A Quality Management System in compliant to ISO 13485:2003 (RQ345)

Synopsisquality management system (QMS), a representation of the ISO 9001 series of standards, has come a long way. From the ISO 9001:2000 onwards, the system involves a process approach methodology. Some industries are governed by their specific harmonized standards. In automotives and telecommunications, they are the TS 16949 (formerly QS 9000) and TL 9000. While in the medical devices, it is the ISO 13485 and 21 CFR 820 (USA). Two others standards, ISO 14001 and ISO 18000 span across industries. They address the environment management system (EMS) and the Occupational Health & Safety Management System (OHSMS) respectively. It must be highlighted that all these standards are based, to a large extent, on the ISO 9001:2000. The importance of ISO 9001 is paramount. With this backdrop in spite of this course being ISO 13485, there will be constant reference made to ISO 9001.

The pace with which technology changes and hence the way of doing things, has influenced the QMS in the different industries greatly in addition to their differing effects and considerations. ISO 13485 provides harmonized medical device regulatory requirements for QMS focusing on meeting customer requirements and maintaining effectiveness instead of customer satisfaction and continual improvement in ISO 9001.

In addition there is also emphasis on safety, risk analysis, and traceability in the requirement for medical devices in ISO 13485 standards. As such, much more is required in the documentation and extra requirements on work environment and risk management for ISO 13485. Product/Process traceability and advisory note/recall are other requirements. Another important aspect in the compliance to ISO 13485 is when special process such as sterilisation is involved.

All management systems require compliance to applicable regulatory requirements which varies drastically according to processes and products. In the course of implementation, it is important to have clarity and appreciation of the regulatory requirements. Organizations certified ISO 13485 fulfill all the quality management requirements for product certification/product registration of medical devices under this directive.

What You Will Learn

• Insight to the contents and significances of the relevant standards and regulations.
• Prepare the participants to develop or improve; implement or maintain their organization’s quality management system (QMS).

Who Should AttendThose who involve in the the design and development, production, installation, servicing, and sales of medical devices; or those who are currently in the ISO team to implement an effective management system complying with the standard requirements.

PrerequisiteBasic understanding of the ISO 9001 is required.

Course MethodologyThis course is presented in an interactive classroom style utilizing lecture, open discussion, examples, and Q&A sessions.

Course Duration2 days, 9am - 5pm

Course Structure1) Overview of Quality Management Systems and Product Certification

• Standards: timeline
• Standards: structural context
• Quality management system: process flow

2) Deliberations of the ISO 13485 Standards

• Scope
• Normative reference
• Terms & definition
• Quality management system
• Management responsibility
• Resource management
• Product realisation
• Measurement, analysis and improvement

3) Differences Between ISO 13485 and ISO 9001

• Highlights of the differences in the clauses
• Explanation