ISO 9001 Documentation

ISO9001 Documentation refers to any information in whatever medium presented. This includes, but is not limited to, forms, software, reference guides, presentations, web-based information, etc... Documented Information refers to information that must be controlled and maintained. This includes the medium (i.e. the form itself) as well as the information (i.e. the record created when filling out the form). 

The information that is included in ISO 9001 Documentation shall include 1. documented required by ISO 9001, and 2. documents determined by the organization as being necessary for the effectiveness of the QMS. This includes documents of External Origin (i.e. User Manuals, Regulations, Reference Documents). Documents provide consistency of how a process is executed and protect the organization from loss of knowledge in the event of sudden employee turnover. 

he following is a cross-reference to every section of the 9001 Standard where ISO 9001 Documentation is required: 

ISO 9001 Documentation Clause	Topic	Type of documented information	Requirement
4.3	Determining the scope of the QMS	Document	The scope of the organization’s QMS shall be available and be maintained as documented information.
4.4.2 a	QMS and its processes	Document	To the extent necessary, the organization shall maintain documented information to support the operation of its processes.
4.4.2 b	QMS and its processes	Record	To the extent necessary, the organization shall retain documented information to have confidence that the processes are being carried out as planned.
5.2.2 a	Communicating the quality policy	Document	The quality policy shall be available and maintained as documented information.
6.2.1	Quality objectives and planning to achieve them	Document	The organization shall maintain documented information on the quality objectives.
7.1.5.1	Monitoring and measuring resources	Record	The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
7.1.5.2 a	Measurement traceability	Record	Measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standard exists, the basis for calibration or verification shall be retained as documented information.
7.2 d	Competence	Record	The organization shall retain appropriate documented information as evidence of competence.
7.5.1 b	Documented information	Document	The organization’s QMS shall include documented information determined by the organization as being necessary for the effectiveness of the QMS.
8.2.3.2	Review of the requirements for products and services	Record	The organization shall retain documented information, as applicable, on the results of review and on any new requirements for products and services.
8.3.2 j	Design and development planning	Record	The organization shall consider the documented information needed to demonstrate that design and development requirements have been met.
8.3.3	Design and development inputs	Record	The organization shall retain documented information on design and development inputs.
8.3.4 f	Design and development controls	Record	The organization shall apply controls to the design and development process to ensure that documented information of these activities is retained.
8.3.5	Design and development outputs	Record	The organization shall retain documented information on the design and development outputs.
8.3.6	Design and development changes	Record	The organization shall retain documented information on design and development changes and the results of reviews.
8.4.1	Control of externally provided process, products and services	Record	The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.
8.5.2	Identification and traceability	Record	The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain documented information necessary to enable traceability.
8.5.3	Property belonging to customers or external providers	Record	When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.
8.5.6	Control of changes	Record	The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.
8.6	Release of products and services	Record	The organization shall retain documented information on the release of products and services. The documentation shall include evidence of conformity with the acceptance criteria and traceability to the person(s) authorizing the release.
8.7.2	Control of nonconforming outputs	Record	The organization shall retain documented information that describes the nonconformity, actions taken, any concessions obtained and identifies the authority deciding the action in respect of the nonconformity.
9.1.1	Monitoring, measurement, analysis and evaluation	Record	The organization shall retain documented information as evidence of the results [of QMS performance evaluation].
9.2.2 f	Internal audit	Record	The organization shall retain documented information as evidence of the implementation of the audit program and the audit results.
9.3.3	Management review outputs	Record	The organization shall retain documented information as evidence of the results of management reviews.
10.2.2	Nonconformity and corrective action	Record	The organization shall retain documented information as evidence of the nature of the nonconformities and any subsequent actions taken and the results of any corrective action.