How long does ISO 17025 certification take to complete? What are the necessary steps you can’t miss?
The ISO 17025 certification is the ultimate benchmark for laboratory service management operations. It ensures that a company complies with the industry’s best practices. A company demonstrates commitment and value towards the quality of service management to its target audience. When a company decides to get accredited, one of the first questions that most have is, “How long does ISO 17025 certification take?”
The answer on the internet might vary since there are several factors that directly and indirectly impact the timing. Resources, complexity, number of employees, and present readiness are some of the deciding factors for ISO certification. The present blog sheds light on this aspect. It lists the type of procedures a company must not overlook while getting ready for accreditation.
How Long Does ISO 17025 Certification Take?
It normally takes 6-12 months for a company to get completely ready and ISO certified. The following aspects strongly impact the timeline for ISO 17025 certification. The following list will help you have an understanding –
Current level of compliance: The implementation and accreditation process might not take much time when your laboratory already follows the ISO quality management policy and principles. The process will be completed within a short span.
Size and complexity of operations: If the number of employees and the level of complexity in procedures are high, then documentation for testing scopes and methods will take more time.
Resource allocation: If your laboratory already possesses dedicated employees who understand their responsibilities, then the process accelerates.
Accreditation body’s schedule: The timeline also depends on the availability of the accreditation body. If the auditors are not available on time, then the process gets delayed.
Here’s a general breakdown:
| Stage | Typical Duration |
| Gap Analysis & Planning | 2–4 weeks |
| System Development & Documentation | 2–3 months |
| Implementation & Internal Audit | 2–4 months |
| Management Review & Corrective Actions | 1–2 months |
| External Assessment & Accreditation | 1–2 months |
Total Estimated Duration:6 to 12 months
The Necessary Steps You Can’t Miss – Getting ISO 17025 certification isn’t just about meeting documentation requirements—it’s about establishing a reliable, traceable, and quality-driven testing environment. Missing key steps can delay certification or lead to non-conformities during audits.
1. Conduct a Gap Analysis – The preparation starts with a gap analysis. It is a comparison between the current quality control system and the objectives of ISO 17025. Through an effective analysis, companies can detect missing elements in calibration traceability and validation processes.
2. Develop a Quality Management System (QMS) – Create or update your QMS documentation, including the Quality Manual, SOPs, test methods, and calibration procedures. Ensure your documentation aligns with both management and technical clauses of ISO 17025.
3. Implement and Train Staff – Once documentation is ready, train your team to follow the new procedures consistently. Competence, impartiality, and consistency are core ISO 17025 principles—so ongoing staff awareness and training are crucial.
4. Perform Internal Audits – The management must perform an internal audit to ensure the system is compliant and efficient enough to get accredited. The impartial audit would measure the competitiveness and help to reduce nonconformities. This way, the management gets enough time to design corrective actions and reduce the flaws.
5. Management Review – Management review is pivotal to ensure compliance and readiness of the system. The overall performance of the quality management system must be evaluated and reviewed to ensure a comprehensive improvement program. Through management review, companies can ensure the preparedness of the system for the external audit.
6. Corrective Actions – It is now time to implement corrective actions to reduce non-conformities. The management must keep proper records of the root causes and the strategies taken for addressing each non-conformity.
7. Apply for Accreditation – Once your laboratory management system is prepared enough, it is time to apply to a recognized accreditation body. After the registration, the authorities will review documents and conduct the formal audit.
8. Undergo External Assessment – Next is an external audit conducted by a third party. The accreditation body visits the laboratory and evaluates the level of competence. They review the documents and observe the activities before the audit takes place. If they find any issue related to operations, they ask the management to rectify it so that they can issue the certification.
9. Receive Certification – Once the auditors decide that the non-conformities do not exist anymore, they inform the authority, who then grants the accreditation. The certification shows technical competence as well as the reliability of the laboratory.
To find experienced professional support for obtaining the ISO objective sand the internal audit requirements, contact us at Compliancehelp Consulting LLC. We are a premier firm that can help you achieve any ISO certification in the USA. Our customized solutions for ISO and other global certifications are ready to make the seemingly exhausting accreditation process comfortable and completed on time. From consultation to audit and analysis, we will cover everything. Get help to clear your concepts regarding the clauses of any management system standard you require.