ISO 9001:2015 Clause 5.3 Organizational roles, responsibilities and authorities

ISO 9001:2015 Requirements

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. Top management shall assign the responsibility and authority for:

1. ensuring that the quality management system conforms to the requirements of ISO 9001:2015
2. ensuring that the processes are delivering their intended outputs;
3. reporting on the performance of the quality management system and on opportunities for improvement, in particular to top management;
4. ensuring the promotion of customer focus throughout the organization;
5. ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

1) Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.

This clause emphasizes the importance of clearly defining and communicating the responsibilities and authorities associated with various roles within an organization’s structure. Each employee needs to know who is responsible for the various elements of the management system to ensure a successful implementation. Develop an organization chart and create job descriptions to satisfy the requirements in order to clearly define roles, responsibilities and authorities and communicate those responsibilities and authorities throughout your organization.You should develop and make available to all employees a list of key personnel and their job descriptions, responsibilities, along with an organization chart of key employees as they relate to your management system. This should effectively define, document, and communicate the organizational structure of the management system. Please note that this method is a suggestion, and other ways of meeting the requirement for organizational structure may be used.

Let’s break down the key points:

1. Responsibilities: Every role within an organization has specific tasks and duties that contribute to the overall functioning and achievement of goals. These responsibilities need to be well-defined and understood by the individuals holding those roles.
2. Authorities: Alongside responsibilities, individuals need to have the necessary authority to make decisions and take actions related to their roles. Authority grants them the power to carry out their responsibilities effectively.
3. Assignment: It’s essential to assign specific responsibilities and authorities to individuals based on their skills, expertise, and the needs of the organization. This alignment ensures that the right people are in the right roles.
4. Communication: Once roles, responsibilities, and authorities are determined, clear communication is key. The organization’s leadership must effectively communicate these aspects to the individuals involved. This could be through job descriptions, official documents, meetings, or other channels.
5. Understanding: It’s not enough to communicate the information; it’s equally important that individuals understand what’s expected of them. This understanding ensures that they can fulfill their roles and exercise their authorities in a way that aligns with the organization’s goals.

When top management takes these steps seriously and ensures that roles, responsibilities, and authorities are well-defined, communicated, and understood, it helps to create a more efficient, organized, and accountable workforce. It minimizes confusion, prevents duplication of efforts, and enhances overall productivity. This principle is fundamental in building a well-functioning and effective organization.

2) Ensuring that the quality management system conforms to the requirements of ISO 9001:2015

Assigning responsibility and authority for ensuring that the quality management system (QMS) conforms to the requirements of ISO 9001:2015 involves a structured approach to ensure that the QMS is effectively managed and maintained. Here’s a step-by-step guide on how top management can achieve this:

1. Identify Key Roles: Determine the key roles and positions within the organization that will be directly responsible for the QMS. These roles may include a Quality Manager, Quality Assurance Officer, Process Owners, and other relevant personnel.
2. Define Responsibilities: Clearly define the specific responsibilities of each identified role in relation to the QMS. Responsibilities should include activities such as monitoring processes, conducting internal audits, reviewing performance data, and ensuring compliance with ISO 9001:2015 requirements.
3. Allocate Authority: Assign the necessary authority to each role to ensure they have the power to make decisions and take actions related to the QMS. This could involve decision-making authority, resource allocation, and the ability to initiate corrective and preventive actions.
4. Document Roles and Responsibilities: Document the defined roles, responsibilities, and associated authorities in a formal document. This could be part of the organization’s quality manual, policies, or a separate roles and responsibilities matrix.
5. Communication: Communicate the assigned roles, responsibilities, and authorities throughout the organization. Ensure that everyone involved is aware of who is responsible for what and how decisions will be made.
6. Training and Support: Provide training and support to individuals in the designated roles. This ensures they have the necessary knowledge and skills to carry out their responsibilities effectively and in accordance with ISO 9001:2015.
7. Monitoring and Reporting: Establish a mechanism for ongoing monitoring and reporting of QMS performance. This could involve regular meetings, performance reviews, and the use of key performance indicators (KPIs) to assess the effectiveness of the QMS.
8. Empower Continuous Improvement: Encourage a culture of continuous improvement within the organization. Empower those responsible for the QMS to identify areas for improvement, initiate corrective actions, and implement changes that enhance the QMS’s effectiveness.
9. Review and Adapt: Periodically review the roles, responsibilities, and authorities to ensure they remain aligned with the organization’s needs and changes in the business environment. Adjustments may be necessary as the organization evolves.
10. Lead by Example: Top management should demonstrate their commitment to the QMS by actively participating in its oversight, reviewing performance data, and taking action on improvement opportunities.

By following these steps, top management can effectively assign responsibility and authority for the QMS and ensure that it remains in conformity with the requirements of ISO 9001:2015. This approach promotes accountability, transparency, and a systematic approach to quality management throughout the organization.

3) Ensuring that the processes are delivering their intended outputs

Assigning responsibility and authority for ensuring that processes are delivering their intended outputs involves a structured approach to monitoring and managing processes within an organization. Here’s a step-by-step guide on how top management can achieve this:

1. Process Identification: Identify the key processes within the organization that contribute to the delivery of products, services, or other outcomes. These processes could include production processes, customer service, sales, quality control, etc.
2. Define Process Owners: Assign specific individuals or teams as process owners for each identified process. Process owners are responsible for overseeing the process from end to end, ensuring its efficiency, effectiveness, and alignment with organizational goals.
3. Clarify Responsibilities: Clearly define the responsibilities of each process owner. This includes responsibilities related to process design, implementation, monitoring, improvement, and ensuring the intended outputs are achieved.
4. Allocate Authority: Provide process owners with the necessary authority to make decisions related to the process. This could involve decision-making power, resource allocation, and the ability to implement changes to improve the process.
5. Document Roles and Responsibilities: Document the roles, responsibilities, and authorities of process owners in a formal document. This could be part of the organization’s process documentation or a separate process ownership matrix.
6. Establish Performance Metrics: Define key performance indicators (KPIs) that measure the effectiveness and efficiency of each process. These metrics should be aligned with the intended outputs and overall organizational goals.
7. Monitoring and Reporting: Implement a system for continuous monitoring of process performance. Process owners should regularly review the KPIs, analyze data, and report on the process’s performance to top management.
8. Review Meetings: Conduct regular review meetings where process owners present the performance data, discuss challenges, and propose improvements. Top management can provide guidance and support based on the reported data.
9. Empower Continuous Improvement: Encourage process owners to identify opportunities for improvement within their respective processes. Provide them with the authority to implement changes and innovations that enhance process outcomes.
10. Collaboration and Communication: Foster collaboration between process owners and other relevant departments. Effective communication ensures that cross-functional processes are well-coordinated and aligned.
11. Training and Support: Provide process owners with training and resources to enhance their process management skills. This empowers them to effectively oversee and optimize their processes.
12. Top Management Engagement: Top management should actively participate in process review meetings and support process owners in their roles. Their involvement demonstrates commitment to process improvement.
13. Recognition and Accountability: Recognize and reward process owners for their contributions to process improvement and achieving intended outputs. Hold them accountable for their performance.
14. Review and Adapt: Regularly review and adapt the process ownership structure and responsibilities as the organization evolves and new processes emerge.

By following these steps, top management can effectively assign responsibility and authority for ensuring that processes are delivering their intended outputs. This approach promotes a culture of accountability, process improvement, and alignment with organizational goals.

4) Reporting on the performance of the quality management system and on opportunities for improvement, in particular to top management;

Assigning the responsibility and authority for reporting on the performance of the quality management system and opportunities for improvement to top management is a crucial aspect of maintaining effective quality control and continuous improvement within an organization. Here’s how top management can achieve this:

1. Define Roles and Responsibilities: Clearly define the roles and responsibilities of top management in relation to the quality management system (QMS) and improvement opportunities. This can be done through job descriptions, organizational charts, and documented responsibilities that outline what is expected of top management in terms of oversight, decision-making, and engagement with the QMS.
2. Quality Policy and Objectives: Top management should establish the organization’s quality policy and objectives. These should align with the overall business strategy and demonstrate the commitment to quality. The quality policy should be communicated throughout the organization, and objectives should be measurable, achievable, and relevant to the organization’s mission.
3. Reporting Structure: Design a reporting structure that ensures regular communication and reporting of QMS performance and improvement opportunities to top management. This can be facilitated through routine meetings, reports, dashboards, and other communication channels.
4. Key Performance Indicators (KPIs): Define relevant Key Performance Indicators (KPIs) that measure the effectiveness of the QMS and reflect areas for improvement. Top management should be involved in selecting these KPIs, as they need to provide meaningful insights into the organization’s performance.
5. Regular Performance Review Meetings: Schedule periodic meetings specifically dedicated to reviewing the QMS performance and improvement opportunities. These meetings should involve top management and relevant stakeholders. During these meetings, discuss the KPIs, analyze trends, identify gaps, and strategize for improvement.
6. Continuous Improvement Culture: Top management should foster a culture of continuous improvement by promoting the importance of seeking out and acting upon improvement opportunities. This involves not only addressing current challenges but also proactively identifying potential areas for enhancement.
7. Allocation of Resources: Provide the necessary resources, including human resources, technology, budget, and training, to support the effective reporting and implementation of improvement initiatives. This demonstrates a commitment to achieving the desired outcomes.
8. Escalation and Decision-Making Authority: Define the levels of escalation and decision-making authority that top management possesses concerning QMS performance and improvement initiatives. This ensures that critical decisions can be made promptly and that any roadblocks are addressed effectively.
9. Communication and Transparency: Establish transparent communication channels for sharing QMS performance data, improvement plans, and progress updates with the entire organization. This helps create a sense of ownership and accountability across all levels.
10. Lead by Example: Top management should lead by example by actively participating in improvement projects, demonstrating commitment to quality, and showcasing a willingness to adapt and change for the betterment of the organization.

Remember that assigning responsibility and authority for QMS performance reporting and improvement opportunities requires ongoing commitment and involvement from top management. It’s a collaborative effort that requires alignment between top management’s strategic vision and the operational implementation of quality management principles.

5) Ensuring the promotion of customer focus throughout the organization

Promoting customer focus throughout the organization is essential for maintaining customer satisfaction, driving innovation, and achieving long-term success. Here’s how top management can effectively assign the responsibility and authority for ensuring the promotion of customer focus:

1. Set Clear Expectations: Top management should clearly communicate their expectations regarding the importance of customer focus and its alignment with the organization’s overall mission and goals.
2. Define Roles and Responsibilities: Assign specific roles and responsibilities for promoting customer focus. Designate individuals or teams responsible for understanding customer needs, gathering feedback, and driving initiatives to enhance customer satisfaction.
3. Establish Customer-Centric Objectives: Incorporate customer-centric objectives into the organization’s strategic planning. These objectives should be measurable and directly tied to overall business goals. Assign responsibility for achieving these objectives to relevant individuals or departments.
4. Leadership Involvement: Top management should lead by example. Demonstrating a commitment to customer focus sends a powerful message to the entire organization. Regularly engage in discussions about customer needs, experiences, and feedback.
5. Training and Development: Provide training and development opportunities to employees to enhance their customer-centric skills. Assign responsibility for implementing training programs and workshops to relevant departments or individuals.
6. Customer Feedback Mechanisms: Establish mechanisms for collecting and analyzing customer feedback. Assign responsibility for managing customer feedback channels, such as surveys, reviews, and complaints, to specific individuals or teams.
7. Cross-Functional Collaboration: Assign the responsibility to foster collaboration between different departments to ensure a holistic approach to customer focus. Create cross-functional teams responsible for addressing customer needs from various angles.
8. Customer-Centric Metrics: Define and track metrics related to customer satisfaction, loyalty, and engagement. Assign the responsibility for tracking these metrics to designated individuals or teams.
9. Continuous Improvement Initiatives: Assign responsibility for identifying areas of improvement based on customer feedback and market trends. Create a culture where employees feel empowered to suggest and implement changes that enhance the customer experience.
10. Recognition and Rewards: Assign the responsibility for implementing a recognition and rewards system that acknowledges employees who excel in promoting customer focus. This can encourage employees to prioritize customer needs.
11. Regular Communication: Facilitate regular communication from top management that highlights the importance of customer focus. This could be through company-wide meetings, newsletters, or other internal communication channels.
12. Empowerment for Problem Resolution: Give employees the authority to address customer issues promptly and effectively. Assign responsibility for ensuring that employees have the necessary tools and empowerment to resolve customer concerns.
13. Review and Feedback Loops: Establish a regular review process where top management assesses the effectiveness of customer focus initiatives. Assign responsibility for gathering data and preparing reports to evaluate progress.
14. Incorporate Customer Insights into Decision-Making: Assign the responsibility for ensuring that customer insights and feedback are considered when making strategic and operational decisions.
15. Lead Customer-Centric Culture: Ultimately, it’s top management’s responsibility to cultivate and sustain a customer-centric culture. This involves integrating customer focus into the organization’s values, mission, and daily operations.

By assigning clear responsibilities and authorities for these actions, top management can effectively ensure the promotion of customer focus throughout the organization. It’s important to lead by example and create an environment where every employee understands the significance of prioritizing customer needs.

6_ Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Maintaining the integrity of the quality management system (QMS) during planned changes is critical to ensure consistent quality, compliance, and effectiveness. Here’s how top management can assign responsibility and authority to ensure QMS integrity during changes:

1. Designate Change Management Teams: Assign responsibility to a change management team or individual who will oversee the planning, execution, and monitoring of QMS changes. This team should consist of representatives from relevant departments, including quality, operations, compliance, and affected areas.
2. Change Impact Assessment: Assign the responsibility to conduct a thorough impact assessment before implementing changes. This involves analyzing how proposed changes will affect different aspects of the QMS, processes, documentation, and personnel.
3. Change Control Process: Assign responsibility for establishing a formal change control process. This process should outline how changes are identified, evaluated, approved, communicated, and implemented. Clearly define roles and responsibilities within this process.
4. Risk Assessment and Management: Assign responsibility for conducting risk assessments related to proposed changes. This helps identify potential risks to QMS integrity and allows for appropriate mitigation strategies to be developed and implemented.
5. Authorization and Approval: Define the authority required for approving changes at different levels. Assign the responsibility for ensuring that proper authorization is obtained before implementing any changes to the QMS.
6. Document Control: Assign responsibility for managing the documentation associated with QMS changes. This includes updating policies, procedures, work instructions, and other relevant documents to reflect the approved changes.
7. Training and Communication: Assign responsibility for developing a training plan to ensure that all personnel affected by the changes are educated on the new processes, procedures, and requirements. Communication should be clear and consistent.
8. Validation and Verification: Assign responsibility for validating and verifying changes as needed. This may involve testing new processes, conducting audits, or reviewing data to ensure that the changes have been implemented correctly.
9. Monitoring and Measurement: Assign responsibility for monitoring the performance of the QMS after changes are implemented. This includes tracking key performance indicators (KPIs) to assess the effectiveness of the changes and identifying any potential issues.
10. Continuous Improvement: Assign responsibility for evaluating the results of the changes and identifying opportunities for further improvement. This involves collecting feedback, analyzing data, and making necessary adjustments.
11. Escalation Protocols: Define escalation protocols and assign responsibility for addressing any unexpected issues or challenges that arise during the implementation of changes. This ensures that issues are resolved promptly.
12. Management Review: Assign responsibility for reporting on the changes made to the QMS during management review meetings. Top management should be kept informed of the status and outcomes of QMS changes.
13. Post-Implementation Audit: Assign responsibility for conducting post-implementation audits to ensure that the changes have been properly executed and are producing the desired results.
14. Compliance and Regulatory Considerations: Assign responsibility for ensuring that any changes adhere to relevant regulations and standards. This may involve working with legal and regulatory affairs teams.
15. Lessons Learned: Assign responsibility for capturing lessons learned from the change management process. This information can be valuable for future changes and improvements.

By clearly assigning responsibility and authority for these steps, top management can ensure that changes to the quality management system are planned, executed, and monitored in a way that maintains its integrity and effectiveness. Open communication, collaboration, and a systematic approach are key to successful change management within the QMS.

Documented Information Required:

There are no mandatory requirement for this clause. It does provide general guidance on the information that should be documented and maintained.

1. Procedure for Role Assignment: Create a procedure that outlines how roles and responsibilities are assigned, communicated, and updated within the organization. This procedure can help ensure consistency and accuracy in role assignments.
2. Roles and Responsibilities Matrix: Maintain a matrix that maps out different roles, their respective responsibilities, and associated authorities. This matrix can serve as a quick reference guide for personnel to understand who is responsible for what.
3. Approval and Authorization Records: Keep records of approvals and authorizations for specific actions, decisions, or changes that require formal approval from higher levels of authority. These records demonstrate that the necessary approvals were obtained.
4. Training Records: Maintain records of training sessions and qualifications that demonstrate employees’ competencies and their alignment with assigned roles and responsibilities.
5. Communication Records: Keep records of communication related to roles, responsibilities, and authorities. This can include meeting minutes, emails, and other forms of communication that pertain to these aspects.
6. Organizational Changes Records: If there are changes to the organizational structure, roles, or responsibilities, document the details of these changes, including reasons, dates, and parties involved.
7. Performance Evaluation Records: Keep records related to the evaluation of personnel performance with regard to their assigned roles and responsibilities. This can include performance appraisals, feedback, and improvement plans.
8. Organizational Chart: Organization charts are used to show the overall hierarchy of a business and the roles, responsibilities and authorities, including job titles and lines of reporting that operate within the quality management system. The organization chart should include the roles and responsibilities that are required to comply with quality management system requirements to ensure they are integrated within your business processes. All employees should be encouraged to understand their own, and others’, responsibilities for implementing and maintaining business and QMS processes. All defined accountabilities, responsibilities and authorities must be stated in your documentation and communicated throughout your organization. Top management are responsible for reviewing, maintaining and communicating your business’s organization chart.
9. Job Descriptions: For each job title identified, your organization should develop a job description to provide a narrative of what the role entails and to identify all associated tasks. Top management are responsible for assigning relevant roles and responsibilities (e.g. the tasks allocated to each role) and the authorities (e.g. permissions and interfaces allocated within each role).The assignment of relevant roles, responsibilities and authorities that affect conformity across your organization includes the roles of Top management, Management Representative, Line Managers, Departmental Managers, Supervisors, Process Owners, and Process Users, etc. relating to:
   • Conformance of the QMS to ISO 9001;
   • Delivery of process output results ;
   • Reporting of QMS performance and improvement opportunities ;
   • Promoting customer focus ;
   • Maintaining the integrity of the QMS when changes occur .

Arrangements to demonstrate that relevant roles, responsibilities and authorities are communicated and understood, and include as appropriate your organization chart, resource allocation spreadsheets, role profiles, accountability statements, job descriptions, training matrices, and skills, competence, qualification and performance reviews. Job descriptions should comprise the following criteria:

1. Title of the job;
2. Where the role sits within the team, department and wider business;
3. Who the role reports to, and other key interactions;
4. Key areas of responsibility and the deliverables expected;
5. Short, medium and long-term objectives;
6. Scope for progression and promotion;
7. Required education and training;
8. Soft skills and personality traits necessary to excel;
9. Location and travel requirements;
10. Remuneration range and benefits available;
11. Convey our organization’s culture and identity.

The quality accountabilities and responsibilities of each employee are integral components of their respective job descriptions. Remember that the specific documents and records you need may vary depending on the complexity and size of your organization. The goal is to have a clear and effective system in place that ensures everyone understands their roles, responsibilities, and authorities, and that decisions are made and communicated appropriately within the organization. It’s important to tailor your documentation and record-keeping to best suit your organization’s needs while meeting the intent of ISO 9001:2015 Clause 5.3.