Documented Information Procedures – What You Need To Know Ahead of The Deadline

ISO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that have not yet upgraded to the revised standard, the ISO 9001:2008 certification expiry date will soon be approaching.  Control of documents is an intrinsic element of ISO 9001: 2015 and with the transitional period set to end you should be aware of the need to maintain and retain. We explain how you can best manage documented information in this article.

Documented Information

Control of documents and records has always been key to a successful quality management system. Clause 7.5 of this updated standard addresses “documented Information”.  It is required that “documented information” be either maintained – in the case of procedures, or retained – in the case of records.

Procedures and records are therefore a vital part of a organisations quality system and good documentation practices are necessary when creating and maintaining documented information.

The following 5 general points are relevant to documented information created or completed:

  • documented information must be accurate
  • documented information must be written in a manner that ensures consistency
  • records must be filled out in indelible ink for long term legibility
  • handwritten entries must be made at the time tasks are performed
  • handwritten entries and should be legible

Avoiding Errors

Ideally errors should be avoided, but if an error dose occur, it is important how it is then handled. Amendments should always be made in a compliant manner;

  • place a single line through the error so that the original entry remains legible
  • record the correction close to the error
  • provide a brief comment with signature and date
  • in the event an entry was previously omitted, provide rationale for the delay
  • all fields on a record should have an entry even if it is ‘NI A’ thus indicating that not completing a field is deliberate
  • comments must be signed and dated where appropriate

It is the responsibility of an organisation to decide which documents and records are needed to demonstrate the effectiveness of the quality system and establish procedures to control this information. The aim is to ensure that only approved documentation is available and changes or modifications to this documented information are undertaken in a controlled manner.

We can assist you with quality, documentation and ISO related issues.  If you would like to have an initial discussion with us about the issues above then please feel free to contact us on 00353 52 61 76 706 or simply complete your details below and we will get back to you straight away.


About the Author
Christine McGrath
Regulatory Affairs Manager
Christine McGrath is the Regulatory Affairs Manager for the Pharm Regulatory team. She is responsible for scheduling all client projects and making sure we have the right people working on each project. She works with companies around the world on issues relating to registration of new medicines to managing technical and complex hurdles affecting existing marketing authorisations. Christine has extensive experience of regulatory procedures from working on the submission of clinical trials to managing the submission of a new active substance for a CEP with the EDQM. You can read more articles by Christine by clicking the link below.
Other articles by Christine