Management review iso 9001 version 2023 năm 2024

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

9.3.2 Management review inputs

The management review shall be planned and carried out taking into consideration:

1. the status of actions from previous management reviews;
2. changes in external and internal issues that are relevant to the quality management system;
3. information on the performance and effectiveness of the quality management system, including trends in:
   • customer satisfaction and feedback from relevant interested parties;
   • the extent to which quality objectives have been met;
   • process performance and conformity of products and services;
   • nonconformities and corrective actions;
   • monitoring and measurement results;
   • audit results;
   • the performance of external providers;
4. the adequacy of resources;
5. the effectiveness of actions taken to address risks and opportunities ;
6. opportunities for improvement.

9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:

1. opportunities for improvement;
2. any need for changes to the quality management system;
3. resource needs. The organization shall retain documented information as evidence of the results of management reviews.

1)Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

Management review is a regular evaluation exercise where the performance of the quality management system is reviewed to check if the systems are producing the desired results. This process requires the top management to periodically review various elements of the Quality Management System and ensure its suitability, adequacy and effectiveness. That means the top Management shall review that the Quality Management System to check if it still fits its purpose (suitable), is still sufficient (adequate) and is still able to achieve its intended purpose (effective).While assessing the suitability and adequacy of the Quality Management System this clause requires management additionally consider any changes to the context of the organization and also alignment between the QMS and the strategic direction of the organization. The intent is not only to review the performance of the Quality Management System but to also evaluate the need for any changes in the quality policy, objectives and other elements of the Quality Management System. Management review is an additional performance evaluation check apart from internal audits and monitoring and analysis which helps in ensuring the effectiveness of the quality management system. Management oversight is important for any management system or a continuous improvement initiative to succeed. It is, therefore, crucial that management remains committed to holding these meetings on a regular basis to keep themselves abreast with the performance of the management system. Management reviewing the management system at regular intervals helps in understanding changes in the context which is important to ensure that the Quality Management System always remains in sync with changing business scenarios. A key output of the management review meetings is the identification of process improvements which in turn helps in improving quality and customer satisfaction which are key to the success of any company and business growth. Management review should be conducted at planned intervals; this could be daily, weekly, monthly, quarterly, semi-annually or annually. The frequency should be decided by the Management based on the size and nature of the organization. It is a common misconception among companies implementing ISO 9001 requirements that management review is a separate exercise that should be done by the top management at a fixed frequency. While this approach is fine but there can be various ways of making the management review more effective, less time consuming and fused with existing processes in place. The goal should be to meet all the requirements of ISO 9001. Top management can look at different aspects of the management system and decide which of the elements can be discussed or is already being discussed in existing ongoing meetings. For example, if top management has a meeting already in place where they review the customer satisfaction survey results; this is one element of the management system that should be reviewed. So, Instead of having this agenda again in the management review, the management team shall continue the existing practice and ensure that the records of the meeting are being maintained. In a larger organization, where multiple layers of management are there, a more suitable approach would be to have management meetings at different levels to capture data which then can serve as an input to the strategic planning meetings of the Executive Team. To conclude, an organization may conduct management reviews as a standalone activity or in a combination of related activities (e.g. meetings, reports, etc.) and the frequency at which it needs to be conducted should be based on the business environment, size of the organization and complexity of the work being done.

The organization should conduct its Management Review of its Quality Management System (QMS) in a structured and systematic manner to ensure that it effectively evaluates the QMS’s suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. Here are the key steps and considerations for conducting a Management Review:

1. Preparation and Planning:
   • Schedule the Review: Determine the frequency of the management review meetings as per your organization’s needs and requirements (e.g., annually, biannually, quarterly).
   • Identify Participants: Invite relevant stakeholders, including top management, quality managers, process owners, and other key personnel.
   • Gather Data: Collect relevant data and information to be reviewed during the meeting. This may include performance metrics, customer feedback, audit results, non-conformances, corrective and preventive actions, and changes in the external and internal context of the organization.
2. Conduct the Review Meeting:
   • Opening and Agenda: Start the meeting with an agenda that outlines the topics to be discussed. Ensure that the objectives of the review are clear to all participants.
   • Review Objectives: Discuss the purpose of the management review, which is to assess the QMS’s suitability, adequacy, effectiveness, and alignment with the organization’s strategic goals.
   • Review Data: Present and discuss the collected data and information, focusing on key performance indicators, trends, and any issues or opportunities for improvement.
   • Evaluate Adequacy and Suitability: Assess whether the QMS is still appropriate and sufficient for the organization’s needs and objectives.
   • Evaluate Effectiveness: Determine if the QMS is achieving its intended outcomes, such as product or service quality, customer satisfaction, and compliance with standards.
   • Strategic Alignment: Ensure that the QMS supports the strategic direction of the organization and discuss any necessary adjustments.
   • Risk Assessment: Consider any emerging risks or opportunities that may impact the QMS.
   • Resource Allocation: Discuss resource requirements, including personnel, training, technology, and infrastructure, to support the QMS effectively.
3. Decision-Making:
   • Action Items: Identify and assign action items to address any issues or opportunities for improvement identified during the review.
   • Prioritization: Determine the priority of actions based on their significance and impact on the QMS and the organization.
   • Resourcing: Allocate necessary resources to implement the action items effectively.
4. Follow-Up:
   • Track Progress: Monitor the progress of action items and ensure they are completed within the specified timelines.
   • Documentation: Maintain records of the management review meeting, including minutes, decisions made, and action plans.
5. Communication and Reporting:
   • Report Outcomes: Communicate the results of the management review to relevant stakeholders within the organization. This may include sharing the insights gained and actions taken.
6. Continuous Improvement:
   • Use the outcomes of the management review to drive continuous improvement in the QMS and the organization’s quality performance.

Remember that the management review process should be documented, and the records should be retained for future reference and as evidence of compliance with quality management standards if required. Additionally, it’s essential to create a culture of continuous improvement within the organization to ensure that the QMS remains dynamic and responsive to changing needs and circumstances. A well-structured management review of a Quality Management System (QMS) is a critical tool to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. Here’s how the management review process achieves these objectives:

1. Continuing Suitability and Adequacy:
   • Assessment of Business Context: During the management review, top management evaluates the external and internal factors affecting the organization. This assessment helps determine if the QMS remains suitable and adequate to address the evolving needs and circumstances of the organization.
   • Review of Objectives and Goals: The management review assesses whether the QMS aligns with the organization’s current objectives and goals. If business goals have changed, the QMS may need adjustments to stay aligned.
   • Identification of Risks and Opportunities: By discussing risks and opportunities in the management review, the organization can ensure that the QMS is equipped to address emerging challenges and capitalize on opportunities effectively.
2. Effectiveness:
   • Performance Metrics: The management review evaluates key performance indicators (KPIs) and other metrics to assess the effectiveness of the QMS in meeting quality-related objectives. This analysis helps identify areas where the QMS may be falling short or excelling.
   • Customer Feedback: Customer satisfaction and feedback are crucial indicators of QMS effectiveness. Reviewing customer complaints, surveys, and feedback can reveal areas for improvement.
   • Audit and Compliance Results: The outcomes of internal and external audits, as well as compliance assessments, are reviewed to ensure that the QMS is meeting established standards and regulatory requirements.
   • Non-Conformance and Corrective Actions: The review process examines instances of non-conformance and the effectiveness of corrective and preventive actions taken. This helps determine if the QMS is addressing issues adequately.
3. Alignment with Strategic Direction:
   • Strategic Goals and Objectives: The management review ensures that the QMS is aligned with the organization’s strategic goals and objectives. If there are any deviations or conflicts, adjustments can be made to realign the QMS.
   • Resource Allocation: The review process discusses resource requirements to support the QMS and the organization’s strategic direction. This includes personnel, training, technology, and infrastructure.
   • Change Management: If the organization’s strategic direction is shifting, the management review can help plan and implement necessary changes in the QMS to accommodate new strategies and priorities.
4. Action Planning and Implementation:
   • Based on the findings of the management review, action items and improvement plans are developed. These action items may include process changes, resource allocation, training, and policy updates to enhance the QMS.
   • Assign responsibilities and timelines for implementing these actions, ensuring that they address any identified gaps or opportunities for improvement.
5. Monitoring and Follow-Up:
   • After the management review, ongoing monitoring and follow-up are essential to ensure that the agreed-upon actions are carried out effectively.
   • Regularly track progress on action items and adjust plans as needed to address any unexpected challenges or changes in the business environment.
6. Continuous Improvement:
   • The management review process should feed into the organization’s culture of continuous improvement. It should encourage a proactive approach to identifying and addressing issues, even before they become critical.

By following these steps and maintaining a disciplined and well-documented management review process, an organization can ensure that its QMS remains aligned with its strategic direction and continues to be suitable, adequate, and effective in achieving its quality objectives.

2) The management review shall be planned and carried out taking into consideration the status of actions from previous management reviews

Certainly, considering the status of actions from previous management reviews is a crucial aspect of ensuring the effectiveness and continuity of the Quality Management System (QMS) and the management review process. Here’s how this practice contributes to the overall improvement of the QMS:

1. Continuous Improvement: Reviewing the status of actions from previous management reviews allows management to track progress on identified issues and improvement initiatives. This helps ensure that the organization is actively working towards resolving problems and enhancing its processes.
2. Accountability: It holds individuals and teams accountable for implementing the agreed-upon actions and improvements. When actions are assigned and tracked from one management review to the next, it encourages responsible parties to fulfill their commitments.
3. Prevents Recurrence: By examining the status of previous actions, management can determine whether corrective and preventive actions taken in response to previous issues have been effective in preventing their recurrence. If issues persist, additional measures can be devised.
4. Resource Allocation: Assessing the status of actions provides insights into resource allocation. If certain actions have been consistently delayed or remain incomplete, it may indicate resource shortages or other obstacles that need to be addressed.
5. Data-Driven Decision-Making: Management reviews should be data-driven. By reviewing the outcomes and progress of previous actions, decisions in the current management review can be based on tangible evidence and real-world results.
6. Demonstrating Commitment to Improvement: Demonstrating that the organization is actively tracking and addressing issues from one management review to the next shows a commitment to quality and continuous improvement, which can positively impact employee morale and stakeholder confidence.

To effectively incorporate the status of previous actions into the management review process:

• Maintain a centralized record or database that tracks all action items, their due dates, responsible parties, and current statuses.
• During the management review meeting, review the status of each outstanding action item from previous reviews. Discuss the reasons for delays or completion, if applicable.
• Use this information to inform decision-making in the current review. Prioritize actions that are overdue or critical to the QMS’s effectiveness.
• Encourage open and honest discussions about challenges and obstacles that have hindered the completion of actions and seek solutions to overcome them.
• Ensure that action items are closed out or formally documented as ongoing if they require further attention.

By continuously monitoring and addressing the status of actions from previous management reviews, organizations can maintain a proactive approach to quality management and drive meaningful improvements in their processes and systems.

3) The management review shall be carried out taking into consideration of changes in external and internal issues

Considering changes in external and internal issues during the management review is a crucial aspect of ensuring that the Quality Management System (QMS) remains effective, relevant, and aligned with the organization’s goals and context. Here’s how taking these changes into account can enhance the management review process:

1. Adaptation to External Factors:
   • Market Trends: Changes in market trends, customer preferences, and competitive landscapes can impact the organization’s ability to meet customer needs. Reviewing these changes allows the organization to adjust its QMS to stay competitive and responsive.
   • Regulatory Changes: Shifts in regulations and compliance requirements can affect how the organization operates. Monitoring and addressing these changes within the QMS ensure ongoing adherence to legal and regulatory obligations.
   • Technological Advances: Advances in technology may create new opportunities for process improvement or require adjustments in how products or services are delivered. Integrating relevant technological changes into the QMS can lead to efficiency gains.
   • Economic Conditions: Economic fluctuations, such as recessions or growth periods, can influence resource availability and budget considerations. The QMS should be adaptable to these changes.
2. Internal Factors:
   • Organizational Structure: Changes in the organization’s structure, such as mergers, acquisitions, or reorganizations, can impact processes, responsibilities, and workflows. The QMS should reflect these changes to ensure clarity and efficiency.
   • Resource Allocation: Alterations in resource availability, such as personnel, budget, or technology, can affect the QMS’s ability to meet quality objectives. Adjustments may be needed to optimize resource allocation.
   • Customer Feedback: Changes in customer feedback and expectations are vital inputs for QMS improvement. Addressing evolving customer needs can enhance customer satisfaction and loyalty.
   • Process Performance: Continuous monitoring of internal processes and their performance metrics helps identify areas for improvement and optimization within the QMS.

Incorporating changes in external and internal issues into the management review process involves the following steps:

1. Data Gathering: Collect relevant data and information about external and internal changes since the last management review. This may include market research, regulatory updates, customer feedback, internal performance data, and more.
2. Analysis: Analyze the collected data to identify the potential impacts of these changes on the QMS and the organization’s strategic goals.
3. Discussion: During the management review meeting, engage in discussions regarding how these changes affect the organization and its quality management processes.
4. Decision-Making: Make informed decisions based on the analysis and discussions. Determine whether adjustments to the QMS are necessary to address these changes effectively.
5. Action Planning: If changes require modifications to the QMS, develop action plans with clear responsibilities and timelines for implementation.
6. Follow-Up: Monitor the progress of action items related to addressing changes in external and internal issues and ensure they are completed as planned.

By systematically considering changes in external and internal issues, organizations can maintain a QMS that is adaptive, resilient, and better positioned to meet evolving customer needs, regulatory requirements, and strategic objectives. This approach supports the ongoing improvement of the QMS and the organization’s overall performance.

3) The management review shall be carried out taking into consideration of information on the performance and effectiveness of the quality management system, including trends in

1. Customer Satisfaction and Feedback from Relevant Interested Parties:

• Customer satisfaction and feedback are key indicators of the QMS’s effectiveness in meeting customer needs.
• Monitoring customer satisfaction trends helps identify areas for improvement in products, services, or processes.
• Feedback from relevant interested parties, including suppliers, partners, and regulators, provides insights into broader stakeholder satisfaction and expectations.

2. Extent to Which Quality Objectives Have Been Met:

• Quality objectives are specific, measurable goals set by the organization to achieve desired quality outcomes.
• Reviewing the achievement of these objectives assesses the overall performance of the QMS and its alignment with organizational goals.
• Deviations from objectives may indicate areas needing improvement.

3. Process Performance and Conformity of Products and Services:

• Analyzing process performance metrics helps identify areas where processes may be falling short of expectations or where improvements are needed.
• Assessing the conformity of products and services against established quality standards ensures that quality requirements are consistently met.

4. Nonconformities and Corrective Actions:

• Examining nonconformities (instances where products, services, or processes did not meet established requirements) and corrective actions taken to address them helps gauge the QMS’s ability to identify and rectify issues.
• It promotes a culture of continuous improvement by learning from past mistakes.

5. Monitoring and Measurement Results:

• Monitoring and measurement results include data related to various aspects of the QMS, such as product quality, process efficiency, and compliance.
• Reviewing these results provides insights into the overall health of the QMS and highlights areas where adjustments may be necessary.

6. Audit Results:

• Audit results from internal and external audits assess the organization’s compliance with standards, regulations, and its own procedures.
• Audit findings help identify areas of non-compliance and areas that require corrective or preventive action.

7. Performance of External Providers:

• The performance of external providers, such as suppliers and service providers, can directly impact the organization’s product or service quality.
• Evaluating the performance of these providers ensures that they meet the organization’s quality and reliability standards.

To effectively incorporate these factors into the management review process:

1. Data Collection: Gather relevant data and information for each of these factors. This may include customer feedback, performance metrics, audit reports, and records of nonconformities and corrective actions.
2. Analysis: Analyze the data to identify trends, patterns, and areas requiring attention or improvement.
3. Discussion: During the management review meeting, engage in discussions regarding the findings and their implications for the QMS and the organization.
4. Decision-Making: Based on the analysis and discussions, make informed decisions regarding adjustments or improvements to the QMS, processes, or resources.
5. Action Planning: Develop action plans, as necessary, to address identified areas for improvement and assign responsibilities and timelines.
6. Follow-Up: Monitor the progress of action items and ensure they are completed in a timely manner.

5) The management review shall be carried out taking into consideration the adequacy of resources;

Considering the adequacy of resources during the management review is crucial to ensure that the Quality Management System (QMS) has the necessary resources to effectively meet its objectives and support the organization’s quality goals. Adequate resources encompass various elements, including personnel, infrastructure, technology, and financial resources. Here’s how addressing the adequacy of resources in the management review can benefit the QMS:

1. Personnel: Assessing the sufficiency and competence of personnel involved in QMS-related roles and responsibilities is vital. This includes evaluating whether staff members have the necessary skills, training, and qualifications to perform their roles effectively.
2. Infrastructure: Adequate infrastructure, facilities, and equipment are essential to support the QMS. This might involve reviewing whether facilities and equipment are in good condition, maintained, and capable of meeting quality requirements.
3. Technology: Technology plays a significant role in modern QMS. Evaluating the adequacy of technology resources, including software, hardware, and data management tools, ensures that the QMS is efficient and up-to-date.
4. Financial Resources: Adequate financial resources are required to support various QMS activities, such as training, process improvements, audits, and compliance efforts. A review of financial allocations helps ensure that these activities are adequately funded.
5. Training and Development: Assessing the organization’s training and development programs helps determine if employees receive the necessary training to perform their roles effectively and stay updated on quality standards and procedures.
6. Documentation and Records: Adequate resources should be allocated to maintain accurate documentation and records as required by the QMS and relevant standards. This ensures transparency and traceability of processes.
7. Quality Assurance and Control: Adequate resources should be available to support quality assurance and control activities, including inspections, testing, and monitoring, to ensure that products or services meet quality requirements.

Incorporating the adequacy of resources into the management review process involves the following steps:

1. Resource Assessment: Gather data on the current state of resources, including staffing levels, qualifications, infrastructure, technology, and budget allocations.
2. Resource Utilization: Evaluate how resources are being utilized within the organization and whether they align with the QMS’s objectives and priorities.
3. Identify Resource Gaps: Identify any resource shortages, deficiencies, or areas where resources may not be effectively allocated to support the QMS.
4. Discussion and Decision-Making: During the management review meeting, engage in discussions about the adequacy of resources and their impact on the QMS’s performance.
5. Action Planning: If resource gaps or deficiencies are identified, develop action plans to address them. Determine whether additional resources are required or if existing resources need to be reallocated.
6. Follow-Up: Monitor the progress of resource-related action items and ensure they are completed as planned.
7. Budget Considerations: If financial resources are a concern, discuss budget considerations and allocation adjustments to better support the QMS and quality-related initiatives.

By considering the adequacy of resources during the management review, organizations can ensure that their QMS operates effectively, efficiently, and in alignment with quality objectives. This proactive approach helps prevent resource-related obstacles from hindering the QMS’s ability to consistently deliver high-quality products or services.

6) The management review shall be carried out taking into consideration the effectiveness of actions taken to address risks and opportunities

Considering the effectiveness of actions taken to address risks and opportunities during the management review is a critical aspect of maintaining a robust and responsive Quality Management System (QMS). Here’s how this practice contributes to the overall improvement of the QMS:

1. Risk Management:
   • Identification: Review the effectiveness of risk identification processes within the organization. Determine whether identified risks are comprehensive and accurate.
   • Assessment: Assess whether the organization has appropriately evaluated the significance and potential impact of identified risks on quality objectives and overall performance.
   • Mitigation: Evaluate the actions taken to mitigate or manage identified risks. Assess whether these actions have been effective in reducing risk exposure and preventing negative consequences.
2. Opportunity Management:
   • Identification: Review how opportunities for improvement are identified within the organization, including opportunities related to enhanced quality, efficiency, and innovation.
   • Assessment: Assess whether the organization has effectively evaluated the potential benefits and advantages associated with identified opportunities.
   • Leveraging Opportunities: Examine the actions taken to capitalize on identified opportunities. Evaluate whether these actions have been successful in realizing benefits and enhancing the QMS.
3. Continuous Improvement:
   • Learning from Actions: Evaluate whether the organization has a culture of learning from actions taken to address risks and opportunities. Determine if lessons learned are being applied to future risk and opportunity management efforts.
   • Feedback Loop: Ensure that feedback from risk and opportunity management is integrated into the QMS’s continuous improvement processes.
4. Documentation and Reporting:
   • Documentation: Review the documentation of risk assessments, risk treatment plans, opportunity assessments, and actions taken. Ensure that these records are complete and well-maintained.
   • Reporting: Assess how risk and opportunity management results are communicated within the organization. Determine if relevant stakeholders are informed about risks, opportunities, and the actions taken to address them.
5. Resource Allocation:
   • Resources for Risk Mitigation: Evaluate whether the organization has allocated appropriate resources (personnel, technology, budget, etc.) to effectively address identified risks.
   • Resources for Opportunity Realization: Assess whether resources have been allocated to seize and leverage identified opportunities.

Incorporating the effectiveness of actions taken to address risks and opportunities into the management review process involves:

1. Data Collection: Gather data on the results of risk and opportunity assessments, actions taken, and their outcomes.
2. Analysis: Analyze the data to determine whether the actions were successful in managing risks and exploiting opportunities. Assess whether further actions are needed.
3. Discussion: During the management review meeting, engage in discussions about the effectiveness of risk and opportunity management within the QMS.
4. Decision-Making: Make informed decisions based on the analysis and discussions. Determine whether adjustments or improvements are necessary in risk and opportunity management processes.
5. Action Planning: If the review reveals areas where actions are needed to enhance the effectiveness of risk and opportunity management, develop action plans with clear responsibilities and timelines.
6. Follow-Up: Monitor the progress of action items related to improving risk and opportunity management practices and ensure they are completed as planned.

By focusing on the effectiveness of actions taken to address risks and opportunities, organizations can better position themselves to proactively manage challenges, exploit opportunities for improvement, and enhance the overall performance of the QMS. This approach promotes resilience and continual improvement within the organization.

7) The management review shall be carried out taking into consideration the opportunities for improvement

Considering opportunities for improvement during the management review is a fundamental aspect of maintaining a dynamic and continually improving Quality Management System (QMS). Here’s how this practice contributes to the overall enhancement of the QMS:

1. Identification of Improvement Opportunities:
   • Process Efficiency: Review processes within the organization to identify areas where efficiency can be improved. This may involve streamlining workflows, reducing waste, or optimizing resource utilization.
   • Cost Reduction: Identify opportunities to reduce costs without compromising quality. This may involve sourcing materials more efficiently, improving supplier relationships, or implementing cost-effective technologies.
   • Enhanced Quality: Look for ways to enhance the quality of products or services, which can lead to improved customer satisfaction and market competitiveness.
   • Innovation: Encourage a culture of innovation to identify and implement new ideas, technologies, or approaches that can provide a competitive advantage or improve quality.
2. Customer Focus:
   • Customer Feedback: Review customer feedback and complaints to identify trends or recurring issues. Use this information to drive improvements in products, services, and customer satisfaction.
   • Customer Expectations: Stay attuned to changing customer expectations and preferences. Identify opportunities to better align products and services with customer needs.
3. Regulatory and Compliance:
   • Changes in Regulations: Monitor changes in regulatory requirements and standards. Identify opportunities to ensure compliance while also streamlining processes.
   • Risk Mitigation: Identify potential risks and compliance issues within the QMS and develop strategies to mitigate them.
4. Performance Metrics:
   • Key Performance Indicators (KPIs): Continually assess KPIs to identify areas where performance falls short of targets or where improvement is possible.
   • Benchmarking: Compare your organization’s performance to industry benchmarks and best practices to identify gaps and opportunities for improvement.
5. Resource Optimization:
   • Resource Allocation: Review resource allocation, including human resources, budget, and technology. Identify opportunities to optimize resource allocation for improved QMS performance.
6. Documentation and Record-Keeping:
   • Documentation Review: Evaluate the quality and completeness of documentation and records within the QMS. Ensure that accurate records are maintained to support decision-making and compliance.

Incorporating opportunities for improvement into the management review process involves the following steps:

1. Data Collection: Gather data on identified improvement opportunities from various sources, including performance metrics, customer feedback, process evaluations, and compliance assessments.
2. Analysis: Analyze the data to determine the feasibility, potential impact, and priority of each improvement opportunity.
3. Discussion: During the management review meeting, engage in discussions about the identified opportunities for improvement within the QMS.
4. Decision-Making: Make informed decisions based on the analysis and discussions. Determine which improvement opportunities to prioritize and pursue.
5. Action Planning: Develop action plans with clear responsibilities and timelines for implementing the chosen improvement opportunities.
6. Follow-Up: Monitor the progress of action items related to improvement opportunities and ensure they are completed as planned.

9) The outputs of the management review shall include decisions and actions related to opportunities for improvement; any need for changes to the quality management system; resource needs.

The outputs of the management review are critical for driving improvements and ensuring the effectiveness of the Quality Management System (QMS). These outputs typically include decisions and actions related to:

1. Opportunities for Improvement: During the management review, the organization identifies various opportunities for improvement across different aspects of the QMS, such as processes, products, services, and customer satisfaction. The decisions and actions related to these opportunities may include:

• Prioritizing improvement initiatives based on their potential impact on quality, customer satisfaction, and strategic objectives.
• Assigning responsibilities for implementing improvement projects or initiatives.
• Defining clear objectives and performance targets for improvement efforts.
• Allocating resources, including personnel, budget, and technology, to support improvement initiatives.
• Establishing timelines and milestones for the implementation of improvement actions.
• Monitoring and measuring progress toward achieving the identified improvements.
• Reviewing and adjusting improvement strategies as necessary based on results and feedback.

2. Changes to the Quality Management System (QMS): The management review often reveals the need for changes to the QMS to enhance its effectiveness, alignment with strategic goals, and responsiveness to evolving circumstances. Decisions and actions related to changes in the QMS may include:

• Identifying specific areas or processes within the QMS that require modification, enhancement, or streamlining.
• Updating documented procedures, policies, or work instructions to reflect changes in processes or requirements.
• Revising quality objectives and performance metrics to align with current organizational goals and customer expectations.
• Ensuring that changes are communicated effectively throughout the organization.
• Assigning responsibilities for implementing QMS changes and monitoring progress.
• Conducting impact assessments to understand the implications of proposed changes on various aspects of the organization.

3. Resource Needs: Adequate resources are essential for the effective operation of the QMS. Decisions and actions related to resource needs may include:

• Identifying specific resource requirements to support the QMS, such as additional personnel, training, technology, or budget allocations.
• Allocating resources strategically to address gaps or deficiencies identified during the management review.
• Prioritizing resource allocation based on the significance of QMS-related activities and their impact on quality and organizational objectives.
• Establishing mechanisms for monitoring and managing resource utilization to ensure efficiency and effectiveness.
• Integrating resource needs into the organization’s strategic planning and budgeting processes.

Overall, the outputs of the management review, including decisions and actions related to improvement opportunities, changes to the QMS, and resource needs, play a vital role in driving continual improvement, maintaining compliance with quality standards, and aligning the QMS with the organization’s strategic direction. These outputs provide a roadmap for enhancing quality, efficiency, and customer satisfaction while ensuring that the QMS remains agile and adaptable to changing circumstances.

10) The organization shall retain documented information as evidence of the results of management reviews.

Here are the key documents and records required for the management review process

1. Management Review Agenda: Document that outlines the topics and objectives to be addressed during the management review meeting. This helps ensure that the review covers all relevant areas of the QMS.
2. Management Review Minutes: Detailed records of what was discussed during the management review meeting, including decisions made, actions assigned, and any key points raised. Minutes provide evidence of the review process and its outcomes.
3. Quality Policy and Objectives: The organization’s quality policy document and documented quality objectives. These provide context for the review and help assess alignment with the strategic direction of the organization.
4. Performance Data and Metrics: Data related to the performance of the QMS, including key performance indicators (KPIs) and other relevant metrics. This data may include trends, results of performance evaluations, and any areas of concern or improvement.
5. Customer Feedback and Complaints: Records of customer feedback, complaints, and their resolution. These documents help assess customer satisfaction and identify areas for improvement.
6. Audit Results: Reports from internal and external audits, including findings, non-conformities, and corrective actions. Audit results provide insights into the QMS’s compliance and effectiveness.
7. Non-Conformities and Corrective Actions: Records of identified non-conformities, their root causes, and the actions taken to address them. This includes documented information on corrective and preventive actions.
8. Risk and Opportunity Assessments: Documentation related to risk and opportunity assessments, which may include risk registers, assessments of their significance, and action plans to address identified risks and opportunities.
9. Changes to the QMS: Records of any changes made to the QMS, including updates to policies, procedures, processes, and quality objectives. This documentation helps track changes and their impact on the QMS.
10. Resource Allocation and Needs: Information on resource allocation, including personnel, technology, training, and budget allocations, to support the QMS. This ensures that resource needs are addressed during the review.
11. Action Plans: Documentation of action plans developed as a result of the management review, including details of what actions are needed, who is responsible, and timelines for completion.
12. Follow-Up Records: Records that show the progress of action items identified in previous management reviews, demonstrating that they have been addressed or are in progress.
13. Historical Records: Previous management review records, which help provide context and historical perspective during the current review. These records may include past agendas, minutes, and action items.
14. Other Relevant Documents: Any other documents or records that are pertinent to the specific needs of the organization and the management review process.

It’s essential for organizations to maintain these documents and records in an organized and accessible manner to demonstrate their commitment to the management review process and compliance with ISO 9001:2015 requirements. These records provide evidence of the organization’s ongoing efforts to evaluate, improve, and maintain the effectiveness of its QMS.

Published by Pretesh Biswas

Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your system development, training or auditing needs. He has helped dozens of organizations in implementing effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has experience in training at hundreds of organizations in several industry sectors. His training is unique in that which can be customized as to your management system and activities and deliver them at your facility. This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic equipment, assemblies & components, batteries, computer hardware and software, printing, placement and Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students. Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education & professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001. He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt . View all posts by Pretesh Biswas

Does ISO 9001 require management reviews?

The ISO 9001 requires top management to regularly evaluate the adequacy, suitability, and effectiveness of their organisation's Quality Management System.

How often is the ISO 9001 management review?

Critical management review agenda items, such as; process performance, customer feedback and monitoring and measuring results should be reviewed monthly, while less critical agenda items, such as reviewing the quality policy and objectives should be undertaken less frequently, perhaps every quarter.

What is the latest version of ISO 9001 QMS?

As of September 2023, the current version of the ISO 9001 standard is ISO 9001:2015. However, that may not be the case for much longer.

What is a management review meeting as per ISO 9001:2015?

Management Reviews are an opportunity to evaluate the systems and controls that are in place, to review feedback, make improvements and track corrective action, to assure that changes are monitored, reported and evaluated, and to determine the overall effectiveness of the quality programme (QMS).