Issuing an ISO Assessment

During the audit, or physical onsite inspection of procedures in action, the auditors will issue findings if they assess anything that doesn’t meet requirements, or nonconformities. The length of this step of the ISO Registration Process will depend on the scope of the audit and the size your organization.

In general, the flow of activities during the audit is as follows:

1. Opening Meeting. An introduction of the audit team and key personnel in your company. The scope and general approach to the audit is discussed. This is also the time to question anything that is unclear in the audit schedule and communicate any last minute changes to the system or schedule.
2. Brief tour of the facility. Keep it brief, the auditors just want to get a general feel for the layout and processes involved. This may also be done at the preassessment.
3. Additional review of documents. Audit team members review documentation for areas they will audit.
4. Examination. The audit is conducted, personnel are interviewed, and objective evidence is collected to show the system has been effectively implemented.
5. Daily review. At the end of each day or the beginning of the next, the audit team reviews any issues identified during the assessment. Potential findings or nonconformities may be clarified at this time.
6. Closing Meeting. The audit team states their conclusions regarding the audit and presents any findings or nonconformities that were identified along with any observations they may have.
7. Audit Report issued. Within a few weeks of the audit, the Registrar issues the audit report. The report generally restates what was discussed in the closing meeting.

During the audit, if the auditors find anything that does not meet with the requirements of the ISO standard or that does not meet the requirements of your procedures, they determine the severity and issue a finding. Audit findings are usually called nonconformities and fall into one of two categories depending on severity.

• A Minor Nonconformance deals with minor infractions of procedures or minor failures of the system in meeting the ISO 9001:2008 requirements. These will not hold up your registration.
• A Major Nonconformance deals with issues where nonconforming product is likely to reach the customer or where there is a breakdown in the Quality System that results in the system not being effective in meeting the requirements of the standard. This will hold up your registration.

The primary difference to you between a major and minor nonconformance is that your registration cannot proceed until all major nonconformities are closed and verified by the Registrar. This usually involves a re-audit of the involved areas and, of course, the associated costs. Minor nonconformities require a corrective action plan and they are closed at the first surveillance.

ISO AUDITORS

Auditors work for or contract to Registrars to perform registration assessments and surveillances. They are the “front line” in the process. The Registrars are responsible for ensuring Auditors meet qualification requirements. Their requirements include training in auditing, ISO 9001 training, and at least one member of the audit team must have experience in the industrial sector of the company being audited.

Verify credentials. If a person claims to be certified as an ISO 9000 lead auditor, ask to see proof of his or her certification. Make sure the certification is current by checking the expiration date. Facts about ASQ’s certification are available via the ASQ website.

Auditors collect the objective evidence demonstrating the effectiveness (or lack thereof) of the company’s quality management system and make registration recommendations to the Registrar. The Registrar has the ultimate decision, however.