ISO 17025 Quality Manual

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Table of Contents

Introduction 
Quality Policy Statement 
1.0 Scope 
2.0 References 
3.0 Terms and Definitions 
4.0 Management Requirements 
4.1 Organization 
4.2 Management System 
4.3 Document Control 
4.4 Review of Requests, Tenders, and Contracts 
4.5 Subcontracting of Tests and Calibrations 
4.6 Purchasing Services and Supplies 
4.7 Service to the Client 
4.8 Complaints 
4.9 Control of Nonconforming Testing and/or Calibration Work 
4.10 Improvement 
4.11 Corrective Action 
4.12 Preventive Action 
4.13 Control of Records 
4.14 Internal Audits 
4.15 Management Reviews 
5.0 Technical Requirements 
5.1 Technical Requirements - General 
5.2 Personnel 
5.3 Accommodations and Environmental Conditions 
5.4 Test and Calibration Methods and Method Validation 
5.5 Equipment 
5.6 Measurement Traceability 
5.7 Sampling 
5.8 Handling and Transportation of Test and/or Calibration Items 
5.9 Assuring the Quality of Test and Calibration Results 
5.10 Reporting the Results

 

INTRODUCTION

XYZ Company recognizes its responsibility as provider of quality services.  To this end, XYZ Company has developed and documented a quality management system to better satisfy the needs of its customers and to improve management of the company.  The quality system complies with the international standards ISO/IEC 17025:2005 and ISO 9001:2008.

This manual has been prepared to define the quality system, establish responsibilities of the personnel affected by the system, and to provide general procedures for all activities comprising the quality system. In addition, this manual is utilized for the purpose of informing our customers of the quality system, and what specific controls are implemented to assure service quality.

4.0 Management Requirements

4.1 Organization and Management

4.1.1 XYZ Company holds legal responsibility for its operation and is organized to operate in accordance with the requirements of ISO/IEC 17025, whether carrying out work in its permanent facilities or on location, at customer sites.

4.1.2 XYZ Company is not part of an organization performing activities other than testing and/or calibration; therefore, there is no potential conflict of interest amongst its personnel.

The organization of XYZ Company is illustrated below in Figure 1.

4.2 Quality System

4.2.1 Documentation of the System

4.2.1.1 The Quality Manual is the principal document that defines the quality system at XYZ Company.

4.2.1.2 Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality. Quality procedures will be readily available to personnel for reference and implementation. The quality document structure contains this Quality Manual, Quality Procedures, Work Instructions, and Quality Records.

4.3 Quality Policy

4.3.1 XYZ Company Quality Policy:

XYZ Company will provide our employees with adequate procedures to satisfy standards acceptable to most industrial entities. We will strive to improve the quality of our services at reduced cost and to constantly satisfy the expectations of our customers and relevant agencies.

The Senior Management and Staff of XYZ Company also undertake to ensure that all activities are conducted in strict accordance with company documented procedures and comply with the requirements of the ISO/IEC 17025 Standard.

4.4 Review of Requests, Tenders, and Contracts

4.4.1 Contract/order review is an integral part of the quality system at XYZ Company. All contracts/orders are reviewed and accepted only if the requirements are clear and understood, and the company has the capability and capacity to assure full customer expectations.

4.4.2 Records of reviews, including any significant changes, are maintained.

4.4.3 Communications are maintained with the client from request/quote through commencement of work. This includes informing the client of any deviation from the contract.

4.4.4 The process for contract review is further defined in the Contract Review Procedure.

4.9 Control of Nonconforming Testing and/or Calibration Work

4.9.1 XYZ Company has established and maintains a policy and procedures that are implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the client.

4.9.2 The policy and procedures shall ensure that nonconforming work or problems that do not conform to requirements are identified and managed, to prevent unintended use or delivery. This procedure ensures that non-conforming work or problems are corrected, where applicable, and subject to verification after correction to demonstrate conformity. Where required by the contract, the proposed rectification of non-conforming work or problems is reported for concession to the customer, the end user, regulatory body, or other applicable authority.

4.9.3 Identification of nonconforming work or problems with the quality system or with testing and/or calibration activities can occur at various points within the quality system, and technical operations such as customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews, and internal or external audits.

4.9.4 Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of XYZ Company operations with its own policies and procedures, the corrective actions procedure shall be followed to identify the root cause(s) of the problem and to eliminate this (these) cause(s).

4.9.5 The process for nonconforming testing and/or calibration work is further defined in the Control of Nonconforming Testing or Calibration Work Procedure.

5.0 Technical Requirements

5.1 Technical Requirements - General

5.1.1 XYZ Company recognizes that many factors determine the correctness and reliability of the tests and/or calibration performed by a laboratory. These factors include contributions from: human factors (5.2), accommodation and environmental conditions (5.3), test and calibration methods and method validation (5.4), equipment (5.5), measurement traceability (5.6), and handling of test and calibration items (5.8).

5.1.2 The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests and between (types of) calibrations. XYZ Company takes into account these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

5.2 Personnel

5.2.1 XYZ Company's management ensures the competency of all who operate specific equipment, who perform tests and/or calibrations, evaluate results and sign test reports and calibration certificates. When using staff that is undergoing training, adequate and appropriate supervision is provided. Personnel performing specific tasks are qualified on the basis of appropriate education, training, experience, and/or demonstrated skills, as required.

5.4.5 Validation of methods

5.4.5.1 All standard and non-standard test methods and procedures are validated to ensure that such methods and procedures are fit for their intended use and are relevant to the requirements of ISO/IEC 17025 Clause 5.4.5 as well as the client.

5.4.5.2 The results of such validation are recorded together with the procedure utilized and any other relevant information. The record states whether the method or procedure is fit for the intended use.

5.4.6 Uncertainty of Results

5.4.6.1 The uncertainty of calibration results are calculated and documented in accordance with the requirements of ISO/IEC 17025 Clause 5.4.6. The Estimation of Uncertainty of Measurement Procedure is applied to all in house calibrations/tests OR The uncertainty of measurement is available on the certificate of analysis or calibration certificate from a subcontractor.

5.4.6.2 The Estimation of Estimation of Uncertainty of Measurement Procedure is applied for estimating uncertainty of measurement, except when the test methods preclude such rigorous calculations. In certain cases it is not possible to undertake metrologically and statistically valid estimations of uncertainty of measurement. In these cases the laboratory attempts to identify all the components of uncertainty and make the best possible estimation, and ensure that the form of reporting does not give an exaggerated impression of accuracy. Reasonable estimation is based on knowledge of the performance of the method and on the measurement scope, and makes use of previous experience and validation data.

The degree of rigor needed in an estimation of uncertainty of measurement depends on factors such as:

Requirements of the test method

Requirements of the client

The existence of narrow limits on which decisions on conformance to a specification are based

In cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied the estimation uncertainty of measurement by following the test method and reporting instructions (see section 5.10).

5.10 Reporting the Results

5.10.1 The results of each test, calibration, or series of tests or calibrations carried out by the laboratory are reported accurately, clearly, unambiguously, and objectively, and in accordance with any specific instructions in the test or calibration methods. The results are normally reported in a test report or a calibration certificate and include all the information requested by the client and necessary for the interpretation of the test or calibration results, and all information required by the method used. In the case of test or calibrations performed for internal clients, or in the case of a written agreement with the client, the results may be reported in a simplified way and may not require the formalized calibration certificate, but all data (data that would be on an actual calibration certificate if one were to be generated) is readily available and kept permanently on file

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