Documented Information Required by ISO 9001:2015
Documented information is broken up into two types, documents and records. A form is a kind of document. When the form is filled out it becomes a record. Quality manual, policy, procedure or work instructions are other kinds of documents.
The specific documents and records you are required to control are listed in the table below.
|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 maintained documented information on the quality objectives.|
|188.8.131.52||Monitoring and measuring resources||Record||The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.|
|184.108.40.206 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.|
|220.127.116.11||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.|
The documented information listed above is required because it confirms that your QMS is maintained and effective. Documented information is also used as evidence of conformance, provides consistency in how a process is executed, assists with training and prevents loss of knowledge.
All documented information must be controlled. This means that you have a process for identifying, reviewing and approving documents as well as using an appropriate format and media for the contents of the documented information. You need to ensure the documented information is available for those that need to access it, is protected, version controlled and inactive/old versions are disposed of properly. In addition, a retention policy needs to be established for specifying the length of time you will retain your required records.
What processes should be documented?
If you have a complex or inconsistent process, it is highly recommended that it be documented. Also, consider documenting any process where only one employee knows how to execute. This protects the organization from loss of knowledge in the event that the employee no longer works at the organization.
It can be challenging to develop documented information to meet all the requirements. Our Quality Manual and Procedures package is a fully documented QMS used by hundreds of companies worldwide to successfully register to ISO 9001. Use this package as the foundation of your system, tailor the documents for your organization and benefit from the professionally designed processes while saving time.