The external assessment is the final hurdle in the accreditation process. It can be a stressful experience, but with proper preparation, you can ensure a smooth and successful audit. This survival checklist will help you and your team get ready for the big day.
One Month Before the Audit
- Confirm the audit plan: Review the audit plan with the lead assessor to ensure you understand the scope and schedule.
- Conduct a full internal audit: Use your internal audit program to do a full sweep of your quality management system. This is your last chance to find and fix any issues before the assessor does.
- Review previous findings: If this is a re-assessment, review the findings from the previous audit and ensure that all corrective actions have been effectively implemented.
One Week Before the Audit
- Prepare your documents: Gather all the documents that the assessor will want to see, including your quality manual, procedures, work instructions, and records. Organize them in a way that is easy to navigate.
- Brief your staff: Hold a meeting with your team to review the audit plan and discuss what to expect. Remind them to be honest and open with the assessor.
- Clean the laboratory: A clean and organized laboratory creates a good first impression.
During the Audit
- Be a good host: Greet the assessor upon arrival and show them to a comfortable working area. Offer them a drink and let them know who their main point of contact will be.
- Answer questions honestly: If you don't know the answer to a question, say so. Don't try to guess or make things up.
- Provide evidence: When the assessor asks to see a record or a procedure, provide it promptly.
After the Audit
At the closing meeting, the assessor will present their findings. If there are any non-conformities, you will be given a deadline to submit a corrective action plan. Take the findings seriously and use them as an opportunity to improve your quality management system.