26 Things You Must Check Before the ISO Auditor Comes

ISO9001 and other Quality Systems require that the organization conduct periodical compliance audits during the course of the year. As the date of the Third Party audit (Registration or Surveillance) approaches, the urgency to conduct internal audits to demonstrate compliance with this requirement and to detect and correct any nonconformance increases substantially. A lot of anxiety is experienced before such audits. This is particularly true for small companies without prior ISO audit experience. Often, your audit team does not know how to identify the most important things that need double-checking before the Registrar visit. Below is an abbreviated checklist that zeroes in on the most important issues that your internal audit team should review :

General Requirements:

Is the Quality Policy posted at various locations? Do employees understand the policy and are they able to explain it in their own words? Are your Management Review minutes documented and easily accessible? Do employees understand the Company's Quality Objectives and how their jobs contribute to them? Can employees explain how they know their jobs are being done correctly? Document Controls:

Are prior revisions of all documents (procedures, work instructions, and forms) removed from all work stations? Are all document revisions properly logged? Are obsolete procedures marked as such and stored in an archived file? Records Control:

Are records stored in an orderly manner? Are record files complete and easily accessible to the auditor? Human Resources:

Has your training plan been updated? Is there evidence that you measure the effectiveness of the training? Infrastructure:

Are maintenance records up to date? Is the workplace clean and orderly? Design and Product Development (where applicable):

Are all design controls being used? Is there evidence that formal design reviews have taken place? Purchasing:

Has the approved vendor list been kept up to date? Are vendor evaluations conducted periodically? Are all Supplier Corrective Actions closed? Product realization:

Is there a plan for controlling product Quality? Are processes controlled at predetermined points? Is there evidence that product and parts are protected from damage throughout? Are products and assemblies identified throughout? Monitoring Measuring Devices:

Are all measuring devices calibrated and properly labeled? Corrective Actions:

Are all Corrective Actions closed? Have you confirmed that the Corrective Actions were effective? Are nonconforming products and parts segregated and identified?

Once your audit team assures compliance with the above audit points, it can spend any remaining time addressing other details that may come up during the Registrar audit. This list will also assist process owners in sustaining the Quality Management System.