"As appropriate" in ISO 13485:2016

Marcelo

Inactive Registered Visitor
#11
For distributor who involves only storage and distribution, I think it is obviously not appropriate the following, unless otherwise required,
"e) implementation of defined operations for labelling and packaging;".

Even this case, is it required to document a justification?
As I mentioned, although the "document" was removed due to other reasons, the expectation was to have any justification documented. So yes.

The problem with the "obvious" stuff in an audit is that it's impossible to verify oif the something was not done because it was obvious or simply forgotten.
 
Last edited:
Elsmar Forum Sponsor

TWA - not the airline

Trusted Information Resource
#12
As I mentioned, although the "document" was removed due to other reasons, the expectation was to have any justification documented. So yes.

The problem with the "obvious" stuff in an audit is that it's impossible to verify oif the something was not done because it was obvious or simply forgotten.
Marcelo, though I can understand this, I must say that from the perspective of an auditee it is really annoying to have to comply with "expectations" that have not been adequately put in writing.
 

Marcelo

Inactive Registered Visitor
#13
Marcelo, though I can understand this, I must say that from the perspective of an auditee it is really annoying to have to comply with "expectations" that have not been adequately put in writing.
I understand your comment but , although I'm usually ok with the "Show me the shall" mentality, I don't think it should substitute good sense.

This is even truer in the case of ISO 13485:2016 which, due to several reasons, have SEVERAL inconsistencies - 29 the last time I counted - I 'm creating a table of those and may share it in the future.

But let's see one illustrative example - 4.2.3 says - "Medical device file - For..., the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements."

If you read only the requirement, what is one interpretation? "Documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements" seems to imply a kind of checklist that shows how each clause of the standard (and regulatory requirements) was implemented in which document (clause xx - document yy, clause aa - document bb).

However, fortunately in this case, the rest of the clause still shows the original expectation - this clause is the clause that was created for the DMR (we did create another similar clause in 7.3.10 for the DHF).

So, if you only look at the requirement of 4.2.3 as written, it's requiring, besides what is mentioned in the content, more stuff that does not make much sense. If you are using good sense, you would only have a DMR doe this. If not, you would have the DMR and compliance checklists. I would suggest to only have the DMR and argue about this inconsistency, if asked.

On the other hand, as I mentioned on my previous comment, even if the standard does not clearly state anymore that the justification in the case of not appropriate should be written, if you are asked during an audit, it would be impossible for the evaluator to conclude if the "obvious" stuff was really considered or only forgotten, if you don't write a justification. Please note that, for other similar cases (exclusions and non-applicabilities), the requirements for documented justifications are still there (in 4.2.2 a)), so again, I would suggest it makes sense to document the justification for the not appropriate requirements, even if the standards does not explicitly mentions so anymore (due to the inconsistency I mentioned).
 

TWA - not the airline

Trusted Information Resource
#14
Marcelo, I am all for good sense and I agree that it is good business sense to have a system that documents what you did in such a way that you can easily retrieve the information w/o having to rely on your memory (see also one of my earlier replies to the OP regarding resources).
However in the regulated industries there is a big difference between explicit "must have" requirements and everything else. E.g. if I must document a justification then this means I have to do it in each and any instant and if I forgot it in just one case then I have a deviation even if I can argue that for this specific case it was obvious. With "as appropriate" single incidents of missing written documentation can be explained when the decision was "obvious" and such a situation would therefore not be non-conforming. Of course I cannot work without having a process that defines how to document, but an auditor would at least have to find multiple instances of missing documentation that need to be explained in order to have a finding. I am looking at this a little bit like with some requirements in the CFR where an approval with date and signature is needed for some docs like the design input: you have documented all the relevant/necessary information but still are not compliant when the formal requirements are missing. Of course I cannot develop a product w/o documented design input, but if the requirement was to document the design input "as appropriate" maybe I could just file the paper napkin where the doc scribbled the "must haves" of a new product...
 

Marcelo

Inactive Registered Visitor
#15
With "as appropriate" single incidents of missing written documentation can be explained when the decision was "obvious" and such a situation would therefore not be non-conforming.
Not in the 2003 version of the standard.

I was just trying to point out that the change was due to a specific problem with the use of the "document" statement of the new version, not because it was deemed not necessary to document every justification. So, even the OP being correct in saying that the current version does not formally require documenting justifications for non appropriate, it does not mean that he should not do it. But obviously he (or anyone) can simply decide not to document because it's obvious.

Even then, I would suggest at least to think about how this "obvious" thing would be explained when someone asks how it obvious that the requirement is not required to:

- product to meet requirements;
- compliance with applicable regulatory requirements;
- the organization to carry out corrective action;
- the organization to manage risks.

Which are the other "requirements" for being or not appropriate as defined in 0.2 :p
 

Marcelo

Inactive Registered Visitor
#17
True, and therefore I would just stay with my old documentation system in that regard as this should already be compliant and "doing nothing" is a no brainer. But I might now start to argue in an audit when single instances of undocumented "obvious" would be declared to be a deviation.
Sure, but is it better than to simply write a statement of why it's not appropriate?

I understand the comment of balance of resources, but I would be more worried about risks. You may find that, depending on who your arguing with, your arguments might not work, even if true.

And I still point to the fact that if you follow 0.2, all requirements are appropriate if they are needed to meet requirements, or compliance with regs, or corrective action, or to manage risks. I think it would be very difficult to justify that anything is "obvious"related to those.
 

TWA - not the airline

Trusted Information Resource
#18
Marcelo, as I already posted I also find it easier to just write it down and be done. And I would never set up a system that tells people it is oK to not write it down; that is why I stated I would not change a compliant system in that regard, even if a regulation might now be more lenient.
However, people are people after all, and therefore in real life even in your best processes sometimes mistakes happen (and auditors somehow have this unfailing intuition and always pick this one occurrence in 10000 where there is a problem). That is why it is important for me to know what exactly the regulation requires but also what not. As an auditee I cannot bring forward the argument of the "spirit" of the regulation, so why should a standard? I agree that I may not (always) win an argument even if I was right (and I actually indeed recall some instances where this was just the case), but it is somehow part of what makes me a professional (pain in the ass ;-)) in the medical device field that I not only focus on the product but also know the regulations on a level where sometimes I can actually "throw the gauntlet" and ask "show me the shall".
 

Marcelo

Inactive Registered Visitor
#19
(and auditors somehow have this unfailing intuition and always pick this one occurrence in 10000 where there is a problem).
My opinion is that the problem is not you forgetting to do 1 occurrence in 10000, but the auditor calling this a deviation. This is bad auditing (and I know we have a lot of bad auditors out there). Unfortunately, most auditors and organizations are too focused on finding this one occurrence to put in their reports and says that they work is being done, instead of focusing in the right and important stuff.
 
Thread starter Similar threads Forum Replies Date
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
S When is ISO 13485:2016 6.4.2 Contamination Control appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
Q Writing appropriate ISO 13485 Audit Report Findings Internal Auditing 15
apestate Job shop seeking QMS intends to manufacture devices, is ISO-13485 appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
Le Chiffre Is ISO/IEC 27001 appropriate for most small businesses? IEC 27001 - Information Security Management Systems (ISMS) 2
J Ethics Training and Policy appropriate for an ISO 17025 Testing Laboratory ISO 17025 related Discussions 4
B Appropriate ISO Clauses reference in Procedure Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Most appropriate ISO Standard for Design & Integration company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Customer Audit Finding against ?where appropriate? of ISO 9001, Clause 7.4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J How do you audit or interpret 'Where Appropriate' in ISO 9001 Clauses such as 7.4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Appropriate Equipment for ISO/IEC 17025:2005 Clause 5.6.3.3 - Intermediate Check ISO 17025 related Discussions 5
E What are appropriate deviations for a LHR/DHR? (Medical Device Company) Manufacturing and Related Processes 3
C ICP versus AA: How to determine appropriate specification for assay method verification Qualification and Validation (including 21 CFR Part 11) 1
K Please help identify appropriate statistical treatment Statistical Analysis Tools, Techniques and SPC 13
A Electric terminal crimping machines - Is SPC appropriate for this process? Manufacturing and Related Processes 4
W EU GMP Annex XI - What is an "appropriate QMS"? Other Medical Device Related Standards 2
F Appropriate Control Chart Statistical Analysis Tools, Techniques and SPC 5
N Taking exception to REACH Requirement - Appropriate Language REACH and RoHS Conversations 4
Q When does the FDA deem something "where appropriate"? 21CFR820.30(g) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S What is appropriate PPM level for a Plastic Injection Moulding Supplier Quality Tools, Improvement and Analysis 4
D What is the appropriate way to write a conclusion from a % contribution result? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Why customer satisfaction is not appropriate regulatory objective in medical device? ISO 13485:2016 - Medical Device Quality Management Systems 8
C What is the most appropriate Bioburden Test Method for Surgical Gloves ISO 13485:2016 - Medical Device Quality Management Systems 10
J Lean Appropriate KPIs for a Distribution Centre Lean in Manufacturing and Service Industries 1
I Is ARIMA (Time Series Analysis) Model appropriate for this Dental Research? Using Minitab Software 4
L Most appropriate Auditor to check the FMEA & PCP of a Manufacturing Process IATF 16949 - Automotive Quality Systems Standard 5
J Appropriate In-Process Monitoring Frequency for 2X per day Change Set-Up. Statistical Analysis Tools, Techniques and SPC 3
C Appropriate ways to address Competency? Generic vs Specific ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Appropriate use of the REF symbol in IVD kits and kit components Other Medical Device Related Standards 2
somashekar What is D&D Output for appropriate information for Production? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M 8.2.4.2 Appearance Items - When Masters for Colour, Grain, etc are not appropriate? IATF 16949 - Automotive Quality Systems Standard 6
D General Guideline for an appropriate Sample Size for measuring Cp and Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 11
D Appropriate Statistical Methods to set up an Alert/Warning Limit Quality Assurance and Compliance Software Tools and Solutions 15
B What is the Appropriate Sample Size for a Customer Survey? Customer Complaints 5
J The appropriate Attribute MSA for Automatic Visual Inspection Machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J Appropriate Test Environments for In-Glass Liquid Thermometer Calibrations General Measurement Device and Calibration Topics 2
R How to select appropriate standards for Multi-Functional Physical Therapy Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
T Appropriate Lean Six Sigma Green Belt Project Proposal? Six Sigma 10
I ASQ CQT Exam - Appropriate study time and best resources recommendations Professional Certifications and Degrees 8
T Determining the appropriate Sample Size using an AQL Table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 29
B Appropriate Standards for Food Packaging Adhesive Manufacture Food Safety - ISO 22000, HACCP (21 CFR 120) 7
O Can anyone recommend appropriate standard for Reliability Testing of Cables Other Medical Device Related Standards 3
C What is the most appropriate MSA (Measurement System Analysis) Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
C What is the appropriate DPPM for to be used In-Process Inspection Other Medical Device Related Standards 2
S Pp/Ppk & Cp/Cpk - Which is appropriate for Long/Short Term Study? Statistical Analysis Tools, Techniques and SPC 20
K Recommendations for an appropriate Recorder used at low temperature (Below 500?F) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M z Test vs. F Test - The most appropriate for comparing the Variances Statistical Analysis Tools, Techniques and SPC 3
C Starting an MSA study - How to decide which is appropriate or required Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
somashekar Hazardous Waste: Is this an appropriate interpretation Miscellaneous Environmental Standards and EMS Related Discussions 1

Similar threads

Top Bottom