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Auditor Skill For ISO 13485 ISO 9001 ISO 14971

Auditor Skill For ISO 13485 ISO 9001 ISO 14971

Duration (Days)

2

Overview

This course is designed for participants to have an insight of ISO 13485 and making comparisons to ISO 9001 and other FDA'S quality system regulations. Participants will gain an awareness of the relationship between ISO 13485, ISO 14971 and ISO 19011:2011 and understand how to go through the entire audit process and managing an audit program.

Objectives

  • Understand on the latest ISO13485:2003 Medical Devices QMS Requirements

  • Compare the requirements between ISO 13485 and ISO 9001

  • Recognize the relationship between ISO 13485 and ISO 14971

  • Compare the requirements between ISO 13485 and FDA's Quality System Regulation

  • Describe the responsibilities of an internal auditor and describe the role of internal audit in the maintenance and improvement of management systems

  • Plan and prepare for an internal audit, gather audit evidence through observation, interview and sampling of documents and records, write factual audit reports that help to improve the effectiveness of the management system according to the ISO1901:2011 auditing guidelines

  • Establish, implement, maintain, review and finally continually improving the auditing related business operation fulfilling the legal and regulatory requirements

Course Outline

  • ISO 13485 Standard Development 

  • ISO 13485 and ISO 9001 QMS

  • FDA regulations

  • ISO 13485 and ISO 14971 Risk Management

  • Documentation requirements

  • Implementation steps

  • Quality audit 

  • Environmental auditing 

  • Types of audits 

  • Roles of internal auditor, audit and client

  • Principle of quality auditing

  • Evidence based approach 

  • Accreditation and certification

  • Quality management representative roles

  • Audit planning and prepareation 

  • Auditing methodology 

  • ISO 19011 : 2011 standard on quality and environment

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