Internal Audit certificate using ISO 17025

 

Ø INTRODUCTION


 This new standard aligns and harmonizes ISO/IEC 17025:1999 with ISO 9001:2008. The training incorporates and explains the amendments to clauses where ISO determined that such changes were necessary. The technical requirements for laboratories who provide testing and calibration services are enhanced by the use of management systems that incorporate the requirements of ISO 9001:2008.

The acceptance of testing and calibration results between countries and industries should be facilitated if laboratories will comply with this International Standard. The use of this standard will also facilitate cooperation between laboratories and other bodies and assist in the exchange of information and experience, standards and procedures. The introduction of the Process Approach to Management Systems and a new auditing standard which allows efficient and effective auditing of these systems can be used by internal and external auditors to meet the requirements of laboratory and quality systems. Our 5-Day training provides insight to the quality, lab and auditing facets with a fast paced, interactive approach.

 

Ø Objectives

 

At this program's conclusion, participants should be able to:

 

l  Get certified as “Certified ISO 17025 Lead Auditor/Assessor”

l  Discuss the background and principle of ISO 17025:2005 as well as recognize management systems

l  Recognize audit process which includes internal audit cycle, requirements,objectives, effectiveness, improvement, conformance adding value to the QMS andthe organization

l  Determine audit planning through internal audit programmes and audit criteria

l  Prepare the audit plan, review document and carryout resource planning, prepare checklists and pre-audit contract

l  Conduct audit interviews as well as audit different types of systems and processes

l  Identify the purpose and content of the internal audit report as well as recognize the audit audience

l  Perform corrective action and determine opportunities for improvement

l  • Employ follow up and explain close-out of audit findings as well as discuss management review

 

 

Ø TRAINING METHODOLOGY


This training course will combine presentations with instructor-guided interactive discussions between participants relating to their individual workplace. Practical exercises, video material and case studies aiming at stimulating these discussions and providing maximum benefit to the participants will support the training.

This interactive training course includes the following training methodologies as a percentage of the total tuition hours:

l  30% Lectures, Concepts, Role Play

l  30% Workshops & Work Presentations, Techniques

l  20% Based on Case Studies & Practical Exercises

l  20% Videos, Software & General Discussions

l  Pre and Post Test

 

Ø WHO SHOULD ATTEND?

 

l  Technical competence of personnel

l  Reliability and appropriateness of test methods

l  Traceability of measurements and calibrations on national standards

l  Suitability, calibration and maintenance of test equipment

l  Testing environment

l  Sampling, handling and transportation of test items

l  Requirements for a competent and compliant calibration/test laboratory

l  Understand basics for implementing a sound laboratory system from quality, calibration, and test perspectives

l  Recall the differences between registration, certification and accreditation

l  ISO/IEC 17025:2005 through key word recognition

l  Identification of  the documents and records required by ISO/IEC 17025:2005

 

 

                                                                               Outline

Day 1

 

Laboratory Accreditation (Act 19 of 2006, process and requirements)

 

l  Introduction and Background

l  Definition of Laboratory and Scope

l  Organization, Management, Personnel

l  Lab Quality System and Quality Requirements

l  Accommodations and Environment, Equipment and Reference Materials

l  Calibration and Test Methods

l  Records, Certificates, Reports, Complaints

l  Laboratory Quality Manual

l  Development of the Lab Scope

 

Day  2

 

 

ISO/IEC 17025:2005 - Management Requirements

 

l  Organization

l  Management System

l  Document control

l  Contracts with customers, review, tenders

l  Sub-contracting

l  Purchasing, critical services and supplies, evaluation

l  Service to the customer, feedback

l  Handling of complaints

l  Non-conforming work

l  Improvements

l  Corrective and preventive actions

l  Records maintenance and control

l  Internal auditing

l  Management review processes and records

Day 3

 

 

ISO/IEC 17025:2005 - Technical Requirements

l  Personnel training, competence criteria and authorization (Evaluation of Technical Signatories, Nominated Representative, Analysts, Internal Auditors)

l  Accommodation and environmental conditions

l  Test and calibration procedures, method validation, uncertainty of measurement

l  Control of data

l  Equipment calibration and maintenance

l  Measurement traceability

l  Reference standards and materials

l  Sampling and handling of test and calibration items

l  Assuring the quality of results and quality control

l  Proficiency participation and evaluation of results

l  Test and calibration reports

l  Root cause analysis

Day 4

 

SANAS Requirements and documentation

  • ISO/IEC 17025:2005 - What the Standard Requires

l  Quality system

l  Subcontractor quality

l  Equipment control

l  Maintenance

l  Training

l  Calibration

l  Traceability

l  Test procedures

l  Sample preparation

l  Nonstandard samples

l  Environmental conditions

l  Reports

l  Document control, maintenance, storage, and disposal

l  The auditing and accrediting process

l  Internal audit

 

  • Preparation of Documentation:

l  Documentation requirements

l  How to design a quality manual

l  Effective documentation control

l  Auditing a sample quality manual

 

Day 5

 

360 Overview of ISO/IEC 17025

 

l  The origin of ISO/IEC 17025

l  ISO/IEC 17025 in the marketplace and in government

l  ILAC – Who audits the auditors and the international perspective?

l  Roles of accrediting bodies

l  Who needs accreditation and why

l  Certification vs. accreditation

l  How ISO/IEC 17025 relates to other standards

l  Course Conclusion , Post Test

 

 Schedule

 

  • 08:30 – 10:15 First Session
  • 10:15 – 10:30 Coffee Break
  • 10:30 – 12:15 Second Session
  • 12:15 – 12:30 Coffee Break
  • 12:30 – 14:00 Third Session
  • 14:00 – 15:00 Lunch

 

Fees

 The Fee for the seminar, including instruction materials, documentation, lunch, coffee/tea breaks & snack :