ISO 13485 - List of required / needed procedures and records attached

Mark Meer

Trusted Information Resource
#31
Question: is it necessary/recommended to maintain these as separate controlled documents?

If recommended, why?

It seems to me that, for example, "control of documents" and "control of records" would go nicely together in a single document control SOP.

Or another example might be workplace, infrastructure, maintenance and control of equipment all being contained in a single "Resource Management" SOP.

We've got a system where the number of documents is huge. A new SOP seems to be written everytime there is a new "documented procedure" requirement.
If I could start from scratch, it'd be nice to create a compliant system with a minimal number of documents to maintain....

P.S. also made a post in the EU MD sub-forum, where I may have (mistakenly?) jumped to the conclusion that separate documents are not required.
I think the discussion as to whether or not this is the case, or even recommended, best belongs in this thread though...
 
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Sam Lazzara

Trusted Information Resource
#32
Question: is it necessary/recommended to maintain these as separate controlled documents?
It seems to me that, for example, "control of documents" and "control of records" would go nicely together in a single document control SOP.
Or another example might be workplace, infrastructure, maintenance and control of equipment all being contained in a single "Resource Management" SOP.
Mark,

There is no right or wrong answer when it comes to this. How you design your quality system procedure structure is entirely up to you. My personal preference is to have fewer procedures that cover more ground. Since procedures typically fail in the white space between procedures (the interfaces) I have come to believe that fewer procedures leads to fewer conformance problems. Also, it is easier for users to "find" the procedures they need.

Currently, I am working with a comprehensive quality system document set that includes a Quality Manual (3 documents in my model) that calls out 21 SOPs maximum. All companies, regardless of business model need 17 of those SOPs. There was a time in my career when I covered the same requirements using 40 SOPs.

Your example of combining the control of documents and records (a type of document) into a single SOP makes sense to me. In fact, I have a single SOP called Documents and Records that covers all aspects of document and record control for internal and external documents; internal document types, numbering, change control, language translations; document archiving/retention; electronic data backup/security, etc. There was a time when I had 3 or 4 SOPs covering these same topics.

Here is a link that shows my current Quality Manual/SOPs by title, and how they cross-reference to ISO 13485:2003 and 21 CFR 820.
 
Last edited:

Mark Meer

Trusted Information Resource
#33
Thanks Sam. Nice to know that there are others who seek to create less documents.

All companies, regardless of business model need 17 of those SOPs
Again, the question is: are separate controlled procedural documents required for each? Why these 17?

For example, I see in your system you have "Suppliers" and "Purchasing & Receiving Inspections" as separate documents. For a simple company couldn't these be merged into a single "Purchasing & Supplier Control" document?

That's bring the count down to 16...
 

Sam Lazzara

Trusted Information Resource
#34
Hi Mark,

Are separate controlled procedural documents required for each?
No, separate procedures are not required to address the various requirements.
This is our chance to be creative in the design of our quality systems.
Just develop your own logic, don't miss anything, and be able to explain your mastery over the requirements and how you address them.

Why these 17?
Because it works for me; but that is definitely in the eye of the beholder.

The overall goal is not to minimize the number of procedures. If that was the case you could write a "Quality Manual" that embeds all of the procedures (and I have seen that done too).

On a related note, some of my logic for having separate procedures has to do with minimizing what I call "training baggage". For example, all company personnel need to understand their obligation to notify the QA unit about potential product complaints. Does that mean they need to know the details for how complaints are processed? Absolutely not. They just need to know about their basic obligation. I handle this by having a General Quality System Controls SOP that informs ALL personnel of this obligation and others. That way I do not need to train ALL personnel on the Product Complaints SOP, and when the Complaints SOP gets revised I have much less training baggage than I would if all personnel required retraining.

There is no single best way. What I have shown is just my preferred way. I have logic for why I separate procedures, but that is my logic. We all need to create our own path.
 

Ronen E

Problem Solver
Staff member
Moderator
#35
Question: is it necessary/recommended to maintain these as separate controlled documents?

If recommended, why?

It seems to me that, for example, "control of documents" and "control of records" would go nicely together in a single document control SOP.

Or another example might be workplace, infrastructure, maintenance and control of equipment all being contained in a single "Resource Management" SOP.

We've got a system where the number of documents is huge. A new SOP seems to be written everytime there is a new "documented procedure" requirement.

If I could start from scratch, it'd be nice to create a compliant system with a minimal number of documents to maintain....

P.S. also made a post in the EU MD sub-forum, where I may have (mistakenly?) jumped to the conclusion that separate documents are not required.
I think the discussion as to whether or not this is the case, or even recommended, best belongs in this thread though...
Hi Mark,

I think that if you dig deep enough you will find that initially the idea was to have one QMS document - the quality manual - which was divided into parts covering the various aspects of quality management. Then it evolved to including parts / processes by reference, hence the structure we are all familiar with today.

I appreciate Sam's approach for its efficiency. In a way it "industrializes" the process of creating a new QMS, and I estimate it is appropriate in about 80% of the cases. However, having worked with small start-up companies that are taking their first steps in establishing a QMS (some are specification developers, trying to penetrate their first market), I think that sometimes a more customised approach is more appropriate, and certainly sometimes far less than 17 SOPs are required (and not due to "forcing" unrelated topics together). Coming back to the single document (quality manual) notion helps me stay focused on what they actually NEED, both in terms of number of separate SOPs and the length of each.

Cheers,
Ronen.
 
A

Anoopnest

#36
Dear All,
Please find attached a list I prepared for the Procedures and records required for compliance with ISO13485:2003. If any one has any improvement, please share it.

Thanks
Hi,
We are a hardware design and development service company. we are planning to take ISO13485 certificate for our QMS.
Currently our QMS is ISO 9001: 2008 certified.
For Medical Hardware Projects, What are the Hardware artifacts (Documents) required for ISO13485 QMS Compliance?
 

Mark Meer

Trusted Information Resource
#37
Currently our QMS is ISO 9001: 2008 certified.
For Medical Hardware Projects, What are the Hardware artifacts (Documents) required for ISO13485 QMS Compliance?
If you are planning for ISO13485 compliance, I'd recommend purchasing a copy. There is a comprehensive table in the appendices detailing all the differences between 9001 & 13485.

If you're already 9001 certified, you've probably already got most requirements covered.
You'll have to add risk management, work-space controls...
...and of course any applicable regulatory documentation....

...to name a few things... but like I say, it's all in the appendices of the standard.
 
J

joylc

#40
Good post! Does anyone got an updated list for required SOP for ISO 13485:2016?
Here is the list I came up with:
4.1.6 Computer software for QMS validation
4.2.4 Document control
4.2.5 Control of records
5.6.1 Management review
6.4.1 Monitor/control of work environment
7.3.1 Design & development
7.3.8 Design transfer
7.3.9 Design change control
7.4.1 Purchasing
7.5.1 Production control
7.5.4 Servicing
7.5.6 Process validation (process software validation)
7.5.7 Sterilization validation
7.5.8 Identification
7.5.9.1 Traceability
7.5.11 Preservation of product
7.6 Monitoring & measurement (calibration, computer software for monitoring & measurement validation)
8.2.1 Feedback
8.2.2 Customer complaints
8.2.3 Regulatory reporting
8.2.4 Internal audits
8.2.6 Monitoring & measurement of product
8.3.1 Nonconforming product
8.3.3 Advisory notices
8.3.4 Rework
8.4 Analysis of data
8.5.2 Corrective action
8.5.3 Preventive action

A couple of sections call out the need for multiple procedures which is what the (comments) are showing. I am planning to lump all software validations into the process validation procedure.
 
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