ENVIRONMENTAL LABORATORY SECTOR VOLUME 1 …

1 ENVIRONMENTAL LABORATORY SECTOR VOLUME 1 MANAGEMENT AND technical requirements FOR laboratories performing ENVIRONMENTAL ANALYSIS Module 2: Quality Systems General requirements Working Draft Standard July 2011 Box 2439 Weatherford, TX 76086 817-598-1624 2009 The NELAC Institute Some material in this document is reproduced from ISO/IEC 17025:2005 with permission of the American National Standards Institute (ANSI) on behalf of the International Organization for Standardization (ISO). No part of the reproduced language may be copied or reproduced an any form, including an electronic retrieval system or be made available on the internet, a public network, by satellite or otherwise without prior written permission of ANSI, 25 West 43rd Street, New York, NY 10036.

2 EL-V1M2-ISO-2009 FormattedTNI Voting Draft Standard July 2011 EL-V1M2-ISO-2009: Quality Systems General requirements page i FOR COMMITTEE USE ONLY NOT FOR COPYING OR DISTRIBUTION This document contains copyright information from ISO/IEC 17011 and/or 17025 and thus must be handled as a controlled document for review and discussion purposes only. All copies must be returned to the committee at the conclusion of the meeting. TNI Voting Draft Standard July 2011 EL-V1M2-ISO-2009 page ii PREFACE This Standard is the result of many hours of effort by those volunteers on The NELAC Institute (TNI) Quality Systems Committee.

3 The TNI Board of Directors wishes to thank these committee members for their efforts in preparing this Standard as well as those TNI members who offered comments during the voting process. It is conformant with the requirements of ISO/IEC 17025:2005(E)ISO/IEC 17025:2005, and includes applicable clauses from that international standard. The ISO clauses are provided in italics. Additional TNI text is provided in a normal font. This Standard may be used by any organization that wishes to implement a program for the accreditation of ENVIRONMENTAL laboratories . TNI Voting Draft Standard July 2011 EL-V1M2-ISO-2009: Quality Systems General requirements page iii This page intentionally left Voting Draft Standard July 2011 EL-V1M2-ISO-2009 page iv VOLUME 1, MODULE 2 Quality Systems General requirements Table of Contents INTRODUCTION, SCOPE AND APPLICABILITY.

4 1 Introduction .. 1 Scope .. 1 NORMATIVE REFERENCES .. 2 TERMS AND DEFINITIONS .. 2 Additional Terms and Definitions .. 2 Sources .. 6 Exclusions and Exceptions .. 7 MANAGEMENT requirements .. 7 Organization.

5 7 Management .. 10 Document Control .. 13 Review of Request, Tenders and Contracts .. 14 Subcontracting of ENVIRONMENTAL Tests .. 15 Purchasing Services and Supplies .. 15 Service to the Client .. 16 Complaints .. 16 Control of Nonconforming ENVIRONMENTAL Testing Work .. 16 Improvement .. 17 Corrective Action .. 17 Preventive Action.

6 18 Control of Records .. 18 Internal Audits .. 21 Management Reviews .. 21 Data Integrity Investigations .. 22 technical requirements .. 22 General .. 22 Personnel .. 22 Accommodation and ENVIRONMENTAL Conditions .. 26 ENVIRONMENTAL Methods and Method Validation .. 27 Calibration requirements .

7 28 Measurement Traceability .. 30 Collection of Samples .. 32 Handling Samples and Test Items .. 32 Quality Assurance for ENVIRONMENTAL Testing .. 35 Reporting the Results .. 36 TNI Voting Draft Standard July 2011 EL-V1M2-ISO-2009: Quality Systems General requirements page v This page intentionally left Voting Draft Standard July 2011 EL-V1M2-2009 page 1 VOLUME 1, MODULE 2 1 2 Quality Systems General requirements 3 4 5 INTRODUCTION, SCOPE AND APPLICABILITY 6 7 Introduction 8 9 Each LABORATORY shall have a quality system.

8 The LABORATORY s quality system is the means by which 10 an organization ensures the quality of the products or services it provides and includes a variety of 11 management, technical , and administrative elements such as: 12 13 a) policies and objectives, 14 b) procedures and practices, 15 c) organizational authority, 16 d) responsibilities, and 17 e) performance measures.

9 18 19 The quality system provides the framework for planning, implementing, assessing, and improving 20 work performed by an organization so as to provide the client with data of known and documented 21 quality, sufficient to evaluate the usability of the data to the clients needs. The quality system shall 22 be documented in the LABORATORY s quality manual and related quality documentation, and shall be 23 referenced in the quality manual. 24 25 This Standard contains detailed quality system requirements for consistent and uniform 26 implementation by the laboratories conducting testing and the consistent and uniform evaluation of 27 those laboratories by accreditation bodies.

10 Each LABORATORY seeking accreditation under this 28 Standard shall ensure that they are implementing their quality system and that all Quality Control 29 procedures specified in this module are being followed. The Quality Assurance policies, which 30 establish quality control procedures, are applicable to ENVIRONMENTAL laboratories regardless of size 31 and complexity. 32 33 This Standard is consistent with ISO/IEC 17025:2005 requirements that are relevant to the scope of 34 ENVIRONMENTAL testing services. 35 36 All items identified in this document shall be available for an on-site assessment.