ISO/IEC 17025 : 2017 General Requirements for the Competence of Testing & Calibration of Laboratories

What are the Goals?

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

Who is this Training Course for?

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

Daily Agenda

Day One: 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 Two: 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 Three: 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 Four: 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 Five: 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