Norma ISO 9001:2015. Auditorias Internas 9.2. Segunda Parte

Auditing Plan and Process Overview

In this section, the importance of the auditing plan in the internal audit process of ISO 9001 is discussed, emphasizing the key elements such as auditor selection, criteria, and audit objectives.

Planning Audits - Key Considerations

• The total time for each audit and individual process should be determined based on factors like process significance to customers, legal requirements, organizational changes, and previous audit results.

• Finite resources in an organization necessitate careful planning by considering factors like required competence, process complexity, and budget for internal auditors.

• The audit plan includes scheduling visits to different processes with specified times allocated per auditor. It considers processes, dates, times, responsible auditors, and ISO 9001 requirements.

Audit Agenda Development

• The audit agenda outlines activities including auditing processes, locations to visit, break times, team meetings. It details date/time/process/auditor/auditee information.

• Specific ISO 9001 requirements are linked to audited processes in the agenda. For instance: top management processes (clauses 4-6), core processes (clause 8), support processes (clause 7), evaluation processes (avoiding clauses 9 & 10).

Viability Assessment for Audits

• Before proceeding with audits for each process, a viability assessment is conducted to ensure sufficient information availability cooperation from auditees adequate time/resources exist.

• Failure to plan adequately may lead to risks; hence reviewing organizational documents before audits is crucial. The audit agenda must cover all criteria ensuring audit objectives are met comprehensively.

Checklist Preparation and Execution

This part delves into the importance of checklists in auditing procedures to ensure compliance with objectives and scope while providing guidance for auditors.

Checklist Significance

• Checklists are vital tools ensuring objective achievement during audits by verifying compliance with set objectives/scopes guiding auditors through every part of the process.

• Checklists detail audit criteria related to ISO 9001 requirements per audited process. They transform these requirements into questions facilitating evidence collection during audits.

Example Checklist Format

• Transforming ISO 9001 requirements into questions aids checklist creation. For instance: Communication of Quality Policy (5.22 clause), requiring documented availability/communication/comprehension/application/maintenance within organizations.

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In this section, the importance of quality policy within an organization is discussed, along with questions that can be formulated regarding its publication, approval, communication, and employee contribution to policy compliance.

Formulating Questions about Quality Policy

• Questions to consider:

• Where is the quality policy published?

• When and how was the quality policy approved?

• How has the quality policy been communicated?

• How does staff contribute to policy compliance?

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This part emphasizes the significance of checklists in audits for controlling audit times, finding and recording evidence efficiently, and planning sample collections.

Importance of Checklists in Audits

• Key points:

• Checklists help control audit times.

• They facilitate evidence location and recording.

• Checklists aid in planning sample collections before audits.

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Sampling strategies are discussed concerning audits within organizations to manage time effectively while ensuring thorough evaluation.

Sampling Strategies in Audits

• Considerations for sampling:

• Sampling necessary due to time constraints in audits.

• Example: Evaluating competence among a large workforce.

• Determining critical positions for products/services evaluation through sampling.

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The process following sampling strategies involves verifying requirements through resume samples and conducting an opening meeting as part of the audit plan.

Verification Process and Opening Meeting

• Steps involved:

• Concluding resume sample verification for compliance.

• Conducting an opening meeting after sharing the audit plan.

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The importance of a concise opening meeting in audits is highlighted, focusing on confirming plans, activities, communication channels, methodology, language use, resources, facilities, and team feedback.

Significance of Opening Meetings

• Key aspects covered:

• Confirming audit plans during the opening meeting.

• Establishing effective communication channels.