ISO Requirements or Good Documentation Practices?

 

Calibration

Question

Are these standard for ISO or just good documentation practices?

1. All entries, except IPQA, should be made with blue ball pen in clear and legible handwriting.
2. IPQA entries shall be done in black ball pen.
Answer

I can sense what it is happening at the place where this question originated. In the past, I saw a company where the person in charge of the Quality System was saying “this is a ISO requirement” to enforce what in this person’s opinion was a best practice. Nobody questioned those statements because “it is an ISO requirement”. So, the answer to the question is, those are best practices, not ISO requirements. Please see below the ISO 9001:2015’s clause pertaining to this question.

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:

  1. a)       it is available and suitable for use, where and when it is needed;
  2. b)       it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:

  1. a)       distribution, access, retrieval and use;
  2. b)       storage and preservation, including preservation of legibility;
  3. c)       control of changes (e.g. version control);
  4. d)       retention and disposition.

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations.

NOTE  Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.

As you can see, no reference to any ink color whatsoever. Legal documentation tends to be completed by using blue ink to differentiate originals from Xerox copies. However, today’s technology allows us to have color copies.

Regards,

Aura Stewart

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