Course Outline
Introduction
Overview of ISO 13485
- Objective and applicability of ISO 13485
- Significance of ISO 13485 within the medical device sector
- Essential terminology and definitions
ISO 13485 Architecture and Clauses
- Comprehension of the framework (Annex SL)
- Summary of principal clauses: 4 through 8
Quality Management Principles
- Process methodology and PDCA (Plan-Do-Check-Act) cycle
- Risk-based reasoning applied to medical devices
- Emphasis on customer orientation and regulatory obligations
Core Requirements of ISO 13485:2016
- Detailed analysis of clauses 4 through 8
- Design and development oversight
- Risk management across the product lifecycle
- Control of documentation and records
Establishment and Sustainment of ISO 13485 QMS
- Procedure for instituting an ISO 13485-aligned QMS
- Education and proficiency standards for personnel
- Surveillance and assessment of processes
Inspection and Accreditation Procedures
- Basics of internal and external inspections
- Preparation for accreditation: expected protocols
- Identification of non-conformities and corrective measures
Conclusion and Subsequent Actions
Requirements
- Elemental knowledge of quality management frameworks
Intended Audience
- Quality Assurance Managers
- Quality Engineers
- Auditors and Regulatory Compliance Personnel
Testimonials (5)
Theory followed by practical examples and exercices. Job well done!
Vincenzo Delle Donne - Department of National Defence
Course - ISO 37301 Compliance Management System
the expertise & knowledge of the trainer
Erica DeRosa DeRosa - Aecon Group INc.
Course - ISO 37001 Anti-Bribery Management System
With both my 2022 ISO 9001 audit prep-related training & the recently completed ISO 9001 audit prep refresher course; Dereck has helped me significantly with regards to gaining a new & practical perspective of the ISO 9001:2015 clauses & sections & how they apply to our business. Dereck has also helped me with both training courses --- to improve my ISO-related communications both with our company's employees and the external ISO Auditors .
Dana Foster - Corrigan Oil Company
Course - ISO 9001 Foundation
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