ISO 17025 Lead Implementer Training Course Outline
Module 1: Introduction to ISO 17025
Module 2: Requirements of ISO 17025
Module 3: ISO 19011 Relationship to ISO 17025
Module 4: Scope
Module 5: Normative References
- Introduction to Normative References
Module 6: Terms and Definitions
Module 7: General Requirements
- Overview
- Impartiality
- Confidentiality
Module 8: Structural Requirements
- Overview of Structural Requirements
Module 9: Resource Requirements
- Introduction
- General
- Personnel
- Facilities and Environmental Conditions
- Equipment
- Metrological Traceability
- Externally Provided Products and Services
Module 10: Process Requirements
- Introduction to Process Requirements
- Review - Requests, Tenders, and Contracts
- Selection, Verification, and Validation of Methods
- Sampling
- Handling Test or Calibration Items
- Technical Records
- Evaluation of Measurement Uncertainty
- Ensure Results Validity
- Reporting of Results
- Complaints
- Nonconforming Work
- Control of Data and Information Management
Module 11: Management System Requirements
Module 12: Management System Documentation
- Overview
- Document Categories
Module 13: Control Management System Documents
- Overview
- Primary Document Control Requirements in the ISO 17025 Standard
Module 14: Control of Records
Module 15: Address Risks and Opportunities
- Overview of Address Risks and Opportunities
Module 16: Improvement
Module 17: Corrective Actions
- Steps to Take Corrective Actions
Module 18: Internal Audit and Management Reviews
- Internal Audit
- Management Reviews
Module 19: Terminology – ISO 9000, VIM etc.
- ISO 9000 Terminology in English
- What is ISO 9000?
- Common ISO Definitions
Module 20: Fundamental Audit Concepts and Principles
Module 21: Auditing Requirements and Assessment: ISO 17011:2017, ISO 19011:2018
- Auditing: ISO 17011:2017
- Auditing: ISO 19011:2018
Module 22: Recognition and Oversight of ILAC, IAAC, APAC etc.
- Description of ILAC
- ILAC’s Global Role
- Abbreviations
- ILAC Documents
- ILAC P10 Traceability Policy
Module 23: Test Reports, AB Symbols, Equipment Stickers, and Certificates
- AB Symbols
- Certificates
- Certificate Naming Convention
Module 24: Clauses 4, 5, and 6 Review
- Clause 4: General Requirements
- Clause 5: Structural Requirements
- Clause 6: Resource Requirements
Module 25: Clauses 7 and 8 Review
- Clause 7: Process Requirements
- Clause 8: Option
Module 26: Guidelines for Auditing: ISO 19011
- ISO 19011 Auditing Guidelines
- What is ISO 19011?
- Standard Facts of ISO 19011
- Who ISO 19011:2018 should be Used?
- What does ISO 19011:2018 Accomplish?
Module 27: GUM (Uncertainty), PT/ILC, and Traceability
- GUM (Uncertainty)
- PT/ILC
- Traceability
Module 28: Opening and Closing Meeting Activities
- Opening Meeting
- What Happens in an Opening Meeting?
- Closing Meeting
- What Happens in a Closing Meeting?
Module 29: ISO 19011 Relationship to ISO 17025
Module 30: Auditing Technical Methods
Module 31: Reporting Audit Results
Module 32: Audit Checklists
- ISO 17025:2017 Audit Checklist for Laboratory Accreditation System Requirements
- Content of ISO/IEC 17025:2017 Audit Checklists
Module 33: Review of Standards and Internal Auditing Issues
- Review of Standards
- Internal Auditing Issues
Module 34: Introduction to Lab Management System (LMS)
- Standard and Regulatory Framework
- Laboratory Management System
- Laboratories and Accreditation Principles
- Testing and Calibration Concepts
- Identifying the Objective and Scope
- Understanding Organisation
- Analysing Existing System
Module 35: Planning LMS Implementation
- Leadership and LMS Project Approval
- Laboratory Policies
- Document Management Process
Module 36: Implementing LMS
- Design of Controls
- Drafting of Specific Policies and Procedures
- Communication Planning
- Training and Awareness Planning
- Resource Management
- Customer Management
- Operations Management
Module 37: Monitoring, Measurement, and Continuous Improvement
- Monitoring, Analysis, and Evaluation
- Treating Problems and Nonconformities
- Continual Improvement
- Accreditation Preparation
- Implementers Evaluation