ISO 9001 ISO-9001-Lead-Auditor Release Date

The purpose of a Stage 1 third-party audit is to determine an organization’s readiness for their Stage 2 Certification Audit. During the Stage 1, the auditor will review the organization’s management system documented information, evaluate the site-specific conditions, and have discussions with personnel. The objective is to assess the alignment of the organization’s design with ISO 9001 requirements and to identify any areas of concern that could be classified as a nonconformance during the Stage 2 Audit. The auditor will also use the Stage 1 Audit to complete Stage 2 Audit planning, including a review of the allocation of resources and details for the next phase of the audit. Therefore, the option that best describes the purpose of a Stage 1 third-party audit is A, to determine the auditees understanding of ISO 9001. The other options are not correct, as they are not the main focus of a Stage 1 audit:

•B. To get to know the organization’s customers: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization’s customers, but rather in the organization’s ability to meet customer and applicable statutory and regulatory requirements.

•C. To learn about the organization’s procurement processes: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization’s procurement processes, but rather in the organization’s ability to control externally provided processes, products and services.

•D. To introduce the audit team to the client: This is not the purpose of a Stage 1 audit, as the auditor is not there to make introductions, but rather to conduct a preliminary examination of the organization’s compliance with ISO 9001 standards.

References: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update, The ISO 9001 Audit Process Explained | ISO Explained, What is an ISO Stage 2 Audit? — RiskOptics - Reciprocity

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According to the ISO 9000:2015 document, the seven quality management principles are:

• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management

For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.

Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:

Table

Quality management principle

Potential benefit

Customer focus

Increased revenue and market share

Engagement of people

Enhanced trust and collaboration throughout the organization

Improvement

Enhanced drive for innovation

Evidence-based decision making

Increased ability to demonstrate effectiveness of past actions

According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate. The organization is also required to maintain documented information on the quality objectives, as per clause 7.5.1.

Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization’s quality policy, as they are based on those of a competitor, rather than the organization’s own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization’s vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.

Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.

References:

• ISO 9001:2015(en), Quality management systems — Requirements, clause 6.2.1 and 7.5.1
• ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2
• ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section “Learning objectives”
• ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6