Introduction

Two of the most important objectives in the revision of the ISO 9000 series of standards have been

  • To develop a simplified set of standards  that will be equally applicable to small as well as medium and large organizations, and
  • For the amount and detail of documentation required to be more relevant to the desired results of the organization's process activities.

ISO 9001:2008, Quality Management Systems - Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documentation.

 

ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

It is stressed that ISO 9001 requires (and always has required) a "Documented Quality Management System", and not a "System of Documents".

What is a Document? - Definitions and References

The following are some of the main objectives of an organization's documentation, independent of whether or not it has implemented a formal QMS;

(a) Communication of Information

As a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization's products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

(b) Evidence of conformity

Provision of evidence that what was planned, has actually been done.

(c) Knowledge sharing

To disseminate and preserve the organization's experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2005). It must be stressed that, according to ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of "document" in ISO 9000:2005 clause 3.7.2 gives the following examples:

  • Paper
  • Magnetic
  • Electronic or optical computer disc  
  • Photograph
  • Master sample

Users are also referred to ISO/TR 10013:2001, Guidelines for quality management systems documentation for further guidance.

ISO 9001:2008 Documentation Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to "establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard"

Clause 4.2.1 General explains that the quality management system documentation 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, and
  • Records required by this International Standard;

The notes after Clause 4.2 make it clear that where the standard specifically requires a "documented procedure", the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from on organization to another due to:

  • The size of organization and type of activities;
  • The complexity of  processes and their interactions, and
  • The competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.