ISO 9001:2015 Requirements (Onsite Only)

Description

This 1.5 day on-site course will explain and interpret the ISO 9001:2015 requirements, as well as, identify the changes from the ISO 9001:2008 standard. Students will participate in 7 class workouts and 7 team activities.

Course Outline – Day 1

Course Introduction
Reasons for Revision
Annex SL
Key Changes
Terminology Changes
Standard Comparisons
Requirement Changes
Clause Structure
Requirement Grouping

Introduction to ISO 9001:2015
0.1 General
0.2 Quality Management Principles
0.3 Process Approach
0.3.2 Plan-Do-Check-Act Cycle
0.3.3 Risk-based Thinking
0.4 Relationship with Other Management System Standards

1. Scope
2. Normative References
3. Terms and Definitions

4. Context of the Organization
4.1 Understanding the Organization and its Context
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System
4.4 Quality Management System and its Processes
Class Workout – Clause 4
Team Activity – Clause 4

5. Leadership
5.1 Leadership and Commitment
5.1.1 General
5.1.2 Customer Focus
5.2 Quality Policy
5.2.1 Developing the Quality Policy
5.2.2 Communicating the Quality Policy
5.3 Organizational Roles, Responsibilities, and Authorities
Class Workout – Clause 5
Team Activity – Clause 5

6. Planning 
6.1 Actions to Address Risks and Opportunities
6.2 Quality Objectives and Planning to Achieve Them
6.3 Planning of Changes
Class Workout – Clause 6
Team Activity – Clause 6

7. Support
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
7.5.1 General
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
Class Workout – Clause 7
Team Activity – Clause 7

8. Operation
8.1 Operational Planning and Control
8.2 Requirements for Products and Services
8.2.1 Customer Communication
8.2.2 Determining the Requirements related to Products and Services
8.2.3 Review of Requirements related to Products and Services
8.2.4 Changes to Requirements related to Products and Services
8.3 Design and Development of Products and Services
8.3.1 General
8.3.2 Design and Development Planning
8.3.3 Design and Development Inputs
8.3.4 Design and Development Controls
8.3.5 Design and Development Outputs
8.3.6 Design and Development Changes

Course Outline – Day 2

8.4 Control of Externally Provided Processes, Products, and Services
8.4.1 General
8.4.2 Type and Extent of Control
8.4.3 Information on External Providers
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision
8.5.2 Identification and Traceability
8.5.3 Property Belonging to Customers or External Providers
8.5.4 Preservation
8.5.5 Post-Delivery Activities
8.5.6 Control of Changes
8.6 Release of Products and Services
8.7 Control of Nonconforming Process Outputs
Class Workout – Clause 8
Team Activity – Clause 8


9. Performance Evaluation
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.1.1 General
9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation
9.2 Internal Audit
9.3 Management Review
9.3.1 General
9.3.2 Management Review Inputs
9.3.3 Management Review Outputs
Class Workout – Clause 9
Team Activity – Clause 9

10. Improvement
10.1 General
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement
Class Workout – Clause 10
Team Activity – Cause 10

Annex A and B
Course Summary
Questions and Answers
Course Evaluations
Student Certificates

Course Handouts

Copy of Presentation Slides
Annex SL – Appendix 2
Clause Map – ISO 9001:2008 to ISO 9001:2015
Clause Map – ISO 9001:2015 to ISO 9001:2008
Clause Quick Reference
Required Documented Information
Revised Quality Management Principles
Risk Assessment Worksheets
Changes from ISO 9001:2008

Duration

1.5 days

Class Hours

Day 1 = 8:30 AM to 4:30 PM
Day 2 = 8:30 AM to 12:00 PM

On-site Course

An on-site class is $3000, plus instructor travel expenses, plus $100 per student for materials. An all-inclusive price (fees, materials, and expenses) will be quoted.

A copy of the standard will not be needed for the course exercises. The class size should be at least 4 students and no more than 25 students.

NOTE: If you are interested in getting on our calendar for an on-site class, please send an email to [email protected]).

Whittington & Associates

We are committed to providing expert training, effective consulting, and valuable auditing. If you have any questions about our services, please contact us at 770-862-1766, or [email protected].