Introduction

ISO 13485 is the medical industry's medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. The standard requires that such organizations prioritise excellent quality practices and develop a reliable quality management system to establish and demonstrate their competence. This standard is applicable to all organizations, regardless of size or complexities. The standard is applied to demonstrate the ability to consistently manage quality that meet regulatory requirements. This course helps aspiring participants to understand how ISO 13485 helps to continual improve organisational quality management system using its best practice. Participants learn the details of each clauses of the standard requirement to be able to apply within their organization.

Objective

To describe the concept overview of the ISO 13485 requirement.

To provide knowledge on quality management system (QMS) and describe how Risk-Based Thinking is applied in ISO 13485.

To explain the importance of customer-specific requirements in the quality management system.

To build awareness in QMS and encourage continual improvement within organization.

Content

Session 1:  Introduction

Describe quality management approach and how to use process mapping to understand a process. Identify which elements impact process performance and determine measures that can be used to monitor and improve the performance of the process.

Session 2:  Terms and Definitions

Describe relevant terms and definitions that normally use in the quality system.

Session 3:  Risk-based thinking and tools of Related Standards

Describe quality concept is implemented in conjunction with quality management system. Explain risk-based thinking fosters a proactive culture of prevention and improvement

Session 4:  Interpretation of standard requirement

Describe the ISO 13485 requirement clause by clause that implemented in conjunction with quality management system. Explain concept and awareness to improve effectiveness of the quality system.

Session 5:  Conclusion

Conclude requirement and explain step to implement the system.

*Exercise workshop will also be delivered in each key sessions*

Prerequisites

Basic knowledge in quality is optional. Experience in any industry will be more benefit.

Who should attend

This course is suitable for anyone in the industry who either already take a role concerns to quality or expect to do so as;

Managerial staff

Supervisor/Leader

Engineer

Officer

Anyone who interested

Benefit

Upon successful completion of this training, participants will have knowledge of ISO 13485 standard requirement. Participants will know the process approach that can help organization streamline processess, which will lead to increased efficiency and productivity.