ISO 13485 Lead Auditor - India
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ISO 13485 Lead Auditor - India at The knowledge academy Overview
ISO 13485 Lead Auditor - India
at The knowledge academy
Gain a comprehensive overview of Lead Auditor
Duration | 5 days |
Mode of learning | Online |
Credential | Certificate |
ISO 13485 Lead Auditor - India at The knowledge academy Highlights
ISO 13485 Lead Auditor - India
at The knowledge academy
- Earn a certificate of completion
ISO 13485 Lead Auditor - India at The knowledge academy Course details
ISO 13485 Lead Auditor - India
at The knowledge academy
Skills you will learn
What are the course deliverables?
- To improve the quality of medical devices manufactured by a company
- To promote harmonisation of regulatory requirements for manufacturers
- To provide access and evidence in accordance with regulatory requirements
- To engage management actively and undertake management system activities
- To protect the confidentiality of all documents and information obtained in the audit
- To obtain quality objectives from the manufacturer and pass them to the organisation
More about this course
- This program will help learners with the implementation of a quality management system for medical devices and methods to conduct auditing activities to ensure the overall performance of an organisation. Obtaining knowledge of this training assists organisations in eliminating problems and reducing the work burden
ISO 13485 Lead Auditor - India at The knowledge academy Curriculum
ISO 13485 Lead Auditor - India
at The knowledge academy
Introduction to ISO 13485:2016
Introduction
What is ISO 13485:2016?
Benefits of Implementing ISO 13485
Applications of ISO 13485
ISO 13485 Clauses 1 and 2
Clauses 1 - Scope
Clauses 5 - Management Responsibility
Clauses 6 - Resource Management
Clause 2 - Normative References
ISO 13485 Clauses 3 and 4
Clause 3 - Terms and Definitions
Clause 4 - Quality Management System
Requirements and Quality Systems
Requirements and Quality Systems
Clause 5
Clause 6
Clause 7
Overview of ISO 13485:2016 Requirements
Requirements of ISO 13485:2016
General Requirements
Documentation Requirements
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ISO 13485 Lead Auditor - India
at The knowledge academy
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