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Assessment of Laboratory Competence
This course is a comprehensive look at the ISO/IEC 17025:2005 requirements and a detailed approach to the assessment of a laboratory’s competence. The course is applicable to all testing and calibration laboratories and it provides an understandable explanation of the international laboratory standard and how it should be applied and implemented. In this course, you will receive a detailed review of the A2LA accreditation process and you will also gain critical insight into the interpretation of the requirements of this international laboratory standard
COURSE CONTENT:
- Course introduction
- Pre-course quiz
- Conformity assessment concepts
- Peer evaluation of accreditation bodies
- Accreditation benefits and process
- ISO/IEC 17025:2005 and background on its development
- Management system concepts
- Benefits of a quality manual and related documents
- Use of exercises and discussions to understand critical processes
- Ethical constraints
- Organizational structures
- Management system structures
- Document development and control
- Customer contract development
- Quality-critical services and supplies
- Customer feedback, complaints and nonconforming work
- Corrective actions and preventive actions
- Internal audits and management reviews
- Analyst competency
- Method validation
- Measurement uncertainty
- Equipment calibration and maintenance
- Measurement traceability
- Sample handling
- Quality control
- Results reporting
- Auditing principles and practices
- Review of ISO/IEC 17025 requirements
- Benefits of assessments and internal audits
- Selecting, training and qualifying assessors and internal auditors
- Communication skills and human relation aspects of an assessment
- Planning assessments and internal audits
- Conducting document reviews (gap analyses)
- Effective questioning and auditing techniques
- Gathering information and evidence
- Writing assessment findings and deficiencies
- A2LA assessor policies and procedures
- Course review
- Final examination
PREREQUISITE:
Hands-on laboratory experience and knowledge of ISO/IEC 17025:2005
TARGET ATTENDEES:
Laboratory assessors, lead assessors, laboratory directors and laboratory internal auditors
EXAMS:
a) A Pre-Course Quiz is administered to evaluate each attendee’s current awareness of ISO/IEC 17025 and assessment concepts; and
b) A Final Exam is administered to demonstrate each attendee’s ability to apply the knowledge gained from this course. The passing grade for the Final Exam has been established at 70%. Additionally, throughout this course, the course instructors will be monitoring the attendees’ participation in all of its various activities.
LEARNING OUTCOMES:
After successful completion of this course, attendees will be able to:
- Understand accreditation concepts and benefits
- Design an appropriate quality manual and supporting system documents
- Develop and implement required technical documents
- Understand the difference between management reviews and internal audits
- Develop and implement a detailed internal auditing program
- Select, train and qualify internal auditors
- Employ effective techniques for auditing
- Base audit findings on the evidence identified during audits
- Handle difficult situations during audits
CEUs AWARDED:
3.3 CEUs Awarded*
PRESENTATION STYLE:
The course materials will be presented in an “interactive” lecture style (50%), as well by using application exercises and role playing (50%). The exercises are progressive in nature to facilitate the development of appropriate internal auditing techniques.
REFERENCE:
ISO/IEC 17025:2005