Internal process audit – laboratory

This course focuses on the internal auditing of laboratory processes, as part of the quality management system of the laboratory or the company in which the laboratory operates. It reflects the recommendations of ISO 19011:2018 “Guidelines for auditing management systems” and is harmonized with our “Internal process auditing” course, which is applicable to all companies, whatever their sector of activity.

As the course has been adjusted to reflect the laboratory context, the ‘competence’ aspect as put forward in ISO/IEC 17025:2017 “General requirements for the competence of testing and calibration laboratories” (although of course also applicable to the 2005 version of this standard).

The first day will enable you to discover and understand the different stages of an audit, from preparation to follow-up of corrective actions. You’ll get hands-on with practical workshops on interpersonal relations during an internal audit. On the second day, you will experience all the stages of an audit by carrying out an audit of a chosen process in your own laboratory.

Target clientele

This course has been designed to train new internal auditors.

It may also be useful for auditors who wish to refresh their knowledge, particularly in the light of the new edition of ISO 19011.

The person in charge of defining, implementing or managing the internal quality audit program can also benefit from it, and communicate specific aspects of the company’s system.

Course objective

This 2-day course aims to provide participants with the knowledge and techniques required for successful internal audits of the processes at the heart of a laboratory’s quality management system, whether the reference standard is ISO/IEC 17025:2005 or ISO/IEC 17025:2017.

Content

You will prepare and experience an audit in your company, based on lists of questions prepared as a team during the session. You will lead a closing meeting in which you will present your audit findings to the managers of the sector(s) audited.

This course, when combined with the appropriate academic or professional qualifications, will enable you to carry out an internal audit effectively and competently.

Among other things, the course covers the following:

• Process-related concepts
• The foundations of auditing
• Audit preparation
• Use of information-gathering grids
• Audit opening
• Information gathering
• Audit psychology
• Effective post-audit meetings
• Audit report – editing
• Corrective action follow-up

Prerequisites

Certain skills will maximize an effective transfer of the knowledge and skills required of an auditor, including understanding :

• the nature of a quality management system, compliant with ISO/IEC 17025:2005 or 2017, or ISO 9001:2015 ;
• of process mastery,
• of the laboratory environment.
• NB: If necessary, consult our other courses to develop the above aspects.

Duration

2 days (14 hours)

Evaluation

An examination may be offered, enabling the audit program manager and participants to assess the acquisition of the knowledge taught. A certificate of achievement will be issued on merit.

Notwithstanding the exam, a 14-hour training certificate is issued to each participant.

Rates

• 1 150 $ / participant in virtual class
• 1 250 $ / participant in classroom
• Request a quote for a private group session