An International Standards Organization (ISO) Stage 2 audit evaluates the implementation and effectiveness of a company’s management system. It is often referred to as the “certification audit,” the final step to achieve compliance with several notable ISO standards.
The process for achieving ISO certification follows a consistent approach for all management systems standards, including ISO 9001, ISO 14001, ISO 45001, and ISO 27001.
It’s crucial for companies seeking certification to understand the nuances of an ISO audit and the different types of ISO audits you might undergo. The certification audit, or Stage 2 audit, plays a pivotal role in confirming the practical implementation of the management system and assuring compliance with the ISO standard in question.
What are the stages of the ISO certification process?
Embarking on ISO certification is not easy. For most companies that do so it’s a strategic move, one to demonstrate the company’s seriousness at achieving a high standard of performance. Certification unfolds in two stages.
Stage 1 Audit: Preparation Assessment
This preliminary audit assesses the organization’s readiness for ISO certification. The audit involves a meticulous review of management system documentation and initial implementation. The goal here is to assure that the organization has designed processes, policies, and more to meet the specific requirements of the chosen ISO standard. This phase resembles a “tabletop audit,” primarily centered around documentation review.
During Stage 1, the auditor delves into the organization’s documented information, evaluates site-specific conditions, and confers with the organization’s personnel. The objective is to assess the alignment of the organization’s design with ISO requirements.
Stage 2 Audit: Certification Audit
The Stage 2 audit is much more comprehensive. It reviews the full implementation and effectiveness of the management system. Conducted by an ISO-accredited external auditor, this stage involves an in-depth audit, including control testing and internal policies and procedures evaluation. It is performed by an independent auditor accredited to perform ISO audits.
The Stage 2 audit scrutinizes all relevant documented information, key performance objectives, internal audits, and processes, looking at the organization’s full compliance with the chosen ISO standard. It serves as the final step towards achieving ISO certification.
What is the purpose of a Stage 2 ISO audit?
The primary purpose of an ISO Stage 2 audit is to confirm the full implementation of the management system and its practical adherence to the chosen ISO standard. This second stage audit aims to:
- Assess compliance with all applicable requirements of the ISO standard and regulatory requirements;
- Evaluate how well the management system aligns with the organization’s quality manual, procedures, and controls;
- Identify any nonconformities or gaps that require corrective action before ISO certification.
The Stage 2 audit is conducted on-site and involves a review of documentation, interviews, and inspections. The audit team will verify that the management system is fully implemented, controls are adequate, and the organization is ready for ISO certification.
The audit report will list any minor nonconformities or opportunities for improvement. If significant nonconformities are identified, these must be addressed before ISO certification can be issued. Following initial certification, surveillance audits are conducted annually over a three-year cycle so that your certification remains effective.
What to expect during a Stage 2 audit
During the ISO Stage 2 audit, the auditor (who is accredited by a certification body, also known as a registrar) will determine the degree of compliance with the requirements of the applicable standard. The auditor will also report any nonconformities (or potential nonconformities) that the company must correct before it can issue the certification.
If the Stage 2 audit is successful, the certification body will certify the company’s management system as ISO-compliant.
ISO 9001 is the international standard for a Quality Management System (QMS), and it requires an organization to conduct a two-stage registration audit to become certified.
The two-stage registration audit is an external audit performed by a third party. If both Stage 1 and Stage 2 audits are successful, an organization will be certified to ISO 9001. A Stage 1 audit determines whether an organization is prepared for the ISO Stage 2 Certification Audit.
One to two months after the Stage 1 audit, auditors from the certification body will return to audit the organization’s entire quality management system. This Stage 2 audit assesses the implementation and success of the organization’s ISO 9001 management system.
During the ISO 9001 Stage 2 audit, the auditor will:
- Evaluate the documented information to assure that the management system conforms with the selected standard’s requirements;
- Report how well the quality management system complies with the company’s quality manual and procedures;
- Report any nonconformities to evaluate them later;
- Create the organization’s surveillance plan and select dates for the first surveillance visit in the following months.
If the auditor identifies any major nonconformities, the certification body will only issue an ISO certification once your organization completes corrective action on those areas of concern.
Accreditation requirements stipulate that if the nonconformities aren’t fixed within six months, the organization will need to undergo a whole new Stage 2 audit before it can receive certification.
Finding auditors with industry-specific expertise
Your choice of auditor is tremendously important for ISO certification, especially when navigating the intricacies of specialized sectors. Selecting an auditor with expertise in your industry will significantly enhance your audit experience. Here’s why it matters:
Tailored understanding. Auditors well-versed in specific industries bring a tailored understanding to the audit process. This assures that assessments align well with the unique requirements of the sector.
Effective challenge navigation. Specialized sectors often present unique challenges and regulatory frameworks. Industry-specific auditors are adept at navigating these challenges, minimizing the risk of confusion (or, worse, an audit failure) and assuring a comprehensive audit.
Enhanced relevance. Industry-specific expertise allows auditors to focus on the specific risks, transactions, and processes inherent to the sector, which results in more actionable insights for organizations.
Customized recommendations. Auditors with a deep understanding of a particular industry can tailor their recommendations to align with sector-specific best practices and standards. This level of customization assures that the auditor’s guidance is insightful and directly applicable to your company.
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