ISO 9001:2015 Documented Information
Documents and Records
The ISO 9001:2015 standard no longer uses the terms “documents” and “records”. Both are now called “documented information”. As per the ISO 9000:2015 definition, the term documented information refers to information that must be controlled and maintained. Therefore, it expects that you also maintain and control the medium as well as the information.
The key identifier of a record verses a document is that records are documented information that is “retained” and documents are documented information that is “maintained”. A form is a document, when the form is filled out it becomes a record. Both documents and records most be controlled following the requirements of the ISO 9001:2015 standard covered in clause 7.5.
What are the requirements for documentation in the ISO 9001:2015 standard?
Your documented information must include documents and records that are required by the standard and essential for your organization’s operations to be effective. ISO 9001:2008 required six specific procedures in order to be compliant. ISO 9001:2015 no longer requires procedures, but if your organization needs them to be effective, you must have them.
Documented information is used as evidence of conformance, provides consistency is how a process is executed, assists with training and prevents loss of knowledge. 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.
The following documented information is still required by the 9001 standard:
You are also no longer required to have a quality manual, but if you have one keep it. Your quality manual is your recipe book for how you manage quality in your organization. A quality manual similar to ours, can also serve as an introduction (or a table of contents) for the QMS.
Controlling documented information 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.
It can be overwhelming to know what documented information to include in your QMS and time consuming to developed. Our Quality Manual and Procedures package is a fully documented QMS used by hundreds of companies worldwide to successfully obtain ISO 9001 certification. 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.
Click here for a full list of all required documents and records.
Integrated-Standards.com has many tools to help you integrate ISO Standards in their existing format, which will be simplified with Annex SL.