10 Fundamental Steps to Obtain ISO/IEC 17025 Accreditation

‍

Becoming certified to ISO/IEC 17025 is a complete process that requires commitment, planning, and meticulous execution by the laboratory. Here are the 10 fundamental steps a laboratory needs to follow to obtain accreditation in ISO/IEC 17025:

1. Management Commitment

The organization's management must be fully committed to the ISO/IEC 17025 certification process. This involves allocating appropriate resources, setting clear goals, effectively communicating expectations to all team members, and actively participating in the stages of the accreditation process.

2. Understanding the Requirements of the Standard

It is imperative that the entire laboratory team, from management to analysts to interns, understands the requirements of ISO/IEC 17025 and how they apply to their specific operations. This includes careful analysis of each section of the standard and identification of gaps between the requirements and current laboratory practices. When everyone is clear on why, the day-to-day laboratory process flows naturally and aligns with the requirements of the standard.

3. Initial Evaluation

Before starting the certification process, many laboratories prefer to carry out an initial assessment to identify areas for improvement and define an action plan. This assessment can be carried out internally or through expert consultants. At this stage, you must be honest about the current state of the laboratory, in order to map all the control needs that need to be implemented.

4. Development of the Quality Management System

Based on the requirements of ISO/IEC 17025, the laboratory must develop and implement a robust and comprehensive quality management system. This involves the creation of operating procedures, work instructions, registration forms, and other documents necessary to document and standardize laboratory activities.

5. Implementation of Improvements

During this process, the laboratory must implement the improvements identified during the initial evaluation and development of the quality management system. This may involve updating equipment, training staff, reviewing procedures, and other corrective and preventative measures.

6. Training and Awareness

All laboratory employees must be properly trained on the requirements of ISO/IEC 17025 and their responsibilities within the quality management system. Awareness of the importance of compliance with laboratory procedures and policies is also critical.

7. Implementation of Operational Controls

The laboratory must implement effective operational controls to ensure the accuracy, reliability, and traceability of its analyses. This may include establishing sampling methods, test procedures, acceptance and rejection criteria, and proper calibration and maintenance of equipment. Currently, many laboratories choose to have the support of specialized laboratory management software.

Learn More: Compliance Made Simple: Harness the Full Potential of LIMS Automation in Your Lab

8. Preparation for the Certification Audit

Prior to the certification audit, the laboratory should conduct internal audits to review compliance with ISO/IEC 17025 requirements and identify any non-conformities that need to be addressed. The laboratory must also prepare all the necessary documentation and choose a team to represent the laboratory during the audit.

9. Certification Audit

Once the lab is ready, you can request a certification audit by a recognized accrediting body. During the audit, auditors will review the laboratory's documentation, observe its operations, and conduct interviews with staff to assess compliance with the requirements of the standard.

10. Monitoring and Continuous Improvement

After certification, the laboratory must continue to monitor and evaluate its quality management system to ensure its effectiveness and continued compliance with the requirements of ISO/IEC 17025. This includes conducting regular internal audits, analyzing performance data, and implementing corrective and preventive actions as needed.

By following these steps, the laboratory can achieve certification to ISO/IEC 17025 and demonstrate its commitment to quality, reliability, and technical competence in its testing and calibration operations.

Learn More: How LIMS Facilitates ISO 17025 Certification in Food Testing Labs