Implementing the quality system

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

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

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

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... 

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... 

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. 

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

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. 

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

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). 

An audit carried out to establish whether the quality system conforms to a prescribed standard in both its design and its implementation. 

Companies that have no quality system or that have just started implementing a quality system should be aware that the guidelines do not show how to select and implement quality systems. In the latter case, the book will still be useful in helping combine and streamline management systems. In addition, the comparison of different Quality Management systems in Chapter 9 may provide some useful input to Quality Management system selection. 

To facilitate industry application of modern quality management techniques, including the implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance. 

In agribusiness and the food industry, management of quality is often assumed to be a rather controllable process. This may be illustrated by the great attention paid to the development and implementation of quality systems in the past decade. These quality systems are commonly based on procedures and control circles as mechanisms to control and assure quality. After implementation, however, it often appears in practice that the intended results are not obtained and exact reasons are not clear. ... 

Whereas ISO Guide 34 sets requirements for the quality system of a GRM producer, ISO Guide 35 (1989) provides guidance on how to implement many of these requirements. Among these, the document also provides a general and statistical outline of the process that leads to CRMs. The current edition of ISO Guide 35 is a little outdated, but stiU most of the contents are valid. 

Quality assurance is the part of quality management focused on providing confidence that quality requirements will be fulfilled. It is all the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that the analytical service will fulfil the requirements for quality. Quality assurance is the essential organizational infrastructure that supports all reliable analytical measurements. It encompasses... 

Two important aspects are internal audits and product quality review. Internal audits are implemented to regularly monitor the compliance activities in drug manufacture and to ensure rectification to these activities if deviations occur. Trending and statistical analysis of data provide early warning of impending problems. Product quality review checks the relevance and adequacy of the manufacturing activities. It provides input to update and improve the quality system. 

In order to implement the quality policy in the daily work, quality management systems are installed, covering quality planning, quality control, quality assurance and quality improvement. To ensure that the quality assurance system is in place and effective, external standards are used, for example the DIN EN ISO 9000 ff. standard system, commonly shortened to ISO 9000 (DIN is an acronym for Deutsches InstitutfiXr Normung, meaning German Industry Standard ). 

Formally writing down the company s policies and requirements and how the staff can implement the quality assurance system... 

Management Responsibilities The FDA feels that a robust quality system model calls for management to play a key role in the design, implementation, and management of the quality system. 

Quality Management (QM) Accountabihty for the successful implementation of the quality system. 

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