ISO 17025
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ISO 17025: Calibration Laboratories




To state the details of ISO 17025 as it relates to calibration laboratories.



  • Explain the rationale for ISO 17025.
  • Explain the management requirements from a regulatory perspective
  • Explain the technical requirements from a regulatory perspective.

About the Class

  1. In-house projects will be used to demonstrate and practice the skills and principles of this class.

  2. The optional final exam is approximately 25 questions.

  3. Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.

  4. This class can accommodate up to 25 people.

  5. Duration: 4 hours. 




1.   Overview

2.   Definitions

3.   How ISO standards are developed.


Scope and Overview

1.   Normative references

2.   Terms and definitions

3.   Organization

4.   Personnel responsibilities


Management Requirements

1.   Top management

2.   Management systems

3.   Management systems policies

4.   Management systems commitment

5.   Management systems communication

6.   Quality manual

7.   Technical management


Documentation Control

1.   Documents and approval

2.   Procedures

3.   Management system

4.   Document changes


Review: Requests, Tenders and Contracts

1.   Procedures

2.   Record reviews


Subcontract of Tests and Calibrations

1.   Competent contractors

2.   Laboratory responsibilities

3.   Responsibility for subcontractor


Purchasing Services and Supplies


Service to Customers




Control of Non-conforming Work


Corrective Actions


Preventive Actions


Control of Records


Internal Audits


Management Review


Technical Requirements




Accommodation and Environmental Conditions


Methods and Validation






Handling Test Items


Quality of Results


Reporting Results


Top 483 Observations


Wrap Up



Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.


For a prompt reply to requests and questions:  415.948.5220 |    |   Fax: 954.566.5225

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