139 Understanding ISO 17025

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.

sample certificate of calibrationBrief 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 access to the on-line electronic course workbook, including most of the presentation slides. An initial subscription is included in the price of the course and renewals are available for an additional fee. Printed books are also available for purchase.

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.

Click for a printable course outline (pdf).

Course Outline

Chapter 1 - Introduction and Overview

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  • Understanding 17025—Comments
  • Measurement Progress
  • Quality Control and Standards: 1920s
  • Control Charts
  • Quality Standards (Manufacturing)
  • Quality and Standards, 1970-present
  • Calibration Quality Standards, 1962–Present

Chapter 2 - Scope, Normative References, Terms

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  • Section 1: Scope
    • Mutual Recognition
    • Accreditation Bodies in U.S.
    • Types of Audits
  • Section 2: Normative References
  • Section 3: Terms and Definitions

Chapter 3 - Organization and Management

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  • Legal Responsibility
    • Lab’s Responsibility
    • Compliance Regardless of Location
  • Conflicts of Interest
    • Personnel with Authority and Resources
    • Freedom from Undue Influence
    • Protection of Proprietary Information
    • Reporting of Conflicts of Interest
  • Organization Structure
    • Responsibilities
    • Adequate Supervision, Training
    • Technical Manager
    • Quality Manager
    • Alternate Personnel
    • Key Managerial Personnel

Chapter 4 - Management System; Documentation Control

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  • Management
    • Quality Management System
    • Responsibility of Management
    • Hierarchy
  • Quality Manual
    • Examples of:
      • Quality Manual
      • Policy Statement
      • Quality Procedure
      • Quality Instructions
  • Roles and Responsibilities
  • Integrity of Management System

Chapter 5 - Requests, Tenders, Contracts, Purchasing

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  • Requests/Tenders/Contracts
    • Records of Reviews
      • Subcontracted work
      • Deviation
  • Subcontracting of Test/Calibrations
    • Informing the Customer
    • Responsibility for Subcontractors
    • List of Approved Subcontractors
  • Purchasing services and supplies
    • Verification Procedure
    • Purchasing Documents
    • Evaluation of Suppliers

Chapter 6 - Customer service, Control of Nonconforming Test and Calibrations, Corrective and Preventive Action

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  • Service to customer/Feedback from Customer
    • Sample Customer Survey Form
    • Sample Feedback Form
    • Complaints
  • Control of Nonconforming Tests and Calibrations
  • Corrective Action
    • Improvement
    • Cause Analysis
      • Problem Solving Model
      • Five Why’s
    • Selection and Implementation of Corrective Action
    • Monitoring of corrective actions
    • Additional Audits
  • Preventive Action

Chapter 7 - Control of Records / Internal Audits / Management Review

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  • Control of Records
    • Retention
    • Confidentiality
    • Backup of Electronic Records
    • Technical Records
      • Recording of Calculations and Data
      • Incorrect Entries
  • Internal Audits
    • Deficiencies Noted from Audit Results
    • Recording Findings and Actions Taken
    • Audit Follow-up
  • Management Review
    • Management Review Agenda
    • Assignment of Tasks, Follow-up

Chapter 8 - Technical Requirements: General, Personnel, Accommodation and Environmental Conditions

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  • General Technical Requirements
    • Importance of Quality and Reliability
  • Personnel
    • Competence
    • Education and Training
    • Contractor Competence
    • Job Descriptions
    • Personnel Authorization
  • Accommodation and Environmental Conditions
    • Monitoring Environmental Conditions
    • Separation Between Activities
    • Controlled Areas
    • Housekeeping

Chapter 9 - Test/Calibration Methods and Method Validation

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  • General
  • Selection of Methods
    • Laboratory-Developed Methods
    • Non-Standard Methods
  • Definition of Validation
    • Validation Requirements
    • Relevance to Customers’ Needs
  • Estimation of Uncertainty of Measurement
    • Accuracy and Precision
    • Testing Laboratories—Uncertainty
    • Completeness of Uncertainty Estimate
    • Estimating Uncertainty – 7 Steps
    • Uncertainty Report
  • Control of Data
    • Use of Computers or Automation

Chapter 10 - Equipment

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  • Presence of Equipment for Accreditation
  • Equipment Specifications
  • Equipment Operators, Instructions
  • Identification of Equipment
  • Equipment Records
  • Equipment Procedures
  • Equipment misused or found defective
  • Indication of Calibration Status
  • Test Equipment Returning to Laboratory
  • Intermediate Checks
  • Correction Factors
  • Protecting Equipment Calibration

Chapter 11 - Measurement Traceability / Sampling / Handling of Test and Calibration Items / Assuring Quality of Test and Calibration Results

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  • Measurement Traceability
    • Calibration Traceability
    • Exceptions to SI Unit traceability
    • Specific Traceability Requirements (Testing)
    • Reference Standards
    • Reference Materials
    • Intermediate Checks
    • Transport and Storage
  • Sampling
    • Deviations of Sampling
    • Recording Relevant Sampling Data
    • Sampling Procedures
  • Handling of test and calibration items
    • System of Identification
    • Record of Abnormalities
    • Protect customer equipment
  • Assuring Quality of Test and Calibration Result

Chapter 12 - Reporting the Results

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  • Test Reports and Calibration Certificates
    • Additional Requirements for Test Reports
    • Test reports (Sampling)
    • Sample Test Report
  • Additional Requirements for Calibration certificates
    • Sample Calibration Report
    • Sample Calibration Certificates
    • Before and After Data / Examples
    • Interval Recommendations
  • Opinions and Interpretations
  • Testing/Calibration Results from Subcontractors
  • Electronic Media
  • Report and Certificate Format
  • Amendments

Chapter 13 - Internal Audit Process: ISO 17025

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  • Learning Objectives
  • Definitions
  • Common Audit Tasks
  • External and Internal Audits
  • Desirable and Undesirable Auditor Traits
  • The Standard
    • Interpreting the Requirements
  • Planning
    • Checklists
    • NVLAP HB 150 External Audit Checklist
  • Evaluate Documentation
  • Interviewing Techniques
    • Types of Questions
  • Taking Notes
  • Information Collection
  • Findings
    • Nonconformance
    • Observations for Improvement
  • Reporting the results
  • Internal Audit Planning Exercise

Knowledge Check - Review Questions

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Guidelines for Establishing Applications for Specific Fields

Summary and overview

Award of Certificates for successful completion

Click for a printable course outline (pdf).