supply chain management training

ISO 13485 Supplier Quality Auditing

Course Description
Supply chain management is an essential part of an organization’s business due to the increase in dependence on outsourcing. Supplier Quality Auditing is critical in verifying a supplier’s processes, products or services for compliance against regulatory requirements, customer specific requirements or agreed standards.

The key question: do you know what hidden risks lie within your global supply chain?

Results of the audit provide useful information for decision making which can impact supplier selection and control.  Consideration must be taken to ensure auditor competency in providing reliable audit results.

This course is highly engaging and interactive with the focus on how to conduct effective quality audits of suppliers, to evaluate a new supplier’s ability to meet your contractual requirements, and to re-evaluate an existing supplier’s performance. This course is designed using the guidelines of ISO 9011:2018.

Who should attend?
The course is aimed at auditors currently conducting internal and/or supplier auditing, who wish to improve their knowledge, skills and auditing approach.

Learning Objectives

  • The theory of auditing – Audit scope, criteria, objectives
  • Management systems theory – PDCA, concepts of Quality management principles
  • Preparing for an audit – Audit program, plan and checklists
  • Performing the audit – Conducting a live simulated audit including gathering information, communication with the supplier, interviewing skills, holding an opening meeting, gathering evidence of capability and performance
  • Reporting the audit – Audit report, non-conformities, closing meeting, providing audit feedback to the supplier of audit findings
  • Revisiting the audit – Audit follow-up activities

Workshop Outline

1) Purpose of conducting supplier audits
2) Quality Management Systems – definition and structure
3) Process-based, metrics-driven and risk-based auditing fundamentals

  • Exercise – Construct a process map

4) Prepare for the Case Study – identify supplier to be audited
5) Steps required to prepare for a supplier audit – Audit Planning

  • Identify, collect and review information to prepare a risk-based audit plan
  • Communicating the audit plan with the supplier – Audit Notice
  • Audit team
  • Exercise – Prepare audit plan

6) Conducting the audit

  • Auditor conduct
  • Documentation templates
  • Taking notes
  • Collecting objective evidence
  • Auditing techniques
    • Document review
    • Interviewing
    • Observing and Sampling
  • Detailed review of the auditing criteria, including ISO 13485:2016 and US FDA 21CFR Part 811. Briefly review the correlation of ISO 13485:2016 with ISO 9001:2015.
  • Auditing situations (role play)
  • Exercise – conduct mock process audit

7) Preparing the audit report

  • Key elements of the audit report
  • Determine when a practice or situation represents a nonconformance or finding
  • Risk-based audit findings
  • Determine methods to analyze, classify and write nonconformities or findings.
  • Exercise – practice writing a non-conformance

8) Report audit results to the supplier
9) Corrective action of audit findings – key aspects

  • Close out audit findings

Course Format
Combination lecture and classroom exercises. Available at QSG’s training facilities and on-site at your organization
8:30am-4:30pm(EST) each day

Course instructors:
Angelo Scangas – President and CEO

Payment Type
Date Attending
Name of Attendee(s)
Name of Company

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