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ISO/IEC 17025 can be an intimidating document the first time you pick it up

Let me help you . . . first, we should start with the building blocks

 

The NEW ISO/IEC 17025 (2017)

First, it's been divided into new sections, aligning with ISO 9001 (2015).  Most of the content and requirements remains very, very familiar.  Think of it as moving from one 4 bedroom, 2 1/2 bath ranch style home to a 4 bedroom, 2 1/2 bath colonial style home.  The rooms are the same, but their location has changed.  We just need to identify 'what went where'.  Here is an outline of the revised requirements:   

Section 4:  General Requirements - 4.1 Impartiality and Section 4.2 Confidentiality

Section 5:  Structural Requirements - Management, organizational structure, personnel

Section 6:  Resource Requirements - 6.1 General, 6.2 Personnel, 6.3 Facilities and Environmental Conditions, 6.4 Equipment, 6.5 Metrological Traceability, 6.6 Externally Provided Products and Services

Section 7:  Process Requirements - 7.1 Review of Requests, Tenders and Contracts, 7.2 Selection, Verification and Validation of Methods, 7.3 Sampling, 7.4 Handling of Test Items, 7.5 Technical Records, 7.6 Evaluation of Measurement Uncertainty, 7.7 Ensuring the Validity of results, 7.8 Reporting of Results, 7.9 Complaints, 7.10 Nonconforming Work, 7.11 Control of Data and Information Management

Section 8:  Management System Requirements - 8.1 Options, 8.2 Management System Documentation, 8.3 Control of Management System Documents, 8.4 Control of Records, 8.5 Actions to Address Risks and Opportunities, 8.6 Improvement, 8.7 Corrective Actions, 8.8 Internal Audits, 8.9 Management Reviews

Next, preparing your organization for the migration to the new version of ISO/IEC 17025 (2017).  Most of your efforts should be focused on helping your staff not stress out.  If you were working in a forensic lab during the transition from the ASCLD/LAB Legacy program to the ISO/IEC 17025 based accreditation program, this transition is going to be soooooo much easier.2

Elements of ISO/IEC 17025 (2005)

4.1 - Organization

4.2 - Management System

4.3 - Document Control

4.4 - Review of Requests, Tenders and Contract

4.5 - Subcontracting

4.6 - Purchasing of Services and Supplies

4.7 - Service to the Customer

4.8 - Complaints

4.9 - Control of Non-conforming Work

4.10 - Improvement

4.11 - Corrective Action

4.12 - Preventive Action

4.13 - Control of Records

4.14 - Internal Audits

4.15 - Management Review

5.1 - General

5.2 - Personnel

5.3 - Accommodation and Environmental Conditions

5.4 - Test Methods and Validation

5.5 - Equipment

5.6 - Measurement Traceability

5.7 - Sampling

5.8 - Handling of Test Items

5.9 - Assuring the Quality of Test Results

5.10 - Reporting the Results


Resources

iso.org - brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges

ilac.org - global recognition body for accrediting bodies

ascld.org - forensic management resource

afqam.org - forensic quality manager resource

ISO/IEC 17025: 2017 - General Requirements for the Competence of Testing and Calibration Laboratories (can be purchased from iso.org or ansi.org) - the 2017 revision replaces the 2005 revision

ILAC G19 (2014) - Modules in the Forensic Science Process (free on the ILAC website: ilac.org)


The Game Plan

First, learning the language of ISO is essential. 

Next, learning how to apply the requirements in your organization will help you achieve your final goal of accreditation.

Then, get your people on board and help them develop a plan. 

Here comes the whiteboard:  a project plan and timeline for goal setting.  Rather than tackle everything at once, start with 'what's done already' and then identify the gaps.  Develop a series of smaller, manageable goals - keeping in mind the larger priority and ultimate goal. 

Let me be your translator.


Let me be your guide. 




Training might be a good step.


I can help you develop a schedule and keep you on track.