ISO 17025 Lead Implementer - Cuba

ISO 17025 Lead Implementer Training Course Outline

Module 1: Introduction to ISO 17025

• ISO 17025

Module 2: Requirements of ISO 17025

• Overview

Module 3: ISO 19011 Relationship to ISO 17025

• ISO 19011
• ISO 17025

Module 4: Scope

• Overview

Module 5: Normative References

• Introduction to Normative References

Module 6: Terms and Definitions

• Overview

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

• Options
  • Option A
  • Option B
• 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
  • What is ISO 9000?
  • Common ISO Definitions

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, 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

• ISO 19011
• ISO 17025

Module 30: Auditing Technical Methods

• Overview

Module 31: Reporting Audit Results

• Internal Audit Report

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

Who should attend this ISO 17025 Lead Implementer Course?

The ISO 17025 Lead Implementer Training Course is designed to equip professionals with the knowledge and skills required to lead the implementation of a laboratory Quality Management System based on the ISO 17025 standard. This course can be beneficial to a wide range of professionals, including:

• Laboratory Directors and Managers
• Quality Managers
• Technical Managers
• Quality Assurance Officers
• Procurement Managers
• Compliance Officers
• Internal Auditors
• Consultants

Prerequisites of the ISO 17025 Lead Implementer Course

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

ISO 17025 Lead Implementer Course Overview

Among the ISO 17025 Training Courses, the ISO 17025 Lead Implementer Training is designed to provide delegates with a thorough understanding of the international standard for testing and calibration laboratories. This standard, ISO/IEC 17025, outlines the requirements for competence, impartiality, and consistent operation in laboratories, ensuring reliable results and data.

It is crucial for professionals to master ISO 17025 as it serves as a benchmark for demonstrating competence and reliability in laboratory operations. Laboratory Managers, Quality Assurance Personnel, and professionals responsible for ensuring accurate test and calibration results should aim to acquire in-depth knowledge of ISO/IEC 17025 to enhance their organisations' credibility and compliance with international standards.

This 3-day training by the Knowledge Academy aims to equip delegates with the essential skills and knowledge needed to implement and maintain ISO/IEC 17025 standards effectively. The course covers key aspects such as management system requirements, documentation, and auditing, providing a practical and hands-on approach to mastering the implementation of ISO 17025.

Course Objectives

• To understand the principles and requirements of ISO/IEC 17025
• To gain insights into the documentation and management system requirements
• To learn effective strategies for implementing ISO 17025 in a laboratory setting
• To acquire auditing skills for assessing compliance with ISO 17025 standards
• To identify potential challenges and best practices for successful implementation
• To ensure delegates are well-prepared to lead ISO 17025 implementation efforts in their organisations

Upon completion of this course, delegates will be equipped with the knowledge and skills needed to implement ISO/IEC 17025 effectively, enhancing the quality and reliability of laboratory operations. They will be better positioned to lead their organisations in achieving and maintaining compliance with international standards, ultimately contributing to improved confidence in testing and calibration results.

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

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

ISO 17025 Lead Implementer Exam Information

To achieve the ISO 17025 Lead Implementer, 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