Regulatory Open Forum

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

The rule of thumb is that references to the standard in general, don't require the year, but references to the specific version do.

For example, "ISO 14971 covers medical device risk management".

However, a company does not implement a standard in general, but a specific version. A company should say it has implemented ISO 14971:2007 or EN ISO 14971:2012. In this system, think of the year as the revision. It is also important to include the "in-between" changes. EN ISO 13485:2016 is not the same as EN ISO 13485:2016/AC:2018.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 30-Jul-2018 10:19
From: Mike Kilkelly
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

We have a controlled standards list that our QM refers to, and in that list we specify the standard's year/revision that we are currently claiming compliance with.  Our procedures refer to the relevant standard(s), but not the year/revision.  This way when standards are revised, we only need to revise one document and not dozens.

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Original Message:
Sent: 30-Jul-2018 13:32
From: Dan O'Leary
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

The rule of thumb is that references to the standard in general, don't require the year, but references to the specific version do.

For example, "ISO 14971 covers medical device risk management".

However, a company does not implement a standard in general, but a specific version. A company should say it has implemented ISO 14971:2007 or EN ISO 14971:2012. In this system, think of the year as the revision. It is also important to include the "in-between" changes. EN ISO 13485:2016 is not the same as EN ISO 13485:2016/AC:2018.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 30-Jul-2018 10:19
From: Mike Kilkelly
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

As usual, Dan's advice is spot on.  Pushing this a little further, I would recommend referencing the specific version standard(s) generally only in your Quality Manual so that it is clear upon which one your Quality Management System (QMS) is developed.  If there is need for a reference within your SOP's to a version-specific element or requirement, maybe especially if it was a change from a previous version to which you want to call attention, then you could add that standard's version.  Alternatively, I would recommend moving away from having lots of references to the standard throughout your QMS and, rather, centralize the structure to those standards within the Quality Manual, to minimize the number of scrubs you have to do on the entire QMS when standard versions change.  Make sense?

------------------------------
Rem Siekmann MBA, ASQ CBA
Senior Principal Engineer
Bellaire MI
United States
------------------------------

Original Message:
Sent: 30-Jul-2018 10:19
From: Mike Kilkelly
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

I agree with Dan and Rem, although in addition I would say that it is helpful to have the version and year mentioned in the internal documents to ensure that anyone using that document is aware of updates to referenced standards.

------------------------------
Jean Bigoney PhD, RAC
Regulatory Affairs Specialist
Murphy NC
United States
------------------------------

Original Message:
Sent: 30-Jul-2018 10:19
From: Mike Kilkelly
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

​Hi Mike.

Let me throw out some practical issues that sort of (I think) prove Dan and Rem's points.

If you don't reference a version then the inspection team (FDA, NB, etc.) will almost always expect that your system is compliant with the then current version of the standard.  The rub is that if a standard has changed since your system was developed (even if it is only a few months into the new version) it could be found as a deficiency if the system is not entirely set up to manage any changed requirements from the prior version.  You might be able to explain that during an audit but would you really want to since it is relatively simple to fix the problem in general by simply being a little more specific as regards to what you have based your system upon?

Second, in relation to Rem's comment about centralizing references, I always like the idea of essentially creating an SOP on reference documents or standards.  That way, anywhere you would reference a particular standard or document, you simply reference SOP XXX - Standards and other reference documents.  The SOP can then be broken down into "types" of standards or reference documents based on which part of your QMS the standard or document is linked to.  Then you simply reference all of your references to one SOP and it is far simpler to keep a single document clean and updated than it would be for multiple SOPs to require updating every time you decided to update your system (or any procedure for that matter) to a newer version of the standards.  Consider also the potential for questions when you have the same standard referenced in 12 procedures but only changed 11 of them (missing 1 entry) - that again becomes a discussion/defense you probably don't want to deal with during (or in response to) an audit and the findings.

I don't know what is the "best" way but I have found in several companies I have worked for that this process of having a centralized SOP that lists all of your references which can be broken out by different purposes for the standards has worked very well to avoid having to scour every SOP to ensure that the references are always the same reference version.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 30-Jul-2018 10:19
From: Mike Kilkelly
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Victor,

The idea of a Standards SOP seems like a ideal fix to the situation.  However, how do you overcome situations such as dating of your pertinent/critical SOPs?  For example, you have an SOP with an effective/released date in 2015, however, 13485:2016 is referenced in your Standards SOP?  We received this very question in our last EU 13485 compliance audit.  We were directed that year of your standard should be referenced within your SOP to show/prove a continuous iteration of compliance.  So if your SOPs are not updated or haven't been post 2016 with a least an up revision that says something to fact that the revision was to review continued compliance to 13482:2016, you may face an issue.  

Again, this is just the experience I have dealt with in the last year.


------------------------------
KATHERIN HARRIS
Regulatory Affairs/Quality Assurance Specialist
San Antonio TX
United States
------------------------------

Original Message:
Sent: 31-Jul-2018 08:41
From: Victor Mencarelli
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

​Hi Mike.

Let me throw out some practical issues that sort of (I think) prove Dan and Rem's points.

If you don't reference a version then the inspection team (FDA, NB, etc.) will almost always expect that your system is compliant with the then current version of the standard.  The rub is that if a standard has changed since your system was developed (even if it is only a few months into the new version) it could be found as a deficiency if the system is not entirely set up to manage any changed requirements from the prior version.  You might be able to explain that during an audit but would you really want to since it is relatively simple to fix the problem in general by simply being a little more specific as regards to what you have based your system upon?

Second, in relation to Rem's comment about centralizing references, I always like the idea of essentially creating an SOP on reference documents or standards.  That way, anywhere you would reference a particular standard or document, you simply reference SOP XXX - Standards and other reference documents.  The SOP can then be broken down into "types" of standards or reference documents based on which part of your QMS the standard or document is linked to.  Then you simply reference all of your references to one SOP and it is far simpler to keep a single document clean and updated than it would be for multiple SOPs to require updating every time you decided to update your system (or any procedure for that matter) to a newer version of the standards.  Consider also the potential for questions when you have the same standard referenced in 12 procedures but only changed 11 of them (missing 1 entry) - that again becomes a discussion/defense you probably don't want to deal with during (or in response to) an audit and the findings.

I don't know what is the "best" way but I have found in several companies I have worked for that this process of having a centralized SOP that lists all of your references which can be broken out by different purposes for the standards has worked very well to avoid having to scour every SOP to ensure that the references are always the same reference version.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 30-Jul-2018 10:19
From: Mike Kilkelly
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

In general, you don't need to identify the standard in the SOP unless you refer to it. In my opinion, it is a bad practice to list documents in an SOP unless the text of the SOP explicitly refers to the document. Your SOP should tell the user how your company implements a process or procedure. The user, typically, doesn't need to know if the process comes from 13485, QSR, or the combination of the two.

Including a standard in the SOP without a reference in the text makes the SOP cluttered and creates a document control problem.

If you reference a standard, then be explicit about its version. For example, does the QMS implement ISO 13485:2016 or EN ISO 13485:2016? An SOP about the Medical Device File would have different content depending on the version of standard. However, the SOP would not to state the version; I would put it in the Quality Manual or some associated document.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 31-Jul-2018 10:29
From: KATHERIN HARRIS
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

Victor,

The idea of a Standards SOP seems like a ideal fix to the situation.  However, how do you overcome situations such as dating of your pertinent/critical SOPs?  For example, you have an SOP with an effective/released date in 2015, however, 13485:2016 is referenced in your Standards SOP?  We received this very question in our last EU 13485 compliance audit.  We were directed that year of your standard should be referenced within your SOP to show/prove a continuous iteration of compliance.  So if your SOPs are not updated or haven't been post 2016 with a least an up revision that says something to fact that the revision was to review continued compliance to 13482:2016, you may face an issue.

Again, this is just the experience I have dealt with in the last year.


------------------------------
KATHERIN HARRIS
Regulatory Affairs/Quality Assurance Specialist
San Antonio TX
United States

Original Message:
Sent: 31-Jul-2018 08:41
From: Victor Mencarelli
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

​Hi Mike.

Let me throw out some practical issues that sort of (I think) prove Dan and Rem's points.

If you don't reference a version then the inspection team (FDA, NB, etc.) will almost always expect that your system is compliant with the then current version of the standard.  The rub is that if a standard has changed since your system was developed (even if it is only a few months into the new version) it could be found as a deficiency if the system is not entirely set up to manage any changed requirements from the prior version.  You might be able to explain that during an audit but would you really want to since it is relatively simple to fix the problem in general by simply being a little more specific as regards to what you have based your system upon?

Second, in relation to Rem's comment about centralizing references, I always like the idea of essentially creating an SOP on reference documents or standards.  That way, anywhere you would reference a particular standard or document, you simply reference SOP XXX - Standards and other reference documents.  The SOP can then be broken down into "types" of standards or reference documents based on which part of your QMS the standard or document is linked to.  Then you simply reference all of your references to one SOP and it is far simpler to keep a single document clean and updated than it would be for multiple SOPs to require updating every time you decided to update your system (or any procedure for that matter) to a newer version of the standards.  Consider also the potential for questions when you have the same standard referenced in 12 procedures but only changed 11 of them (missing 1 entry) - that again becomes a discussion/defense you probably don't want to deal with during (or in response to) an audit and the findings.

I don't know what is the "best" way but I have found in several companies I have worked for that this process of having a centralized SOP that lists all of your references which can be broken out by different purposes for the standards has worked very well to avoid having to scour every SOP to ensure that the references are always the same reference version.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 30-Jul-2018 10:19
From: Mike Kilkelly
Subject: Referencing Version (year) of standards in Quality Manual and SOP's

I'm interested in hearing what people think about how standards are referenced in company quality manuals and SOP's.
Is it necessary for the reference to contain the year of issue or not? e.g's. refer to ISO 13485:2016 or just ISO 13485.. Company xyz maintains a risk management compliant to ISO ISO 14971 or need ISO 14971:2007 ?



regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------