Laboratory Quality Manager and Laboratory Assessor

Overview

The training course is designed to teach laboratory personnel and future laboratory assessors how to install, maintain, improve and assess a Laboratory Quality Management System that meets the requirements of ISO/IEC 17025, ISO 15189 Standard and OECD GLP, and is applicable for laboratories of any size and any activities related to calibration and testing.

 

The training covers valuable topics for accredited or to-be accredited laboratories such as uncertainty estimation, method validation, proficiency testing, calibration and modern interpretation of traceability subject, as well as audit methods and tools. During the course the participants obtain knowledge about the modern approaches to QMS, based on the version of the Standard ISO 9001.

 

 

Prerequisites

• Either university degree or equivalent in chemistry, physics, engineering or relevant fields
• or secondary education plus two years of experience in a testing or calibration laboratory

 

 

Target group

• Laboratory and Quality Managers
• Laboratory staff dealing with quality of analysis and / or calibration
• Laboratory Assessors

 

 

Content

This modular training program includes 9 interrelated workshops (WS) and an examination:

 

Workshop 1 (WS 1): ISO/IEC 17025, ISO 15189 Management System

WS 2: Quality Assurance and Quality Documentation

WS 3: Basic statistical tools for Laboratories

WS 4: Internal Quality Control for Laboratories, Method Validation

WS 5: Quantifying Uncertainty in Analytical Measurements

WS 6: Traceability of Measurements

WS 7: Inter-laboratory Quality Control Measures

WS 8: Risk Management

WS 9: Laboratory Audit

 

 

Note

• Working language of the training course is English.
• The workshops also can be attended selectively.
• The participants will be awarded a confirmation of participation.

 

 

Registration

For further information, dates and registration please contact Dr. Eugenia Soboleva, qualityaustria Network partner, Product Management Laboratories.

 

 

 

Examination for Laboratory Quality Assurance Managers and Laboratory Assessors

 

Content

The purpose of the examination is to assess the applicants knowledge on the following subjects:

• Quality Management System: development, maintenance, improvement
• Specific Quality Assurance and Quality Control Tools for calibration and testing laboratory
• Laboratory Assessment: standards, tools, approaches

 

 

Prerequisites

Attendance of the qualityaustria training course for "Laboratory Quality Managers and Assessors" LQMAT

 

 

Format

The written exam takes place at the end of the last day of the LQMAT course and consists of single or multiple choice questions, the oral part includes a group work followed by presentation.

 

 

Certificate

Upon successful completion of the examination and submitted practical evidence the participants receive the certificates Laboratory Quality Manager and Laboratory Assessor.

 

 

Validity of the certificate

3 years

 

 

Criteria for extension

For Laboratory Quality Managers

The competence of a Laboratory Quality Manager shall be reconfirmed using at least two of the below described recertification methods:

1. Professional development by task-specific/related training (on-site, videoconferencing or e-learning) of at least one day (8 hours), which may include a knowledge evaluation (covering e.g. new developments on standards and/or relevant laws/new methods and instruments).
2. Examination: The minimum sum of ERP for the examination shall be 20.
3. Providing evidence regarding professional practice: Declaration by the employer or by contractor(s) on at least one full year of work-experience in a function that includes tasks related to the “Laboratory Quality Manager” task description in the recertification period. 

 

For Laboratory Assessors

At least three complete system audits with at least 15 audit days either internal, 2^nd or 3^rd party audits (9 days of them on site) in the last 3 years, as to be declared by the employer or contractor(s)/customer(s) of the certified person.

 

Alternatively: Evaluation by a designated peer: 2 days of on-site witnessing, where the candidate is acting as auditor. The audit documentation prepared by the candidate shall be evaluated by the peer.

 

 

Note

• If participants do not have the requested practical experience, the certificate "Laboratory Quality Manager Candidate" or "Laboratory Assessor Candidate" will be issued.