ISO 9001 Control of Documents

ISO 9001 Control of Documents is the clause every QMS professional is most curious about. The common perception about ISO 9001 standard implementation and generally implementation of ISO standards is that they are documentation centric. However the case is otherwise, yes, documentation is necessary, but documents aren’t the only thing ISO 9001 emphasis on.

Here in this article we are going to understand the clause ISO 9001 Control of Documents. In ISO 9001:2015 this clause is referred as 7.5.3 Control of Documented Information. Previously, in the ISO 9001:2008 version this clause was ISO 9001:2008: Control of documents 4.2.3, this clause is now superseded by ISO 9001:2015 clause 7.5.3, which is “Control of Documented Information”.

Lets understand it clause by clause, see below clause:

7.5.1 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.

This clause mention two conditions for the documentation:

  1. ISO standard requires it / mandatory documentation
  2. The documentation specific to the management system of company

Furthermore, in the later notes of the clause mentioned that the documentation system may vary in organizations based on:

  1. the type and size of organization
  2. the nature of business
  3. the type of product / services
  4. how complex the processes are
  5. how complex is the overall industrial practices
  6. the competency of the workforces / personnel / staff

What kind of documents we need

The clause 7.5 documented information (in ISO 9001:2015) does not list down the required documents. However below are the type of documents we may need as per the industrial practices. We will publish the list of ISO 9001 mandatory documents in upcoming articles, but for now, lets talk about the type of documents we need:

  1. Policies
  2. Procedures / Standard Operating Procedures (SOPs) / Method Statements (MSTs) / Work Instructions / Safe Work Practices (SWPs) / Plans
  3. Memos / Notices / Letters
  4. Forms / Formats / Checklists
  5. Manuals
  6. Reports / Stats
  7. Log Books / Logs
  8. Contracts

These are some of the type of documents that we need when we are going to make documentation for ISO9001. After the overall documentation system is prepared and finalized, it is locked and becomes unchangeable, however if the change is inevitable, to change any documentation proper approval system will be followed.

In the next article we will discuss about the ISO 9001 list of mandatory documents

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