ISO 17025 Requirements

Course Introduction

The basic requirements for a management system for testing and calibration laboratories are based on the international standard ISO/IEC 17025. These are used for the assessment and accreditation of laboratories worldwide by Accreditation Bodies in order to enhance the confidence of the market for the testing and calibration results these laboratories issue.

The ISO/IEC 17025 was revised in 2017 in order to reflect the latest changes in market conditions and technology as well as encompass the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management. Laboratories already accredited to ISO/IEC 17025:2005 will need to transition their processes to the new version within a three-year period from the publication date of the new standard.

Objectives

This training course will give you advanced knowledge on the ISO/IEC 17025:2017 requirements, on auditing and assessment techniques, on the new concept of risk management, on the good laboratory practices and on validation/calculation of measurement of uncertainty methods. The course contents meet the requirements of registration to the registries of STAREGISTER Inc., as an auditor or assessor of Management Systems for Laboratories.

Training Methodology

This interactive training course includes the following training methodologies as a percentage of the total tuition hours:-

• 30% Lectures, Concepts, Role Play
• 70%  Workshops & Work Presentations, Techniques, Based on Case Studies & Practical Exercises, Software & General Discussions
• Pre and Post Test

Target Audience

This training is aimed at Accreditation Assessors, laboratory management and personnel of accredited and non-accredited laboratories, and laboratories with ISO 9001 certification, that are considering or that would like to know more about accreditation to ISO/IEC 17025:2017. Specifically:

• All Directors / Laboratory Managers, Scientists, Engineers, Auditors Assessors and Consultants
• All Personnel of accredited laboratories or under application for accreditation of laboratories that plan to be accredited against ISO/IEC 17025
• All Personnel responsible for technical or quality management of tests or calibrations performed

Daily Topics

• Introduction to Laboratory Accreditation and Overview of ISO/IEC 17025:2017
• Management and leadership skills for the lead implementer to organize all the quality activities of the laboratory
• Interpretation, explanation and techniques of implementation of Quality System Management, Requirements of ISO/IEC 17025:2017
• Documentation and validation of laboratory's testing methods and measurements
• Calculation of measurement of uncertainty
• Risk Management Methods
• Proficiency Testing / Interlaboratory Programs
• Quality Control Charts (QC charts)
• Conducting Internal Audits
• Requirements of Accreditation Bodies and assessment techniques

• Pre-Test
• Introduction
• Determination of Course Goals & Introduction to ISO 17025 Requirements
  • ISO 17025 contents
  • Organization – Responsibilities
  • Introduction to control of documents & records – Use of LIMS for managing records
  • Requests for tenders
  • Suppliers/Subcontractors – Detailed record keeping through LIMS  LIMS design – Basic considerations

• Service to the Customer & Internal Audits as a Tool for Quality Assurance
  • Service to the customer - Complaints
  • Control of non-conforming work/testing
  • Corrective/Preventive actions – Implementation & Monitoring of corrective actions  Control of records
  • Internal auditing as a tool for addressing complaints & implementing a proactive strategy
  • Management review

• Technical Requirements – Personnel and Test method Development
  • Technical records – LIMS as a unique traceability tool
  • Personnel (scientific, technical, administrative)
  • Accommodation & Environmental conditions
  • Test methods & Method validation. Estimation of uncertainty of measurement
  • Selection of methods – Laboratory-developed methods, Non-standard methods
  • Control of data for all of above topics – Use of LIMS as a data recording tool

• Technical Requirements – Equipment and Quality Assurance
  • Measurement traceability through LIMS
  • Equipment – Measurement traceability, Reference standards & Reference materials
  • Sampling – Handling of test items & The role of LIMS as the first link in the sample traceability chain (from sample login to issue of Test Certificate)
• In-house testing & subcontracted analysis. Issuing of relevant working forms using the LIMS
• Quality Assurance (QA) of test results & Ways of reporting the test results – The LIMS contribution to assuring traceability of QA and Analytical data
• Technical requirements – Test reports, Implementation of LIMS & Accreditation

Requirements

• Format of Test Certificates & Amendments of Test Certificates – Use of LIMS for issuing Test Certificates and keeping track of changes
• Opinions & Interpretations (O&I’s) on Test Certificates
• Electronic transmission of results – LIMS contribution to assist in speedy, targeted and foolproof delivery of results
• Preparation & Application for accreditation
• Role playing – Internal/External audits exercise
• Course Conclusion
• Post-Test and Evaluation

For Registration & more information please contact

NAYEL Training Centre 

T: +971 4 379 7245 | M: +971 50 249 6876 WhatsApp +971 50 249 6876

Email [email protected]