in ISO/TS 16949 clause... 

Introducing a quality system, thus requiring awareness of ISO 9000, the quality policies and objectives, and training in the implementation of quality system procedures, standards, guides, etc. 

All the planned and systematic activities implemented within the quality system and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality (ISO 8402). 

All activities of the overall management function that determine the quality policy, objectives, and responsibilities and implement them by means such as quality planning, quality control, and quality improvement within the quality system (ISO 8402). 

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