Quality system objective

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. 

Job descriptions or job profiles are useful in describing what a person is responsible for however, it rather depends upon the reason for having them as to whether they will be of any use in managing quality. Those produced for job evaluation, recruitment, salary grading, etc. may be of use in the quality system if they specify the objectives people are responsible for achieving and the decisions they are authorized to take. 

The standard requires that the quality system be reviewed at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of ISO 9001 and the supplier s stated quality policy and objectives. There is also a supplementary requirement in clause 4.2.8 for the performance of the system to be evaluated to verify the effectiveness of its operation. 

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. 

What evidence demonstrates that your quality system is suitable and effective in satisfying ISO/TS 16949 and your stated quality policy and objectives ... 

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 ... 

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. 

If we look at ISO 10013, which is referenced for guidance in preparing a quality manual, we will see that it shows that the quality manual is a top-level document containing the stated quality policy, the quality objectives, and a description of the quality system (see Figure 2.2). The definition in ISO 8402 supports this concept and the requirement aligns with this definition. However, ISO 8402, ISO 10013, and the above requirement from ISO 9001 provide a choice as to whether the manual contains or refers to procedures. 

It would be sensible to document your quality policies separately from your quality objectives and keep these separate from the other quality system documentation. A solution is to have ... 

This is probably one of the most powerful requirements in the standard, much underused in ISO 9000 quality systems. If you examine the words closely you will find that it can be applied to any situation where measures can be taken to prevent problems. A common weakness in many organizations is the absence of planning. Planning is a preventive action. We plan to achieve an objective which we would fail to meet if we didn t make adequate provision for the resources and activities needed to meet our objective. Therefore, although the standard does not require plans for every activity, if preparation is necessary before an activity can take place and such preparation has not been accom-... 

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

The requirements for internal audits apply to audits of the quality system, including the policies, practices, products, and services to which the quality system relates. They are not limited to audits of procedures. In order to determine whether the quality system is effective in maintaining control, you need to check that the resultant products and services meet the specified requirements and that prescribed quality objectives are being achieved. If the products and services are not meeting the specified requirements, or the prescribed objectives are not being achieved, something is clearly amiss with the quality system. The requirements do not apply to audits of suppliers or subcontractors as they are covered in clause 4.6 of the standard. 

Planned arrangements is another unusual term, especially when throughout the standard the terms documented quality system and documented procedures have been used. However, so that audits are not restricted to documented procedures and policies, the term planned arrangement has been used. It encompasses contracts, specifications, plans, objectives, strategies - in fact any arrangement made by the organization to satisfy customer needs. You therefore need to define what constitutes your planned arrangements. 

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 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). 

It is to be hoped that the variety of certification schemes will not multiply, or the client is likely to be confused rather than informed. When making his choice he may usefully remember that the criteria of good quality systems are as applicable to service organizations as they are to manufacturers, and that clarity regarding the objectives of the service offered together with practical common sense in providing this service are the real indicators. 

Each construction organization shall be responsible for developing a QSP. The Quality System shall include a quality manual, quality policy and objective, structure of organization, documented procedures, work instructions, a quality plan, and document and data control. 

Quality System shall provide for control of material and product identification during all stages of production and delivery. Identification is based on applicable drawings, specifications, or other documents. When required or specified, complete traceability of material or product shall be maintained by issuing unique or batch control numbers and/or markings. The identification and trace-ability procedure shall be fully documented to provide objective evidence of compliance with this Code in accordance with this requirement. 

GR-6.2.2.10 Personnel Training. The Quality System for personnel training shall provide for documentation of the objectives and the expected outcome of the training. The input defining the training needs shall be provided to support each Quality System function and the specific project requirements. 

Clause 4.2.2 of ISO/IEC 17025 requires that a quality policy statement be issued by the top management and that the quality system policy and objectives are defined and documented in the quality manual. 

The objective of this guidance is to describe a quality systems model and demonstrate how and where the elements of this model can fit within the requirements of the CGMP regulations. The philosophy being put forward is that quality should be build into the product, and testing alone cannot be relied on to ensure product quality. 

Building and documenting a quality system to meet specified quality and regulatory requirements and achieve quality objectives... 

Under a comprehensive quality system the QU can expect an expanded and more visible role within the organization with greater accountability to and interaction with upper management. The QU should ideally be independent of the other organizational units to assure clear delineation of responsibility and authority and avoid conflicts. In certain instances, such as auditing, independence or objectivity is central... 

The evaluation component of a QMS is intended to provide objective information and data that allow the organization to assess the conformity of the product, evaluate the performance of its quality system, and maintain and improve its effectiveness [10]. The cGMP regulations similarly require evaluation activities as shown in Table 4. 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

A corrective action is initiated to correct the cause of an identified nonconformity and to prevent it or similar problems from reoccurring. It may include initial and follow-up actions (e.g., conducted after root cause analysis). Current quality system models and the cGMP regulations emphasize corrective actions and require that actions be documented. Under current quality system models, preventive actions include actions taken in response to quality data to address the cause of potential nonconformities to prevent their occurrence. An effective CAPA system therefore includes both reactive and proactive components. The effectiveness of corrective and preventive actions should be evaluated using objective criteria when possible and the evaluation documented. 

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