Assessment of Laboratory Competence
($1595 non-members/$1545 members)
A2LA can offer on-site training at your facility for $2500/day plus expenses.
For additional information, please contact Ms. Julie Collins, A2LA Training and Membership Manager, at 301 644 3235 or
.
This course is a comprehensive look at the ISO/IEC 17025 requirements, as well as the process of accreditation and the assessment of a laboratory’s competence. Previously taught in separate courses, the merged subject matter enables the instructors to present an understandable explanation of the standard and how it should be applied. In this course, you will gain critical insight into 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 evaluate laboratory documents and quality manuals. You will have an opportunity to review sample quality system documents from other laboratories. A quality manual will be examined as to its impact on laboratory operations and the purpose it serves. You will learn what information it should contain, what writing style is most effective and the requirements needed to keep a quality manual and system documents up to date.
This course also gives attendees the knowledge needed to evaluate a laboratory’s internal quality audit program as required by ISO/IEC 17025, and to initiate the sequence of activities involved in scheduling, planning, conducting and reporting on assessments. Participants will learn to employ effective techniques for obtaining objective evidence and information. Key critical assessment issues, including the evaluation of analyst/technician competency, method validation, measurement traceability and measurement uncertainty, will also be presented.
Target Attendees: Laboratory assessors and lead assessors, laboratory directors, laboratory managers, quality managers, and technical laboratory staff
Instructor:
Ken Stoub – Group Seven
Course Hours:
8:00 AM – 5:00 PM (Monday – Thursday)
8:00 AM – 12:00 PM (Friday)
Course Reference: ISO/IEC 17025:2005
Prerequisite: Hands-on laboratory experience
Exams:
Two exams:
a) Pre-Course Quiz to evaluate the attendee’s current awareness of ISO/IEC 17025 and assessment concepts and
b) a Final Exam to demonstrate the attendee’s ability in applying 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.
Graders: Daren Valentine and Ken Stoub
Presentation Style: The course materials will be presented in an “interactive” lecture style (50%), as well using application exercises and role playing (50%).
Course Content:
- Course Introduction
- Pre-Course Quiz
- Overview of Conformity Assessment concepts
- Accreditation of accreditation bodies
- Accreditation benefits and process
- ISO/IEC 17025
- Background of ISO/IEC 17025
- Critical terminology
- Requirements examined and explained
- Critical quality system elements emphasized
- Quality system documentation
- Benefits of quality manual and related documents
- Document control, maintenance, storage and disposal
- Quality system structures
- Evaluating the compliance of documents and the control system
- Assessments of laboratory competence
- Review of requirements
- Human relation aspects of assessment
- Planning assessments
- Developing checklists
- Effective questioning and assessment techniques
- Final course material review and examination
