General quality system

ISO Guide 62 1996 General requirements for bodies operating assessment and certification/registration of quality systems... 

General criteria for certification bodies operating quality system certification... 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

All equipment should comply with the relevant British and other Standards regarding dimensions, methods of determining ratings, compliance with safety regulations, robustness and general quality of manufacture [70]. BS.5750, Quality Systems, concentrates on the subject of product quality as it affects design, manufacture and installation. In addition to Standards, there are various Codes of Practice [71, 72]. 

General Requirements (Implement quality system and continually improve it)... 

Previously, Chapter 2 examined the importance of the organisation, training and educational qualifications of personal as core elements of quality systems in general. Personal hy ene is a specific additional aspect that must be addressed to prevent the contamination of drugs. Training and practices must be adopted so as to achieve ... 

General requirements - Implement and maintain a quality system... 

Sec. 820.182 Device history record - Maintain the production records for each batch of devices Sec. 820.186 Quality system record - Compile or refer to location of general procedures relating... 

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. 

ISO Guide 34 (1996) Quality system guidehnes for the production of reference materials. (Revised March 1998 as ISO/REMCO document No 464 General requirements for the competence of reference material producers . The revised Guide 34 will appear early 2000.) International Organization for Standardization, Geneva. 

In a modern quality system, the organizational unit responsible for quality-related activities within the organization generally has a central role in the... 

This chapter will focus on those additional GMP requirements for the manufacture of excipient ingredients under an ISO 9001 compliant quality system. While certification to ISO 9001 is unnecessary for compliance to excipient GMPs, many of the manufacturing-related requirements as noted above are essential for adequate GMP conformance. With the numerous ISO 9001 compliance resources available, this chapter will assume the reader has the knowledge to implement those relevant general ISO 9001 requirements. 

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