Control of Documented Information QnA

•       Why the 'Control of documented information QSP' does not contain any forms?

The 'Control of Documented information’ Procedure (that you have purchased) regulates the Documented Information Management activities in full compliance with ISO 9001: 2015.

Here is the additional information regarding the Documented Information Format.

1) ISO 9001:2015 does not contain any requirements as for the Documented information format

2) ISO 10013 recommends that the format of the documented information is the Organization’s own decision.

3) It is a good practice to use 5 W method when developing the document (the document is considered self-sufficient if it answers the following 5 questions:

- WHAT to do?

- HOW to do it?

- WHO does it? (distribution of responsibility and authority)

- WHERE to do it?

- WHEN to do it?)

As defined in ISO 10013, it is a decision of the Organization to define the amount and the structure of the documented information (document titles, their number, detailed descriptions, etc.).

•       What are the required records for cl. 7.5.1.a and cl. 7.5.1.b of ISO 9001:2015?

ISO 9001:2015 7.1.5  General: ‘The organization’s quality management system shall include: a) documented information required by this International Standard; b) documented information determined by the organization as being necessary for the effectiveness of the quality management system. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: — the size of organization and its type of activities, processes, products and services; — the complexity of processes and their interactions; — the competence of persons.’

In ISO 9001:2015 7.5.1.а the documented procedures (traditionally called Level 2), execution of which implements the requirements of the Standard are discussed. A good practice, that started with the version of ISO 9001:2000,  shows that to meet all the requirements about 17 Documented Procedures are necessary. They are listed in the Program of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation (the Program is available for free download from our site).

ISO 9001:2015 7.5.1.b talks about a lower level Documented information (it is traditionally called Level 3), including that provide the details for the Procedures mentioned above, and other documents, that are used by the Organization. A good practice is to link the different levels of documentation via references:

- In Quality Manual (Level 1) to Documented Procedures (Level 2);

- In the Documented Procedures (Level 2) to the Level 3 documents.

This makes it possible to interconnect all the QMS Documented information.