ISO 17025
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ISO 17025: Calibration Laboratories

 

 

Purpose

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

 

Objectives  

  • 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. 

Topics

 

Introduction

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

 

Complaints

 

Control of Non-conforming Work

 

Corrective Actions

 

Preventive Actions

 

Control of Records

 

Internal Audits

 

Management Review

 

Technical Requirements

 

Personnel

 

Accommodation and Environmental Conditions

 

Methods and Validation

 

Equipment

 

Sampling

 

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 |  skillsplus@aol.com    |   Fax: 954.566.5225

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