Project Checklist For ISO 17025:2017 Implementation [PDF]

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Project Checklist for ISO 17025:2017 Implementation

Implementation phases

Documents from ISO 17025 Documentation Toolkit to be used

Tasks

Done

Research which benefits of ISO 17025:2017 would be applicable to your company. Obtain management support

Present the benefits to the management and get their commitment. Get formal approval for the project. Decide whether you are going to use consultants or you will be using documentation templates to do the implementation yourself. Purchase the ISO 17025:2017 standard. Educate your project team.

Establish your project

Write the project plan, clearly defining the objectives of the implementation project for laboratory operations, processes to put in place, documents to be written, deadlines, and roles and responsibilities in the project.

01 Project Plan

Define which stakeholders need to be informed about each step in the project. Organize the kick-off meeting. Identify requirements

Determine the context of the laboratory. Identify interested parties. Identify the requirements of interested parties. Add required

Project Checklist for ISO 17025:2017

©2021

00.2 Appendix 2 – List of External Documents

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[organization name]

Implementation phases

Documents from ISO 17025 Documentation Toolkit to be used

Tasks

Done

external documents to the List of External Documents. Identify applicable statutory or regulatory requirements for your type of work (testing /calibration). Define the scope, management commitment, and responsibilities

Address risks and opportunities

Write the Quality Policy.

02 Quality Policy

Decide on the Quality Objectives.

02.1 Appendix 1 – Quality Objectives

Write the Quality Manual.

03 Quality Manual

Identify laboratory risks and opportunities.

Define processes and procedures

05.1 Appendix 1 – Registry of Key Risks and Opportunities

Identify all processes and procedures necessary for the QMS.

01 Project Plan

Write mandatory & additionally identified procedures.

00.1 Appendix 1 – List of Internal Documents

The procedure for document control.

00 Document and Record Control Procedure

The procedure for competence, training and awareness.

04 Competence, Training and Awareness Procedure

The procedure for addressing risks and opportunities.

05 Addressing Risks and Opportunities Procedure

The procedure for externally provided products and services.

06 Externally Provided Products and Services Procedure

The procedure for facilities and environmental condition.

07 Facilities and Environment Procedure

The procedure for equipment and calibration.

08 Equipment and Calibration Procedure

The procedure for customer service.

09 Customer Service Procedure

Project Checklist for ISO 17025:2017

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05 Addressing Risks and Opportunities Procedure

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Implementation phases

Tasks

Documents from ISO 17025 Documentation Toolkit to be used

The procedure for test and calibration method.

10 Test and Calibration Method Procedure

The procedure for quality assurance.

11 Quality Assurance Procedure

The procedure for sampling.

12 Sampling Procedure

The procedure for handling of items received.

13 Handling of Items Received for Testing Procedure

The procedure for complaint, nonconformity and corrective action.

14 Complaint, Nonconformity and Corrective Action Procedure

The procedure for evaluation of measurement uncertainty.

15 Evaluation of Measurement Uncertainty Procedure

Done

16 Testing Report Procedure The procedure for testing or calibration report.

Implement processes, procedures, and controls

17 Calibration Report and Certificate Requirements Procedure

The procedure for internal audit.

18 Internal Audit Procedure

The procedure for management review.

19 Management Review Procedure

Additional identified procedures

00.1 Appendix 1 – List of Internal Documents

Implement all the processes, procedures, and controls defined for the QMS.

01 Project Plan

00 Document and Record Control Procedure Maintain records of implementation.

00.3 Appendix 3 – List of Types of Records 00.4 Appendix 4 – Registry of Records for Retention/Central Archive

Perform training and

Perform training for all employees who lack required

Project Checklist for ISO 17025:2017

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04 Competence, Training and Awareness Procedure

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Implementation phases

Documents from ISO 17025 Documentation Toolkit to be used

Tasks

Done

04.1 Appendix 1 – Training Program 04.2 Appendix 2 – Training Record and Performance Monitoring

skills.

04.3 Appendix 3 – Record of Attendance

awareness programs

04.4 Appendix 4 – Competence Approval and Authorization Record Perform awareness programs for all employees and third parties that have a role in your QMS.

Choose an accreditation body

Identify suitable accreditation bodies; obtain accreditation application information and quotes. Select the accreditation body. 00 Document and Record Control Procedure Maintain all the records required by your own policies and procedures.

00.3 Appendix 3 – List of Types of Records 00.4 Appendix 4 – Registry of Records for Retention/Central Archive 14 Complaint, Nonconformity and Corrective Action Procedure

Operate the LMS

Perform corrective actions as needed.

14.1 Appendix 1 – Corrective Action Report (CAR) 14.2 Appendix 2 – Complaint, Nonconformity and CAR Log 06.1 Appendix 1 – Supplier Evaluation and Approval Record

Make sure you monitor all your systems.

07.1 Appendix 1 – Record of Laboratory Environmental Controls 8.3 Appendix 3 – Calibration Record

Project Checklist for ISO 17025:2017

©2021

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Advisera Expert Solutions Ltd. https://advisera.com/17025academy/

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[organization name]

Implementation phases

Documents from ISO 17025 Documentation Toolkit to be used

Tasks

Done

8.4 Appendix 4 – Equipment Maintenance Record 9.1 Appendix 1 – Customer Order Review 9.2 Appendix 2 – Customer Satisfaction Questionnaire 9.3 Appendix 3 – Report of Customer Satisfaction 11.1 Appendix 1 – Proficiency Testing Record 18 Internal Audit Procedure Develop the audit program.

18.1 Appendix 1 – Internal Audit Program 18.2 Appendix 2 – Internal Audit Checklist

Conduct internal audit(s) to determine effectiveness of the implementation.

18.3 Appendix 3 – Audit Nonconformity Report 18.4 Appendix 4 – Internal Audit Process Checklist

Perform internal audit and improvements Write internal audit reports.

18.5 Appendix 5 – Internal Audit Report 14 Complaint, Nonconformity and Corrective Action Procedure

Perform corrective actions.

14.1 Appendix 1 – Corrective Action Report (CAR) 14.2 Appendix 2 – Complaint, Nonconformity and CAR Log

Perform management review

Perform management review.

19 Management Review Procedure

Maintain records from management review.

19.1 Appendix 1 – Management Review Record

Perform corrective actions.

14 Complaint, Nonconformity and Corrective Action Procedure 14.1 Appendix 1 – Corrective Action Report (CAR) 14.2 Appendix 2 – Complaint,

Project Checklist for ISO 17025:2017

©2021

ver [version] from [date]

Advisera Expert Solutions Ltd. https://advisera.com/17025academy/

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[organization name]

Implementation phases

Documents from ISO 17025 Documentation Toolkit to be used

Tasks

Done

Nonconformity and CAR Log Ensure continual improvement.

Apply for Accreditation

19.1 Appendix 1 – Management Review Record

Complete application process and submit requested documents for document review.

To get all the documents needed to implement the standard, download the ISO/IEC 17025 Documentation Toolkit - in the free preview, you will be able to see the Table of Contents of each of the mentioned documented procedures, as well as a few sections from each document.

Project Checklist for ISO 17025:2017

©2021

ver [version] from [date]

Advisera Expert Solutions Ltd. https://advisera.com/17025academy/

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