Although the Standard is copyrighted, and we cannot provide a copy here, we have summarized the major requirements of the standard. For critical decision making, be sure to refer to the actual Standard, which can be ordered from ASQ on-online.

4.0 Quality management system

4.1 General Requirements

The Quality Management System (QMS) is the collection of processes, documents, resources, and monitoring systems that direct the work of an organization regarding product and service quality. The organization needs to establish, document, carry out, and maintain this system to  meet the requirements of ISO 9001:2000.

4.2 Documentation requirements

4.2.1 General

The organization needs to document either electronically or on paper the quality policy, quality objectives, and quality manual. Written procedure, plans, and operations need to describe how product and service quality is attained. Certain records, providing evidence of activities that were carried out (i.e. purchase orders, sales contracts, inspection records, design review notes, etc.), have to be retained

The quantity, detail, and form of the documentation can differ from one organization to another depending on size, type of activities, or complexity of processes.

4.2.2 Quality manual

The quality manual describes the extent of the QMS and may exclude certain sections of the Standard that don't pertain to the organization. All of the quality procedures are either included in the quality manual or are referenced by it. The interaction between processes making up the QMS is also described.

4.2.3 Control of documents

All of the documents in your QMS must be legible, identified, reviewed, authorized, up-to-date,  issued, distributed, and periodically updated. Obsolete documents have to be identified and protected from unintended use. Documents that come from outside the organization also have to be identified and controlled.

4.2.4 Control of records

Certain records need to be kept to demonstrate how the QMS is operating. These records must be legible, and  easy to identify and retrieve. A written procedure must describe how they are identified, stored, protected, retrievable, and define their retention and disposal times.

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