ISO 17025 Lead Auditor - United States

ISO 17025 Lead Auditor Training Course Outline

Module 1: Introduction to ISO 17025

Module 2: Requirements of ISO 17025

Module 3: The Relationship between ISO 19011 and ISO 17025

Module 4: Scope

Module 5: Normative References

Module 6: Terms and Definitions

Module 7: General Requirements

• Impartiality
• Confidentiality

Module 8: Structural Requirements

Module 9: Resource Requirements

• General
• Personnel
• Facilities and environmental conditions
• Equipment
• Metrological traceability
• Externally provided products and services

Module 10: 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
• Option A
• Option B

Module 12: Management System Documentation

Module 13: Control Management System Documents

Module 14: Control of Records

Module 15: Address Risks and Opportunities

Module 16: Improvement

Module 17: Corrective Actions

Module 18: Management Reviews

Module 19: Terminology – ISO 9000, VIM etc.

Module 20: Fundamental Audit Concepts and Principles

Module 21: Auditing Requirements and Assessment: ISO 17011:2004, ISO 19011:2011

Module 22: Recognition and Oversight of ILAC, IAAC, APLAC

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

Module 24: Clauses 4, 5, and 6 Review

• Case studies on clauses 4, 5 and 6

Module 25: Clauses 7 and 8 Review

• Case studies on clauses 7 and 8

Module 26: Guidelines for Auditing: ISO 19011

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

Module 28: Opening and Closing Meeting Activities

Module 29: Auditing Technical Methods

Module 30: Reporting Audit Results

Module 31: Audit Checklists and Audit Reports

Module 32: Review of Standards and Internal Auditing Issues

Module 33: Introduction to Lab Management System (LMS)

• Standards and regulatory frameworks
• Laboratory management systems
• Laboratories and accreditation fundamental principles
• Testing and calibration concepts
• Implementation of LMS
• Understanding the organization
• Analyzing existing systems

Module 34: Planning LMS Implementation

• Leadership and LMS project approval
• Scope of LMS
• Laboratory policies
• Organizational 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 Course in the United States is a program designed to provide professionals with the knowledge to lead and conduct audits of testing and calibration laboratories in accordance with the ISO standards. This course can be beneficial to a wide range of 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 Training Course Overview

ISO 17025 Certification, the international standard for laboratory competence, is paramount in ensuring the accuracy and reliability of test results. Professionals across various industries in the United States should aim to master this standard to uphold quality in testing and calibration laboratories.

To attain ISO is crucial for professionals involved in laboratory management, quality assurance, and auditing processes. This course in the United States not only demonstrates compliance with global standards but also enhances the credibility and reliability of laboratory operations.

The Knowledge Academy's 5-day ISO 17025 Lead Auditor Training in the United States equips delegates with the knowledge and skills needed to conduct effective audits. Covering key aspects of the standard, this training ensures participants understand how to navigate the audit process, interpret requirements, and contribute to maintaining a robust quality management system.

Course Objectives

• To understand the principles and requirements of ISO
• To acquire skills for planning and conducting ISO 17025 audits
• To interpret and apply ISO requirements effectively
• To evaluate laboratory management systems for compliance
• To identify areas for improvement in laboratory processes
• To contribute to continuous improvement in laboratory quality

Upon completion of this training in the United States, delegates will possess the expertise to conduct ISO audits, ensuring the highest standards of quality and reliability in laboratory practices. This ISO certificate enhances professional capabilities and contributes to the overall success of laboratory operations.

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