A laboratory inspection is a critical step in achieving or maintaining accreditation. A well-prepared laboratory demonstrates compliance with regulatory standards, enhances credibility, and ensures high-quality results. A fit-for-purpose Quality Management System (QMS) is fundamental to successful inspections, as it provides a structured framework for compliance, continual improvement, and risk management.

We have detailed below a concise Step-by-Step guide to preparing for your laboratory inspections in order to achieve and maintain accreditation:

Step 1: Review Accreditation Requirements
• Familiarise yourself with the relevant accreditation standards (e.g., ISO/IEC 17025, UKAS, GLP, MHRA).
• Ensure all team members understand the requirements and their role in compliance.
• Maintain up-to-date copies of regulatory guidelines and make them accessible to staff.

Step 2: Conduct a Gap Analysis
• Compare current laboratory practices against accreditation criteria.
• Identify deficiencies and areas requiring improvement.
• Develop an action plan with clear deadlines and responsibilities.

Step 3: Ensure Proper Documentation
• Verify that all policies, procedures, and records are current, accurate, and complete.
• Ensure that Standard Operating Procedures (SOPs) are up to date and reflect actual practices.
• Maintain records of staff training, equipment calibration, maintenance logs, and quality control data.

Step 4: Train and Educate Staff
• Conduct refresher training sessions on accreditation standards and laboratory policies.
• Ensure staff are proficient in QMS procedures and understand inspection protocols.
• Perform mock inspections to test readiness and identify potential gaps.

Step 5: Perform Internal Audits
• Schedule internal audits to assess compliance with accreditation requirements.
• Use audit findings to implement corrective and preventive actions (CAPA).
• Document audit results and improvements for review during inspections.

Step 6: Validate Equipment and Testing Methods
• Confirm that all laboratory instruments are properly calibrated and validated.
• Ensure testing methods are validated, verified, and documented according to accreditation requirements.
• Maintain traceability of measurements and calibration records.

Step 7: Assess Quality Control Measures
• Verify that quality control (QC) procedures are in place and effective.
• Review QC data to ensure accuracy and consistency of results.
• Implement corrective actions for any QC failures.

Step 8: Review Safety and Compliance Measures
• Confirm adherence to health, safety, and environmental regulations.
• Ensure proper waste disposal, chemical handling, and emergency preparedness.
• Maintain up-to-date risk assessments and safety training records.

Step 9: Organise and Prepare for the Inspection
• Assign responsibilities for guiding inspectors and providing requested documents.
• Conduct a final review of key areas, including sample tracking, data integrity, and personnel records.
• Prepare responses for potential auditor questions.

Step 10: Post-Inspection Follow-Up
• Address any non-conformities or recommendations from the inspection report.
• Implement corrective actions and document improvements.
• Review the inspection findings with staff to reinforce continuous improvement.

By following this structured guide, laboratories can achieve and maintain accreditation while fostering a culture of excellence and continuous improvement. A proactive approach to laboratory inspections, supported by a fit-for-purpose Quality Management System, enhances compliance, efficiency, and credibility.

Genial’s iPassport QMS solution is a cloud-based quality management suite designed to help digitise, streamline and improve the day to day management of quality and compliance. It provides you with the tools to meet your regulatory compliance requirements – from document control, through non-conformities to risk management, ensuring you have the smoothest pathway through to your certification or accreditation needs.

Why choose iPassport?

iPassport is trusted by laboratory and quality managers at some of the world’s best known healthcare and research facilities. Continually improved and refined since its launch in 2007, we are widely acknowledged as a leader in our field.

✅ Easy to use
Our intuitive system can be easily integrated into your ways of working.

✅ Meet requirements
Functionality designed to give you the smoothest pathway to accreditation or certification.

✅ Web-based system
Access 24/7 from any location, no local IT support or installation required

✅ Managed
Continual system improvements including new features, modules and architectural enhancements.

✅ Secure
Robust encryption and controls; 99.9% uptime guaranteed as part of SLA

✅ Cost effective
Reduce admin time and eliminate paper; all modules included as standard

To find out more about iPassport, simply get in touch to book your free demo or speak to one of our experts.