Course Outcomes
Delegates will develop the competence to plan, conduct, report and follow up audits in line with ISO 19011 and ISO/IEC 17021 principles. They will gain practical skills in evaluating system effectiveness, identifying nonconformities, and recommending improvements, while maintaining professional objectivity. A strong emphasis is placed on communication, critical analysis, and audit leadership to ensure participants can deliver value-driven audit outcomes.

By the end of the course, participants will be confident in leading an audit team, managing all stages of the audit process, and guiding organizations toward improvement. Participants will be prepared to perform internal and external audits against ISO 13485, supporting manufacturers and suppliers in delivering safe, compliant, and effective medical devices.  They will be able to link the standard’s requirements to regulatory expectations, product safety, and risk-based thinking, ensuring a holistic approach to compliance in the medical device sector.

This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an internationally accepted CQI/IRCA (Charted Quality Institute - International Register of Certificated Auditors) registered certificate.

Content

1. Introduction to Medical Device Quality Management Systems

• Purpose and benefits of a medical device QMS
• Role of third-party certification in compliance and trust
• Differences between first, second, third-party, and regulatory audits
• Auditor’s role in assessing conformity
• Key ISO 13485 terms and links to ISO 9000
• QMS as a basis for compliance and improvement

 
2. Process-Based Medical Device Quality Management Systems

• PDCA cycle in medical device QMS
• Processes for establishing, implementing, monitoring, and improving a QMS
• Importance of these processes for auditors

 
3. Accreditation, Certification and Auditor Competence

• Benefits of accredited third-party certification
• Value for organisations, stakeholders, and regulators
• Certification and accreditation terminology and processes
• Auditor competence requirements (skills and behaviours)
• Importance of confidentiality, integrity, and impartiality
• CQI Professional Code of Conduct for ethical practice

 
4. Audits: Definitions, Principles and Types

• Purpose of different audit types (first, second, third-party, regulatory)
• Auditor’s role in assessing compliance with requirements
• Application of core auditing principles (impartiality, accuracy, value)

 
5. MD QMS Audit Questionnaire

• Use of Learner Guide in pairs/teams
• Task completed within set timeframe
• Reporting findings back to class
• Tutor support and monitoring
• Expectations for presenting and assessing results

 
6. Preparing for the onsite audit

• Purpose and process of Stage 1 audit
• Documentation review and outputs
• Preparing for Stage 2 audit (plan, team, documents)
• Confirming scope, objectives, methods, and resources
• Applying a risk-based approach to audit planning

 
7. Developing a checklist

• Preparing key documents for Stage 2 audit
• Developing effective audit checklists
• Creating sampling plans
• Using specialist document formats
• Ensuring structured, consistent, and objective-aligned audit process

 
8. Conducting the on-site audit (stage 2 audit)

• Reviewing audit outcomes and evaluating objective evidence
• Preparing clear, balanced audit conclusions
• Highlighting compliance, positive findings, nonconformities, and improvement opportunities
• Conducting Stage 2 on-site audits (logistics, meetings, evidence gathering)
• Implementing audit plan and following audit trails
• Using documented information effectively
• Building rapport with auditees and managing interviews
• Applying risk-based sampling for reliable evidence

 
9. Audit Review

• Reviewing audit findings and preparing conclusions
• Evaluating objective evidence for conformity and nonconformity
• Preparing balanced audit conclusions
• Identifying compliance levels and positive findings
• Highlighting risks and opportunities for improvement
• Ensuring outcomes support organisational growth

 
10. Audit Reporting and Follow-Up

• Preparing, presenting, and managing audit reports and conclusions
• Writing and grading nonconformity reports
• Presenting findings at closing meetings
• Emphasising follow-up and verifying corrective/preventive actions
• Assessing opportunities for improvement
• Applying a risk-based approach to surveillance, re-audits, and regulatory audits
• Managing audit reporting and follow-up to maintain system performance

 
Methodology
The course consists of knowledge-based presentation, case studies, role plays, exercises, workshops and group discussions. This activity-based learning results in deeper understanding of the material and has a greater impact on job performance. A mock examination paper will be discussed throughout the course to help participants to be familiar with the style of the question.
 
Examination and Certification
In order to satisfactorily complete the course, each participant must:

1. Complete/attend all elements of the course
2. Pass the continuous assessment
3. Pass the written examination  

Evaluation parameters
1. Continuous Assessment:

• Punctuality, presentation skills, interactive approach, involvement, role-play, daily tests

2. Virtual examination, 2 hours duration:

• The examination consists of 4 sections
• Closed book examination, study materials and other materials will not be allowed during the examination for reference
• An unmarked copy of ISO 13485 will be allowed to be referred
• Total marks of examination: 90 marks
• Passing criteria 1: 70% of 90 mark – 63 marks
• Passing criteria 2: 50 % in each of the 4 sections

If English is not your first language, you can apply for an additional 24 minutes which will be added to the 2 hour course duration.

Participants who score 70% and above in both the continuous assessment and written examination will be issued an CQI/IRCA (Charted Quality Institute - International Register of Certificated Auditors) registered certificate of successful completion of the course, which is renowned in certification and carries worldwide acceptance.

In addition, upon completion participants will also receive a course certificate issued by Medicoindustrien and SGS.

Who should attend
The training is relevant for:

• Quality professionals
• Consultants
• Management representatives, Managers or Process owners
• ISO 13485:2016 Coordinators
• Auditors/ Lead Auditors

Knowledge of ISO 13485 and its application within a medical device organization is strongly recommended together with experience with conducting internal or supplier audits.

Prerequisites
Before starting this course, learners are expected to have prior knowledge of ISO 13485, including an understanding of its requirements.

They should also be familiar with Medical Device Management System auditing, including the Plan-Do-Check-Act (PDCA) cycle, the relationship between ISO 13485 and international regulatory requirements, and commonly used quality management terms and definitions from ISO 13485 and ISO 9000. In addition, learners are expected to understand the process approach used in MD QMS, have working knowledge of relevant medical device regulatory processes and auditing standards in applicable countries, and be aware of how these relate to ISO 13485.

Finally, learners should possess a working knowledge of risk management principles related to medical device design (e.g., ISO 14971), and understand the purpose and benefits of conducting a business impact analysis. Please note that examinations may include questions based on this prior knowledge.

Trainer
Jane Oglesby, Medical Device Lead Auditor, SGS United Kingdom