Document control is one of the most important parts of the QMS. ISO 9001 as well as AS9100 emphasized this part of the system.
This article will support you in implementing a document control procedure that is efficient and meet ISO and AS requirements.
ISO9001/AS9100 DOCUMENT CONTROL REQUIREMENTS
ISO 9001 and AS9100 covers document control requirements in clause 7.5 :
“Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).”
It is also worth noting that ISO9001 or AS9100 promote lightweight and scaleable document control procedure based on the scale of the organization:
“The extent of the QMS documented information can differ from one organization to another due to the:
a) size of organization and its type of activities, processes, products and services;
b) complexity of processes and their interactions
c) competence of persons”
In addition to that, all customers have their own requirements which are mostly in-line with AS or ISO but they may add specifics to certain items (eg: record retention periods, customer change notice, …).
HOW TO ADDRESS AS/ISO REQUIREMENTS
In my opinion, this is one of the areas where as QA members we need to come up with efficient ideas to meet the ISO/AS requirements while keeping the system agile. From the different experience or QMS benchmark I could witness, the difficulty is not to develop a complex system that will satisfy all requirements (making rules is very easy) but rather :
- how to ensure that all these rules will be followed and respected;
- how to avoid bureaucracy;
- how to avoid complex approval loops;
- how to instill the TPS culture of standard work (where updating/making documents is not a burden);
Your document control system shall cover the below points :
- Appoint who will be the document control owner. This person will ensure that documents are meeting the procedure requirements, provide sequential numbers, support originators with the templates to use and rules, organize the document control library and access levels (eg: shared drive, Sharepoint, dropbox, google drive), etc.
- Develop a document control procedure that will cover all the requirements (details to be shared below)
- Establish a document control tracker
- Develop templates for at least procedures and instruction. If possible for forms and visual aids.
- Train your company members or at least inform them they should seek support from the document control specialist.
As you may appreciate the items 1, 3, 4, 5 above are straight forward and can be within the same day with some experience. Item #2 will require some consideration as it will explain how you approach the document control.
To support you with this task, you can head directly to the download link at the bottom of this post and obtain your copy of the document control procedure and 5 related templates. If you wish to develop your own procedure,
DOCUMENT CONTROL PROCEDURE REQUIREMENTS
In case you would like to develop your document control procedure from scratch or further improve an existing procedure, below are the attention points from AS9100 and ISO9001 to consider:
- The procedure shall explain how the documents will be numbered. While AS/ISO does not provide details about numbering, a common practice is to have a numbering system that encompasses the process number, document type, incremental number, and revision number.
- The approval process ensures the right approval levels based on the document type and/or change content.
- The way revisions will be controlled and disseminated
- The way documents will be made available in the point of use: electronically, hard copy. If hard copy, how they will be controlled.
- How to ensure consistency between all QMS documents (using templates)
- How will you control that the content is not altered?
- How to manage external documents?
- How to manage the retention period and record retention?
- Management of obsolete documents and retirement
Download our ready-to-use Document Control Procedure which includes the procedure but also 5 templates for procedures, work instructions, visual aids, document control tracker. These documents are meeting AS/ISO requirements and will require a little adjustment to be adapted to your organization’s QMS.
For further resources related to AS9100 Rev D or ISO9001:2015 implementation, refer to the below posts: