ISO 13485 Lead Implementer 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

What is your situation?

For consultants: Get more sales meetings with prospects

How to get the interest of top management in your project?

How to present the project

Other techniques for presenting the project

For consultants: Writing a great proposal

Recap quiz

Introduction & suggested reading

Define the scope of the project

Key stages of the project

Tips for project management

Estimating the project

Communication

Use of tools

Define roles and responsibilities

Project manager beware

Project documentation

Write a Project Plan

Kick-off meeting

Recap quiz

Introduction & suggested reading

Executing the project work

Work assignment

Managing work assignments and resources

Enabling smooth project execution

Gathering information and recommending changes

Introducing documentation and changes in day-to-day use

Overcoming the resistance to change

Recap quiz

Introduction & suggested reading

Verifying and issuing a status report

Communication about the project status

Monitor and control meeting

Internal audit

Management review purpose

Management review preparation and execution

Acceptance and implementation closure

Recap quiz

Introduction & suggested reading

Go for certification or not?

Choose a certification body

Certification process

Stage 1 and Stage 2 audits

Prepare the certification audit

Logistics of the certification audit

Preparing your people for the certification audit

What to expect from the certification auditors

After the certification audit

Recap quiz

Introduction & suggested reading

Keeping the certification

Improving the management system

Top management leadership and example

Keep the management system updated

Until the next surveillance audit

What is the surveillance audit

Recap quiz

Instructions for taking the exam and obtaining the certificate