Supplier Auditing ISO 13485:2016 with MDSAP

Course Summary

Students participating in this course will gain knowledge and skills to conduct supplier audits that support ISO 13485: 2016 management system requirements and the MDSAP Audit Model.

Event Details

16 hours
9:00am-5:00pm (EST) each day

Training includes formal classroom tutorials, practical role-playing, group workshops, and open forum discussions. Much of the training will be conducted using the two documents listed in the prerequisites. Supplemental slides will be provided by the instructor as and when necessary.

This course is not an information dump with hundreds of slides from the instructor.

Participants will need to make their own notes to reinforce and track their learning.

Description

Medical device supplier auditing requires technical knowledge as well as a deep understanding of international medical device regulations. It also requires that auditors maintain a balance between the needs of the suppliers and their customers. Students participating in this course will gain knowledge and skills to conduct supplier audits that support ISO 13485: 2016 management system requirements and the MDSAP Audit Model.

Although ISO 13485: 2016 may have recognition in many parts of the world, the Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries: Australia, Brazil, Japan, Canada, and the United States.  In this training program, participants gain insights on requirements for suppliers from both, and therefore can become better skilled auditors when it comes to dealing with suppliers. This affords the opportunity to reduce or eliminate potential nonconformances related to suppliers.

Through training participants will learn how to plan, conduct, report, and follow up on supplier audits that enable compliance with requirements from both ISO 13485:2016 and MDSAP. This 2-day course uses the principles/practices of effective supplier audits that are a combination of the deep and rich experience of the instructor blended with suitable elements from ISO 19011:2018, “Guidelines on Auditing Management Systems.” The instructor has spent decades in various roles in the medical device industry, and has coached thousands of professionals in R&D, Design, Manufacturing, Supply Chain Management, Quality, and Regulatory functions.

Participants will gain much needed understanding and practice auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions. This course provides extensive practical training and hands-on exercises that will help prepare participants to identify nonconformities, write the same, and create reports that are succinct and easy to understand. These in turn facilitate proper action on the part of suppliers to eliminate / prevent nonconformances.

Upon completion of training, participants will be capable of conducting supplier audits that support ISO 13485:2016 and jurisdiction requirements of the countries participating in the MDSAP program as they apply to suppliers in the medical device field.

Who Should Attend

This course is designed for Supplier Quality Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to perform supplier audits for compliance with ISO 13485, MDSAP, and beyond.

Learning Objectives

Through training, participants will be able to:

  • Describe the requirements for suppliers per ISO 13485 Medical Device Quality Management System (QMS)
  • Demonstrate awareness of MDSAP fundamentals as they apply to suppliers
  • Understand the structure and scope of the supplier audit
  • Create appropriate documents to satisfy requirements for suppliers of medical devices based on ISO 13485:2016 and MDSAP countries
  • Identify medical device QMS terms
  • Describe the intent and requirements of ISO 13485:2016
  • Determine the evidence from suppliers to demonstrate conformity to ISO 13485:2016 and MDSAP
  • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology, as appropriate to supplier audits
  • Apply the principles, processes, and methods of auditing
  • Demonstrate the activities involved in preparing for an audit
  • Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a supplier audit

Course Outline

This course includes a comprehensive review of appropriate sections of ISO 13485:2016, MDSAP, and know how to run successful supplier audits:

  • The Challenges in Auditing Suppliers
  • The Requirements from ISO 13485, and MDSAP ISO Standard Explained
  • Creating an Audit Plan, Action Items, Objectives, and Scope for the supplier audit
  • Key elements of dialog between / with the audit client and the auditee (suppliers)
  • The auditing process and audit instruments
  • Audit trails, and the documentation process
  • How to conduct a supplier audit – opening meeting, performing the audit, and closing meeting
  • Identifying and properly documenting nonconformities
  • How to write the audit report
  • Case studies to develop skills for identifying nonconformance.
  • Verification and Close Out of Corrective Actions

Prerequisites

Participants must have a copy of the following two documents: ISO 13485:2016, and MDSAP-AU-P0002.008-Audit-Approach

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