As records management professionals, we must constantly look for opportunities to increase our abilities. In so doing, we enhance our own positions, enhance the records management profession as a whole, and increase our contributions to the companies for which we work. At this time, there is an opportunity: ISO 9000 will impact almost all companies in North America, including those involved in manufacturing and providing services.
ISO 9000 is a series of international quality assurance standards. These standards established by the International Organization for Standardization, referred to as I.S.O. and pronounced I-SO, have been adopted by 55 countries, including the United States and Canada, as their own national standards.
Company executives and business owners are becoming aware of the importance of having their organizations' quality assurance systems registered to international quality assurance standards. Registration involves the audit, and approval, of a quality management system against ISO 9000 series standards, by an independent registrar, also known as a third-party registrar. Over 14,000 companies have been certified in Britain and another 20,000 companies have been certified in Europe, while only 700 company sites, or facilities, have been registered in the United States. Even fewer companies have been registered in Canada.(1)
GENERAL REQUIREMENTS OF ISO 9000
The ISO 9000 series of international quality assurance standards is a model for the management of a quality assurance system designed to ensure that, at a minimum, a series of steps are taken to make sure that a company satisfies its customers' requirements. It is the basis for the implementation and management of a quality assurance system. As such, it is not a technical (or engineering) document, but rather a generic document intended to apply to all different manufacturing industries and service companies.
The ISO 9000 standards generally require that a comprehensive quality assurance program be developed. This includes the purchasing function, the sales and marketing function and the human resources function, along with the functions that you would normally expect. This program must include continuing senior management review and internal audits.
Companies will not be allowed to get away with a good story! The program will have to be totally documented and the program will have to be carried out as documented.
Recordkeeping will be critical! The outside auditors, or registrars, will not accept subjective evidence of compliance. They will demand records and information to objectively show companies' compliance with the requirements. One registrar has stated that of those companies which have failed registration to date, 70 percent of them have failed because of inadequate record systems.(2) A quality assurance consultant noted that document control was a common weak link found during third-party audits.(3) Another consulting group indicated that poor document control was something that frequently let companies down, and was very important. Relevant paperwork and documents must be kept where they are needed so that people can use them to do their job right.(4)
More specifically, and quoting directly from one of the guidance standards, ISO 9004:
"The quality management system should establish, and require the maintenance of, a means for identification, collection, indexing, filing, storage, maintenance, retrieval, and disposition of pertinent quality documentation and records.
Policies should be established concerning availability and access of records to customers and suppliers. Policies should also be established concerning procedures for changes and modifications in various types of documents.
The system should require that sufficient records be maintained to demonstrate achievement of the required quality and verify effective operation of the quality management system. …