Making preparations for an ISO/IEC 17025 certification assessment can be very stressful most especially if it’s your very first assessment. Regardless of the extent of your experience related to ISO 17025 certification assessment or internal audits, there will always be some uncertainty of how the audit will go and the final result.

To help reduce the stress of future assessments, below are items that needs to be considered when creating an efficient ISO 17025 checklist. If all of your records are digital, then you need to electronically prepare these items and put on a drive for each of the auditors.

ISO 17025 Checklist Items

Quality Manual

An efficient ISO 17025 checklist contains a quality manual as this is the heart of a quality management system. Even though an actual manual is not required, a lot of organisations choose to use this format to describe their management system.

Standard Operating Processes

Every assessor will want to make sure that the organisation processes meet the ISO 17025 standard.

Scope of Accreditation

The scope of what the certification covers is required to have in documented form and should therefore be one of the elements included in your ISO 17025 checklist.

Document Control

A major element for a quality system is how the organisation control their documents and should therefore be included in the ISO 17025 checklist. This covers every document that makes up a quality management system. So, it is important to review the control of documents and necessary changes, corrections and updates.

Complaint Log

An efficient ISO 17025 checklist has to include a complaint log. The organisation needs to ensure complaints are documented for the assessors to review as they would want to ensure that every event is documented and dealt with in accordance to the standard.

Customer Feedback

A great way to get feedback from customers is via the use of surveys. If this is how the organisation gets its feedback, results of surveys should be available for review. And if surveys are not used, the organisation should collect customer feedback in another form.

Nonconformity Reports

As the assessor you want to review how the organisation deals with nonconformities and if preventive and corrective actions that has been implemented to manage the nonconformity. Also you would want to see how root cause analysis is being performed in the organisation.

Corrective Actions

This should be included in the ISO 17025 checklist because if the company has carried out any corrective action since its previous assessment, copies of the corrective action records should be available. You will want to see the evidence that the supposed corrective actions have been implemented and the effectiveness monitored to avoid a recurrence.

Preventive Actions

Just like corrective actions, this should also be in the ISO 17025 checklist because if the organisation carried out preventive actions since the last assessment, records of these actions needs to be made available for the assessors review so as to know if the actions were monitored to ensure efficiency.

Internal Audits

Internal audit must be included when creating an efficient ISO 17025 checklist because it is the opportunity for the organisation to assess its quality management system for effectiveness, nonconformity and chances for improvement. Every assessor would want to know the outcome of internal audits. Moreover, they want to confirm if the organisation is performing internal audits on regular basis in compliance with the ISO 17025 standard.

Management Reviews

These are an essential part of the quality management system of a company and assessors would want to see that the management of the organisation is involved in the quality of its organisation. Thus, it is essential to have copies of proof of management reviews and the outcome of the reviews.

If you are interested in implementing ISO 17025 within your organisation or looking to outsource your internal audits, please contact us for a free consultation.