Audit Checklist for ISO 13485:2016

Elsmar Forum Sponsor
R

randomname

#2
I never understand the rationale for this question. The checklist is the standard. Simply evaluate whether each "shall" is being met. Put a question mark at the end of each sentence. ...
 

al40

Quite Involved in Discussions
#3
Yes,
I know I am trying to put together a presentation and wanted to show an example of an checklist.
Thanks,
AL40
 
#6
Hi does anyone know why the Internal Audit checklist for ISO 13485-2016 does not have clause 7.5 and 7.6?

Thanks ( new to this so be gentle :) )
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Welcome to The Cove

Hi does anyone know why the Internal Audit checklist for ISO 13485-2016 does not have clause 7.5 and 7.6?
Nobody here saw the internal audit checklist you are referring to, because, as implied, is internal to an organization.

What kind of business is it? A distributor? If so, 7.5 would still apply, but 7.6 might be a justifiable "exclusion".
 
#8
Hi does anyone know why the Internal Audit checklist for ISO 13485-2016 does not have clause 7.5 and 7.6?

Thanks ( new to this so be gentle :) )
Because they forgot to add it? Anything which comes from the internet, from an unqualified source has to be treated with extreme caution. As others have stated, internal audits shouldn't be done to the ISO 13485 standard as the (only) criterion...
 

Wolf.K

Involved In Discussions
#9
The best thing is always to create your own checklist. You need to know the differences to 13485:2003 anyway. Just get the last version of the standard, prepare a table with corresponding headlines, and just rephrase the sentences of the standard as questions. You can use the list posted in this thread as a starting point and just update it corresponding to the new version. Then you will learn the differences. This just takes two or three days.
 
Thread starter Similar threads Forum Replies Date
G ISO 22442 Supplier Audit Checklist - Medical devices utilizing animal tissues General Auditing Discussions 0
R ISO 9001:2015 and EMS 14001:2015 combined audit checklist General Auditing Discussions 5
S Audit checklist for "Design Controls" per ISO 13485 wanted Internal Auditing 3
S ISO 9001 Audit Checklist - Red, Yellow and Green status Quality Manager and Management Related Issues 10
D Internal Audit Checklist for the latest ISO/TS 16949 standard IATF 16949 - Automotive Quality Systems Standard 11
C ISO 27001:2013 ISMS Internal Audit Checklist/Questionnaire IEC 27001 - Information Security Management Systems (ISMS) 19
M Risk Management (ISO 14971:2007) Internal Audit Checklist ISO 14971 - Medical Device Risk Management 7
G ISO 9001 Internal Audit Checklist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
T One Supplier Audit Checklist to cover ISO 9001:2008 and 13485:2003 Supplier Quality Assurance and other Supplier Issues 1
T I'm seeking ISO 13485:2003 Supplier Audit Checklist Supplier Quality Assurance and other Supplier Issues 1
J ISO 9001 Checklist Type Internal Audit Forms? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Checklist for ISO 27001 ISMS Internal Audit IEC 27001 - Information Security Management Systems (ISMS) 2
D ISO TS 29001 (Petroleum Petrochemical Natural Gas) - Internal Audit Checklist example Other ISO and International Standards and European Regulations 3
K ISO/IEC 23026 Audit checklist wanted Other ISO and International Standards and European Regulations 2
K ISO 22000 Audit Checklist wanted Food Safety - ISO 22000, HACCP (21 CFR 120) 6
K ISO 28000 Internal Audit Checklist wanted Supply Chain Security Management Systems 10
R Product Audit Checklist according to ISO/TS 16949 IATF 16949 - Automotive Quality Systems Standard 24
A ISO 27001:2005 ISMS Internal Audit Checklist/Questionnaire IEC 27001 - Information Security Management Systems (ISMS) 14
P Internal ISO 9001 Audit - Process Audit Checklist Internal Auditing 31
B Internal Audit Checklist fo ISO 9001 Internal Auditing 1
I ISO 20000 Checklist for Gap Analysis and Internal Audit Other ISO and International Standards and European Regulations 2
N All-or-Nothing Rating System - Internal Audit Checklist - ISO 9001 Internal Auditing 5
C IMS (ISO 14001/ BS OHSAS 18001) combined Audit Checklist & Schedule ISO 14001:2015 Specific Discussions 1
T ISO 22442 - Audit checklist? Other ISO and International Standards and European Regulations 1
M Does Anybody have an ISO 22000 internal audit checklist for sharing? Internal Auditing 11
J ISO 9001 Audit Checklist Excel .xls Template Excel .xls Spreadsheet Templates and Tools 15
S ISO 9001: 2000 - Internal Audit Checklist for Software Projects Internal Auditing 9
B ISO 22000 Audit Checklist wanted Food Safety - ISO 22000, HACCP (21 CFR 120) 1
netwizard Looking for an ISO 9001:2000 Internal Audit Checklist - UOP (Information Technology) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S TS/ISO 16949 Process Audit Checklist required Process Audits and Layered Process Audits 3
Ajit Basrur Quality Manual and Audit Checklist for ISO 17025 ISO 17025 related Discussions 1
D ISO 22000:2005 Audit Checklist Internal Auditing 7
Douglas E. Purdy Non-Conformance due to obsolete ISO/TS 16949 audit checklist General Auditing Discussions 36
GStough Looking for a Simplified Internal Audit Checklist (ISO 9001 / ISO 13485) form General Auditing Discussions 14
R ISO 9001 Audit Checklist - Need to rewrite the audit questions at our MFG facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Checklist for ISO 17025 Audit needed ISO 17025 related Discussions 15
B Purchasing Element Audit Checklist to audit against ISO 9001 Document Control Systems, Procedures, Forms and Templates 6
C ISO 14001:2004 Internal Audit Checklist? Internal Auditing 3
C ISO 14001 / 18001 - How to incorporate these two standards - Internal audit checklist ISO 14001:2015 Specific Discussions 20
D How to create an Process Oriented ISO 14001:2004 Audit Plan & Checklist General Auditing Discussions 21
Z ISO 14001:2004 EMS audit checklist wanted! General Auditing Discussions 6
F ISO 9001:2000 Calibration Audit Checklist General Measurement Device and Calibration Topics 4
A Seeking: ISO 9001:2000 Internal Audit Checklist for Newbie Internal Auditing 20
Q The Checklist to ISO/TS16949 - Is it a Process Audit or Elemental? Process Audits and Layered Process Audits 8
D Question about ISO 9001 Registrar Audit Checklist - No more checklists? General Auditing Discussions 9
I ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based Internal Auditing 26
C ISO 13485:2003 Compliance Audit Checklist - Example Attached ISO 13485:2016 - Medical Device Quality Management Systems 9
J ISO 14001 Internal Compliance Audit Checklist ISO 14001:2015 Specific Discussions 1
G ISO 9001:2000 Audit Checklist Needed General Auditing Discussions 4
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1

Similar threads

Top Bottom