Detailed Standard Description


ISO 9001

Quality Management Systems - Requirements
Release Date:
ISO 9001:2000 specifies requirements for a quality management system where an organization
  1. needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and

  2. aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
Superseeded By:
ISO 9001:2008
Inactive Date:

Standard FAQ


What documents need to be controlled in ISO 9001:2000?

According to the ISO 9001:2000 standard clause 4.2.3 states:

"Documents required by the Quality Management System shall be controlled.
Clause 4.2.1 states:
"The quality management system shall include:
  • documented statements of a quality policy and quality objectives
  • a quality manual
  • documented procedures required by this International Standard
  • documents needed by the organization to ensure the effective planning, operation, and control of its processes
  • records required by this International Standard"

What documented procedures are required by the ISO 9001:2000 quality management system standard?

For ISO 9001:2000 the required procedures are:

  1. Control Of Documents
  2. Control Of Records
  3. Internal Auditing
  4. Control Of Nonconforming Product
  5. Corrective Action
  6. Preventive Action

What is a controlled document?

A controlled is a document that must be controlled as to its revision level and distribution.

Do you think that organizations, which implement an ISO Quality Management System, do it for the benefits that compliance brings, or is it only for certification?

In my experience, I have found that a number of companies & organizations go for ISO certification only because they have to or it is a customer requirement to do business. For medical device manufacturers in the US, FDA GMPs, harmonized with ISO, are mandatory. Top Managements usually look primarily at their bottom lines and see ISO as an expense, not a benefit. They may hire a QA or Engineering Manager to be responsible for ISO enforcement, documentation, and compliance - but primarily to keep the companies out of trouble with customers, government, and regulatory auditors. Only token management support is provided and when they're caught in a non-conformance situation or with a deficient product, they expect the assigned compliance person to get them out of trouble.