Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing

S

snappy

#11
Distinguish between "service" and "rework/repair".

You expect the product to require service. The product is not nonconforming due to flaws in workmanship, but because of use. You provide service as the product requires it. Although your service may involve restoring the product to proper working order (and you might even refer to it as rework), you have a service contract--meaning that you expect the product to require servicing.

Hope this helps.
 
Elsmar Forum Sponsor
X

XeniAnnoula

#12
Wow, thanks to all of you for chiming in while I slept ;)

MIREGMGR, thanks for the nicely-put definition: I agree that for bespoke and servicing, multiple work sessions are normal.

DB, I see what you mean about the rework within a service attempt. However, in terms of this section of the standard, I think what you describe wouldn't apply at least partly because there's no specific, approved process which is being breached.

Marcelo, is there a specific document you are referring to which has official ISO definitions? I'd be happy enough to look at the definitions, however, in this case it appears there isn't a specific definition of rework. It was the first question I asked our advisor when we disagreed, and since it's heavily discussed on this forum, it seems clear there's no single, dominating, clarifying definition. I wish there were!

Meanwhile, Googling for ISO definitions for repair comes up with nothing, and for service(s) what you already mention come up: that ISO's 'product' can include services, and that 'services' can include providing repair service. But this I already knew ...

It's difficult to define what the process is and where rework might begin, though, if/when service includes (1) investigative diagnosis and (2) iterative change-and-test repair, such as board swapping, with no clear demarcation of the boundary between (1) and (2), and sometimes no quickly clear certainty that (2) is done until further equipment use determines that a "flaky" or occasional problem has ceased to recur
MIREGMGR, I particularly appreciated you clarifying what I'd made a mess of: what you describe above is exactly what I'd meant. It isn't rework, it's just the way servicing goes!

So service visits are repair, as defined in the standards, not rework.
Well, good, it appears we're in agreement on this. (However, if you please, what's "21 CFR 820"?)

And, finally, Snappy: I'm using service and repair as being pretty much synonymous, but not rework and repair as being synonymous. But I agree that the equipment needing servicing/repair does not constitute a non-conformity.

:thanks:

I'm willing to consider this closed (though happy to receive more). Hugely appreciate all the input!
 

Marcelo

Inactive Registered Visitor
#13
Marcelo, is there a specific document you are referring to which has official ISO definitions? I'd be happy enough to look at the definitions, however, in this case it appears there isn't a specific definition of rework. It was the first question I asked our advisor when we disagreed, and since it's heavily discussed on this forum, it seems clear there's no single, dominating, clarifying definition. I wish there were!
ISO 9000 has definitions for the majority of terms used in ISO quality system standards.

In item 2 of ISO 13485 - Normative References, it mentions - ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.

However, if you please, what's "21 CFR 820"?
21 CFR 820 is the quality system regulation for the US. It´s based on old versions of ISO 13485.



If your advisor does not know how ISO standards work, I think you have another type of problem...
 
X

XeniAnnoula

#14
Thank you. I realized you were referring to 9000:2005 after I asked that. I don't personally have a copy of that document, but I'm sure our advisor does. I assume 'rework' isn't covered since she advised there was no official definition. Aside from that word, so far I haven't felt the need for this document, but perhaps I'm wrong?

As for her not knowing how ISO standards work, I don't think I've said that! She's very, very knowledgeable. We just happen to disagree on a few relatively minor points.
 

Marcelo

Inactive Registered Visitor
#15
From ISO 9000:

3.6.7
rework
action on a nonconforming product (3.4.2) to make it conform to the requirements (3.1.2)
Aside from that word, so far I haven't felt the need for this document, but perhaps I'm wrong?
A lot of this discussion does seem to come from a problem with definitions (in fact, I would say that a alot of discussions here in the Cove com from people not knowing basic definitions and other background information for standards).

If I could make a suggestion, you might need to ask again your "knowledgeable" advisor (I know so many of them...) to focus on the definitions (and other basic background on ISO standards) before trying to interpret the documents.
 
X

XeniAnnoula

#16
Wow, where's the emoticon for 'gobsmacked'?! I'm reeling here: there IS an official definition?

Yes, I agree with you that a lot of this discussion -- in fact most of it -- is from a problem with definitions. And right this minute I'm going to have to retract what I said about having a problem with the advisor although I'll try to give her the benefit of the doubt (did she not 'hear' me when I asked if there was an official definition?).

Your opinion please since you're tuned in here Marcelo: would you consider a piece of equipment requiring normal after-sales service as a non-conforming product? I would not.

Thank you very much for your attention to what is, after all, not your problem.
 

Marcelo

Inactive Registered Visitor
#17
would you consider a piece of equipment requiring normal after-sales service as a non-conforming product? I would not.
No, service is mainly related to repair (as defined in ISO 9000), not rework. That´s what I tried to explain in the comments I made before.


Thank you very much for your attention to what is, after all, not your problem.
This is an information and experience sharing forum (People helping people, as Marc like to say). When you put a question here, it becomes my (our) problem :)
 
Last edited:
X

XeniAnnoula

#18
I didn't miss your previous points -- as I said, I think we're in agreement. And the good news is that a 'rework' documentation loop can be ruled out for our repeat service visits. The bad news is that obviously I now have a bit of a question mark in my head regarding our advisor ... :(

As for this forum taking on other people's problems and making them their own, what a lovely thing. It has been a real help and I'm very grateful for all the contributions and the time you've all taken to help!
 

Marcelo

Inactive Registered Visitor
#19
Just to make it a little more clear:

The definition of rework, with note, is:

3.6.7
rework
action on a nonconforming product to make it conform to the requirements
NOTE Unlike rework, repair can affect or change parts of the nonconforming product.
And repair

3.6.9
repair
action on a nonconforming product to make it acceptable for the intended use

NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance.

NOTE 2 Unlike rework , repair can affect or change parts of the nonconforming product
As I mentioned before, rework is mainly focused on a non-conforming product created during you pre-market (before delivery) process. As the notes mentioned, rework does not change the product, it simply puts the product back as it should be (in conformity with the requirements).

Repair, on the other hand, relates mainly to post-market. For example, after use, the product degrades. You might need to repair it (service) to put it again in a accepted condition for use. But service does not put the product back as new (this would be refurbishment, which is a kind of rework).

That´s why there´s a subtlety in the definitions. Rework put the product in conformance with the requirements - this is a new product (it´s a product that´s just been created). Repair make the product acceptable for use - this is not a new product, not a product that has just been created.
 
X

XeniAnnoula

#20
Yes, sigh, I concur with all of this: this was the reason for the initial disagreement with our advisor. Not that I knew the 'official ISO definition' of the word 'rework' ... but because I knew its standard definition in standard English, which made it quite clear to which part of the overall life of a product it would apply! Glad to see ISO's not twisting the language for its own purposes :)

Okay, this one's solved, with jury votes and official definitions. Phew!

A zillion thanks.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
L Need HELP with Internal Audit Program ISO 13485.2003 Quality Management System (QMS) Manuals 3
R ISO 13485 Software Validation Requirements - Help needed ISO 13485:2016 - Medical Device Quality Management Systems 4
S Please help on ISO 13485 medical device related services Other Medical Device Related Standards 1
X Help with ISO 13485 Clause 6.4 as it applies to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 25
G Need help in an upcoming ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 7
S Freshman needs help with ISO 13485 Audit Process ISO 13485:2016 - Medical Device Quality Management Systems 46
R ISO 13485 Surveillance Audit Nonconformances and Report Help Needed ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 Help - Determining what processes I specifically need to document ISO 13485:2016 - Medical Device Quality Management Systems 9
K ISO 13485 Audit help needed General Auditing Discussions 20
R Help for implementing ISO 13485 (provision of software to Hospitals) ISO 13485:2016 - Medical Device Quality Management Systems 4
J Need step-by-step ISO 13485 implementation help ISO 13485:2016 - Medical Device Quality Management Systems 8
E Contract manufacturer seeking help understanding ISO 13485 Validation requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
P Can somebody help me to identify the 27 ISO 13485:2003 procedures? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q ISO 3310 Clarification Help - Aperture sizes for sieves used for particle sorting Other ISO and International Standards and European Regulations 2
L Please help me with the process of getting ISO 9001 certified Quality Management System (QMS) Manuals 15
A ISO 9001 Help - New Quality Manager - Upper Management Support Issues ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S ISO 17025 - Help in Getting accreditation- Where to start from ISO 17025 related Discussions 12
D Customer Audit - Root Cause Help - ISO 9001:2008 Cl. 7.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
V Revised ISO std vs ISO13485:2003 - Help Please!!! ISO 13485:2016 - Medical Device Quality Management Systems 4
S How will ISO 9001 help the machinists in a very small Machine Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S ISO 9001:2008 Clause 8.2.3 Monitoring and Measurement of Processes Help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Informational Please help this newbie understand ISO 9001 Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
Q ISO 9001 - 3 BIG questions to help a Newbie's Sanity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Help me understand the ISO section 7.5.2 from API Q1 perspective Oil and Gas Industry Standards and Regulations 4
R First ISO 9001 Management Review....HELP Management Review Meetings and related Processes 7
0 The Uncertainty of an Estimate of the Bias ISO 5725-1 - Help Measurement Uncertainty (MU) 8
Q New Auditor looking for help with ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
P Supplier Scorecard for ISO 9001 - Help me review the draft from my purchasing team ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R OHSAS 18001 & ISO 9001 Implementation - help! Process Maps, Process Mapping and Turtle Diagrams 7
S Help with Master Thesis focusing on ISO/TS 16949 and CSR in automotive SC IATF 16949 - Automotive Quality Systems Standard 2
R ISO 9001 Implementation in the Bus/Coach Industry - Confused and Help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
O ISO 9000 section 7.2.1(c) Compliance help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Bi-Annual ISO 9001 Surveillance Audit Help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
C CRMs (Customer Relationship Management) to help achieve ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T ISO 14001 Implementation Help & Question about Supplier Approval ISO 14001:2015 Specific Discussions 5
T Design & Development in Updating Machines and Equipment - ISO 9001 Help Design and Development of Products and Processes 4
1 I don?t have any experience with ISO 9001 - Help Quality Manager and Management Related Issues 9
P ISO 9001:2008 Gap Analysis Template - Please help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J ISO 9001 and Improvement of Business Performance - Research help Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Help with ISO 9001 Implementation in Oil Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Incidents that occur during a Third Party Supplier Audit - Help for ISO 9001 General Auditing Discussions 23
S ISO 2859-1 or Ansi ASQ Z1.4 in using AQL or AOQL - Need Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K ISO 9001 Clause 4.2.4 Control of Records - Documented Procedure help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom