Course Highlights
  • Understand the requirements of ISO 9001:2015 standard in plain and simple language
  • Understand the steps required for a company to implement the standard
  • Understand the history of ISO 9001 standard
Skills you will learn!
Curriculum

3 Topics
History of ISO 9001 Revisions
Quality Gurus Inc Certificate and Digital Badge
Pre-Course Diagnostic Test

8 Topics
9001:2008 vs 9001:2015 High Level Comparison
Five terms now have a new name
No Quality Manual
No Management Representative
No Exclusion Clause
Process Approach
Preventive Action is out and Risk Based Thinking is in
DOWNLOAD - Key changes from ISO 9001:2008

5 Topics
SCOPE OF THE STANDARD (Clause 1)
NORMATIVE REFERENCES (Clause 2)
TERMS AND DEFINITIONS (Clause 3)
DOWNLOAD - Clause 1 2 and 3
Practice Activity - QUIZ - Clause 1 2 and 3

7 Topics
CONTEXT OF THE ORGANIZATION (Clause 4)
4.1 Understanding the Organization and its Context
4.2 Needs and Expectations of Interested Parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
DOWNLOAD - Clause 4
Practice Activity - QUIZ - Clause 4

6 Topics
LEADERSHIP (Clause 5)
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles responsibilities and authorities
DOWNLOAD - Clause 5
Practice Activity - QUIZ - Clause 5

6 Topics
PLANNING (Clause 6)
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
DOWNLOAD - Clause 6
Practice Activity - QUIZ - Clause 6

14 Topics
SUPPORT (Clause 7)
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
DOWNLOAD - Clause 7
Practice Activity - Quiz - Clause 7

18 Topics
OPERATION (Clause 8)
8.1 Operational planning and control
8.2 Requirements for products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
Definitions - Design review verification and validation
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
DOWNLOAD - Clause 8
Practice Activity - QUIZ - Clause 8

6 Topics
PERFORMANCE EVALUATION (Clause 9)
9.1 Monitoring measurement analysis and evaluation
9.2 Internal audit
9.3 Management review
DOWNLOAD - Clause 9
Practice Activity - QUIZ - Clause 9

6 Topics
IMPROVEMENT (Clause 10)
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
DOWNLOAD - Clause 10
Practice Activity - Quiz - Clause 10

5 Topics
Transition Timeline
Quality Manual - To have it or not to have it?
Organizational Knowledge - Implementation Approach
Actions to address risks and opportunities - Implementation Approach
Download Slides for Section 11

5 Topics
Who is Responsible for Revision?
Why the standard is being revised?
ISO 9001:2015 Revision Timeline
High Level Structure - HLS
Download Section 12 Slides

1 Topic
Bonus Lecture

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Mastering ISO 9001:2015 Quality Management System-Accredited

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