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Auditing ISO 9001:2015 Clause 4,0 - Context of the Organization
by Walt Prystaj
Auditing Clause 4 of ISO 9001:2015, "Context of the Organization," requires understanding the organization’s external and internal environment, interested parties, scope of the Quality Management System (QMS), and the processes within it. Here’s a guide to auditing Clause 4 with objectives, questions, and types of evidence to look for.
Objectives for Auditing Clause 4
1. Assess Understanding of the Organization’s Context: Verify if the organization has identified relevant internal and external factors affecting its QMS.
2. Evaluate the Identification of Interested Parties and Their Requirements: Confirm that the organization has considered the needs and expectations of interested parties in shaping the QMS.
3. Check the Appropriateness of the QMS Scope: Ensure the scope of the QMS is accurately defined and aligns with the organization's activities and objectives.
4. Review the Management of QMS Processes: Evaluate if the organization has established, implemented, and controlled processes needed for the QMS.
Audit Plan for Clause 4
1. 4.1 Understanding the Organization and Its Context
• Objective:
Verify that the organization has identified and continually monitors external and internal factors that affect its purpose and strategic direction.
• Sample Questions:
o What methods are used to identify internal and external issues that impact the QMS?
o Can you describe some key external and internal factors identified by the organization, and how they influence the QMS?
o How often are these factors reviewed, and who is responsible for this review?
• Evidence to Look For:
o Records or documented analysis of internal and external factors (e.g., SWOT analysis, PESTLE analysis).
o Meeting notes or reports discussing the organization’s context.
o Evidence that these factors are periodically reviewed, such as records from management review meetings.
2. 4.2 Understanding the Needs and Expectations of Interested Parties
• Objective:
Ensure that the organization has identified relevant interested parties (e.g., customers, suppliers, employees) and understands their needs and expectations.
• Sample Questions:
o Who are the organization’s key interested parties, and how were they identified?
o How are the needs and expectations of interested parties determined and reviewed?
o How does the organization ensure that relevant interested parties’ requirements are integrated into the QMS?
• Evidence to Look For:
o A list or register of interested parties and their identified needs and expectations.
o Procedures or processes for capturing and reviewing interested parties’ needs.
o Records of any actions taken based on interested parties’ requirements (e.g., customer feedback mechanisms, supplier performance evaluations).
3. 4.3 Determining the Scope of the Quality Management System
• Objective:
Confirm that the scope of the QMS is clearly defined and includes any exclusions, with justifications as applicable.
• Sample Questions:
o How was the scope of the QMS determined?
o Does the scope include all relevant processes, products, and services that affect the QMS?
o Are there any justifications for exclusions, and are they documented and justified according to the standard?
• Evidence to Look For:
o Documented scope of the QMS, including boundaries and applicability.
o Justifications for any exclusions (if applicable), ensuring they comply with ISO 9001:2015 requirements.
o Documentation linking the scope to relevant processes, products, and services.
4. 4.4 Quality Management System and Its Processes
• Objective:
Verify that the organization has identified, established, and controls the processes needed for the QMS and that these processes achieve intended results.
• Sample Questions:
o What are the key processes in the QMS, and how were they identified?
o How does the organization determine process inputs, outputs, resources, and responsibilities?
o How are risks and opportunities assessed for each process?
o How is process performance monitored and measured, and what evidence is used to determine effectiveness?
• Evidence to Look For:
o Process maps or flowcharts detailing QMS processes, including inputs, outputs, responsibilities, and interactions.
o Records of resources allocated to each process and evidence of process ownership.
o Performance metrics or Key Performance Indicators (KPIs) showing process monitoring and measurement.
o Risk assessments associated with processes and any mitigation actions taken.
Practical Tips for Auditing Clause 4
1. Review Documentation in Advance: Before the audit, review relevant documents such as the QMS manual, context analysis reports, and process documentation to understand the organization’s context and QMS structure.
2. Speak to Management and Process Owners: Engage with management and those responsible for QMS processes to understand how they identify and review context and interested parties’ needs.
3. Observe QMS Processes in Action: Observe process interactions and the use of resources within the QMS to ensure they align with documented processes.
4. Check for Consistency Across Documents and Practices: Ensure that documentation aligns with actual practices and that the organization’s context, interested parties, scope, and processes are consistently understood and applied.
