INTRODUCTION FOR UNDERSTANDING OF TL 9000 REQUIREMENT – RELEASE 6.3
This 2 days Understanding of TL 9000 Requirement – Release 6.3 is based on seven Quality Management Principles plus Information and Communication Technology (ICT) that participants shall adhere to and apply to promote organizational improvements in the following areas:
- Customer Focus
- Leadership
- Engagement of People
- Process Approach
- Continuous Improvement
- Evidence-Based Decision Making
- Relationship Management
- ICT focus
LEARNING OBJECTIVES
To review and identify the gaps with reference to TL9000 and ISO 9000-2015 standards:
- Know TL 9000 administration and Management
- Review current TL 9000 – 6. 3 standards adequacy and compliance in measurement
- Understanding the Organization and its Context
- Know Management – Leadership, Planning and Support
- Know all about Operations performance
- Understand Requirement for Products and Services
- Know Design and Development Requirement
- Understand Production and service provision
- Able to manage Performance Evaluation
TARGET AUDIENCE
Management team, Internal auditors, QMS Team, IT team.
TRAINING METHODOLOGY
- Lectures based on TL9000 – 6.3: ICT Standards and Documents
- Group discussions and presentations
- Pre Test / Post Test Assessment
- Training Evaluation to establish learning outcome
- Selected video clips
COURSE CONTENTS
Day 1 Training Topics – 9.00am to 5.00pm
Pre Test – Participant’s Knowledge Assessment
Section 1: Introduction – TL 9000 Requirements Handbook Release 6.3 Outline
- Lists the goals of TL 9000
- States the purpose of TL 9000
- TL 9000 Profile and Scope – An organization seeking certification shall determine
- In coordination with its Certification Body (CB)
- TL 9000 scope statement
- ISO 9001 scope statement,
- Requirements determined as not applicable
- Measurement exemptions
- Registration specialty options
- NACE codes
- Product categories
- Locations or sites
- TL 9000 Requirements and Measurements release levels.
- Benefits of implementation
- Relationship to ISO 9001 and other requirements
- Explains how the TL 9000 handbooks are developed and maintained, and defines the effective date of use.
- Exercise 1: What is TL9000? What are the difference between TL9000 and ISO9001?
Section 2: Structure
- Defines the structure of the handbook and terminology used.
Section 3: TL 9000 administration
- Defines the scope of registration including options and required documentation
- Migration path from other standards
- How registrations can be publicized
- How registrars are qualified
- How accreditation bodies are recognized
- Responsibilities of certification bodies, training information and information resources.
- Exercise 2: Discuss and share what you know about TL9000 administration.
Section 4: Understanding The Organization and its Context
- Context of the organization
- 4.1 Understanding the organization and its context
- There are no additional requirements for this section of ISO 9001.
- 4.2 Understanding the needs and expectations of interested parties
- There are no additional requirements for this section of ISO 9001.
- 4.3 Determining the scope of the quality management system
- 4.3.C.2 TL 9000 Profile and Scope – An organization seeking certification shall determine, in coordination with its Certification Body (CB), the
- TL 9000 scope statement,
- ISO 9001 scope statement,
- requirements determined as not applicable,
- measurement exemptions,
- registration specialty options,
- product categories,
- locations or sites,
- ISO 9001 version, and
- TL 9000 Requirements and Measurements release levels.
- The scope statement shall include
- Identification of the organization being registered, which may encompass the entire organization, an organizational unit, or a combination of units
- Products/product lines covered by the registration. If not all products/product lines are included in the
- Registration, then either the included or excluded products/product lines shall be listed.
- 4.4 Quality management system and its processes
- Exercise 3: Who are stakeholders? Explain their roles?
Section 5: Leadership
- 5.0 General requirement of management
- 5.1 Customer focus
- 5.3 Communication methods
- 5.4 Quality policy
- Exercise 4: What do you understand about your organization’s Leadership? Explain their roles and responsibilities
Section 6: Planning
- 6.0 Defines requirements for actions to address risks and opportunities
- 6.1 Planning including quality objectives
- 6.2 Customer input
- 6.3 Supplier input
- 6.4 Long and short term quality planning
- Exercise 5: What are quality objectives which you must adhere to? Discuss and share.
Section 7: Support
- 7.0 Covers resources including business continuity planning and personnel.
- 7.1 Infrastructure and its security
- 7.2 Environment for the operation of processes
- 7.3 Monitoring and measuring of resources
- 7.4 Measurement traceability
- 7.5 Organizational knowledge
- 7.6 Competence,
- 7.7 Various aspects of training
- 7.8 Operator qualification
- 7.9 Quality awareness
- 7.10 Communication
- 7.11 Documented information.
- Exercise 6: What is Operator qualification needed to perform their day to day tasks in production?
Day 2 Training Topics – 9.00am to 5.00pm
Revision: Day 1 lessons recap
Section 8: Operation
8.0 Extensive information about operational planning and control including
- 8.1 Life-cycle model
- 8.1.C.2 Product and Service Security
- 8.1.C.3 End of Life Planning
- 8.1.C.4 Tools Management
- 8.1.C.4-NOTE Examples of tools to be managed
- 8.2 Requirements for Products and Services
- 8.2.1 Customer communication
- Additional requirements for TL 9000 are shown below.
- 8.2.1.C.1 Problem Severity Classification
- 8.2.1.C.1-NOTE The customer and the organization should jointly determine the priority for resolving customer reported problems.
- 8.2.1.C.2 Problem Escalation
- 8.2.1.C.3 Problem Report Feedback
- 8.2.1.HS.1 Product Replacement
- 8.2.1.HS.2 Notification About Critical Problem Reports
- 8.2.1.V.1 Notification About Critical Service Disruption
- 8.3 Design and Development Requirements
- 8.3.3.C.3 Requirements Allocation
- 8.3.4.C-NOTE Organizations may include customers or third parties during various validation stages.
- 8.3.4.C.1 Verification of User Documentation
- 8.3.4.HS.1 Stress Testing
- 8.3.4.HS.2 Abnormal Conditions
- 8.3.4.HS.3 System Testing
- 8.3.4.HS.4 Release Management
- 8.3.5 Design and development outputs
- 8.3.5.HS.1 Product Design and Development Output
- 8.3.5.HS.1-NOTE Product design and development output may also include items such as training materials
- 8.3.5.V.1 Services Design and Development Output
- 8.3.6 Design and development changes
- 8.3.6.C.1 Change Management Process
- 8.3.6.C.2 Informing Customers of Design Changes
- 8.3.6.C.3 Problem Resolution Configuration Management
- 3.6.H.1 Component Changes
- 8.4 Control of externally provided processes, products, and services
- 8.4.1 General
- Additional requirements for TL 9000 are shown below.
- 8.4.1.C.1 Procurement Process
- 8.4.1.C.1 NOTE Sustainability requirements
- 8.4.1.C.2 External Provider Performance Management
- 8.4.2 Type and extent of control
- 8.4.3 Information for external providers
- 8.5 Production and service provision
- 8.5.5 Post-delivery activities
- Additional requirements for TL 9000 are shown below.
- 8.5.5.H.1 Testing of Repair and Return Products
- 8.5.5.HS.1 Emergency Service Provisioning
- 8.5.5.S.1 Software Patching Information
- 8.5.6 Control of changes
- 8.6 Release of products and services
- 8.6.HV.1 Inspection and Test Documentation
- 8.6.HV.2 Documentation Retained from Inspection and Test Activities
- 8.6.S.1 Test Documentation
- 8.7 Control of nonconforming outputs
Section 9
9.0 Performance Evaluation
- 9.1 Monitoring, measurement, analysis and evaluation
- 9.1.1 General
- 9.1.1.C.1 Process Measurement
- 9.1.2 Customer satisfaction
- 9.1.2.C.1 Customer Satisfaction Data
- 9.1.3 Analysis and evaluation
- 9.1.3.C.1 Trend Analysis of Nonconforming Product or Service
- 9.1.3.C.2 Performance Data
- 9.1.3.C.3 Sustainability Assessment
- 9.2 Internal audit – Performance evaluation
- 9.2.1 There are no additional requirements for this section of ISO 9001.
- 9.2.2 Additional requirements for TL 9000 are shown below.
- 9.2.2.C.1 Internal Audit Program Planning – The internal audit program shall include all
- 9.3 Management review
- 9.3.1 General
- 9.3.2 Management review inputs
- 9.3.2.C.1 Sustainability Assessment Results
- 9.3.3 Management review outputs
- Appendix B – Glossary
- Conclusion
- Training Summary
- Post Test – Knowledge Assessment
- Training Evaluation – Level 3
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