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Update of SOPs for ISO 13485:2016 / MDSAP
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Update of SOPs for ISO 13485:2016 / MDSAP
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Update of SOPs for ISO 13485:2016 / MDSAP

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iso 13485 - medical device qms, revisions to a document or standard, risk management and analysis, risk management file (rmf), sop (standard operating procedure)
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  Post Number #1  
Old 23rd November 2016, 11:13 AM
Wolf.K

 
 
Total Posts: 71
Question Update of SOPs for ISO 13485:2016 / MDSAP

Hi,

I wonder how others are updating their SOPs/QSPs for the transition to ISO 13485:2016 (and/or MDSAP), regarding the risk management aspect(s).

I heard, that some people (1) just add a new chapter "Risk Management" to all SOPs and (2) update all other parts as necessary.

Have you already started with the transition?

Truly yours
Wolf
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  Post Number #2  
Old 23rd November 2016, 05:04 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,213
Re: Update of SOPs for 13485:2016 / MDSAP

While I have read the new standard, haven't started work on 2016 version yet ... plan to start mid 2017
  Post Number #3  
Old 28th November 2016, 07:33 PM
yodon

 
 
Total Posts: 1,156
Re: Update of SOPs for 13485:2016 / MDSAP

Haven't started the transition yet but have certainly been thinking about it.

I think it's important to keep the 13485:2016 definition of risk (and qualifiers) in mind. In 0.2 Clarification of Concepts, they say: When the term “risk” is used, the application of the term within the scope of this International Standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.

There is additional commentary on risk in Table A.1 (comparing 13485:2003 with 13485:2016):

Limits application of risk to the safety or performance requirements of the medical device or meeting applicable regulatory requirements.

The intent is clearly to keep the focus remaining on risk to the patients / end users. Not the broad "risk based thinking" in 9001:2015.

Given that, there are a few "themes" regarding risk in the standard (in addition to what I would consider standard product Risk Management per 14971):
  • (non-product) software validation - mentioned 3 times (4.1.6, 7.5.6, 7.6) - validation is to be proportional to the risk (of using the software)
  • purchasing (effectively cited in 4.1.5, 7.4.1, & 7.4.3) - ensuring suppliers posing the greatest risk get the greatest control, ensuring that non-fulfillment is managed based on risk, and that verification of purchased product is commensurate with the risk
  • feedback - ensuring that feedback is looped back into the product risk management process

There are a couple other mentions of "risk" in the standard:
  • 4.1.2 - take a risk-based approach to the control of processes in the QMS
  • 6.2 - assessing effectiveness [of actions taken to ensure competency of personnel] are proportionate to the risk associated with they work they are doing - which again would be scoped back to the risk associated with the product

While adding "Risk Management" to every SOP wouldn't necessarily be a bad thing (sounds like that's driving more towards the broad risk-based thinking in 9001), the focus to meet the standard needs to remain on risk associated with the product.

That's my take; would sincerely like to hear others' thoughts.
Thank You to yodon for your informative Post and/or Attachment!
  Post Number #4  
Old 30th November 2016, 10:03 AM
SteveK's Avatar
SteveK

 
 
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Lurker Re: Update of SOPs for ISO 13485:2016 / MDSAP

I have been updating my SOPs ISO 13485:2016. Under the Scope of each Procedure I have added this statement and clause reference (as alluded to by Yodon).

4.1.2b A risk based approach will be applied to the control of the appropriate processes within this Procedure.

Then in e.g. in my ‘Purchasing’ SOP, the criteria for evaluation and selection of suppliers has a bullet point – ‘All decisions will be proportionate to the risk associated with the final medical device.’ Similarly where other clauses reference ‘risk’ and fit in with an SOP I reference it.

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. All these SOPs will be kept in draft form; apart from a new "Software Validation" SOP which I have used in practice, as my next audit (early next year) will be to the old standard. I also reference the relevant clauses of ISO 9001:2015 (but not the text) - as I will try to retain both quality standards in my QMS.

Steve
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  Post Number #5  
Old 5th December 2016, 10:33 AM
Wolf.K

 
 
Total Posts: 71
Re: Update of SOPs for ISO 13485:2016 / MDSAP

Thanks, Steve!
  Post Number #6  
Old 9th December 2016, 10:04 AM
cdhoopes

 
 
Total Posts: 2
Re: Update of SOPs for ISO 13485:2016 / MDSAP

Our updates will start in January 2017. Like Steve, we are going to try meeting both 9001:2015 and 13485:2016 (and 21CFR820) as we are working on both medical and commercial products.

Carol
  Post Number #7  
Old 9th December 2016, 06:22 PM
gretzles

 
 
Total Posts: 18
Re: Update of SOPs for ISO 13485:2016 / MDSAP

We are not accredited to 2003, so I am implementing 2016 from scratch. My plan is to do something like a failure modes analysis for each process as a way to identify control measures.

When processes are updated we would revisit the risks to see if any new risks are being introduced.

Audit findings, non conformances or complaints may also require risk documents to be updated (if occurrence has increased or new risks identified)
  Post Number #8  
Old 20th December 2016, 05:26 AM
shruti_hiregange

 
 
Total Posts: 32
Question Re: Update of SOPs for ISO 13485:2016 / MDSAP

Hello Everyone,

Has anyone done a risk assessment specific for the following section to demonstrate compliance to the revised ISO 13485 standard:

Quote:
Clause 6 Resource management
6.2 Human Resources

The methodology used to check effectiveness of a training is proportionate to the risk associated with the work for which the training or other action is being provided.
If yes then would FMEA be the right technique to evaluate the risks associated with ineffective training?
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