SBS - The Best Value in QMS software

ISO 13485:2016 Gap Analysis with Changes Identified

P

Pearce364

#1
:bigwave:

Hi everyone, glad to see we're back in business, i was wondering if anyone had carried out a gap analysis for the new 13485? And what have been your major changes identified? I'm about to start this process and i'd be grateful for any tips.
 
Elsmar Forum Sponsor

RobertvanBoxtel

Involved In Discussions
#4
Re: ISO 13485:2016 Gap Analysis with changes identified wanted

I find that the white papers referenced provide a clear overview, but still require you to do the real assessment your self.
In our training for all, we provide a document, but yes, we also need to make a living :)
Suggestion: Create a table which for all sections identifies the standards section number. Open both the 2003/2012 version and the 2016 version and check any differences. Then document where in your QMS these new requirements are covered. In case of gaps: define your action(s).

NB's and certifiers will determine the additional day(s) onsite, taking into account your gap analysis (and of course size of company, complexity etc).

Have the NB's perform this "upgrade" audit in addition to one of your surveillance audits already planned, as early as possible. In case major NC's are found against the new standard, you have time to fix them without loosing your current certification.
If your next audit (this or next year) is a renewal, discuss with your NB.

And: Not all are yet accredited for ISO 13485:2016!!!
 

mihzago

Trusted Information Resource
#5
Re: ISO 13485:2016 Gap Analysis with changes identified wanted

The new ISO13485:2016 has a comparison table to the 2003 version in the appendix A.
I took that table, added two more columns, one for the gaps within my processes/procedures and the other for the actions I plan to take to address the gaps.

I then attached this table to my CAPA.


General comment. If your company followed all the latest guidance documents, other standards, and/or best industry practices, and also complied with FDA's QSR and CMDR, then you shouldn't have many changes to your processes or procedures as a result of the updated standard.
My changes were mostly clarifications or changes to the wording to better align it with the new standard.

I took this opportunity to update most of my procedures as part of the periodic review/update.
 

bjohnsonrli

Starting to get Involved
#6
Re: ISO 13485:2016 Gap Analysis with changes identified wanted

Hi there,

I came across a numbering gap analysis a few weeks ago to help me get started. I added a comments section to help with my assessment against our own procedures. This might help you get started. Its something still in the works for us but the good news is we have some time available.

Regards,

Bryan
 

Attachments

P

Pearce364

#7
Re: ISO 13485:2016 Gap Analysis with changes identified wanted

Hi Bryan

Thank you so much, very useful, and much appreciated.

Tracy
 
Thread starter Similar threads Forum Replies Date
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
L ISO 13485:2016 Clause 8.4 - Analysis of Audit Observations ISO 13485:2016 - Medical Device Quality Management Systems 8
S When is ISO 13485:2016 6.4.2 Contamination Control appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Templates for three ISO 13485:2016 SOPs ISO 13485:2016 - Medical Device Quality Management Systems 8
C What falls under the 'Customer Property' according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 29
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
F ISO 13485:2016 Quality Policy Requirements Other ISO and International Standards and European Regulations 18
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
J ISO 13485:2016 sample exam/test ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational Questionário – Análise crítica sistemática – ISO 13485:2016 (Portuguese-only) Medical Device and FDA Regulations and Standards News 0
M Informational ISO 13485:2016 under systematic review Medical Device and FDA Regulations and Standards News 5
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom