ISO 17025:2017 Testing and Calibration Laboratories Lead Auditor Training

Introduction

This training course is an introductory look at ISO/IEC 17025 and its requirements for demonstrating the technical competence of testing and calibration laboratories. In this training course, you will be introduced to the accreditation process and you will also gain insight into the interpretation of the requirements of this international laboratory standard. ISO – International Standards Organization IEC – International Electro Technical Commission. This comprehensive training course will illustrate the ISO17025 requirements for testing laboratories, relevant to the operation of their management system, technical competency, validity of analytical results, and the use of Laboratory Information Management Systems (LIMS) as a tool in satisfying the above. In particular, the importance of LIMS implementation in meeting the traceability requirements of ISO 17025 will be addressed. The training course will also demonstrate the compliance of ISO 17025 with those ISO 9001 and GLP (Good Laboratory Practice) requirements that are relevant to the scope of testing services. In addition, Management and Technical personnel of analytical laboratories will recognize the dire need of implementation of the Standard within their Organization in order to satisfy the needs of their customers and general market needs (e.g. Regulatory Authorities and organizations providing recognition).   

This training course will feature:

• Management requirements of ISO 17025 Quality manual, Document control, Tenders, Suppliers, Service to the customer, Internal audits
• Technical requirements of ISO 17025 Personnel, Equipment, Traceability, Reference standards, Sampling, Quality assurance of results, Test Certificates, O & I’s
• Definition of Laboratory accreditation: Accreditation Bodies (AB’s) and Multilateral Agreements (MLA, MRA, ILAC) on cross frontier recognition of accreditation
• Basic guidelines on the design of a LIMS
• Implementation of a LIMS, in the context of ISO 17025

Objectives

By the end of this training course, participants will be able to:

• Understand and implement Good Laboratory Practice (GLP) in their organizations.
• Comprehend the importance of assuring quality of test and calibration results
• Apply traceability from sample receipt and analysis scheduling until delivery of results, through the implementation of LIMS
• Design LIMS on the basis of ISO 17025 requirements.
• Realize the need for continuous review and improvement of LIMS systems, based on market and regulatory requirements

Training Methodology

This training course will combine presentations with instructor-guided interactive discussions between participants relating to their individual interests. Practical exercises, video material and case studies aiming at stimulating these discussions and providing maximum benefit to the participants will support the formal presentation sessions. Above all, the course leader will make extensive use of case examples and case studies of issues in which he has been personally involved.

Who Should Attend?

This training course is suitable for a wide range of professionals involved in Quality Assurance (QA) in analytical laboratories, but will greatly benefit:

• Management and technical personnel of analytical laboratories, in a wide spectrum of activities (e.g. oil refinery, food and utility industries including potable and wastewater treatment plants, and commercial analytical laboratories)
• Technicians, Specialists and other personnel involved in laboratories
• Those laboratories that are in the process of obtaining ISO 17025 accreditation and those planning to implement a LIMS
• Newly recruited laboratory scientific personnel
• Laboratory accreditation consultants

Course Outline

Day 1: 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

Day 2: 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

Day 3: 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

Day 4: 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

Day 5: 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