Organizations certified for compliance with ISO 9001 certainly know very well the requirements of clause 7.5 “Documented information”. It is the essence of the requirements for document management. On the other hand, organizations certified with IATF 16949 standard must additionally meet the extended requirements of the above-mentioned point.
What is documented information?
Documented information is information, i.e. its content and its media, e.g. paper or electronic.
Requirements in the quality management system regarding document management
A certified quality management system must contain the documented information required by ISO 9001 and IATF 16949. Here are some of the most important requirements gathered from the requirements of these two documents:
- documented information in the system is the information that the organization has deemed necessary for its effectiveness.
- documentation should have adequate identification, description, format and media.
- documented information must be reviewed and approved for suitability and adequacy (also during changes to it).
- it must be controlled so that it is available for use when needed.
- should be secured to maintain, for example, confidentiality or integrity.
- the organization should establish methods for distribution, access, retrieval and use of records, and storage.
The QMS documentation is of key importance for the functioning of the organization. This can take the form of procedures, process flow diagrams, process descriptions, inspection plans, work instructions, etc. It is important that the document is identified and controlled when creating these documents. This is to ensure its adequacy and usefulness. However, the method of control depends on the organization.
Documented information in IATF 16949
The requirements of ISO 9001 standard are expanded in IATF 16949 by the following points:
220.127.116.11 Documentation of the quality management system – we can find here, among others obligation to have a quality book,
18.104.22.168.1 Keeping records – the requirement, inter alia, records retention policy,
22.214.171.124.2 Technical documentation – here it will be, among others on managing changes in such types of documents as standards or technical specifications of the client.
Documented information – tips
- define where the document is to be located,
- train staff in its use,
- include new procedures or instructions in standard workplace training,
- determine if the instructions are adequate and effective,
- check if documented information is available,
- make sure each controlled copy is legible and complete,
- how do you secure outdated documented information,
- only the current version of the document shall be available.
Managing documented information is not something you do to get audited. It is a systemic action aimed at increasing the value of the organization by helping to standardize and control business processes. Therefore, as a system, it must be planned, built and used strategically as an indispensable element of the QMS. Otherwise, it will not bring the intended value.
Get the list of IATF clauses related to documented information
I have compiled documented information in a complete list for you which you can download under this article.
Hope you found this article interesting.
Thank you for your presence.
Agata Lewkowska Ph.D.
PS. If I can help you with quality management issues, please contact me. You may also join me in my private group on Facebook: ISO 9001 & IATF 16949 QualityWise Group.
For people who want to know more:
IATF 16949: 2016 Requirements for quality management systems in serial production and the production of spare parts in the automotive industry, 1st edition, 2016
ISO 9001:2015 Quality management systems — Requirements
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