Audit Criteria Training Materials

M

mecheng10

Registered
#1
#1
Does anyone here know of organizations that offer auditor e-learning materials for common medical device criteria such as ISO 13485, MDSAP, MDR, etc.? I am re-building our auditor competency model and would like to purchase training materials and exams for these that demonstrate understanding instead of creating them from scratch. I'm looking for something in between having them read and acknowledge the documents and having them attend live multi-day training sessions.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
I am in no way endorsing or recommending (I have no idea) but Oriel Stat a Matrix offers training for all that and I would expect they have e-learning offerings.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
eule del ayre IATF 16949 / ISO 9001:2015 audit criteria IATF 16949 - Automotive Quality Systems Standard 17
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
V Process and Internal Audit Criteria matrix wanted Internal Auditing 8
K Internal Audit Scope and Criteria Internal Auditing 9
K ISO 9001:2015 clause 9.2.2 a. - Define the audit criteria and scope Internal Auditing 2
A Where can I find the NADCAP Audit Criteria for all the processes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
JoCam Nadcap AC7120 (Audit Criteria for Circuit Card Assemblies) - Acceptance Criteria AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Acceptance Criteria - ISO 9001:2008 Clause 8.2.4 - Questionable Audit Finding? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
B FDA 21 CFR Part 820 Medical Device Audit Criteria US Food and Drug Administration (FDA) 5
R Should Internal Audit criteria be a Controlled Document? Internal Auditing 5
V SOPs and Internal Audit Criteria for Regulatory Affairs (Submissions Function) US Food and Drug Administration (FDA) 4
R AC7101/11 Nadcap Audit Criteria for Materials Test Laboratories ? Fastener Testing Various Other Specifications, Standards, and related Requirements 1
P Can CBs audit according to OHSAS 18001 criteria when they audit your QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Nissan Supplier Audit Criteria Customer and Company Specific Requirements 7
M Iso/ts 16949 Product Audit Auditor Criteria and Qualifications General Auditing Discussions 3
S Establishing Internal Audit Nonconformity Level Criteria - Major vs. Minor? Internal Auditing 46
W What is the major audit criteria of first party audit and second party audit? General Auditing Discussions 4
B Chrysler PFMEA Audit Criteria Checklist to evaluate your Process FMEA FMEA and Control Plans 7
M Audit Scope vs. Audit Criteria - What is the difference? General Auditing Discussions 2
S What standard/criteria do they use to audit OHSAS 18001? Occupational Health & Safety Management Standards 1
J Audit Criteria And Method Of Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
R Volkswagen Quality Systems Audit - What criteria did they use and how did you prepare Customer and Company Specific Requirements 18
N API Q1 Audit Surveillance - Questions Oil and Gas Industry Standards and Regulations 2
A Alternative to on site audit in China EU Medical Device Regulations 2
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
B Internal audit checklist Internal Auditing 5
V Internal Audit Software IATF 16949 - Automotive Quality Systems Standard 5
J Internal Audit Schedule IATF Internal Auditing 3
Mikey324 External calibration - Finding in our 3rd party audit General Measurement Device and Calibration Topics 58
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
J Stage 2 audit initial cert, few data points ISO 13485:2016 - Medical Device Quality Management Systems 4
S Corrections not allowed during audit ISO 13485:2016 - Medical Device Quality Management Systems 7
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
R GFE Audit - Violation? GFE Location Controls AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
I Audit is tomorrow but I refused to participate Misc. Quality Assurance and Business Systems Related Topics 16
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
D Verify Audit Trail of SaaS system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
D Re-labeler - audit the supplier EU Medical Device Regulations 2
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
A PPAP question for audit APQP and PPAP 16
D Number of people to be interviewed during an internal audit? Internal Auditing 10
B Gamma Quarterly Audit Medical Device and FDA Regulations and Standards News 1
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 69
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom