ISO 17025:2017 Implementation Checklist for Laboratories

The ISO 17025:2017 is a testing standard for laboratories. There are few steps to successfully implementing this testing standard in your laboratory.

Here is the checklist to be followed to ensure the implementation of ISO 17025:2017 is completed the right way.

The key to success for any ISO Certification Standard implementation is the Quality Management System.

It helps the organization in consistently developing quality products and services, establish effective communication channels with the stakeholders and achieve business productivity.

Things to Consider for getting ISO 17025:2018 Certified effectively

1. Get the Support of Top Management

ISO Certification requires a long term commitment, resource utilization, and process enhancements. Managerial support for implementing a business process change is vital.

Often the top management has in-depth knowledge about the organizational systems. Hence, managerial support and advice are a must-have for the successful transformation of systems.

2. Identify the objectives of the Organization

The success of the ISO Certification is when it is aligned with the organizational goals.

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Hence, identifying the business objectives of the organization is essential for implementing the ISO Certification the right way.

The organization must identify the area of daily operations applicable to ISO 17025:2017. The organizational objectives must be in line with the scope of the Certification

3. Define the ISO Certification Scope

The scope of the Laboratory Standard Certification must be defined depending on the scale and operational capability of the testing laboratory.

ISO 17025:2017 Certification involves two main sections – Management Requirements & Technical Requirements.

Management requirements are related to the operation and effectiveness of the QMS within the laboratory. Whereas, technical requirements are in the lines of competence of staff, and calibration equipment’s). 

4. Address Risk and Opportunities

Identify the vulnerabilities in the operational process and take the required corrective actions. Manage the risks by documenting and preparing the quality manual accordingly to mitigate the risk.

Also, the detected vulnerabilities in operational processes are opportunities for the organization to achieve quality improvements.

5. Define Processes and Procedures

The processes and procedures conducted by the laboratory are to be in line with the Quality Management System and the ISO Quality Manual.

Assign responsibilities to employees for streamlining the processes and check for compliance with the ISO Standards.

6. Implement the required Process Controls

At this stage, the organization must develop a plan to implement the required process controls to the operational management system.

Ensure the system is compliant with the ISO Standard operating procedures and the certification guidelines.

7. Conduct Training and Awareness Programs

The employees operating in the organization must be provided with ISO 17025 Awareness training.

It will help in following the standard procedures and onboard them with more responsibilities and accountability.

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Each team must be responsible for the specific operational process.

The awareness programs about the laboratory devices testing standard certification will help in ensuring the process improvements required to comply with the ISO Standard.

8. Operate the Laboratory Management System

The Laboratory Management System must be the control center of all business operations in the organization.

Ensure the system is operating in compliance with the procedures indicated by the ISO Certification Standard.

9. Conduct Internal Audits

The organization team or the hired ISO Consultant must conduct an internal audit to evaluate the laboratory management system against the ISO 17025:2017 Certification requirements.

The internal auditing practices must be carried out periodically to ensure the team is following the operating manuals and the system is compliant with the ISO 17025:2017 Standard.

10. Identify the right Accreditation body

Once the process improvements are implemented and the Laboratory Management System is up and running, the next step is to identify the right Accreditation body for the ISO certification audit.

Aurion ISO Consultants will help in coordinating with the right ISO Certification body for securing the ISO 17025:2017 Certification.

11. Management Review

Management reviews must be an integral part of the ISO certification process.

The team must report to the top management the progress of the Management System and get approvals for the process improvements, resource utilization, risk mitigation, etc.

Implementation Benefits from ISO 17025 Standard

In a nutshell, following the above checklist will ensure the successful implementation of the ISO 17025 Standard for your testing laboratory.

ISO 17025:2017 will ensure the laboratory follows international standards for testing and calibration.

It will help in gaining customer trust quickly due to the ISO Certified Status and the quality of results generated in the laboratory. It also builds a strong reputation for the brand and easily grows business connections.

To know more about ISO 17025:2017 Certification in UAE, connect with our expert ISO Consultants right away!

Contact: Aurion ISO Consultants

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