Document Control is a critical component of a Quality Management System (QMS) that ensures all quality-related documents are properly created, reviewed, approved, distributed, and maintained. It helps organizations maintain consistency, comply with regulations, and prevent the use of outdated or incorrect documents.
Key Objectives of Document Control:
✅ Ensure Accuracy & Consistency – Documents should be up-to-date and properly formatted.
✅ Maintain Compliance – Adheres to industry regulations like ISO 9001, FDA 21 CFR Part 11, IATF 16949, etc.
✅ Prevent Unauthorized Changes – Only authorized personnel should approve revisions.
✅ Improve Traceability – Every document should have a clear revision history.
✅ Enhance Accessibility & Security – Documents should be available to authorized users while preventing unauthorized access.
Types of Documents in QMS:
- Policies – Define the organization’s commitment to quality (e.g., Quality Policy).
- Procedures (SOPs) – Outline step-by-step instructions for operations.
- Work Instructions – Detailed guides for specific tasks.
- Forms & Records – Templates for capturing data (e.g., audit reports, CAPA logs).
- Specifications & Guidelines – Technical details for products/services.
ISO 9001:2015 Requirements for Document Control (Clause 7.5):
An effective Documented Information System should include:
✔ Identification & Labelling – Documents should have clear titles, version numbers, and approval details.
✔ Storage & Protection – Documents should be stored securely (physically or digitally).
✔ Review & Approval Process – Documents must be reviewed and approved before use.
✔ Access Control – Only authorized personnel should make changes.
✔ Revision & Obsolescence Management – Outdated versions should be archived to avoid confusion.
Best Practices for Document Control:
🔹 Use a Document Management System (DMS) or Electronic Quality Management System (eQMS) (e.g. Cataligent) to automate document control.
🔹 Establish a document review schedule to ensure updates are made regularly.
🔹 Train employees on proper document handling and compliance requirements.
🔹 Implement electronic signatures for approvals to enhance security.
Thanks in support of sharing such a pleasant
thought, article is good, thats why i have read it fully
I just could not leave your web site before suggesting that I really enjoyed
the standard information an individual supply for your guests?
Is going to be again ceaselessly in order to check up on new posts
I blog quite often and I genuinely appreciate your information. This article has
truly peaked my interest. I will bookmark your website and keep checking
for new details about once a week. I opted in for your Feed too.
Pretty! This was a really wonderful post. Thank you for providing this
info.
It’s actually a nice and useful piece of information.
I am happy that you simply shared this useful information with us.
Please stay us informed like this. Thanks for sharing.
Very shortly this site will be famous among all blog people,
due to it’s nice posts
Oh my goodness! Incredible article dude!
Many thanks, However I am having problems with your RSS.
I don’t know the reason why I can’t subscribe to it. Is there anybody getting identical RSS problems?
Anyone that knows the solution will you kindly respond?
Thanks!!
Very good info. Lucky me I discovered your website by chance (stumbleupon).
I have book-marked it for later!
Howdy! I know this is kinda off topic nevertheless I’d figured I’d ask.
Would you be interested in trading links or maybe guest authoring a blog article or
vice-versa? My site addresses a lot of the same topics as yours and I think we could greatly benefit
from each other. If you might be interested feel free to send me an e-mail.
I look forward to hearing from you! Awesome blog by
the way!
Thanks for the message! I’m not doing link exchanges or guest posts at the moment, but appreciate you reaching out.
Howdy just wanted to give you a brief heads up and let you know
a few of the pictures aren’t loading properly.
I’m not sure why but I think its a linking issue. I’ve tried
it in two different internet browsers and both show the same outcome.
Thanks for the heads up! I checked on my side and everything seems to be loading correctly, but I appreciate you pointing it out.
Incredible points. Outstanding arguments. Keep up the good work.
We stumbled over here by a different page and thought I
might as well check things out. I like what I see so
i am just following you. Look forward to looking at your web page yet again.
Highly energetic post, I loved that bit. Will there be a
part 2?
Nice post. I was checking constantly this blog and I am impressed!
Very useful info particularly the last part 🙂 I care for such information much.
I was seeking this particular information for a long time.
Thank you and good luck.
Thanks for finally writing about > Document Control in QMS
– Cataligent < Loved it!
Thanks for your marvelous posting! I really enjoyed reading it, you may
be a great author.I will always bookmark your blog and will often come back
at some point. I want to encourage one to continue your great work, have a
nice holiday weekend!
It is not my first time to go to see this site,
i am visiting this web page dailly and obtain pleasant data from here everyday.
Hmm it appears like your site ate my first comment (it was super long) so I guess I’ll
just sum it up what I had written and say, I’m thoroughly enjoying your blog.
I as well am an aspiring blog blogger but I’m still new to everything.
Do you have any tips and hints for inexperienced blog writers?
I’d really appreciate it.
Thanks for reading! Glad you’re enjoying the blog. For new bloggers, the best tip is to stay consistent and write about what genuinely interests you
Great article! We are linking to this particularly
great post on our website. Keep up the good writing.