"As appropriate" in ISO 13485:2016

Yasuaki

Starting to get Involved
#1
ISO 13485:2016 says in 0.2 Clarification of concepts,
"When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. "

On the other hand, ISO 13485:2003 said in 1.2 Application,
"When a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise."

So, ISO 13485:2016 seems not to require documenting a justification for not applying a requirement is qualified by the phrase “as appropriate”, which are required by ISO 13485:2003.

Could someone tell me whether this is correct?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
ISO 13485:2016 says in 0.2 Clarification of concepts,
"When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. "

On the other hand, ISO 13485:2003 said in 1.2 Application,
"When a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise."

So, ISO 13485:2016 seems not to require documenting a justification for not applying a requirement is qualified by the phrase “as appropriate”, which are required by ISO 13485:2003.

Could someone tell me whether this is correct?
Even if it's true, why take the risk? If you have a justification, document it and be done with it. When audit time comes you won't have to struggle trying to come up with what you thought or maybe explain inconsistency across staff's opinions. Instead, you'd only have to open the quality manual (or same) and look up the item. Too easy!

This way you also avoid the risk of your justification becoming outdated as the organisation changes, and going unnoticed. If it's documented it'll be subject to periodic review.
 

TWA - not the airline

Trusted Information Resource
#3
Quite true, but still the OPs question is valid, because it means that if in some cases you forgot to document the justification but can come up with one (whether or not it is the same one you initially thought of) during the audit you now can (and probably should) push back when this is considered to be non-conforming...
 

Yasuaki

Starting to get Involved
#4
Thank you Ronen E.

I agree with you if plenty resources are available.

But most of projects have less margin of resources.
In such cases, resources must be spent for improving important performances, risk reduction and complying with mandatory requirements intensively, not preferred things.

So, whether documenting the justification is mandatory or not is one of important questions.
 

TWA - not the airline

Trusted Information Resource
#5
Thank you Ronen E.

I agree with you if plenty resources are available.

But most of projects have less margin of resources.
In such cases, resources must be spent for improving important performances, risk reduction and complying with mandatory requirements intensively, not preferred things.

So, whether documenting the justification is mandatory or not is one of important questions.
Yasuaki, you're right: resources are always an issue, though they should not be and no auditor/inspector will accept such an excuse. The thing is, that typically it is not much work to document what has already been done (in contrast to actually doing it), but that in the rush of things it is often just forgotten. So in my view you should actually do it (like Ronen already said), but now there is no punishment if you happen to have forgotten in some cases. I know that a lot of managers think that if something is not required by law it is most efficient to just not do it. But that's wrong, there are a lot of things that are not required but still should be done because it is just plain good business sense. Some things if left undone have a tendency to resurface and bite you in the butt:D
 

somashekar

Staff member
Super Moderator
#6
ISO 13485:2016 says in 0.2 Clarification of concepts,
"When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. "

On the other hand, ISO 13485:2003 said in 1.2 Application,
"When a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise."

So, ISO 13485:2016 seems not to require documenting a justification for not applying a requirement is qualified by the phrase “as appropriate”, which are required by ISO 13485:2003.

Could someone tell me whether this is correct?
The best way to 'can justify' is including into your risk management, and risk management records are required....... :cool:
 

Marcelo

Inactive Registered Visitor
#7
The difference between the old edition and the new was made because in the new edition we are using the "document"requirement as a placeholder for other things, as noted in 1.2 - When a requirement is required to be ‘documented’, it is also required to be established, implemented and maintained.

We don't need to establish, implement and maintain, besides documenting, a justification. So the the "document"part of was removed.

This does not mean that you do not have to document it, thought. This problem happens in some other specific clauses too.
 

Marcelo

Inactive Registered Visitor
#8
The other side of the problem is in 8.2.2 - If any complaint is not investigated, justification shall be documented.

This does make any sense with the current use of the "document" requirement, but this was not changed in the final version (I think we may have forgotten it or decided to leave it as a compromise, this happened a lot in this version).
 

TWA - not the airline

Trusted Information Resource
#9
The difference between the old edition and the new was made because in the new edition we are using the "document"requirement as a placeholder for other things, as noted in 1.2 - When a requirement is required to be ‘documented’, it is also required to be established, implemented and maintained.

We don't need to establish, implement and maintain, besides documenting, a justification. So the the "document"part of was removed.

This does not mean that you do not have to document it, thought. This problem happens in some other specific clauses too.
Thanks Marcelo for this clarification. I had already wondered that something actually would get easier with a new revision...
And maybe we should have some kind of usability requirements for the standards in the future:notme:
 

Yasuaki

Starting to get Involved
#10
Thank you for all.

I would like to discuss about "as appropriate" by using a specific example.

For example, "as appropriate" is used in the following sentence in 7.5.1 Control of production and service provision.
"As appropriate, production controls shall include but are not limited to: a) documentation of procedures and methods for the control of production (see 4.2.4); b) qualification of infrastructure; c) implementation of monitoring and measurement of process parameters and product characteristics; d) availability and use of monitoring and measuring equipment; e) implementation of defined operations for labelling and packaging; f) implementation of product release, delivery and post-delivery activities."

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?
 
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