Quality System Standards

There are those who see the emergence of sector standards as a retrograde step, having reached the stage where we have condensed all the world s national quality system standards into one group of 20 standards. Those following the development of ISO 9000 will already be aware that the 20 standards in the ISO 9000 family are soon to be reduced to four (ISO 9000, ISO 9001, ISO 9004, and a replacement for ISO 10011). It... 

Prior to the publication of ISO 9000, several nations had developed national quality system standards, with many used only in the procurement of military equipment. With the emergence of the NATO Quality Control System standards in 1973, the Quality Panel of the UK Society of Motor Manufacturers set out to develop an equivalent standard for non-military applications. The result was BS 4891, which was published in 1972. In 1974 this was followed by BS 5179 with the title Operation and Evaluation of Quality Assurance Systems. However, BS 5179 was intended only as a guide and it was not until 1979, with the publication of BS 5750, that major purchasers in the UK had a standard that could be invoked in contracts. A certification scheme was eventually established in 1983, following the UK government s white paper on competitiveness ... 

In 1983, BSI approached the International Organization of Standardization in Geneva with a view to developing an international quality system standard and eventually a committee was formed. Using BS 5750 as its basis, the ISO 9000 series of standards was born. 

Although the UK, and in particular the UK automotive industry, had been at the forefront of the development of non-military quality system standards, harmonization within the automotive sector beyond BS 5750 was believed too difficult to achieve. Using BS 5750 as a baseline only, the UK motor manufacturers continued to develop their own supplementary standards, many of which are still in use today. BS 5750, and its successor ISO 9000, was enforced by the UK automotive industry and no further harmonization took place. 

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems ... 

The quality assurance requirements are specified, such as quality system standards, quality plans, reports, customer surveillance, and concessions. 

The standard requires purchasing documents to include, where applicable, the title, number, and issue of the quality system standard to be applied to the product... 

Certification based on auditing against a quality system standard for design, production final inspection (e.g. ISO 13485)... 

The ISO 9000 series encompasses the product development sequence from strategic planning to customer service. Currently, it is a series of five quality system standards, with two of the standards focusing on guidance and three that are contractual standards. 

The major elements of the quality system model described in the FDA s pharmaceutical QS guidance document are consistent with existing quality system standards. These elements are as follows ... 

Worldwide, there are a number of quality systems standards in operation. Their division into categories is based on the scope of their subject matter. 

To understand the ongoing harmonization efforts concerning pharmaceutical inspections, specifically as they relate to uniform quality systems standards, we must first describe the current inspectional authorities that FDA and the EU possess. 

As of this writing, there are a number of outstanding issues that remain unresolved and that could threaten the viability of the MRA. One of FDA s biggest concerns is the unharmonized definition of GMP and the EU member states interpretation and enforcement of quality system standards. Another potential problem is the EU s reluctance to conduct inspections of APIs, despite their inclusion in the pharmaceutical GMP annex. 

An organisation may work to a number of different quality system standards. These standards are described in documents, which define the requirements that must be met. 

Supplier Audits should always include the review of a sample of code to ensure compliance with quality system standards, though such a review will never pretend to assume the rigor of a formal Source Code Review. Where suppliers withhold software listings, access agreements should be established and refer to the availability of software and reference documentation in Chapter 11. 

If any omission by the manufacturer in the initial evaluation procedure, or during the follow-up activities, is evident in relation to the requirements, including compliance with quality system standards and failure to notify complaints. 

Use of quantitative 2D NMR spectroscopy is still quite rare in food analysis and quality control. A possible reason can be that experimental set-up, acquisition and processing of 2D NMR experiments are considered to be too difficult or time-consuming compared to ID NMR experiments. Also, restrictions and regulations from the laboratory environment (quality systems, standards) can hinder application of new methodology in quantification. Considering the challenging sample matrices the 2D NMR methods would be excellent tools in quantification. 

The quality system standard chosen as a framework for this guide is ISO 9002, which is appropriate to manufacturing. Requirements specific to excipients have been added. 

International Organization for Standardization (ISO) Provides information about ISO standards, publications, and meetings, (in English and French) http / / www.iso.ch/welcome.html International Organization for Standardization ISO 9000 Guidelines and Tips This in-depth site, from Canada s Praxiom Research Group Ltd., translates the complex ISO 9000 quality system standards into plain English, http //www.connect.ab.ca/ praxiom/ Iron and Steel Society (ISS) http / / www.issource.oi / JLI-Boston Executive Search Exceptional plastics in-... 

Assessment of an analytical laboratory quality system may be made by the laboratory itself. It will have little or no value in the eyes of many customers, however, since it will be seen as a subjective and favorable assessment. However, internal audits and management reviews of the system, made as a requirement of a quality system standard, are self-assessments and are valuable, as explained in the previous section. 

As a part of quality systems, standard procedures can be implemented for functional assessment of employees. Job description of employees and their training records are efficient documents for that purpose. Procedures for the training of a new professimial, the continuous education and the yearly examinadmi of qualification can all be part of the quality system of the preparation unit. Such qualification is... 

The main differences between ISO 13485 and GMP standards is that GMP standards give requirements mainly on manufacturing and controls processes, with the aim to ensure the conformity of the product to the established requirements, as output of the R D process. The ISO 13485 is a more wide-quality system standard, and covers requirements such as customer processes, supplier qualifications and monitoring, purchasing processes, decisional processes, and process measurements. 

A variety of national and international guidelines have been formulated to support method validation. Requirements for the components of a method validation may vary between countries depending on the level of approval that has been obtained. For example, in the United States, Food and Drug Administration (FDA)-approved devices must meet Clinical Laboratory Improvement Amendments (CLlAs) requirements for method validation, if they are deemed of medium or high complexity laboratories operating these tests are subject to inspection and must meet the CLl A quality system standards [12]. However, some POCT devices deemed of low complexity by the FDA may be CLlA-waived such that areas operating only these low complexity tests must simply follow the manufacturer s instructions for those tests to meet CLl A requirements. However, it is not always clear if CLlA-waived devices meet the quahty specification for the analytes being measured. 

British Standards Institute (BSD produces quality systems standard BS5750... 

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