Surveillance Audit By: Neal Stiemert The ISO Man Commeth One of the requirements of the ISO 9001:2000 standard is surveillance audits conducted by your registrar. The purpose of surveillance audits is to provide assurance that your quality system is being maintained to comply with ISO 9001, customer and regulatory requirements. Your certificate is good for a period of three years providing that you maintain the system. Most registrars will conduct surveillance audits on annual or semi-annual cycles, depending on your preference. The vast majority of my clients choose the semi-annual surveillance audits because they tend to go to sleep at the wheel if they are on a yearly cycle. During a surveillance audit, your registrar will audit required elements, some selected processes as defined in your quality manual, and they will review any findings issued during your last surveillance. Required Surveillance Elements: Management review - Be certain that your management reviews were held when scheduled and that all requirements were discussed and documented in meeting minutes. Note: An ineffective management review process is a major nonconformance. Changes to the quality system - Any changes to your documented quality system will be audited to assure that the changes did not compromise compliance to ISO 9001. Internal quality audits - Your internal audit schedule will be checked along with the records of the audits conducted in accordance with the schedule. Be certain that you have good audit records, the schedule was adhered to, and that corrective action was initiated for all audit findings. Note: An ineffective internal audit process is a major nonconformance. Corrective action - Corrective action will be reviewed with a special emphasis in customer complaints. It is important that all corrective actions contain root cause, corrective action and effectiveness verification. Be certain that corrective actions are closed, or the reason for an extension is documented. Selected Processes: Some of the processes defined in your quality manual will be audited along with the inputs, outputs and interactions to each process. The processes audited will be selected by your registrar. The registrar will normally notify you of the audit date, schedule and date(s) for the audit 2-4 weeks before the audit. I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632. Good Luck on Your Next Surveillance! Neal Stiemert President Independent Quality Consultants, Inc. About the Author Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services. Comment on this article