Update of SOPs for ISO 13485:2016 / MDSAP

Marcelo

Inactive Registered Visitor
#21
To clarify, when you say "anyone", there are many qualifiers, no?

First, you have to go through a national member organization, and these, in turn, dictate the "technical committees" that are involved with development of specific standards. Do I have this correct?

The bottom-line is that, it seems (correct me if I'm wrong), to be involved in the development of a specific standard that you're interested in is not a simple matter for the vast majority of small-to-medium sized manufacturers.
I agree that being part of the ISO WG is not an easy task for most organizations.

However, you don't need to be a part of the ISO WG to be part of the development. The WG mostly drafts the text and revised it based on comments, but the comments (after the WD stage) are created by the National Committees mirror committees. So, if you are a member of your country NC mirror committee, you will receive the drafts and can comment. Membership of a NC mirror committee is usually open to interested parties, or they may have some kind of qualifier.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#22
Membership of a NC mirror committee is usually open to interested parties, or they may have some kind of qualifier.
My previous comment (reproduced below) referred exactly to that.

It seems that it has a lot to do with local mentality / culture. In some countries it's fairly easy to join in and contribute but in others it's practically impossible for the common person.
 
M

MikeKen

#23
Software validation and Software re-validation appears in 3 specific clauses -
  • 4.1.2 General Requirements (very general statement to computer software used in the quality management system)
  • 7.5.6 Validation (computer software used in production and service provision
  • 7.6 Control of monitoring and measuring devices (computer software used for the monitoring and measurement of requirements)

Software val/re-Val is required by various regulations today so it won't be anything new for some companies. It really break down into 3 key area

(1) Computer systems/software which are part of equipment. Software should be validation as part of the equipment qualification/validation.
(2) Spreadsheets used to support the QMS. Would need something like a Spreadsheet validation procedure.
(3) Computer Systems – standalone applications (e.g. ERP, eQMS, Minitab). This is the most complex area and Software validation expertise would be needed.

Hope this is a little helpful.
 

Sam Lazzara

Trusted Information Resource
#24
At the end of my SOPs I reference and quote all the relevant standard clauses associated with that particular subject - so I had to update this section specifically.
Steve
I recently cracked the 13485:2016 nut after much consternation.

Rather than cross-referencing to the standard clauses in each individual SOP, I prefer to manage the cross-references by placing them into a single document; in my case, it is the Quality Manual.

On a related note, for managing quality system process risks, rather than adding a Risk section to each SOP as some have suggested, I added a new section to my Quality Manual to address process risks, i.e. SOP risks. Since my Quality Manual already lists the SOPs, this makes sense to me. And by having all of the risk assessment and control information in this single document, it seems easier to manage than sprinkling risk assessment/control info into each SOP.

I have attached the front end of my new QM risk section, so you can see how I have formatted it. Any feedback is appreciated.
 

Attachments

Last edited:

Wolf.K

Quite Involved in Discussions
#25
The risk section in each SOP might have the benefit, that everyone who is working with a certain SOP (at least the process owner) (should) know(s) which risks exist. I think this is helpful to cover the "risk-based approach" requirements? Personally, I like the "risk-based thinking" approach in 9001:2015. We have flat hierarchies in our company, and an open discussion culture with no punishments for mistakes (but with punishments if mistakes are known put not reported). Therefore I think every employee should know the risks associated with the processes he/she is involved with. 13485:2016 does not require this, I know, but my gut feeling likes it!
 

Edward Reesor

Trusted Information Resource
#26
I was recently speaking with someone who has gone through a MDSAP audit and he strongly suggested I use the documents found on the FDA website as a template for our documents. Apparently, the audit format has changed and what is being used is essentially a checklist that follows the format of these documents (done/not done with non-conformity finding). There are no minor/major non-conformities but instead a numerical ranking system (and I believe section 6 is ranked stronger than section 4). As you stray away from conforming, the numbers add up like demerit points.

I was also informed that two auditors are in attendance, doing their respective parts and 20-30 non-conformities are not unheard of for an audit.

My lack of posts won't allow me to hyperlink or post the URL's, however they can be found my searching FDA and MDSAP. There is the program itself as well as a Companion document.
 

Sam Lazzara

Trusted Information Resource
#27
The risk section in each SOP might have the benefit, that everyone who is working with a certain SOP (at least the process owner) (should) know(s) which risks exist. I think this is helpful to cover the "risk-based approach" requirements? Personally, I like the "risk-based thinking" approach in 9001:2015. We have flat hierarchies in our company, and an open discussion culture with no punishments for mistakes (but with punishments if mistakes are known put not reported). Therefore I think every employee should know the risks associated with the processes he/she is involved with. 13485:2016 does not require this, I know, but my gut feeling likes it!
I agree that anyone involved with a quality system process should understand the risks imposed if the associated procedure is not followed.

For my approach where all of the risk information is included in a single document - the Quality Manual - I would ensure that all personnel are trained on the Quality Manual; something I did not require in the past.
 

Sam Lazzara

Trusted Information Resource
#28
I was recently speaking with someone who has gone through a MDSAP audit and he strongly suggested I use the documents found on the FDA website as a template for our documents. Apparently, the audit format has changed and what is being used is essentially a checklist that follows the format of these documents (done/not done with non-conformity finding). There are no minor/major non-conformities but instead a numerical ranking system (and I believe section 6 is ranked stronger than section 4). As you stray away from conforming, the numbers add up like demerit points.
My lack of posts won't allow me to hyperlink or post the URL's, however they can be found my searching FDA and MDSAP. There is the program itself as well as a Companion document.
Hello Edward,

I believe you may be referring to these documents established by the regulatory authorities involved with MDSAP to guide their activities.

Do I have this correct?

Interesting that the MDSAP participants are apparently operating under a QMS that they devised. It appears to be modeled after ISO 9001:2015.
Excerpt from Quality Manual: To enhance consistency, efficiency and effectiveness of day-to-day work, MDSAP has adopted a quality management system model derived from IWA 4 Quality Management Systems – Guidelines for the application of ISO 9001:2015 in local government.

If this is what you were referring to, from my perspective it is not a model that is consistent with ISO 13485:2016. And the obligations of a medical device manufacturer, for example, are quite different than the obligations of government entities running a compliance program.

My apologies if I have misunderstood, or perhaps have not yet found the documents you are referring to.

I do think the MDSAP documents are interesting to look at to "get ideas" to aid in the development or improvement of QMS documents for any type of organization.
 

Edward Reesor

Trusted Information Resource
#29
Hey Sam,
The URL you linked has a different number but was a link to the main page. Yours had the ending of UCM377582.pdf whereas the ones I were referring (probably buried in there somewhere, ended with:
UCM375697.pdf
UCM535976.pdf

That being said, I agree with you completely. Often our 13485 process is much more rigorous than what the government agencies ask for, however the information I was told was that the notifying body was using these MDSAP documents as templates for their audit checklist. My understanding is that the MDSAP checklist is the whip we have to jump to. Folding the new 13485:2016 expectations into that model is the way we plan on going.

One inconsistency we have had to respond to several times is that we chose to apply the highest standard to our SOP's that would exist among the several regulations that we conform to. For example, if a complaint response is 30 days in one jurisdiction, 60 in another and 90 in a third, we chose 30 days to cover all cases. It has been humorous to explain to the 90 auditing body why we go with 30 days when we can take 90.
 
Thread starter Similar threads Forum Replies Date
S How to enforce my colleagues to update SOPs? Document Control Systems, Procedures, Forms and Templates 4
A When will ISO13485 Update be Released? EU Medical Device Regulations 1
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M Trigger to update of TLL VDA Standards - Germany's Automotive Standards 0
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 3
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational Update on ISO TC 210 JWG 1 activities Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Digital Health Update: Mid-Year Update on Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
Marc Software Update 23 November 2018 Forum News and General Information 1
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
M Medical Device News TGA update 26-09-18 - Medical Devices Safety Update, Volume 6 September 2018 Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
Marc 2018 Software update - Donations Appreciated Forum News and General Information 21
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3

Similar threads

Top Bottom