Introduction

Achieving ISO 17025 accreditation is a commendable feat for testing and calibration laboratories. It signifies the laboratory's commitment to quality, accuracy, and technical competence, thus making it distinguishable from competitors. As a matter of fact, for laboratories new to the accreditation process, the road ahead may seem quite overwhelming. The purpose of this article is to demystify the step-by-step process toward ISO 17025 accreditation in order to help laboratories in this journey.

What is ISO 17025?

ISO 17025 is defined as an international standard that specifies the general requirements for the competence of testing and calibration laboratories. It is the guarantee that laboratories are technically proficient, make accurate results, and have a strong quality management system in place. Accreditation to this standard is normally mandatory for laboratories operating in regulated industries, e.g., healthcare, manufacturing, and food safety.

Step 1: Understand the Requirements

The first step for any laboratory seeking accreditation for ISO 17025 is to make sure it understands the requirements of the standard. The standard has regard for two main procedures:

  1. Management Requirements: Quality management systems, document control, and customer service are covered.
  2. Technical Requirements: Competency of personnel, calibration of instruments, test methods, and measurement traceability.

Laboratories should carefully examine the standard and identify the areas that require their improvement or implementation of new processes.

Step 2: Carry Out a Gap Analysis

The gap analysis forms an essential part of any accreditation process-were the laboratory's activities compared against ISO 17025 requirements for the purpose of identifying gaps? The main areas of evaluation normally include:

  1. Competence of Personnel: Are staff suitably qualified and trained for the performance of their assigned tasks?
  2. Equipment: Has all equipment been calibrated and maintained as required?
  3. Test Methods: Test methods shall be validated and standardized.
  4. Documents: Are procedures and policies documented and current?

The results of the gap analysis will thus best direct the laboratory in its journey to comply with the requirements of ISO 17025.

Step 3: Develop an Implementation Plan

After identifying the gaps, the laboratory should prepare an implementation plan that describes in detail how it plans to close the gaps:

  • Updating documents or creating new procedures and policies.
  • Staff training in ISO 17025 requirements and best practices.
  • Upgrade of equipment or facilities as per the findings of the gap analysis.
  • Quality management systems are therefore critical to ensuring consistent operations.

The implementation plan should also contain timelines for accomplishing each item, responsibilities, and resources required.

Step 4: Implement the Changes

With an implementation plan, the laboratory can begin making changes. Possible required changes may be:

  1. Documenting Procedures: All processes must be documented from sample handling to reporting of results.
  2. Staff Training: Ensure every person attending is aware of new procedures as well as their roles toward compliance.
  3. Equipment Calibration: All testing and calibration equipment must be calibrated and traceable to national or international standards.
  4. Carry Out Internal Audits: Frequent internal audits are to detect and isolate likely sources of non-conformance ahead of the formal assessment.

 Step 5: Management Review

Once management is assured that all requirements have been met, before applying for accreditation, it should hold an official review. The management review should cover:

  • The quality management system's effectiveness.
  • Results of internal audits and corrective actions taken.
  • Customer feedback as well as input received from staff.
  • Any gaps or opportunities for improvement that remain.

Thus, the management review also seeks to address some last-minute issues and make sure that the lab has gone through its final check before the accreditation assessment.

Step 6: Choose an Accreditation Body

The accreditation bodies issuing the ISO 17025 accreditation are independent bodies. The laboratories themselves shall search and select a reputable body that is recognized in their industry and area. Some considerations may include the following:

  • The scope of accreditation of the body.
  • Its reputation and recognition by regulatory authorities.
  • The amount charged for the accreditation and the duration taken.

Step 7: Assessment 

The accreditation body will conduct on-site assessments to verify compliance with ISO 17025. This assessment usually consists of:

  1. Document Review: The assessors will review inspection documents, standard operating procedures, records, and all associated documents.
  2. On-site Evaluation: The assessors will observe the laboratory process, interview staff members, and assess equipment and facilities.
  3. Identification of Non-conformities: Non-conformities will be identified where the laboratory does not satisfy the requirement set forth in the standard.

Step 8: Resolve Non-Conformities

Resolution of nonconformities found during the assessment must occur for the accreditation to be granted, including for example: 

  • Update procedures or documentation.
  • Additional training of staff.
  • Change of equipment or facilities.

Upon completion of the handling of any noted nonconformities, the laboratory shall submit proof of corrective action taken to the accreditation body.

Step 9: Get Your Accreditation

Accreditation is conferred by the accreditation body if all conditions are satisfied. The laboratory will either receive an ISO 17025 certificate or will be entered into the directory of accredited laboratories by the accreditation body. Subject to the usual periodic audits, accreditation is awarded for a specific timeframe.

Step 10: Improvement Does Not End Here

Accreditation is only the beginning. Labs must continuously check and improve their processes in order to maintain compliance and highest quality. This includes:

  • Regular internal audits.
  • Review and update procedures whenever necessary.
  • Timely updates on the changes to ISO 17025 standard.

Conclusion

Achieving ISO 17025 accreditation is a rigorous but rewarding process. It demonstrates a lab's commitment to quality, accuracy, and technical competence, enhancing its credibility and competitiveness in the market. By following these steps, labs can navigate the accreditation process with confidence and achieve their goal of becoming ISO 17025-accredited.

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