Top 5 suggestions before certification audit according to ISO 17025 accreditation consultants

 

Getting the ISO 17025 certification adds a competitive edge in the laboratory industry. Why? Because it offers both international recognition and operational excellence. The ISO certification helps laboratories maintain consistent performance that is accurate. To get accredited, a company needs to pass the certification audit with 100% compliance. Without meticulous preparation, small and medium-sized companies often fail during the process. In most cases, the registrar denies the certification.

However, passing the audit becomes seamless when a company obtains professional guidance. The reputed ISO17025 accreditation consultants are the ideal choice for that. These experts help to develop and maintain an effective system. Their help ensures that the system adheres to the fundamental clauses. Their solutions bring clarity, which paves the way for an effective implementation. Their prime focus is to ensure that the suggestions they provide are effective enough to help pass the audit. Here, in this blog, the top 5 suggestions from such consultants have been shared that are necessary before conducting an audit.

Top 5 suggestions before certification audit

1. A gap analysis is crucial - One of the vital steps before a certification audit is performing a gap analysis. This process compares your current quality management system against ISO 17025 requirements. It identifies areas of non-conformity. A gap analysis helps -

●       Prioritize corrective actions

●       Reveal procedural or documentation gaps

●       Prepare your team for what auditors will assess

2. Documentation is key - According to the consultants, incomplete or inconsistent documentation is a leading cause of failure. Before the audit, make sure:

●       Your quality manual has been updated

●       All standard operating procedures (SOPs) are documented and implemented.

●       Equipment calibration records, training logs, and internal audit reports are accessible.

Document control must be robust. It should demonstrate traceability across the lab’s activities. This proves to auditors that your lab operates in a reliable and traceable manner.

3. Internal audit with review meetings - ISO 17025 requires organizations to demonstrate continuous improvement and system monitoring. Accreditation consultants emphasize two critical activities:

1. Internal Audit:

●       Should be conducted by trained personnel or external auditors

●       Must cover all clauses of the ISO 17025 standard

●       Findings should be documented, with corrective actions tracked.

A.     Management Review:

●       Confirms top management's commitment

●       Assesses the effectiveness of the quality system

●       Reviews performance data, risks, and improvement areas

4. Equipment validation - One of the crucial aspects of the ISO 17025 is technical competence. It starts with your laboratory equipment. Before the audit, consultants advise labs to do the following -

●       Ensure all measuring and accredited bodies calibrate test equipment

●       Maintain up-to-date calibration certificates.

●       Validate methods according to recognized protocols.

Failure to maintain equipment traceability or method validation can result in major non-conformities during the audit.

5. Employee awareness campaigns - Even with robust systems, the audit can falter if your team lacks preparation. ISO 17025 consultants recommend conducting pre-audit training to:

●       Familiarize staff with ISO 17025 requirements

●       Clarify roles and responsibilities.

●       Prepare them to respond to auditor queries confidently.

Well-trained personnel make a positive impression and reflect the integrity of your quality management system.

Many companies hire the ISO17025 accreditation consultants only before conducting the certification audit. However, it is better to ask for their long-term support that includes periodic reviews, surveillance audit, and rigorous documentation. Hire these professionals after reading and checking reviews.

FAQs

1. Who are the ISO17025 accreditation consultants?

They are experienced professionals who help in meeting compliance before the certification audit takes place. They help to understand and meet the ISO clauses. Those are the predominant guidelines a company must adhere to pass the process.

2. What are their duties?

To conduct gap analysis, internal audit, and readiness review. However, they help with organizing staff training and arranging protocol for documentation and surveillance audits.

Also Read: What is the difference between ISO 20000 and ISO 27001?