Auditing ISO 9001:2015 Clause 6,0 - Planning
by Walt Prystaj
Auditing Clause 6 of ISO 9001:2015, "Planning," involves evaluating the organization’s approach to addressing risks and opportunities, setting quality objectives, and planning for changes in the Quality Management System (QMS).
Objectives for Auditing Clause 6
1. Evaluate Risk and Opportunity Management: Ensure that the organization identifies risks and opportunities that could impact its QMS and takes appropriate action to address them.
2. Review Quality Objectives and Planning to Achieve Them: Confirm that quality objectives are established, measurable, and align with the organization's overall strategic goals.
3. Assess Planning for Changes in the QMS: Verify that the organization effectively plans changes to the QMS in a controlled manner, considering any impacts on resources, roles, and responsibilities.
Audit Plan for Clause 6
1. 6.1 Actions to Address Risks and Opportunities
• Objective:
Verify that the organization has determined and planned actions to address risks and opportunities relevant to the QMS.
• Sample Questions:
o How does the organization identify risks and opportunities related to the QMS?
o What methods or processes are used to analyze and assess risks and opportunities?
o Can you give examples of actions taken to mitigate risks or capitalize on opportunities?
o How are the effectiveness of these actions evaluated?
• Evidence to Look For:
o Risk assessment records, including risk matrices, SWOT analysis, or any formal risk management documentation.
o Documentation of actions taken to address identified risks and opportunities.
o Records showing the review or evaluation of the effectiveness of these actions (e.g., follow-up reviews, monitoring of risk mitigation activities).
o Meeting notes from management reviews or risk management meetings where risks and opportunities are discussed.
2. 6.2 Quality Objectives and Planning to Achieve Them
• Objective:
Ensure that quality objectives are established at relevant levels, are measurable, and include plans for achieving them.
• Sample Questions:
o What quality objectives have been established, and how do they align with the organization’s overall goals?
o Are the quality objectives measurable? If so, what metrics are used to monitor progress?
o What specific actions or plans are in place to achieve these objectives?
o How frequently are quality objectives reviewed, and who is responsible for tracking progress?
• Evidence to Look For:
o Documented quality objectives, including target metrics or KPIs associated with each objective.
o Action plans or documented steps to achieve each objective, including timelines and assigned responsibilities.
o Records showing the monitoring, measurement, or review of quality objectives (e.g., performance reports, progress tracking sheets).
o Evidence from management reviews discussing the status and progress of quality objectives.
3. 6.3 Planning of Changes
• Objective:
Verify that the organization has a structured approach to planning changes in the QMS, considering potential impacts on resources, responsibilities, and the QMS as a whole.
• Sample Questions:
o How are changes to the QMS planned and implemented to ensure minimal disruption?
o What considerations are made to assess the potential impact of changes on resources, processes, and roles?
o How does the organization ensure that changes are communicated effectively to relevant stakeholders?
o Can you provide examples of recent changes to the QMS and describe how they were managed?
• Evidence to Look For:
o Change management records or documented change requests showing how changes were evaluated and planned.
o Communication records regarding changes (e.g., emails, meeting minutes, training records).
o Documentation showing resource allocation or adjustments related to QMS changes.
o Evidence of monitoring or reviewing the impact of changes post-implementation to ensure effectiveness.
Practical Tips for Auditing Clause 6
1. Review Documented Processes for Risk and Change Management: Ensure that there is a formalized approach for addressing risks and planning changes, and check if these are documented.
2. Engage with Process Owners and Top Management: Engage with those responsible for strategic planning, quality management, and risk assessment to understand how they identify and handle risks and opportunities.
3. Check for Consistency Across Objectives, Risks, and Changes: Look for alignment between quality objectives, risks, and changes in the QMS to ensure they support each other.
4. Verify Evidence of Monitoring and Review: Confirm that there is evidence showing that actions taken to address risks, opportunities, and objectives are reviewed and evaluated for effectiveness.
Example Evidence to Collect
• Risk Management Documentation:
Records detailing risk identification, assessment methods, and actions taken to address risks and opportunities.
• Quality Objectives Documentation: Documented quality objectives with measurable targets, progress tracking, and any supporting plans to achieve objectives.
• Change Control Records: Documentation showing planned changes, including evaluations of potential impacts and records of communications related to the change.
• Meeting Minutes or Review Records: Evidence from management reviews or other meetings discussing risks, opportunities, quality objectives, and QMS changes.
• Performance Metrics and KPIs: Data or reports showing the performance against quality objectives, demonstrating if targets are being met.
Example Questions Summary
1. Risk and Opportunities:
o How are risks and opportunities identified and evaluated?
o What specific actions are taken to address key risks?
2. Quality Objectives:
o What are the organization’s quality objectives?
o How is progress toward these objectives monitored?
3. Planning of Changes:
o What process is followed to plan changes in the QMS?
o How are changes communicated within the organization?
