ISO 17025: SkillsPlus International Inc.

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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

In-house projects will be used to demonstrate and practice the skills and principles of this class.
The optional final exam is approximately 25 questions.
Each student receives a student guide containing a representation of the program’s slides and graphics with space provided for note taking.
This class can accommodate up to 25 people.
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 415.487.3500.

For a prompt reply to requests and questions: 415.487.3500 | allan.dewes@skillsplusinc.com | Fax: 415.487.1926