IATF 16949:2016 Requirements and Transition Guidance

Description

The new IATF 16949:2016 replaces ISO/TS 16949:2009. Organizations certified to ISO/TS 16949:2009 must transition to IATF 16949:2016 by September 2018, the date that ISO 9001:2015 will be withdrawn.

Our 2.5 day IATF 16949:2016 Requirements and Transition Guidance course explains the underlying requirements based on ISO 9001:2015 and the additional requirements unique to IATF 16949:2016.

To help with the transition, the course highlights all the requirement changes from those in the ISO 9001:2008 and ISO/TS 16949:2009 standards. The course also includes transition guidance.

Course Outline – Day 1 (8:30 AM to 4:30 PM)
Course Introduction
Course Objectives
Reasons for Revision
Annex SL
Key Changes
Terminology Changes
Standard Comparisons
Requirement Changes
Clause Structure
Requirement Grouping

IATF 16949 Background
Foreword
History
Goal

IATF 16949 Introduction
0.1 General
0.2 Quality Management Principles
0.3 Process Approach
0.3.1 General
0.3.2 Plan-Do-Check-Act Cycle
0.3.3 Risk-Based Thinking
0.4 Relationship with Other Management System Standards
1. Scope
+ 1.1 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
+ 4.3.1 Supplemental
+ 4.3.2 Product Safety
4.4 Quality Management System and its Processes
+ 4.4.1.1 Conformance of Products and Processes
+ 4.4.1.2 Product Safety
Class Workout – Clause 4
Team Activity – Clause 4

5. Leadership
5.1 Leadership and Commitment
5.1.1 General
+ 5.1.1.1 Corporate Responsibility
+ 5.1.1.2 Process Effectiveness and Efficiency
+ 5.1.1.3 Process Owners
5.1.2 Customer Focus
5.2 Quality Policy
5.3 Organizational Roles, Responsibilities, and Authorities
+ 5.3.1 Supplemental
+ 5.3.2 Responsibility and Authority for Product Requirements and Corrective Actions
Class Workout – Clause 5
Team Activity – Clause 5

6. Planning
6.1 Actions to Address Risks and Opportunities
+ 6.1.2.1 Risk Analysis
+ 6.1.2.2 Preventive Action
+ 6.1.2.3 Contingency Plans
6.2 Quality Objectives and Planning to Achieve Them
+ 6.2.2.1 Supplemental
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
+ 7.1.3.1 Plant, Facility, and Equipment Planning
7.1.4 Environment for the Operation of Processes
+ 7.1.4.1 Supplemental
7.1.5 Monitoring and Measuring Resources
+ 7.1.5.1.1 Measurement Systems Analysis
+ 7.1.5.2.1 Calibration/Verification Records
+ 7.1.5.3.1 Internal Laboratory
+ 7.1.5.3.2 External Laboratory
7.1.6 Organizational Knowledge
7.2 Competence
+ 7.2.1 Supplemental
+ 7.2.2 Competence – OJT
+ 7.2.3 Internal Auditor Competency
+ 7.2.4 Second-Party Auditor Competency
7.3 Awareness
+ 7.3.1 Supplemental
+ 7.3.2 Employee Motivation and Empowerment
7.4 Communication
7.5 Documented Information
7.5.1 General
+ 7.5.1.1 QMS Documentation
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
+ 7.5.3.2.1 Record Retention
+ 7.5.3.2.2 Engineering Specification
Class Workout – Clause 7
Team Activity – Clause 7

Course Outline – Day 2 (8:30 AM to 4:30 PM)

8. Operation
8.1 Operational Planning and Control
+ 8.1.1 Supplemental
+ 8.1.2 Confidentiality
8.2 Requirements for Products and Services
8.2.1 Customer Communication
+ 8.2.1.1 Supplemental
8.2.2 Determining the Requirements related to Products and Services
+ 8.2.2.1 Supplemental
8.2.3 Review of Requirements related to Products and Services
+ 8.2.3.1.1 Supplemental
+ 8.2.3.1.2 Customer-Designated Special Characteristics
+ 8.2.3.1.3 Organization Manufacturing Feasibility
8.2.4 Changes to Requirements related to Products and Services
8.3 Design and Development of Products and Services
8.3.1 General
+ 8.3.1.1 Supplemental
8.3.2 Design and Development Planning
+ 8.3.2.1 Supplemental
+ 8.3.2.2 Product Design Skills
+ 8.3.2.3 Development of Products with Embedded Software
8.3.3 Design and Development Inputs
+ 8.3.3.1 Product Design Input
+ 8.3.3.2 Manufacturing Process Design Input
+ 8.3.3.3 Special Characteristics
8.3.4 Design and Development Controls
+ 8.3.4.1 Monitoring
+ 8.3.4.2 Design and Development Validation
+ 8.3.4.3 Prototype Program
+ 8.3.4.4 Product Approval Process
8.3.5 Design and Development Outputs
+ 8.3.5.1 Supplemental
+ 8.3.5.2 Manufacturing Process Design Output
8.3.6 Design and Development Changes
+ 8.3.6.1 Supplemental
8.4 Control of Externally Provided Processes, Products, and Services
8.4.1 General
+ 8.4.1.1 Supplemental
+ 8.4.1.2 Supplier Selection Process
+ 8.4.1.3 Customer Directed Sources
8.4.2 Type and Extent of Control
+ 8.4.2.1 Supplemental
+ 8.4.2.2 Statutory and Regulatory Requirements
+ 8.4.2.3 Supplier QMS Development
+ 8.4.2.3.1 Automotive Product-Related Software (or Embedded Software)
+ 8.4.2.4 Supplier Monitoring
+ 8.4.2.4.1 Second-Party Audits
+ 8.4.2.5 Supplier Development
8.4.3 Information on External Providers
+ 8.4.3.1 Supplemental
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision
+ 8.5.1.1 Control Plan
+ 8.5.1.2 Standardized Work-Operator Instructions and Visual Standards
+ 8.5.1.3 Verification of Job Set-Ups
+ 8.5.1.4 Verification After Shutdown
+ 8.5.1.5 Total Productive Maintenance
+ 8.5.1.6 Management of Production Tooling and Manufacturing, Test, Inspection …
+ 8.5.1.7 Production Scheduling
8.5.2 Identification and Traceability
+ 8.5.2.1 Supplemental
8.5.3 Property Belonging to Customers or External Providers
8.5.4 Preservation
+ 8.5.4.1 Supplemental
8.5.5 Post-Delivery Activities
+ 8.5.5.1 Feedback of Information from Service
+ 8.5.5.2 Service Agreement with Customer
8.5.6 Control of Changes
+ 8.5.6.1 Supplemental
+ 8.5.6.1.1 Temporary Change of Process Controls
8.6 Release of Products and Services
+ 8.6.1 Supplemental
+ 8.6.2 Layout Inspection and Functional Testing
+ 8.6.3 Appearance Items
+ 8.6.4 Verification and Acceptance of Conformity to Externally Provided Products …
+ 8.6.5 Statutory and Regulatory Conformity
+ 8.6.6 Acceptance Criteria
8.7 Control of Nonconforming Process Outputs
+ 8.7.1.1 Customer Authorization for Concession
+ 8.7.1.2 Control of NC Product – Customer-Specified Process
+ 8.7.1.3 Control of Suspect Product
+ 8.7.1.4 Control of Reworked Product
+ 8.7.1.5 Control of Repaired Product
+ 8.7.1.6 Customer Notification
+ 8.7.1.7 Nonconforming Product Disposition
Class Workout – Clause 8
Team Activity – Clause 8

9. Performance Evaluation
9.1 Monitoring, Measurement, Analysis, and Evaluation
9.1.1 General
+ 9.1.1.1 Monitoring and Measurement of Manufacturing Processes
+ 9.1.1.2 Identification of Statistical Tools
+ 9.1.1.3 Application of Statistical Concepts
9.1.2 Customer Satisfaction
+ 9.1.2.1 Supplemental
9.1.3 Analysis and Evaluation
+ 9.1.3.1 Prioritization
9.2 Internal Audit
+ 9.2.2.1 Internal Audit Program
+ 9.2.2.2 QMS audit
+ 9.2.2.3 Manufacturing Process Audit
+ 9.2.2.4 Product Audit
9.3 Management Review
9.3.1 General
+ 9.3.1.1 Supplemental
9.3.2 Management Review Inputs
+ 9.3.2.1 Supplemental
9.3.3 Management Review Outputs
+ 9.3.3.1 Supplemental
Class Workout – Clause 9
Team Activity – Clause 9

Course Outline – Day 3 (8:30 AM to 12:00 PM)

10. Improvement
10.1 General
10.2 Nonconformity and Corrective Action
+ 10.2.3 Problem Solving
+ 10.2.4 Error-Proofing
+ 10.2.5 Warranty Management Systems
+ 10.2.6 Customer Complaints and Field Failure Test Analysis
10.3 Continual Improvement
+ 10.3.1 Supplemental
Class Workout – Clause 10
Team Activity – Cause 10

Annex A: Clarification of New Structure, Terminology, and Concepts
+ Annex A: Control Plan
Annex B Other International Standards on Quality Management
+ Annex B: Bibliography – Supplemental

Transition Guidance
Auditing IATF 16949
Course Summary
Questions and Answers
Transition Planning
Course Evaluations
Student Certificates

Course Handouts
Copy of Presentation Slides
Answer Keys for Exercises
Annex SL – Appendix 2
ISO/TS 16949 Clause Map – 2009 to 2016
IATF 16949 Clause Map – 2016 to 2009
Required Documented Information
Revised Quality Management Principles
Risk Assessment Worksheets

Duration
2.5 days

Class Hours
8:30 AM to 4:30 PM (Days 1 and 2)
8:30 AM to 12:00 PM (Day 3)

On-site Course
An on-site class is $5000, plus instructor travel expenses, plus $100 per student for materials. An all-inclusive price will be quoted.
Copies of the ISO 9001:2015 and IATF 16949:2016 standards are not needed for the course exercises. All the ISO 9001:2015 and IATF 16949:2016 requirements are covered in the course slides. Students are welcome to bring personal copies of the standards. 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 Larry@WhittingtonAssociates.com.

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 Larry@WhittingtonAssociates.com.