ISO 14001 series

Besides internal quaUty audits, there are audits conducted by external authorities for conformance to estabUshed quaUty systems. The two chief standards affecting the chemical industry are the U.S. Food and Dmg Administration Current Good Manufacturing Practice (GMP) regulation and the International Organization for Standardization ISO 9000 series. A quaUty system performance-related standard is the Malcolm Baldrige National QuaUty Award... 

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. 

Is there a quality manual clearly describing the management system, i.e. as per ISO 9000 series or other ... 

The assessor should establish what percentages of key tollers do have an ISO 9000 series quality assurance system or other. Check whether the purchasing function has copies of certification including scope of certification. 

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. 

Since publication of the 1994 edition of the ISO 9000 series, TC176 has been busy formulating some basic principles of quality management. These principles are recommended as the basis for establishing the quality policy. The eight quality management principles are ... 

There are two types of external documents, those in the public domain and those produced by specific customers. In some cases the issues of both types of documents are stated in the contract and therefore it is important to ensure that you possess the correct version before you commence work. Where the customer specifies the issue status of public domain documents that apply you need a means of preventing their withdrawal from use in the event that they are revised during the term of the contract. Where the issue status of public domain documents is not specified you may either have a free choice as to the issue you use or, as is more likely, you may need to use the latest issue in force. Where this is the case you will need a means of being informed when such documents are revised to ensure that you can obtain the latest version. The ISO 9000 series for instance is reviewed every five years, so could well be revised at five-year intervals. With national and international legislation the situation is rather different as these can change at any time. You need some means of alerting yourself to changes that affect you and there are several methods from which to choose ... 

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 ISO 9000 series has been chosen because it is the most widely used Quality Management system and is a recognized international standard. The use of ISO 9000 in this book is not an endorsement of ISO 9000 over other systems. Rather, it is a practical decision based on the need to select one system to consistently illustrate the ideas contained in the book. 

ISO 14000 has been included in Exhibit 1-1 to illustrate its commonality with the ISO 9000 series. 

A cross-reference table for the requirements listed in Exhibits 4-2 and 5-1 and the ISO 9000 series is provided in Exhibit 1-1. Appendix A provides descriptions of each requirement of ISO 9004. 

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. 

International Organization for Standardization (ISO), ISO 9000 series. Quality Management Systems. 

The ISO 9000 series describes a quality management system applicable to any organization. In this chapter we present the requirements of the standard in a way that is as close as possible to the needs of analytical laboratories. The sequence of the requirements follows that in the ISO 9001 2008 standard. In addition, the guidelines for performance improvement set out in the ISO 9004 are reviewed. Both standards should be used as a reference as well as the basis for further elaboration. 

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. 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

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 movement by industry groups such as the ISO, which attempts to provide recognized standards for many industries, was also grounded in a systems approach with the publication and certification of ISO 9000 series and later with ISO 2000 9004 (www.iso.org), which is based on QMS establishment and eventually continuous improvements once processes become stable. 

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. 

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