Course Highlights
  • The requirements for a Quality Management System according to ISO 9001
  • How to implement a Quality Management System and comply to the requirements of ISO 9001:2015
  • How to audit a Quality Management System
  • Plan, perform and report QMS Audits
  • Auditing a management system according to ISO 19011:2018
Curriculum

8 Topics
Introduction
What is quality?
A Quality Management System (QMS)
ISO 9001 and the ISO 9000 series of standards
About the certification to ISO 9001
Process approach
Risk based thinking
The structure of ISO 9001:2015

4 Topics
Understanding the organization and its context
Needs and expectations of interested parties
Determining the scope of the management system
Quality management system and its processes

4 Topics
Leadership and commitment
Customer focus
Establishing and communicating the quality policy
Organizational roles responsibilities and authorities

3 Topics
Actions to address risks and opportunities
Quality objectives and planning to achieve them
Planning of changes

10 Topics
Resources
People
Infrastructure
Environment for the operation of processes
Monitoring and measuring resources
Organizational knowledge
Competence
Awareness
Communication
Documented information

21 Topics
Operational planning and control
Customer communication
Determining the requirements for products and services
Reviewing the requirements for products and services
Design and development of products and services
Design and development planning
Design and development inputs
Design and development controls
Design and development outputs
Design and development changes
Control of externally provided processes products and services
Type and externt of control
Information for external providers
Control of production and service provision
Identification and traceability
Property belonging to customers or external providers
Preservation
Post-delivery activities
Control of changes
Release of products and services
Control of nonconforming outputs

5 Topics
Monitoring measurement analysis and evaluation
Customer satisfaction
Analysis and evaluation
Internal audit
Management review

3 Topics
Improvement
Nonconformity and corrective action
Continual improvement

10 Topics
Management system auditing
Types of management system audits
Audit scope objectives and criteria
Audit team
The audit plan
Conducting the audit
Nonconformities
The audit report
Thank you and good bye!
ISO 9001:2015 Quality Management System Auditor Quiz

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ISO 9001:2015 Quality management system auditor

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