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

I

isoalchemist

#31
This is a great discussion. I have to agree with Macelo based on 21CFR820. Before it's relased for distribution it is rework.

After release if the customer identifies an issue (on a limited scale) it is a repair regardless of repeat calls for the same unit.

Now to add a little more..............

After release if the manufacturer identifies a problem it is a correction or removal, based on their knowledge and/or the analysis the repair frequency.

After release if the FDA identifies a problem its a recall.
 
Elsmar Forum Sponsor
D

dfevans

#32
Rework is intended to br pre-market. Repair can be post-market, as clear on the note to the definition of repair - and only repair - in ISO 9001 - NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance.
"in ISO 9001 - NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance. "

Does this definition apply to ISO13485?
 

Marcelo

Inactive Registered Visitor
#33
"in ISO 9001 - NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance. "

Does this definition apply to ISO13485?
It does.

However, the main problem here is that the rework requirement from ISO 13485 comes from 21 CFR 820, but there the meaning of rework is different from ISO 13485 - ISO 9001 - as I said before,the original idea of this requirement is based on the fact that rework is only pre-market.
 
V

Vlcekad

#34
Dear Collegues,

I hope this post woul follow the topic.

We have sold EU class III device to Korea, but the distirbutor is unhappy with the expiration of the product. We have still a large quantity of the same lot on the store packed in primary packaging and steripack.

We made stability testing and realized, we can safely extend expiration by one year.

In case of products on the stock (technically unfinished) we want to place a label on the steripack saying that the expiration has been extended. We dont want to take off the label on primary packaging (it shows expiration date) because we would brake the steriliy of primary package.

In case of finished and sold products, however, I think we do not have any tool to extend the existing exspiration.

What does your experience says?
Thank you very much!
 

med_cert

Involved In Discussions
#35
The requirement 820.90b2 seems clear to me, however I am confused why there is no difference between more complicated and less complicated (or risk related components).
Example: in our production we also have a mechanical production unit where simple mechanical components are produced. These components are not traced by serial or batch number.
In case one mechanical part is not in conformance to specifications (for example one hole is missing), this component is returned to the mechanical unit and this hole is drilled. As far as I am familiar, this meets the "rework definition", am I right? If this meets the rework definition, this component should then be traced to the DHR of the device in which this component is integrated. I do not understand this requirement. Why this requirement is important if there is no risk-related rework? What is the practical reason of documentation this kind of rework in DHR?
 

John Broomfield

Staff member
Super Moderator
#36
med_cert,

Yes, creating a missing hole in a component that was declared “complete” would be rework because it conforms with the original spec.

Our concern usually is for repairs that are mislabeled rework.

Repairs usually do not conform to the original spec unless that spec specified permissible repair methods; but still such repairs are not rework.

So, even if the service design specifies measures to promptly compensate the customer for service failure it is still repair not rework.

John
 

med_cert

Involved In Discussions
#37
So based on your reply - we should track this "missing hole" reworked component to the DHR even if this component is not "critical", thus in normal conditions not traceable?

I really do not understand the practical reason for this so I thing I am missing some information (probably I don't have comprehensive understanding). Usually those requirements have the reason... could you please explain me.

Thank you
 

med_cert

Involved In Discussions
#39
Unless the DHR provides exemptions for non critical items then yes.
FDA Part 820.90 section b2 does not provide exemtions... Do you think/believe/claim there is an option for the manufacturer to document the possible exemtions for non critical items not to trace the reworked parts to the DHR?
 
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