ISO 17025 & Laboratory Information Management Systems (LIMS) for Analytical 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 based on 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: 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

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