Access QMS - ISO Standards

INTRODUCTION

INTRODUCTION TO
ISO 9001:2000

INTRODUCTION TO
ISO/TS 16949

SYNOPSIS OF
ISO 14001

INTRODUCTION TO
ISO/IEC 17025

SYNOPSIS OF
ISO 9001/AS9100

ISO/IEC 17025 is and internationally recognized standard for the demonstration of the competence of testing and calibration laboratories.

ISO = International Organization for Standardization
IEC = International Electrotechnical Commission
ISO/IEC 17025 Replaces ISO/IEC Guide 25 and EN 45001
Laboratories that operate in accordance with ISO/IEC 17025 are considered compliant with ISO 9001:2000; however, registration to ISO 9001:2000 does not demonstrate compliance with ISO/IEC 17025.

The ISO/IEC 17025 requirements are divided into two sections:

Section 4-Management Requirements
Section 5-Technical Requirements

Overview of ISO/IEC 17025 ~ Management Requirements

4.1 Organization - This clause covers:

Laboratory identification
Performance of work
Adherence to ISO and regulatory requirements
Conflict of interest with other areas
Authority
Freedom from influence
Client confidentiality
Management structure
Supervision of staff
Technical management
Quality Manager

4.2 Quality System - This clause covers:

Implementation and maintenance
Quality manual
Management commitment
Supporting procedures references
Roles and responsibilities

Overview of ISO/IEC 17025 ~ Technical Requirements

5.1 General - This clause covers:

Factors contributing to uncertainty of measurements
Accounting for uncertainty of measurements

5.2 Personnel - This clause covers:

Ensuring the competence of all personnel
Appropriate supervision of EIT
Formulation of educational and training goals
Job descriptions
Maintenance of qualification records

ISO/IEC 17025 ~ The Registration Process

This would be a typical registration process. However, each registrar has a specific process that it uses. Please check with your registrar for their process.

Laboratory Accreditation Process (summary)

The applicant laboratory obtains all necessary registrar application forms, registrar requirements and policy documents from the registrar.
The laboratory obtains an official copy of ISO/IEC 17025
The laboratory provides the registrar with confirmation that a valid copy of ISO/IEC 17025 has been obtained. The registrar then provides the ISO/IEC 17025 Assessor Checklist to the laboratory.
The applicant laboratory completes and returns the application for accreditation along with all required supporting documentation.
The registrar reviews the application documents and an appropriate assessor(s) is assigned, with laboratory agreement.
The assessor contacts the laboratory to discuss the scheduling of the on-site assessment and request the quality documentation. Once documentation is reviewed for completeness, the assessment can be scheduled with the assessor(s).
The assessment or the pre-assessment is performed and includes: entry briefing; review of quality documentation, records, sample handling; interviews with technicians; demonstrations of tests/calibrations; examination of equipment and calibration records; written report of assessor's findings; and exit briefing.
The laboratory responds to any deficiencies with a written corrective action response.
The corrective action is reviewed by the registrar staff and once complete, is forwarded to the Accreditation Council for a vote.
Accreditation is granted when affirmative votes are received, all concerns are resolved, and all fees are paid in full.



INTRODUCTION INTRODUCTION TO ISO 9001:2000 INTRODUCTION TO ISO/TS 16949 SYNOPSIS OF ISO 14001 INTRODUCTION TO ISO/IEC 17025 SYNOPSIS OF ISO 9001/AS9100	ISO/IEC 17025 is and internationally recognized standard for the demonstration of the competence of testing and calibration laboratories. ISO = International Organization for Standardization IEC = International Electrotechnical Commission ISO/IEC 17025 Replaces ISO/IEC Guide 25 and EN 45001 Laboratories that operate in accordance with ISO/IEC 17025 are considered compliant with ISO 9001:2000; however, registration to ISO 9001:2000 does not demonstrate compliance with ISO/IEC 17025. The ISO/IEC 17025 requirements are divided into two sections: Section 4-Management Requirements Section 5-Technical Requirements Overview of ISO/IEC 17025 ~ Management Requirements 4.1 Organization - This clause covers: Laboratory identification Performance of work Adherence to ISO and regulatory requirements Conflict of interest with other areas Authority Freedom from influence Client confidentiality Management structure Supervision of staff Technical management Quality Manager 4.2 Quality System - This clause covers: Implementation and maintenance Quality manual Management commitment Supporting procedures references Roles and responsibilities Overview of ISO/IEC 17025 ~ Technical Requirements 5.1 General - This clause covers: Factors contributing to uncertainty of measurements Accounting for uncertainty of measurements 5.2 Personnel - This clause covers: Ensuring the competence of all personnel Appropriate supervision of EIT Formulation of educational and training goals Job descriptions Maintenance of qualification records ISO/IEC 17025 ~ The Registration Process This would be a typical registration process. However, each registrar has a specific process that it uses. Please check with your registrar for their process. Laboratory Accreditation Process (summary) The applicant laboratory obtains all necessary registrar application forms, registrar requirements and policy documents from the registrar. The laboratory obtains an official copy of ISO/IEC 17025 The laboratory provides the registrar with confirmation that a valid copy of ISO/IEC 17025 has been obtained. The registrar then provides the ISO/IEC 17025 Assessor Checklist to the laboratory. The applicant laboratory completes and returns the application for accreditation along with all required supporting documentation. The registrar reviews the application documents and an appropriate assessor(s) is assigned, with laboratory agreement. The assessor contacts the laboratory to discuss the scheduling of the on-site assessment and request the quality documentation. Once documentation is reviewed for completeness, the assessment can be scheduled with the assessor(s). The assessment or the pre-assessment is performed and includes: entry briefing; review of quality documentation, records, sample handling; interviews with technicians; demonstrations of tests/calibrations; examination of equipment and calibration records; written report of assessor's findings; and exit briefing. The laboratory responds to any deficiencies with a written corrective action response. The corrective action is reviewed by the registrar staff and once complete, is forwarded to the Accreditation Council for a vote. Accreditation is granted when affirmative votes are received, all concerns are resolved, and all fees are paid in full.