ISO 17025 Lead Auditor - Australia

ISO 17025 Lead Auditor Course Outline

Module 1: Introduction to ISO 17025

• ISO
• ISO 17025

Module 2: Requirements of ISO 17025

• Overview
• Requirements of ISO 17025

Module 3: Relationship between ISO 19011 and ISO 17025

• ISO 19011
• Relationship between ISO 19011 and ISO 17025

Module 4: Scope

• Overview
• Scope of ISO 17025

Module 5: Normative References

• Introduction to Normative References

Module 6: Terms and Definitions

• Overview
• Terms and Definitions

Module 7: General Requirements

• Overview
• Impartiality
• Confidentiality

Module 8: Structural Requirements

• Overview of Structural Requirements

Module 9: Resource Requirements

• 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
• Ensuring Result Validity
• Reporting of Results
• Complaints
• Nonconforming Work
• Control of Data and Information Management

Module 11: Management System Requirements

• Options
• General

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

• Overview

Module 15: Address Risks and Opportunities

• Overview of Address Risks and Opportunities

Module 16: Improvement

• Overview of 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

Module 20: Fundamental Audit Concepts and Principles

• Overview

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, APLAC

• Description of ILAC
• ILAC’s Global Role
• Abbreviations
• ILAC Documents
• ILAC P10 Traceability Policy

Module 23: Test Reports, AB Symbols, Equipment Stickers, 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

• Case studies on clauses 7 and 8

Module 26: Guidelines for Auditing: ISO 19011

• ISO 19011 Auditing Guidelines

Module 27: GUM (Uncertainty), PT/ILC, and Traceability

• GUM (Uncertainty)
• PT/ILC
• Traceability

Module 28: Opening and Closing Meeting Activities

• Opening Meeting
• Closing Meeting

Module 29: Auditing Technical Methods

• Overview

Module 30: Reporting Audit Results

• Internal Audit Report

Module 31: Audit Checklists and Audit Reports

• ISO 17025:2017 Audit Checklist for Laboratory Accreditation System Requirements
• Content of ISO/IEC 17025:2017 Audit Checklists 

Module 32: Review of Standards and Internal Auditing Issues

• Review of Standards
• Internal Auditing Issues

Module 33: Introduction to Lab Management System

• Standards and Regulatory Frameworks
• Laboratory Management Systems
• Laboratories and Accreditation Fundamental Principles
• Testing and Calibration Concepts

Module 34: Planning LMS Implementation

• Leadership and LMS Project Approval
• Scope of LMS
• Laboratory Policies
• Organisational Structure
• Document Management Process

Module 35: Implementing an LMS

• Design of Controls
• Drafting of Specific Policies and Procedures
• Communication Planning
• Training and Awareness Planning
• Resource Management
• Customer Management
• Operations Management

Module 36: LMS Monitoring, Measurement, and Continuous Improvement

• Monitoring, Analysis, and Evaluation
• Treating Problems and Nonconformities
• Continual Improvement
• Accreditation Preparation
• Implementers Evaluation

Module 37: Planning an ISO 17025 Audit

• Audit Approach
• Preparing the ISO 17025 Audit
• Conducting an Opening Meeting

Module 38: Conducting the ISO 17025 Audit

• Communication during Audit
• Audit Procedures
• Observation
• Document Review
• Interview
• Sampling Techniques
• Technical Verification
• Corroboration and Evaluation
• Audit Test Plans
• Formulation of Audit Findings
• Documenting Nonconformities

Module 39: Concluding and Follow-Up of ISO 17025 Audits

• Audit Documentation
• Quality Review
• Closing Meeting
• Evaluation of Corrective Action Plans
• ISO 17025 Surveillance Audits
• ISO 17025 Internal Audit Management Program