The final stage towards ISO 9001 certification is an audit by an external auditor. The auditor will evaluate your quality management system (QMS) to ensure it meets ISO 9001 requirements.
Audits might be intimidating, but if you know what to anticipate and have done all of your preparation, your organization should be recommended for certification. In this post, we will look at the essential processes of an external audit so that you can be better prepared.
A Good Attitude Towards an ISO 9001 External Audits
An external audit is stressful by definition. On the plus side, even if you don't gain certification on the first try, preparing for an audit can provide significant data on areas for development.
Typically, the procedure leads to greater productivity and better-quality management. Even if you do not become certified, your company's procedures will be more efficient and profitable. These will help you plan for the upcoming audit.
When is an ISO 9001 External Audit Performed?
Following the completion of an internal audit, an external ISO 9001 audit should be scheduled. At least two to three months of ISO 9001 documentation and records from your ISO 9001 procedures are required.
The internal audit will serve as a test to identify any issues or non-compliances in your quality management system.
Who does an ISO 9001 External Audit?
A third-party auditor (or auditor team) conducts an external ISO 9001 audit. The auditor will be appointed to you by an ISO 9001 registrant, also known as a Certification Body (CB).
The registrar is an impartial institution that issues the ISO 9001 certification once the third-party auditor has finished the audit and confirmed the certification.
A Third-Party Audit's Stages
The third-party audit procedure is separated into two major portions, each with its own set of processes.
Stage 1: The document or readiness review is the first stage of the audit. This stage determines whether you are prepared for stage 2.
The audit focuses on your QMS documentation as well as the essential policies that support system operation.
The auditor will want to know about your QMS processes, methods, equipment, internal audit status, and which sites are being audited.
The auditor will assess whether you are ready for stage 2 of the audit based on all of the examined material and documents.
Stage 2: Stage 2 is usually done in person; however, it can also be done remotely. Remote audits have grown more widespread since the COVID-19 pandemic.
Stage 2 is divided into three steps.
- First meeting: The auditor will explain the audit procedure and what to expect during the initial meeting. He or she will normally provide a timetable so that you know how long the audit will take. Depending on the size of your organization, the audit could take up to a week.
- Thorough Examination: The audit's key component is an in-depth review. The auditor will examine your documentation, evaluate the effectiveness of your QMS, review your policies and procedures, and analyse your internal audits. The effectiveness of your corrective and preventative measures (CAPA) as well as your key performance objectives and targets will be assessed.
- Closing Meeting and Report: The auditor will provide you with comments, including any non-compliances discovered, during the closing meeting. Then he or she will typically submit a report that describes these issues and recommends corrective actions that must be implemented before attaining ISO 9001 accreditation.
The Potential Outcomes of an ISO 9001 Audit
If the auditor is satisfied that a company is fully compliant with ISO 9001, the auditor will suggest that the company be certified. If any problems are discovered, they will be noted in the report and must be resolved.
The three categories of noncompliance issues that may be discovered are as follows:
Major Nonconformity: A substantial non-conformance occurs when one or more large or small non-conformities against one requirement cause the entire QMS to fail. To gain certification, major nonconformities must be corrected.
Minor Nonconformity: A minor non-conformance is a single observed failure or breakdown in some aspect of the management system. Minor non-conformances have no bearing on the auditor's recommendation for approval, but they must be corrected before your certificate can be granted.
Improvement Potential (OFI): These are the areas that may require explanation or inquiry to increase the QMS's performance. OFIs have no bearing on certification recommendations.
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