[PDF] Quality Manual-HETL FCS 17025-2017 - Maine





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Quality Manual

Quality Manual: Doc # = 001 Approved by: Forensic Lab Director - Lauren Niskach Originally issued: 3-3-2014 Date Revised:March 14, 2021 Page 1 of 108 Electronic Copy is Controlled Printed Copy is Convenience

Refer to SharePoint for the most current version

This document serves as the

Quality Manual for:

Forensic Chemistry Section Maine Health and Environmental Testing Laboratory

221 State Street, SHS 12

Augusta, Maine 04333-0012

Chief of Laboratory Operations: Dr. Kenneth Pote, Ph. D.

Forensic Laboratory Director / Quality Manager:

Lauren Niskach

This Quality Manual meets the requirements of ISO/IEC 17025:2017 and is the main document for our

Management System.

The Management System is

outlined in section 8. The Quality Policy Statement is detailed in section 8.2.2. The Range of Laboratory Activities is addressed in section 5.3.

Quality Manual

Quality Manual: Doc # = 001 Approved by: Forensic Lab Director - Lauren Niskach Originally issued: 3-3-2014 Date Revised:March 14, 2021 Page 2 of 108
Electronic Copy is Controlled Printed Copy is Convenience

Refer to SharePoint for the most current version

About this Document

This document is reviewed at least annually by the Forensic Lab Director / Quality

Manager, and changes

are made as needed. Previous versions are retained on Sharepoint for at least 1 full accreditation cycle. All analysts in Forensic Chemistry acknowledge the existence of any updated version.

Table of Contents

1. Scope ..................................................................................................................................................... 4

2. Normative References .......................................................................................................................... 4

3. Terms and Definitions ........................................................................................................................... 5

4. General Requirements ........................................................................................................................ 13

4.1 Impartiality .................................................................................................................................. 13

4.2 Confidentiality ............................................................................................................................. 16

5. Structural Requirements ..................................................................................................................... 19

5.1 Legal Identification ...................................................................................................................... 19

5.2 Management Responsibility ....................................................................................................... 19

5.3 Range of Laboratory Activities .................................................................................................... 22

5.4 Requirements .............................................................................................................................. 22

5.5 Organization ................................................................................................................................ 22

5.6 Authority and Resources ............................................................................................................. 23

5.7 Communication and Integrity ..................................................................................................... 25

6. Resource Requirements ...................................................................................................................... 26

6.1 General ........................................................................................................................................ 26

6.2 Personnel .................................................................................................................................... 26

6.3 Facilities and environmental conditions ..................................................................................... 31

6.4 Equipment ................................................................................................................................... 36

6.5 Metrological traceability ............................................................................................................. 43

6.6 Externally provided products and services ................................................................................. 45

7. Process Requirements ........................................................................................................................ 48

7.1 Review of requests, tenders and contracts ................................................................................ 48

7.2 Selection, verification and validation of methods ...................................................................... 51

7.3 Sampling ...................................................................................................................................... 56

7.4 Handling of test or calibration items .......................................................................................... 57

7.5 Technical records ........................................................................................................................ 60

Quality Manual

Quality Manual: Doc # = 001 Approved by: Forensic Lab Director - Lauren Niskach Originally issued: 3-3-2014 Date Revised:March 14, 2021 Page 3 of 108
Electronic Copy is Controlled Printed Copy is Convenience

Refer to SharePoint for the most current version

7.6 Evaluation of measurement uncertainty .................................................................................... 64

7.7 Ensuring the validity of results .................................................................................................... 65

7.8 Reporting of results ..................................................................................................................... 73

7.9 Complaints .................................................................................................................................. 79

7.10 Nonconforming work .................................................................................................................. 81

7.11 Control of data and information management .......................................................................... 82

8. Management System Requirements .................................................................................................. 83

8.1 General ........................................................................................................................................ 83

8.2 Management system documentation (ISO 9001 clause 7.5.1 and 4.4.2) ................................... 84

8.3 Control of management system documents (ISO 9001 clause 7.5.2) ......................................... 87

8.4 Control of records (ISO 9001 clause 7.5.3) ................................................................................. 89

8.5 Actions to address risks and opportunities (ISO 9001 clause 6.1) .............................................. 93

8.6 Improvement (ISO 9001 clause 10.3 and 9.1) ............................................................................. 94

8.7 Corrective action (ISO 9001 clause 10.2) .................................................................................... 95

8.8 Internal audits (ISO 9001 clause 9.2) ........................................................................................ 102

8.9 Management reviews (ISO 9001 clause 9.3)............................................................................. 105

9. Revision History ................................................................................................................................ 106

Quality Manual

Quality Manual: Doc # = 001 Approved by: Forensic Lab Director - Lauren Niskach Originally issued: 3-3-2014 Date Revised:March 14, 2021 Page 4 of 108
Electronic Copy is Controlled Printed Copy is Convenience

Refer to SharePoint for the most current version

1. Scope

This Quality Manual

describes the management system for the

Forensic Chemistry Section of Maine's

Health and Environment Testing Laboratory. This manual provides guidance to meet the requirements of ISO/IEC 17025:2017 . It describes the minimum requirements for all areas and how ISO Standards are met.

2. Normative References

Reference List

ANAB, ISO/IEC 17025:2017

-Forensic Science Testing Laboratories Accreditation Requirements, (document #AR-3125). ISO /IEC 17025:2017 (International Organization of Standardization / International Electrotechnical Commission (IEC) - General requirements for the competence of testing and calibration laboratories, 2017

ANAB, ISO/IEC GD3150 - Guiding Principles of Professional Responsibility for Forensic Service Providers

and Forensic Personnel ISO/IEC Guide 99 (also known as JCGM 200), International vocabulary of metrology - Basic and general concepts and associated terms (VIM) ISO/IEC 17000, Conformity assessment - Vocabulary and general principles Scientific Working Group for the Analysis of Seized Drugs (SWGDRUG) Recommendations ANAB PR1018 Policy on Use of ANAB Accreditation Symbols and Claims of Accreditation Status Cross -references

This manual is numerically aligned with the international standard ISO/IEC 17025:2017. It is expected

that this will prove useful during accreditation audits, and expediting the process. Furthermore, section 8 has useful cross-references to the ISO 9001:2015 standard to assist the laboratory during the ISO 9001 registration process (if applicable).

Quality Manual

Quality Manual: Doc # = 001 Approved by: Forensic Lab Director - Lauren Niskach Originally issued: 3-3-2014 Date Revised:March 14, 2021 Page 5 of 108
Electronic Copy is Controlled Printed Copy is Convenience

Refer to SharePoint for the most current version

3. Terms and Definitions

For the purposes of this manual, the terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000

apply. The following terms and definitions apply: ISO Online browsing platform: available at https://www.iso.org/obp IEC Electropedia: available at http://www.electropedia.org

Shall - a requirement

Should - a recommendation

ANAB® - An accreditation program in which any crime laboratory may participate to demonstrate that

its management, technical operations and overall quality management system meet ISO 17025 General Requirements for the Competence of Testing and Calibration Laboratories and ANAB, ISO/IEC

17025:2017

-Forensic Science Testing Laboratories Accreditation Requirements, (document #AR-3125) Accreditation -Formal recognition of a laboratory by an independent science-based organization that the laboratory is competent to perform specific tests.

Administrative Records - Records, electronic or hardcopy, such as case related conversations, evidence

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