ISO 13485 Gap Analysis Checklist - Updating ISO 13485 from the 1996 standard to 2003

C

Charlie

#1
I was wondering if anyone has come across a Gap Analysis Checklist of any kind for updating ISO 13485 from the 1996 standard to 2003?
 
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#2
Charlie said:
I was wondering if anyone has come across a Gap Analysis Checklist of any kind for updating ISO 13485 from the 1996 standard to 2003?
Hi Charlie, and welcome to the Cove.

There are a few GAP Analysis Checklists posted as attachments in the cove. You can find them by searching attachments using the Drop Down Box of the search feature towards the Top Right Side of each forum page (see the screen shot attached to this post).

You can see there are a number of documents to choose from. I like the ISO 13485-2003 Generic Checklist.doc.
 

Attachments

Thread starter Similar threads Forum Replies Date
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
S TGA regulations and ISO 13485:2016 gap analysis MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 2
P ISO 13485:2016 Gap Analysis with Changes Identified ISO 13485:2016 - Medical Device Quality Management Systems 30
G Does anyone have a ISO 13485 Gap Analysis form they'd be willing to share? Quality Manager and Management Related Issues 3
D Gap Analysis Checklist for ISO 13485:2003 2012 ISO 13485:2016 - Medical Device Quality Management Systems 13
5 ISO 13485 and Singapore GDPMDS - Gap Analysis or Comparison ISO 13485:2016 - Medical Device Quality Management Systems 3
S GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 2
U ISO 13485 vs. MHLW GQP & GMP - Gap Analysis needed Various Other Specifications, Standards, and related Requirements 2
S ISO 13485, cGMP and ISO 9001 Gap Analysis ISO 13485:2016 - Medical Device Quality Management Systems 2
Brizilla ISO 13485 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
J ISO 13485- 8.3.1 Non-conforming material high volume ISO 13485:2016 - Medical Device Quality Management Systems 4
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 30
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
J ISO 13485 for Metal Finishing Medical Device and FDA Regulations and Standards News 5
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Lead time to schedule an ISO 13485 audit General Auditing Discussions 2
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
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
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
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 4
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7

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