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
Duration
5 Days
Programme Overview
This comprehensive training course will illustrate the ISO17025 requirements for testing laboratories, relevant to the operation of their management system, technical competency, the 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 the 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
Methodology
Due to its high degree of technical content, this training course will examine ISO17025 requirements and implementation of LIMS with a combination of learning strategies. It will involve both a guided as well as a complex response approach. Role-playing will be applied alongside mentoring. Discussions will be instigated, especially during each session’s wrap up.
Course Outline
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 the above topics – Use of LIMS as a data recording tool
Day Four: Technical Requirements – Equipment and Quality Assurance
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
