Course Outline
Introduction
Overview of ISO 13485
- Purpose and scope of ISO 13485
- Importance of ISO 13485 in the medical device industry
- Key terminologies and definitions
ISO 13485 Structure and Clauses
- Understanding the structure (Annex SL)
- Overview of key clauses: 4 to 8
Quality Management Principles
- Process approach and PDCA (Plan-Do-Check-Act)
- Risk-based thinking in medical devices
- The importance of customer focus and regulatory requirements
Key Requirements of ISO 13485:2016
- Clause-by-clause breakdown (4 to 8)
- Design and development controls
- Risk management throughout the product lifecycle
- Control of documents and records
Implementation and Maintenance of ISO 13485 QMS
- Steps to establish an ISO 13485-compliant QMS
- Training and competency requirements for personnel
- Monitoring and measuring processes
Audit and Certification Process
- Introduction to internal and external audits
- Preparing for certification: what to expect
- Non-conformities and corrective actions
Summary and Next Steps
Requirements
- Basic understanding of quality management concepts
Audience
- Quality managers
- Quality engineers
- Auditors and regulatory compliance staff
Delivery Options
Private Group Training
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- Pre-course call with your trainer
- Customisation of the learning experience to achieve your goals -
- Bespoke outlines
- Practical hands-on exercises containing data / scenarios recognisable to the learners
- Training scheduled on a date of your choice
- Delivered online, onsite/classroom or hybrid by experts sharing real world experience
Private Group Prices RRP from £3800 online delivery, based on a group of 2 delegates, £1200 per additional delegate (excludes any certification / exam costs). We recommend a maximum group size of 12 for most learning events.
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Testimonials (4)
The training was well put together & very informative.
Siobhan Kavanagh - SEEC MM Ltd.,
Course - ISO 9001 Lead Implementer
The quizzes to reinforce the reading and the ability to ask questions at any time
Jonathan
Course - ISO 9001 Lead Auditor
Speed of response and communication
Bader Bin rubayan - Lean Business Services
Course - ISO/IEC 27001 Lead Implementer
Dereck's overall preparedness . Dereck has great communications' skills !!