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  • 1.  Adding Revision Years to Standards in Procedures

    This message was posted by a user wishing to remain anonymous
    Posted 16 days ago
    This message was posted by a user wishing to remain anonymous

    Is it a requirement to add Revision years for standards that you're referencing in a procedure?  For example, we heavily reference the ISO 13485 Standard in our procedures, should we also add the latest rev date: ISO 13485:2016. I see the benefit in either argument, I just want to find out the best practice for something like this. 



  • 2.  RE: Adding Revision Years to Standards in Procedures

    Posted 16 days ago

    There are two conventions. Without the revision you are referring to a generic version. For example, "ISO 13485 provides requirements for a medical device QMS".

    More often you are referring to a specific version. If your procedures refer to the standard, it should be the specific version, which is ISO 13485:2016, since this includes the requirements you are following.

    If you market your device in the EU, then your QMS must follow the EU requirements in EN ISO 13485:2016/A11:2021. You need to be clear about whether your QMS implements the international version or the EU version.

    In most cases, it is best not to refer to the standard. The procedures should tell the people involved how to perform the associated process. The reference to the standard doesn't add value or improve the effectiveness of the procedure. It only creates a need for massive revisions when the standard changes.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 3.  RE: Adding Revision Years to Standards in Procedures

    Posted 15 days ago

    Hello Anon,

    This is one of those "touchy" subjects with differing opinions.  In the "Scope" of a procedure defining the regulatory requirements or other criteria which are being met, I would put the year or revision of the standard.  The reason being is a reader of the document knows in what context of regulatory requirements are being met.  It is quite normal for external auditors wanting the year or revision specified so they are assured the organisation is following the correct version.  For some conditions too, you will also want to make sure the Scope of the procedure includes all relevant standards, i.e. ISO 13485:2016 (for international) and EN ISO 13485:2016 + A11:2021 (for Europe).



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 4.  RE: Adding Revision Years to Standards in Procedures

    Posted 15 days ago

    I have had many arguments with auditors over the years on this one. Here is my position:

    You have so many references to standards, there will be always be one missed or where the date is mistyped and so not detected for correction

    Our quality manual (higher level document than SOP) instructs individual to always check with company standards list for version currently in effect. We have quarterly standards meeting at which we determine whether a new standard should be accepted and purchased. Our view is that a new standard is not de facto "the state of art" because many standards are rapidly amended and as a "rule of thumb" we expect to see 12 months of use, without correction, by at least 10% of our benchmark cohort.

    IMHO As standards committees have fewer industry and more regulator members, the appropriateness and useful of standards to industry has deteriorated and it is not uncommon for standards to be published that conflict with best practice.

    So I would say state you position in a high level quality document and stick to it!

    Good luck!

    Neil



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    Neil Armstrong FRAPS
    MeddiQuest
    Peterborough UK
    Waterford Ireland
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  • 5.  RE: Adding Revision Years to Standards in Procedures

    Posted 13 days ago

    In response to:

    "IMHO As standards committees have fewer industry and more regulator members, the appropriateness and useful of standards to industry has deteriorated and it is not uncommon for standards to be published that conflict with best practice."

    I would have to disagree with that statement in the majority of standards committees I am involved in primarily IEC / TC 62 - "Medical equipment, software, and systems" there is a lot more industry involvement, test labs, consultants from industry, and not as many regulatory bodies including NBs involvement.  Some of the ISO / TC 210 - "Quality management and corresponding general aspects for products with a health purpose including medical devices" Working Groups have a higher percentage of regulators I still think there are more industry than regulators involved.  It is really hard for many regulators to be involved in standards development and you see them more involved in organizations like IMDRF and GHWP.

    As a reference point I am heavily involved in standards development and have been involved for the last approximately 20 years.  See my IEC, ISO, AAMI involvement on my LinkedIIn profile linkedin.com/in/leoeisnersafetyconsultants.



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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
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  • 6.  RE: Adding Revision Years to Standards in Procedures

    Posted 15 days ago

    Hi, 

    Another option is to not state the year/version, but have a separate Regulatory Intelligence SOP that states that any reference to standards refers to the current one. And any new/updated standards/regulations are identified and assessed according to that Reg Intelligence SOP (which establishes a documented procedure to review and amend any SOPs/templates/protocols/reports that would require to comply with any gaps identified). That's how we have justified to auditors why we don't reference to specific year/amendment of a specific standard. 

    For CERs and TRs though we have included the years/versions since the reports reflect a specific result in a specific timeframe.

    Hope this helps,

    Daniela



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    Daniela Mahan Soler Esq, RAC
    Quality and Regulatory Affairs Manager
    SurgVision GmbH
    Munich
    Germany
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  • 7.  RE: Adding Revision Years to Standards in Procedures

    Posted 13 days ago

    Also, agree it is a really good practice to be monitoring not just for standards that update but also regulations, guidance, directives, laws, etc. that apply to products and this is something we try to explain to clients all the time.  One of the first steps we work with almost all of our clients.  Know the product, the intended use, what markets you want to go into and then you can come up with your product requirements as without all this background info the requirements will be lacking in a significant amount of information and also your regulatory strategy may have a HUGE hole in it if you don't know which way to sail the ship.



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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------



  • 8.  RE: Adding Revision Years to Standards in Procedures

    Posted 14 days ago

    The omission of the year/ edition of either standards or guidances may be listed as a deficiency in the NB Deficiency Report (QMS, CE certification). If an earlier version of the standard was used in V&V rather the current version then the Gap Assessment is also expected by the NBs. 

    One document listing all standards, guidances and regulations with their version numbers/ year/ editions, is a recommendation that I make to clients as best practice. 



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    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
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