Audit Checklist for ISO 13485:2016

#11
I don't have a copy of the new standard and was curious as to if it contains the clause 9 and 10 like 9001?
No, the technical committee didn't adopt the so-called "Annex SL" or high level structure of the other management system standards. 13485 is still rooted in ISO9001:2008
 
Elsmar Forum Sponsor
#14
I have prepared this as per ISO 13485:2003;
Please note, this type of checklist isn't really useful for internal audits. Taking the standard and turning it into questions is helpful, maybe for the first go-around with internal audits. Once that happens, this checklist should be dropped and the auditors should develop their own, based upon the audit scope and criteria determined to be necessary, based on risk etc. To do audits to the 13485 criteria each and every time, will tell management NOTHING about their processes.
 
A

aparlma

#15
We've spent the last year trying to get our quality system up and running. We had a few internal (contracted) audits and then a pre-audit with an ISO auditor. I was impressed/embarrassed about how the pre-audit person was simply looking at each line of the ISO 13485:2016 standard and wanted us to show evidence/records. It was simple, yet complete at the same time. Such an eye opener. I then wrote each requirement on a index card and on the back listed areas where I thought we demonstrated compliance. This was a great exercise in realizing areas where we needed to focus our attention.
 

Wolf.K

Quite Involved in Discussions
#18
I'd be annoyed if that's all they did...
But that is the way it goes during standard audits. In the pre-audit, the auditor is allowed to councel, so you can update the QMS according to the suggested changes. But the pre-audit should be very similar to a "normal" audit by the notified body or CB.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#19
In the pre-audit, the auditor is allowed to councel, so you can update the QMS according to the suggested changes. But the pre-audit should be very similar to a "normal" audit by the notified body or CB.
A "pre-audit", if performed by a CB or NB representative CANNOT consult/councel/suggest anything. That would be a threat to impartiality and the Accreditation Bodies would deem that a violation of ISO 17021.
 

Wolf.K

Quite Involved in Discussions
#20
A "pre-audit", if performed by a CB or NB representative CANNOT consult/councel/suggest anything. That would be a threat to impartiality and the Accreditation Bodies would deem that a violation of ISO 17021.
Of course that is right. What I meant is, that you should have a kind of "internal audit" by some other organization/company who is able to a) do the audit and b) give you feedback on missing QMS processes and how to implement them. That is what we had - we "bought" the QMS from EMERGO, updated it, and then hired someone to test us as if we were audited by our notified body.
 
Thread starter Similar threads Forum Replies Date
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
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) 24
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

Similar threads

Top Bottom