質素管理
ISO 13485 — Medical Devices Quality Management System
課程類型、時長及學費
| 課程類型 | 適合對象 | 企業得益 | 時長 | 學費 |
|---|---|---|---|---|
| Foundation | 希望學習管理系統及其流程實施基礎的人士 | 透過理解 ISO 標準的核心要素，為機構建立以最佳實務為本的取向與文化 | 2 天 | HKD 4,400 |
| Lead Implementer | 負責在公司實施及管理管理系統的人員 | 由具備能力的人員帶領推行最佳實務，改善整體流程，邁向符合 ISO 標準 | 5 天 | HKD 11,200 |
| Lead Auditor | 負責在公司審核及監察管理系統的人員 | 由具備能力的人員審核流程，確保管理系統妥善實施，邁向成功合規與認證 | 5 天 | HKD 11,200 |
About the standard
ISO 13485 sets the quality management requirements for the medical devices industry, covering the full device life cycle from production through post-production, decommissioning, and disposal. It is used both by manufacturers and by certification bodies supporting the certification process, giving organizations a proven framework for developing and maintaining efficient, compliant processes that deliver safe, reliable medical devices.
Levels available
- Foundation — For those who want to learn the basics of a medical devices quality management system and its processes under ISO 13485.
- Lead Implementer — For those responsible for implementing and managing a medical devices QMS in their organization.
- Lead Auditor — For those responsible for auditing and monitoring a medical devices QMS to support compliance and certification.
Who should attend
Quality and regulatory affairs professionals in the medical devices industry, along with implementers, auditors, and consultants who support manufacturers or certification bodies, should attend. It is well suited to anyone aiming to demonstrate commitment to product safety and continuous improvement in a regulated industry.
Learning objectives
- Understand the requirements of ISO 13485 across the medical device life cycle.
- Learn to implement and manage a QMS tailored to medical device manufacturing and post-market processes.
- Gain the competence to audit a medical devices QMS for conformity.
- Develop the ability to identify and address quality and safety risks specific to medical devices.
Why attend
Certification increases job opportunities and earning potential, since large medical device companies actively seek professionals who can demonstrate this expertise. It also builds new business connections and competitive advantage by proving your ability to help an organization deliver safer, more effective medical devices and increase customer trust.
PECB link
https://pecb.com/en/education-and-certification-for-individuals/iso-13485