ICTD International Centre for Training and Development

Laboratory Quality Management System (ISO 17025:2005): Sop, Accreditation, Documentation and Auditing

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About the course

Analytical chemistry is experiencing dramatic, turbulent change beyond control of the laboratory and laboratory management. Technological innovations, staffing demographics, new business models, automation, industry consolidation, society and regulatory expectations, and other factors are transforming nearly aspect of the business.

This course is comprehensive look at the latest revision of the ISO 17025 and its documentation and internal auditing requirements. You will gain critical insight on the interpretation of the requirements of this laboratory standard and you will also receive a detailed review of the accreditation process.

You will learn how to design and develop laboratory documents and quality manuals. The quality manual will be examined as to its impact on laboratory operations and what purpose it serves. You will learn what information it should contain, what writing style is most effective and how to keep your documents and quality manual up to date.

This course also gives attendees the knowledge needed to establish an internal quality audit program as required by ISO 17025, and to initiate the sequence of activities involved in scheduling, planning conducting, reporting on and closing out internal quality audits. Participants will be able to employ effective techniques of auditing and the ability to develop the auditing procedures, scheduling and recording systems needed to sustain the program.

Attendees will receive practical instructions on the development, implementation and long-term maintenance of an effective laboratory quality system.

This course takes a strategic view of the laboratory system in the context of current quality management philosophies to determine options for achieving best practices. Experiences will be shared to provide insight into the obstacles and expected outcomes for the various approaches. Further this workshop includes the mission and function of the analytical enterprise along with ways to improve the quality, performance and evaluation of the laboratory.

Course Objectives

Upon successful completion of this course, the delegates will be able to:

  • Apply proper techniques in laboratory quality management and its standard operational procedures, accreditation, documentation and auditing in accordance with the ISO 17025
  • Design and develop laboratory documents (SOP) & quality manuals and recognize the information they should contain, employ an effective writing style as well as maintain documents and quality manuals up to date
  • Employ effective techniques of auditing and develop auditing procedures, scheduling and recording systems needed to sustain and auditing program
  • Recognize the requirements of an ISO 17025 accreditation and review the accreditation process
  • Carryout an internal quality audit program in accordance with ISO 17025 as well as initiate the sequence of activities involved in scheduling, planning, conducting, reporting on and closing out internal quality audits
  • Develop, implement and maintain a long term effective laboratory quality system in the long run in compliance with the requirements of ISO 17025
  • Learn how laboratories are applying current management philosophies to get closer to the business and to streamline operations according to the ISO 17025:2005; SOP, accreditation, documentation and auditing. Practical details of laboratory management such as cost control, maintaining analysis quality, improving laboratory reputation, effective staffing, capital budget justification, and so forth will be discussed but the emphasis will be on systems rather than daily operational issues. Participants are expected to share experiences and best practices.

Course Outline

Day 1

  • Quality Management Scope and Benefits
  • Accreditation
  • Laboratory Risk Management
  • Laboratory Waste Management
  • Dealing with chemical Spillage
  • Quality control aim and definition
  • Types of errors
  • Laboratory quality Management
  • Technical requirements for Good lab Management reference to ISO 17025
  • Personnel
  • Accommodation And Environmental Conditions
  • Calibration Methods And Method Validation
  • Equipment
  • Measurement Traceability
  • Sampling
  • Handling Of Test And Calibration Items
  • Assuring The Quality Of Calibration Results
  • Reporting The Results

Day 2

  • Laboratory Business activity Vision and Mission
  • Management and Leadership, Team Building, Negotiation and decision making
  • Developing employees
  • Laboratory Human resource Management: organization, hiring, training and personnel appraisal
  • Laboratory Financial Management: capital and operating budget
  • Laboratory Procurement Management

Day 3

  • Laboratory safety Management
  • Laboratory Safety check List
  • Fume hood monitoring

Day 4

  • Management Requirements for Good Laboratory Management
  • Reference ISO/EC 17025:2005
  • Organization
  • Quality system
  • Document control
  • Review of requests, tenders and contracts
  • Subcontracting of tests
  • Purchasing services and supplies
  • Service to the client Complaints
  • Control of nonconforming testing work
  • Corrective action
  • Preventive action
  • Control of records
  • Internal audits
  • Management reviews
  • Internal Quality auditing

Day 5

  • Proficiency Test Definition and Benefits
  • Statistical Concept
  • Z- score definition and calculation
  • Statistical process Control
  • Documentation

Course Methodology

A variety of methodologies will be used during the course that includes:

  • (30%) Based on Case Studies
  • (30%) Techniques
  • (30%) Role Play
  • (10%) Concepts
  • Pre-test and Post-test
  • Variety of Learning Methods
  • Lectures
  • Case Studies and Self Questionaires
  • Group Work
  • Discussion
  • Presentation

Who should attend

This course provides an overview of all significant aspects and considerations of laboratory quality management in accordance with the international standards for those who are involved in the laboratory accreditation, documentation and auditing. This includes laboratory managers, superintendents, supervisors, scientists, chemists, analysts and other lab technical staff. Further, the course will be of great value for quality managers, quality engineers, quality auditors and management representatives.

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