ISO 13485 Lead Auditor Course

Introduction to the course

Introduction & suggested reading

What is ISO 13485:2016?

What is the QMS?

Why is ISO 13485:2016 important?

What is the structure of ISO 13485?

Key principles of quality management

Key interested parties in ISO 13485

Implementing ISO 13485 using The Plan Do Check Act Process

The ISO 13485 Project

Certification FAQs

Recap quiz

Introduction & suggested reading

What is a process?

Top management commitment (clauses 5.1 and 5.2)

Quality Policy and objectives (clauses 5.3 and 5.4)

Roles and responsibilities (clause 5.5)

Management review (clause 5.6)

Documentation process (clauses 4.1 and 4.2)

Quality Manual (clause 4.2.2)

Medical Device File (clause 4.2.3)

Handling the QMS documentation (clause 4.2.4)

Records for the QMS (clause 4.2.5)

Importance of Resources management process (clause 6.1)

Managing human resources (clause 6.2)

Managing infrastructure resources (clause 6.3)

Managing work environment (clause 6.4.1)

Managing contamination (clause 6.4.2)

Managing monitoring and measuring equipment (clause 7.6)

Related documentation

Recap quiz

Introduction & suggested reading

Planning of Product Realization (clause 7.1)

Example of planning Product Realization

Overview of Customer-Related processes (clause 7.2.1)

Review of a contract or customer purchase order (clause 7.2.2)

Communication methods for the Customer-Related processes (clause 7.2.3)

Design and development overview (clause 7.3.1)

Planning for design and development (clause 7.3.2)

Design and development inputs (clause 7.3.3)

Design and development outputs (clause 7.3.4 and 7.3.5)

Design and development verification and validation (clause 7.3.6 and 7.3.7)

Design and development transfer to production (clause 7.3.8)

Control of design and development changes (clauses 7.3.9, 7.3.10)

Related documentation

Recap quiz

Introduction & suggested reading

Purchasing overview (clause 7.4)

Vendor Evaluation and performance (clause 7.4.1)

Purchasing information and verification of product (clauses 7.4.2 and 7.4.3)

Production and service provision overview (clause 7.5.1)

Qualification of your infrastructure (clauses 7.5.3 and 7.5.6)

Validation of processes (clauses 7.5.6 and 7.5.7)

Labeling and packaging (clause 7.5.11)

Cleanliness of product (clauses 7.5.2 and 7.5.5)

Identification and traceability (clauses 7.5.8 and 7.5.9)

Customer property and preservation (clauses 7.5.10 and 7.5.11)

Post-delivery processes (clauses 7.5.3 and 7.5.4)

Related documentation

Recap quiz

Introduction & suggested reading

Monitoring and measuring overview (clause 8.1)

Monitoring and measurement of products (clause 8.2.6)

Monitoring and measurement of processes (clause 8.2.5)

Feedback (clause 8.2.1)

Complaint handling (clause 8.2.2)

Reporting to regulatory authorities (clause 8.2.3)

Internal audits (clause 8.2.4)

Control of non-conforming product (clause 8.3)

Analysis of data (clause 8.4)

Improvement (clause 8.5.1)

Corrective actions (clause 8.5.2)

Preventive actions (clause 8.5.3)

Related documentation

Recap quiz

Introduction & suggested reading

Auditor assumptions

Techniques for finding evidence

Sampling the records

Interviewing techniques

The audit findings

Nonconformities

Observations

Internal vs. external audit

Annual audit program

Audit plan for an individual audit

Creation of the checklist

Internal audit report

Corrective action requests and corrective action follow-up

Recording the evidence

Recap quiz

Introduction & suggested reading

What is certification?

Certification process

Certification of integrated management systems

Introduction to accreditation and ISO 17021

Competences of lead auditors required by ISO 17021-1

Introduction to International Accreditation Forum (IAF) documents

Introduction to ISO 19011

Principles of auditing

Recap quiz

Introduction & suggested reading

Audit Team Leader / Lead Auditor

Auditor

Technical Specialist

Certification Reviewer

Audit Client

Management Team

Auditee

Hosts / Guides

Recap quiz

Introduction & suggested reading

Audit criteria and objectives

Audit scope

Selecting audit methods

Sampling evidence in audits

Types of remote auditing techniques

Deciding when to use remote auditing techniques

Planning the use of remote auditing techniques

Selecting the audit team

Managing audit risks

Preparing the audit plan

Allocating audit activities to auditors

Making contact with the audit client

Preparation of audit resources

Recap quiz

Introduction & suggested reading

Opening meeting

Managing site visits

Interviews

Audit evidence requests

Debriefing sessions

Dealing with conflicts

Related documentation

Recap quiz

Introduction & suggested reading

The importance of managing your audit team

Communication with the team before the audit

Managing audit progress

Team meetings

Managing audit findings

Managing audit records

What to do when you hit problems

Evaluating your audit management

Recap quiz

Introduction & suggested reading

Audit findings

How to reach audit conclusions

Planning the closing meeting

Holding an effective closing meeting

Dealing with feedback at closing meetings

Effective audit report writing

Post-audit activities, corrections, and correction actions

Certification review process

Related documentation

Recap quiz

Instructions for taking the exam and obtaining the certificate