ISO 17025 Lead Auditor - United Kingdom

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

Who should attend this ISO 17025 Lead Auditor Course?

The ISO 17025 Lead Auditor Training Course equips professionals with the expertise to lead and perform audits of testing and calibration laboratories, ensuring compliance with ISO 17025 standards. This training is profitable for various professionals, including:

• Lead Auditors
• Quality Managers
• Laboratory Managers
• Quality Assurance Officers
• Technical Experts
• Auditors
• Process Improvement Professionals
• Consultants

Prerequisites of the ISO 17025 Lead Auditor Course

There are no formal prerequisites for this ISO 17025 Lead Auditor Course.

ISO 17025 Lead Auditor Course Overview

ISO 17025 Lead Auditor Training is designed to maintain international standards in testing and calibration laboratories. The ISO 17025 standard ensures these laboratories consistently deliver high-quality, competent, and reliable results. With growing demands for precise and accurate data in industries like healthcare, environmental monitoring, and manufacturing, compliance with ISO 17025 is essential.

Enhancing and ensuring the quality of laboratory processes is essential for professionals aiming to learn ISO 17025. Roles such as Quality Managers, Laboratory Supervisors, and Lead Auditors are crucial to maintaining standards and compliance. This ISO 17025 Training equips them to conduct effective audits, pinpointing areas for improvement, non-conformities, and potential risks.

The Knowledge Academy offers a comprehensive 5-day ISO 17025 Training Course designed to equip delegates with essential skills for leading ISO 17025 audits. This course covers critical concepts and audit techniques, providing a thorough understanding of the standard. Delegates will gain the knowledge needed to contribute significantly to laboratory quality assurance. This course will be conducted under the guidance of our highly experienced trainers.

Course Objectives

• To comprehend the fundamentals of ISO 17025 and its application in laboratory settings
• To gain insights into auditing principles, techniques, and practices
• To understand the role and responsibilities of a Lead Auditor
• To learn how to plan, conduct, and report on ISO 17025 audits
• To identify nonconformities and recommend corrective actions
• To enhance communication and interpersonal skills for effective auditing

After completing this course, delegates will gain the expertise to lead ISO 17025 audits, ensuring compliance with international standards. This course will enhance the quality and reliability of laboratory testing and calibration processes. Knowledge of these skills will open doors for career advancement and contribute to organisational excellence.

What’s included in this ISO 17025 Lead Auditor Course?

• ISO 17025 Lead Auditor Examination
• World-Class Training Sessions from Experienced Instructors 
• ISO 17025 Lead Auditor Certificate
• Digital Delegate Pack

ISO 17025 Lead Auditor Exam Information

To achieve the ISO 17025 Lead Auditor, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice  
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book