ISO 13485:2016 Lead Internal Auditor

CEU: 6.0

Prerequisites:  None

Course Time Period:

You can take training at your own pace. You can logon and logout as many times as needed. You can re-take the exam as many times as necessary until you pass the exam and an online certificate is issued.

Course Content::  (interpretation, examples, auditing/implementation questions, quiz)

Introduction

• What are the general requirements for the ISO 13485 standard?
• What are the requirements for a ISO 13485 process approach?
• How does ISO 13485 relate to other standards?
• How is ISO 13485 compatible with other management systems?Lead Auditor ManagementQuality System
• Lead Auditor Qualifications and Competency
• Lead Auditor Foundations

• What are the general requirements for a Quality Management System?
• What are the audit questions for a Quality Management System?
• What are the general documentation requirements for a Quality Management System?
• What are the documentation auditing questions for a Quality Management System?
• What are the documentation requirements for a Quality Manual?
• What are the audit questions for a Quality Manual?
• What are the requirements for control of documents?
• What are the audit questions for control of documents?
• What are the requirements for control of records?Management
• What are the audit questions for control of records?

• What are the requirements for management responsibility?
• What are the audit questions for management responsibility?
• What are the requirements for management commitment?
• What are the requirements for customer focus?
• What are the requirements for quality policy?
• What are the audit questions for quality policy?
• What are the requirements for planning of quality objectives?
• What are the audit questions for planning of quality objectives?
• What are the requirements for planning of Quality Management System?
• What are the audit questions for planning of Quality Management System?
• What are the requirements for responsibility and authority?
• What are the audit questions for responsibility and authority?
• What are the requirements for management representative?
• What are the audit questions for management representative?
• What are the requirements for internal communication?
• What are the audit questions for internal communication?
• What are the general requirements for management review?

• What are the audit questions for management review?
• What are the requirements for review input for management review?
• What are the audit questions for review input for management review?
• What are the requirements for review output for management review?
• What are the audit questions for review output for management review?
• Resource

• What are the requirements for provision of resources?
• What are the audit questions for provision of resources?
• What are the general requirements for human resources?
• What are the requirements for human resources competence, awareness and training?
• What are the audit questions for human resources competence, awareness and training?
• What are the requirements for infrastructure?
• What are the audit questions for infrastructure?
• What are the requirements for work environment?
• What are the audit questions for work environment?Product
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• What are the requirements for planning of product realization?
• What are the audit questions for planning of product realization?
• What are the requirements for determination of requirements related to the product?
• What are the audit questions for determination of requirements related to the product?
• What are the requirements for review of requirements related to the product?
• What are the audit questions for review of requirements related to the product?
• What are the requirements for customer communication?
• What are the audit questions for customer communication?
• What are the requirements for design and development planning?
• What are the audit questions for design and development planning?
• What are the requirements for design and development inputs?
•            What are the audit questions for design and development inputs?

• What are the requirements for design and development outputs?
• What are the audit questions for design and development outputs?
• What are the requirements for design and development review?
• What are the audit questions for design and development review?
• What are the requirements for design and development verification?
• What are the audit questions for design and development verification?
• What are the requirements for design and development validation?
• What are the audit questions for design and development validation?
• What are the requirements for control of design and development changes?
• What are the audit questions for control of design and development changes?
• What are the requirements for purchasing process?
• What are the audit questions for purchasing process?
• What are the requirements for purchasing information?
• What are the audit questions for purchasing information?
• What are the requirements for verification of purchased product?
• What are the audit questions for verification of purchased product?

• What are the requirements for traceability?
• What are the audit questions for traceability?
• What are the particular requirements for implantable medical devices?
• What are the audit questions for implantable medical devices?
• What are the requirements for status identification?
• What are the audit questions for status identification?
• What are the requirements for customer property?
• What are the audit questions for customer property?
• What are the requirements for preservation of product?
• What are the audit questions for preservation of product?
• Control of Monitoring

• What are the requirements for control of monitoring and measuring devices?
• What are the audit questions for control of monitoring and measuring devices?
• Measurement

• What are the general requirements for measurement, analysis and improvement?
• What are the audit questions for measurement, analysis and improvement?
• What are the requirements for feedback?
• What are the audit questions for feedback?

• What are the requirements for internal audit?
• What are the audit questions for internal audit?
• What are the requirements for monitoring and measurement of processes?
• What are the audit questions for monitoring and measurement of processes?
• What are the requirements for monitoring and measurement of product?
• What are the audit questions for monitoring and measurement of product?
• What are the requirements for control of nonconforming product?
• What are the audit questions for control of nonconforming product?
• What are the requirements for analysis of data?
• What are the audit questions for analysis of data?
• What are the general requirements for improvement?
• What are the audit questions for improvement?
• What are the requirements for corrective action?
• What are the requirements for preventive action?
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