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Understanding ISO 17025

Course No. 139

(Course Outline shown below.)

For Whom Intended This course is for individuals who are involved in testing and calibration laboratories and for others who want a clear understanding of the special requirements that must be met by managers and other personnel in testing and calibration work.

This course is applicable to individuals from a wide range of industries such as Defense, Manufacturing, Utilities, Electronics, Automotive, Medical, Telecommunications, Computers, Aerospace and Universities.

Brief Course Description The course follows the format and content of ISO standard 17025. Its impact on all aspects of test and calibration laboratory operations is analyzed clause by clause. The relationship of ISO 9000 quality programs to ISO standard 17025 is discussed.

Management requirements are discussed in detail, including organizational requirements, the Quality system, Document Control, contracting issues and the handling of complaints, nonconforming work, corrective and preventive action.

In the section on technical requirements, consideration is given to personnel issues, including training and job descriptions. Physical surroundings, test/calibration method development and validation and equipment control are discussed next. Uncertainty, traceability, sampling and quality assurance are covered before a discussion on the reporting of results of testing or calibration activities. The course concludes with guidelines on developing specific applications.

Diploma Programs This course is a required course in TTi’s Metrology/Calibration Specialist (ITS) Diploma Program, and may be used as an optional course for any other TTi specialist diploma program.

Prerequisites There are no definite prerequisites for this course. However, this course is aimed toward individuals involved in a related technical field.

Text Each student will receive a course workbook, including most of the viewgraphs used in the course presentation. Students are required to bring their own copy of ISO-17025 to class with them.

Course Hours, Certificate and CEUs Open courses meet seven hours per day. Upcoming presentation dates can be found on our current open course schedule. Class hours/days for on-site courses can vary from 14-35 hours over 2-5 days as requested by our clients. Upon successful course completion, each participant receives a certificate of completion and one Continuing Education Unit (CEU) for every ten class hours.

Course Outline No. 139

Introduction
- Scope
- Relationship with ISO 9001 and ISO 9002
- Normative references
- Terms and definitions
Management requirements
- Organization
- Quality system, Quality Manual
- Document control
  - Approval and Issue
  - Changes
  - Electronic Format
- Review of requests, tenders and contracts
- Subcontracting of tests and calibrations
- Purchasing services and supplies
- Service to the client
- Complaints
- Control of nonconforming testing and/or calibration work
- Corrective action
  - Cause analysis
  - Selection, implementation of corrective action
  - Monitoring of corrective action, Additional audits
- Preventive action
  - Control of records
  - Internal audits
  - Management reviews
Technical requirements
- Personnel
  - Training
  - Certification
  - Job Descriptions
- Accommodation and environmental conditions
  - Monitoring
  - Housekeeping
- Test and calibration methods and method validation
  - Method selection
  - Lab-Developed Methods
  - Non-standard Methods
  - Validation of Methods
  - Uncertainty
  - Control of Data
- Equipment
  - Capabilities
  - Record-keeping
  - Maintenance
- Measurement traceability
  - Specific Requirements: Calibration, Testing
  - Reference Standards and Reference Materials
- Sampling
- Handling of test and calibration items
- Assuring the quality of test and calibration results
- Reporting the results
  - Test Reports
  - Calibration Certificates
  - Opinions and Interpretations
  - Results from Subcontractors
  - Electronic Reporting
  - Format of Reports and Certificates
Guidelines for Establishing Applications for Specific Fields
Summary and overview
Award of Certificates for successful completion

Printable (.pdf) version of course outline no. 139 ( Adobe Acrobat Reader required).

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