ISO 13485 Lead Auditor Training

ISO 13485 lead auditor training from Sync Resource will help you to develop all the necessary skills and expertise to audit an ISO 13485 based Medical Devices Quality Management System, by applying best and widely recognized audit principles, procedures and techniques, to ensure that the organization or staff is competent in managing and maintaining its Medical Devices Quality Management System.

This lead auditor training will also help you gain the knowledge and develop the skills to professionally and proficiently plan and perform not only internal but also the external audits in compliance with ISO 19011 standard, and the certification process according to ISO/IEC 17021-1 standard.

In short, this training will help you master all tools and techniques necessary for the ISO 13485 internal and external audit to competently, manage an audit program or an auditing team, communicate with customers, and conflict resolution.

Learning Objectives

  • Learn to perform Medical Devices Quality Management System internal/external audit
  • Learn to lead MDQMS audit or audit team
  • Understand the operations of a Medical Devices Quality Management System (MDQMS) based on ISO 13485
  • Understand the correlation between ISO 13485 and other ISO standards and regulatory frameworks
  • Understand your role as a quality auditor to plan, lead and follow up on a management system audit according to ISO 19011
  • Acquire all the necessary skills and knowledge to plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
  • Learn how to lead an audit and audit team
  • Improve your skills to analyze the internal and external environment of an organization, and your audit decision-making in the context of a MDQMS

Who Should Attend?

  • Internal Medical Devices Quality Management System auditors
  • Anyone involved in performing and leading the ISO 13485 certification audit
  • Members of a MDQMS audit team
  • Project managers or consultants wanting to master the ISO 13485 audit process
  • Any individual responsible for the Quality conformity in an organization
  • MDQMS Consultants or Expert advisers
  • Technical experts planning to prepare for a Quality audit function

ISO 13485 Lead Auditor Training

Course Agenda

Duration: 5 Days

Day 1: Introduction to Medical Devices Quality management Systems (MDQMS) and ISO 13485 Standard

  • Course objective and structure
  • Standard and regulatory framework
  • Fundamental principles of quality management
  • Certification process
  • Medical Devices Quality management System (MDQMS)

Day 2: Audit principles, preparation and launching of an audit

  • Fundamental audit concepts and principles
  • Audit approach based on evidence and risk
  • Initiating the audit
  • Stage 1 audit
  • Preparing the stage 2 audit (on-site audit)
  • Stage 2 audit (Part 1)

Day 3: On-site audit activities

  • Stage 2 audit (Part 2)
  • Communication during the audit
  • Audit procedures
  • Creating audit test plans
  • Drafting audit findings and non-conformity reports

Day 4: Closing the audit

  • Documentation of the audit and quality review
  • Closing the audit
  • Evaluating action plans by the auditor
  • Beyond the initial audit
  • Managing an internal audit programme
  • Competence and evaluation of auditors
  • Closing the training

Day 5: Certification Exam

ISO 13485 Lead Auditor Training

Examination

The Sync Resource ISO 13485 lead auditor training fully meets the requirements of the PECB Examination and Certification Programme (ECP).

The “PECB Certified ISO 13485 Lead Auditor” exam is available in different languages (the complete list of languages can be found in the examination application form)
Duration: 3 hours

The exam covers the following competency domains:

Domain 1: Fundamental Principles and Concepts in Quality Management

Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can understand, interpret and illustrate the main Quality Management concepts related to a Medical Devices Quality Management System (MDQMS)

Domain 2: Medical Devices Quality Management Systems (MDQMS)

Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can understand, interpret and illustrate the main concepts and components of a ISO 13485 based Medical Devices Quality Management System

Domain 3: Fundamental Audit Concepts and Principles

Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can understand, interpret and apply the main concepts and principles related to a MDQMS audit in the context of ISO 13485

Domain 4: Preparation of an ISO 13485 Audit

Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can prepare appropriately a MDQMS audit in the context of ISO 13485

Domain 5: Conduct of an ISO 13485 Audit

Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can conduct efficiently a MDQMS audit in the context of ISO 13485

Domain 6: Conclusion and follow-up of an ISO 13485 Audit

Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can conclude a MDQMS audit, and conduct the follow-up activities in the context of ISO 13485

Domain 7: Management of an ISO 13485 Audit Program

Main Objective: To ensure that the ISO 13485 Lead Auditor understands how to establish and manage a MDQMS audit program

ISO 13485 Lead Auditor Training

Certification

After successfully passing the exam, you can apply for the credentials shown on the table below. Certification will be provided once you comply with all the requirements related to the selected credential.

The requirements for PECB Implementer Certifications are: 

Credential Exam Professional Experience MDQMS Audit Experience Other Requirements
PECB Certified ISO 13485 Provisional Auditor PECB Certified ISO 13485 Lead Auditor Exam None None Signing the PECB
code of ethics
PECB Certified ISO 13485 Auditor PECB Certified ISO 13485 Lead Auditor Exam Two years; One year of MDQMS related work experience Medical Devices Quality Management System activities totaling 200 hours Signing the PECB code of ethics
PECB Certified ISO 13485 Lead Auditor PECB Certified ISO 13485 Lead Auditor Exam Five years; Two years of MDQMS related work experience Medical Devices Quality Management System activities totaling 300 hours Signing the PECB code of ethics
PECB Certified ISO 13485 Senior Lead Auditor PECB Certified ISO 13485 Lead Auditor Exam Ten years; Seven years of MDQMS related work experience Medical Devices Quality Management System activities totaling 1000 hours Signing the PECB code of ethics

ISO 9001 Lead Auditor Training

General Information

  • Certification fees are included on the exam price
  • Training material containing over 450 pages of information and practical examples will be distributed
  • A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued
  • In case of exam failure, you can retake the exam within 12 months for free