ISO 13485:2016 QMS Auditor/Lead Auditor Training Course

Instructor SQI
Categories ISO Standards
Total Training Hours 5 days

OBJECTIVES

This training course provides participants with an in-depth Quality Assurance knowledge and Auditing Know-how.
1. Focus on the appreciation of ISO 13485, ISO 19011 and ISO/IEC 17021-1 Standard requirements
2. Strengthen the foundation of audit methodology, skill & techniques to perform First Party & Second-Party Audits and draw
audit conclusion based on audit findings.
3. Learn how to lead an audit team, conduct opening & closing meetings, collection of audit evidence against audit criteria and
to present audit findings and audit conclusion.

DURATION

5-Day Training from 9:00am – 5:00pm (2 hrs exam time on the 5th Day).

WHO SHOULD ATTEND

Executives, Supervisor, Engineer, Managers, Quality Professionals & Management Consultants who are engaged as First-Party & Second-Party Auditor / Lead Auditor.

PRE-REQUISITE

You are expected to acquire the following prior knowledge before attending the class:

Completed the ISO 13485:2016 Internal Auditor Training Course (preferred).
The Application of Plan, Do, Check, ACT (PDCA) Cycle, “Process Approach” and Risk-based Thinking Approach.
Commonly used Quality Management Terms and Definitions in relation to ISO 9001:2015 / ISO 13485:2016.

COURSE FEES

Member: S$2,197.44
Non-Member: S$2,415.44

Registration Fee of S$17.44 apply and Exam & Certification Fees of S$218 apply
All fees stated are inclusive of Registration Fee and 9% GST.

AWARD OF CERTIFICATE

Upon successful completion of examinations, the participants will receive the ISO 13485:2016 Auditor / Lead Auditor Certificates
(SQI Certified) awarded by SQI International Pte Ltd (Subsidiary of Singapore Quality Institute).

Course Content

Total Training Hours: 5 days

COURSE CONTENTS 0/18
- Lecture1.1
  
  Understanding the requirements of ISO 13485:2016, ISO 19011:2018 and ISO/IEC 17021-1:2015 Standards
- Lecture1.2
  
  Establish the link between ISO 13485:2016 Clauses and key processes or functional departments
- Lecture1.3
  
  Application of “Plan, Do, Check, Act (PDCA) Cycle”, “Process Approach” and Risk-based Thinking Approach
- Lecture1.4
  
  Brief Introduction and Application of ISO 14971:2019 In Establishing ISO 13485:2016 Medical Devices-QMS
- Lecture1.5
  
  Assess the capability of the measuring equipment to achieve the desired degree of accuracy.
- Lecture1.6
  
  Interpretation of Process Validation (Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)
- Lecture1.7
  
  Terms & Definition: Audit, Audit Objective, Audit Scope, Audit Criteria, Audit Evidence, Audit Findings & Audit Conclusion
- Lecture1.8
  
   Seven Principles of Auditing and Their Application (Ref: ISO 19011:2018)
- Lecture1.9
  
  Audit Plan vs Audit Program / Management of an Audit Program (Ref: ISO 19011:2018)
- Lecture1.10
  
  Six Essential Steps in Performing an Audit (Ref: ISO 19011:2018)
- Lecture1.11
  
  Responsibilities and Authorities of Auditor and Lead Auditor
- Lecture1.12
  
  Prepare Audit Program, Audit Plan, Audit Checklist and Corrective Action Form
- Lecture1.13
  
  Execution of Audit by applying The Six Key Points of Audit Methodology (Ref: ISO 19011:2018)
- Lecture1.14
  
  Documenting Non-conformity / Non-compliance, Corrective Action & Follow up Verification Audit
- Lecture1.15
  
  Analysis and Presentation of Audit Findings and Audit Conclusion
- Lecture1.16
  
  Necessary attributes or desired professional behaviours of an auditor
- Lecture1.17
  
  How to deal with classic problems during an audit?
- Lecture1.18
  
  Desk-top audit session (Case study with role play)