ISO 9000 series of standards

ISO 9000. The ISO 9000 series of standards was first issued in 1987 and then updated in 1994. The ISO 9000 standard describes the selection criteria for the four standards, ISO 9001—9004. ISO 9001 is composed of 20 items covering manufactured products from design and development in R D to commercial production and after-sale service or technical support. ISO 9002 has 19 of the items in 9001 describing the requirements of a quahty system for the manufacture of an item, such as chemicals, to a specification only the requirement relating to product development is omitted. Chemical companies seldom certify to ISO 9003, which describes the quahty system for a laboratory involved in final inspection and test. Finally, ISO 9004 presents guidelines for total quahty management. 

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. 

The ISO 9000 series of standards has been used for illustrative purposes throughout this book. However, all the leading Quality Management systems have similar structures so you will find the concepts familiar regardless of which system your company has adopted. Chapter 9 summarizes the principal differences and similarities between ISO 9000 and other commonly used Quality Management systems. 

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. 

Furthermore it is well known that the ISO 9000 series of standards are applieable in all kinds of aetivity, both in mannfaotnring and serviee sectors to this end, they can serve their pnrpose to demonstrate the company s qnality management awareness and organizatiom This may apply also to laboratories however it has nothing to do with the particnlar need of laboratories to demonstrate their technical competence with regard to specific tasks. 

The CD-ROM consists of manuals and procedures that should be useful to all companies. As the ISO 9000 series of quality standards becomes more widely adopted by organizations, both in the United States and elsewhere in the world, it is essential for compliant companies to create quality systems manuals and applicable standard operating procedures (SOPs) for their employees. These SOPs enable both new and experienced staff to understand the requirements of the ISO 9000 series of standards, along with the principles and practices of the company, and comply with these regulations to build the elements of quality into their products and services with a particular reference to customer satisfaction. 

For companies already in compliance with the ISO 9000 series of standards, and who are registered, certified, and have long since developed and adopted the quality manual and SOPs, this manual will help them have an easy transition to the new international standard ISO 9001 2000 requirements. This ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM will be of enormous value to recently emerged companies with a big investment in the slogan of quality. While these companies are few, if any, they will have the expertise to fully understand the elements of quality and achieve registration/certification. 

The ISO 9000 series of standards (1994) was based on the process approach. The management organizations that have adopted the 1994 edition of the standards had to describe their business processes and develop quality manuals and procedures needed to support them. The revised ISO 9001 2000 international standard model is very clear it encourages the adoption of the process approach as a means of readily identifying and managing opportunities for improvement. The present family of 21 standards in the ISO 9000 series is reduced to five. 

The development, implementation, and maintenance of a quality manual and key SOPs are essential for compliance with the ISO 9000 series of standards and are a requirement of the international standard ISO 9001 2000. Writing SOPs can be time consuming for those new to the system. Moreover, the standards do not specify how SOPs are to be written, what format they should be in, or how many procedures are enough. 

The ISO 9000 series of standards has been adopted by thousands of companies worldwide since the introduction of registration and certi-hcation. Considering the fact that transition to the revised standard ISO 9001 2000 will take time, Model-2 can be used where quality manual ISO 9001 already exists and needs to be revised in accordance with the requirements of ISO 9001 2000. Reference is made to the applicable clauses of ISO 9001 and ISO 9001 2000. No exclusions are permitted in Model-2. 

The last section of this book provides a set of 20 explicit standard operating procedures written in a global text to describe the elements of the revised standard. The contents of the procedures can be specifically tailored to an individual company s operations, and reference can be made to specific documents and associated applicable procedures. Taking into consideration the fact that thousands of companies are already registered and certified in compliance with the ISO 9001 11994) or ISO 9002 (1994) or ISO 9003 (1994) international standards, reference is made to the corresponding SOPs to indicate applicable clauses of both the second and the third revisions of the ISO 9000 series of standards. 

SOP Number Each SOP is assigned a unique number that appears at the upper right hand corner of the SOP, based on the reference clause of the ISO 9000 series of standard. 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

For laboratory accreditation, based on ISO guide 25 [27] and the EN 45001 standard, as well as for certification, based on the ISO 9000 series of standards [1], it is required that measurement and test results be traceable to international, defined, and accepted physical and physicochemical standards [28], This requirement includes the use of conventionally expressed quantities and units in conformity with the SI [29], It also includes the proper use of the concept of measurement uncertainty. All these are necessary conditions for reliance on the measurement results of another laboratory. Accreditation is granted when a laboratory has demonstrated that it is competent and capable of working in the above-mentioned sense. Technical trade barriers then fall away, and the needs and requests from industrialists, traders, and the general public can be met in the interest of open and fair trade, health, safety, and the environment. 

GLP requirements have the objective to ensure public safety for chemical products. The ISO 9000 series of standards [17] is intended to ensure quality for manufacturing and services companies. In 1987, the European Standards Institution... 

The movement of the Blue Guide toward the ISO 9000 series of standards is an unusual example of convergence between quality assurance of medical and pharmaceutical products and quality assurance in other industries. The ISO 9000 series of standards is becoming the accepted norm for progressive customer-oriented companies in both western and eastern Europe. It rests on three important themes, which if addressed properly will provide a systematic basis to quality assurance ... 

These themes of the ISO standards in no way contradict the themes that have been emphasized in the earlier and parallel pharmaceutical and medical devices GMP Regulations and Guides. Indeed many pharmaceutical companies are already putting pressure on their suppliers to gain accreditation with the ISO 9000 series of standards. It is possible that the way forward for GMPs in the sterile products manufacturing industry as a whole may eventually defer to these standards in the way of the Blue Guide. 

From the table one can see that only helium leak detection with a mass spectrometer leak detector allows a real quantitative statement of leakage rates compliant with the requirements of the ISO 9000 series of standards for quality management. Therefore this method and its variants will be described in more detail in the following. 

Chapter 2 defines the concept of quality assurance, how it has been codified in the ISO 9000 series of standards and how the latter can be translated into a meaningful quality management system on a construction site. A negative image of ISO 9000 is not uncommon in the construction industry,- this is explained and an appropriate response is given. 

Quality is considered in the ISO 9000 series of standards in the sense of fitness for purpose and safety in use. The specific parts are ... 

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