Activity Details

Course Objectives

• Learn about the international standard for accreditation bodies from an international peer Lead Evaluator. Examine its underlying concepts and how it relates to regulatory requirements.
• Understand the implications of implementation.
• In-depth step by step application of the ISO/IEC 17011 Standard as the requirements of an accreditation body

Who should attend

For all accreditation body and regulatory agency staff who manage the operation of a laboratory accreditation program or  certification/ inspection accreditation program and conduct assessments on behalf of their accreditation body.

Training Methods

This 3-day training course examines both the quality system and recognition requirements within the standard, including conditions for application for accreditation, conduct of assessments and impartiality. It includes easy-to-understand approaches for continual improvement and handling of laboratory feedback.

The course contains extensive reference to the international interpretation and implementation guidance documents which are used by ILAC-recognized accreditation bodies.

Course outlines

 Accreditation body

Legal responsibility, Structure, Impartiality, Confidentiality, Liability and financing, Accreditation activity

Management

General, Management system, Document control, Records, Nonconformities and corrective actions, Preventive actions, Internal audits, Management reviews, Complaints

Human resources

Personnel associated with the accreditation body, Personnel involved in the accreditation process, Monitoring, Personnel records

Accreditation process

Accreditation criteria and information, Application for accreditation, Resource review, Subcontracting the assessment, Preparation for assessment, Document and record review, On-site assessment, Analysis of findings and assessment report, Decision-making and granting accreditation, Appeals, Reassessment and surveillance, Extending accreditation, Suspending, withdrawing or reducing accreditation, Records on CABs, Proficiency testing and other comparisons for laboratories

Responsibilities of the accreditation body and the CAB

Obligations of the CAB, Obligations of the accreditation body, Reference to accreditation and use of symbols