ISO 17025 Pre-Audit Checklist Example

Life sciences companies bear an immense obligation to meet the highest quality standards with their products, and ISO 17025 accreditation can serve as a visual sign to customers of this commitment.

Utilizing an internal audit checklist is the ideal way to ensure your lab is prepared for an ISO evaluation. Here’s an example of how it should be utilized.

Pre-Audit Review
Audit Checklist A quality management audit checklist serves as a tool for auditors to review your laboratory’s quality management system and identify any areas needing attention to ensure your lab can comply with ILAC requirements and pass its assessment by ABSB.

Your organization should identify key personnel to interface with the auditor before beginning an audit. This will reduce time needed for gathering and providing explanations. Occasionally an auditor may ask for information that’s unavailable; your team can work together to come up with viable alternatives.

If an ANAB assessor discovers any non-compliances during your laboratory assessment, you must address them immediately – this is both required by them as well as essential to maintaining your certification status. Noncompliances can have detrimental effects on obtaining new business and can even result in contracts being lost – thus it’s preferable to identify them early through pre-audit and immediately implement corrective actions.

Pre-Audit Assessment
If you are undertaking a quality management system audit, preparation is key to its success. A pre-audit survey is an effective tool that can identify any weak points within your organization and enable you to address them prior to evaluation day – helping avoid noncompliance issues while increasing the chance of receiving positive results from auditors.

Assessors will inspect not only whether your laboratory meets ISO requirements and accreditation body advertising policies, but will also examine how you manage customer feedback records and subcontract testing or calibration work. They’ll check to see whether procedures exist that guarantee any nonconforming work is reported properly in your results.

Certification audits and external registrar visits will play a pivotal role in whether or not you achieve accreditation for their industry. It will determine your success.

Pre-Audit Documentation
Pre-auditing can uncover nonconformities you were previously unaware of and enable you to take corrective action before official evaluation begins. This allows for faster progress with greater confidence that your business will pass with flying colors.

Additionally, ISO certification puts you in the best possible position to fulfill any contracts that require ISO certification, such as fulfilling contracts with buyers who pre-audited your company and require a certificate of compliance signed off on by their procurement department.

Implementing a systematic approach protects your organization against human errors that lead to audit errors that reduce evaluation report quality. Checklists eliminate manual processes and help keep processes accurate – saving both time, money and resources at once! Checklists also serve as cost-effective preparation methods, saving both your organization time, money and resources when preparing for audits.

Pre-Audit Inspection
Laboratory professionals should implement an ISO 17025 pre-audit inspection in their lab operations to ensure compliance with international standards. This process provides for an in-depth inspection from outside parties and allows laboratory operators to identify areas of concern before the official certification audit takes place.

As part of a pre-audit, laboratories should appoint an Inspection Readiness Team that will aid with organizing the visit and responding to any needs/requests during it. This team should be familiar with the inspection process and be ready to provide inspectors with all of the documents necessary for them to conduct their assessment, such as research charts, medical records, or regulatory documents that they require for their inspections.

Organization of all Regulatory Files by general heading and reverse chronological order for easy review is also key to building inspector confidence that GMP documentation practices are being implemented and followed, which may reduce the amount of paperwork inspected during actual audits – remember, without paperwork it never happened!