Clause 4.2.1 in ISO 9000 Standards requires quality management system documentation to include 5 types
of document:
(a) Quality policy and objectives
(b) Quality manual
(c) Documented procedures
(d) Documents needed to ensure the effective planning, operation and control of processes
(e) Records
Other than the requirements in clause 4 for documentation, there are 14 other references requiring documentation. These are as follows:
(a) The output of the planning
(b) The quality manual
(c) A documented procedure for document control
(d) A documented procedure for the identification, storage, retrieval, protection, retention time and disposition of records.
(e) Planning of the realization processes
(f) Inputs relating to product requirements
(g) The outputs of the design and development process
(h) Design and development changes
(i) The results of the review of changes and subsequent follow up actions
(j) A documented procedure for conducting audits that includes the responsibilities and requirements
(k) Evidence of conformity with the acceptance criteria characteristics of the product
(l) A documented procedure for nonconformity control activities
(m)A documented procedure for corrective action
(n) A documented procedure for preventive action
This list is somewhat inadequate for documentation purposes because it does not tell us what types of things we should document or provide criteria to enable us to decide what we need to document. ISO 9000 clause 2.7.2 includes a more useful list of document types that are classified as follows:
(a) Quality manuals
(b) Quality plans
(c) Specifications
(d) Guidelines
(e) Procedures, work instructions and drawings
(f) Records
ISO 9001 Standards In General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management systemis influenced by
— its business environment, changes in that environment, or risks associated with that environment,
— its varying needs,
— its particular objectives,
— the products it provides,
— the processes it employs,
— its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to the
product, and the organization’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.