Course overview 

ISO 13485:2016, as an international standard for Quality Management System Requirements stipulated in the medical device industry, involves the design, development, production, installation and service of medical devices. Through the study of this course, students can understand the structure and requirements of ISO13485 Quality Management System. According to ISO 19011:2018 "Audit Management system Guide" to provide students with in-depth knowledge and skills in auditing. So that students have ISO13485 audit basic ability. Meet the requirements of ISO13485:2016 medical device quality management director auditor system director auditor.

The course meets the training requirement for Exemplar Global (TPECS) Auditor certification program for the below achievement.

• Exemplar Global – MD
• Exemplar Global – AU
• Exemplar Global – TL

Course purpose

The course meets the training requirements for Exemplar Global (TPECS) Provisional Auditor Certification for medical device.

Intertek Course advantage

• EG Authorized accredited courses  
• Personally taught by the Chief Gold Training Provider
• Exclusive Gold Teaching Assistant Service
• More questions and practice sharing to ensure learning quality

Course Outline

• Overview of the Quality Management System (ISO13485 & ISO9001 background, principles, objectives, etc.)
• A brief description of the content and structure, scope, terms and definitions of ISO 13485: 2016
• Detailed analysis of ISO 13485:2016 standard terms.
• ISO13485:2016 Chief auditor knowledge and skills analysis (role, responsibility, ISO14971 risk management, regulations, etc.)
• Interpretation of ISO19011 audit guidelines (audit types, audit roles, audit schemes, audit planning, etc., auditor code of Conduct)
• Analysis and implementation of audit process and skills (preparation of audit plan and checklist, issue of non-conformance items; Audit principles, audit skills, audit methods and skills, simulation audit)
• Preparation and follow-up of audit report

Training Provider introduction

Mr. Steven Wang

More than 10 years of clinical medicine practice experience, clinical intervention and laboratory experience. Many years of multinational enterprise medical device quality and design experience. Independently led more than 50 European Union and American product launching projects. The founder of CFP theory. I have served in many EU announcement institutions (UK, Germany, Netherlands), in charge of clinical review of medical devices, microbial sterilization review, CE review and audit of high-risk products, and successively served as technical director, chief lecturer and certificate issuing review, with rich practical experience.

The lecturer adopts a unique practical interactive way. The class is humorous, close to reality and nature, and leads the students to think in a very simple way.

Who should attend

• Individuals who want to obtain a formal qualification in the application of Medical Devices to add to their auditing experience
• Individuals leading their companies to ISO 13485 certification
• Business Managers, Quality Managers, Engineers, Compliance Officers, and Consultants
• Individuals who want to become a Certified Medical Device Quality Management Systems Auditor through their relevant certifying body such as Exemplar Global

Achievement

This course is certified by Exemplar Global under the TPECS scheme.Upon successful completion of this course and passing the examination, students will be granted Certificate of Attainment with the following Exemplar Global competency units 

• Exemplar Global – MD – Medical Device Management Systems   
• Exemplar Global – AU – Management Systems Auditing          
• Exemplar Global – TL – Leading Management Systems Audit Teams 

Course schedule 

5 days (40 hours) 

Course Time and Venues

Course Fees:

RMB 12,000 per person

Limited time discount, register as soon as possible 

Please contact customer service representative for details. 

Payment Information 

Account Name：上海天祥质量技术服务有限公司

Bank Name：美国银行上海分行

Bank Account No. 10717034003

更多信息请咨询：

Freya Yang

Tell:021-53397720

Email:freya.yang@intertek.com

Intertek  

Intertek is a leading Total Quality Assurance provider to industries worldwide with professional, accurate, fast, passionate total quality assurance service, to win the market escort for customers.Our network of more than 1,000 laboratories and offices and over 44,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.

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