ISO 9000 Introduction and Support Package:
Guidance on the Documentation Requirements of ISO 9001:2008
1. Introduction
Two of the most important objectives in the revision of the ISO 9000 series of standards have been
a) to develop a simplified set of standards that will be equally applicable to small as well as
medium and large organizations, and
b) 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”.
2. 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.
ISO 9000 Introduction and Support Package:
Guidance on the Documentation Requirements of ISO 9001:2008
