ISO 9001:2015 Requirements
5.2.1 Developing the quality policy
Top management shall establish, implement and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.
5.2.2 Communicating the quality policy
The quality policy shall:
a) be available and be maintained as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.
1) Top management shall establish, implement and maintain a quality policy
A quality policy is a succinct statement that outlines an organization’s commitment to quality and its approach to meeting customer requirements. It reflects the organization’s values, vision, and mission, emphasizing customer satisfaction, compliance with relevant standards and regulations, continuous improvement, and the active involvement of top management in promoting a culture of quality throughout the organization.top management is responsible for establishing, implementing, and maintaining a quality policy. This policy serves as a formal statement of the organization’s commitment to quality and its intentions regarding the quality management system (QMS). The quality policy guides the organization’s overall approach to quality, customer satisfaction, compliance, and continuous improvement. It should be communicated throughout the organization and be regularly reviewed and updated to ensure its ongoing relevance and alignment with the organization’s goals. The quality policy is a concise statement of an organization’s commitment to quality and its approach to meeting customer requirements. Here’s a step-by-step guide to help your organization develop an effective quality policy:
- Understand ISO 9001 Requirements: Familiarize yourself with ISO 9001:2015 requirements related to the quality policy (Clause 5.2.1). This will help you ensure that your quality policy aligns with the standard’s expectations.
- Gather Inputs: Collect relevant information from various sources, including top management, stakeholders, employees, and customers. Understand the organization’s mission, values, and strategic direction.
- Involve Key Stakeholders: Involve key stakeholders, especially top management, in the process. Their input and buy-in are crucial for developing a policy that reflects the organization’s goals.
- Define Purpose: Clearly articulate the purpose of the quality policy. It should convey the organization’s commitment to quality and customer satisfaction.
- Be Concise and Clear: The quality policy should be concise and easy to understand. Avoid jargon and technical language. Use simple, direct language to communicate your message.
- Include Key Elements: A well-rounded quality policy typically includes the following key elements:
- Customer Focus: Highlight the organization’s commitment to meeting customer needs and expectations.
- Compliance: Express the commitment to complying with applicable laws, regulations, and quality standards.
- Continuous Improvement: Emphasize the organization’s dedication to continuous improvement of processes and systems.
- Leadership Involvement: Indicate that top management is actively engaged in promoting quality.
- Reflect Organizational Values: Align the quality policy with the organization’s core values, vision, and mission. This helps ensure consistency across all aspects of the organization.
- Set Measurable Objectives: Consider including specific, measurable objectives that demonstrate how the organization plans to achieve its quality commitments.
- Seek Feedback: Share draft versions of the quality policy with key stakeholders, employees, and relevant parties to gather feedback and ensure it resonates with the intended audience.
- Top Management Approval: Once the policy is refined and aligns with the organization’s goals, seek formal approval from top management. This signifies their endorsement and commitment.
- Communication: Communicate the finalized quality policy across the organization. Ensure that every employee is aware of the policy and understands its significance.
- Display and Visibility: Display the quality policy prominently in common areas, such as break rooms and hallways, so that employees are reminded of its importance on a regular basis.
- Regular Review: Review the quality policy periodically to ensure its relevance and alignment with organizational goals and changes in the business environment.
- Integration with QMS: Ensure that the quality policy is integrated into the organization’s QMS and guides decision-making, processes, and objectives.
- Training: Provide training to employees to ensure they understand the quality policy and their role in upholding its principles.
Remember that the quality policy serves as a guiding principle for the entire organization. It should be meaningful, achievable, and reflective of the organization’s commitment to delivering quality products or services that meet or exceed customer expectations.
2) Quality Policy is appropriate to the purpose and context of the organization and supports its strategic direction;
Ensuring that a Quality Policy is appropriate to the purpose and context of an organization and supports its strategic direction involves a deliberate and systematic approach. Here’s a step-by-step guide on how to achieve this:
- Understand the Organization’s Purpose and Context: Begin by thoroughly understanding the organization’s purpose, goals, objectives, and strategic direction. Consider the internal and external factors that influence the organization’s operations, such as industry regulations, customer expectations, market trends, and competitive landscape.
- Engage Leadership and Stakeholders: Involve top management and key stakeholders in the process of developing and reviewing the Quality Policy. Seek input and insights from different departments, teams, and individuals who have a vested interest in the organization’s success.
- Align with Strategic Direction: Ensure that the Quality Policy is in alignment with the organization’s strategic goals and objectives. It should contribute to the realization of those goals. Use the Quality Policy as a tool to communicate how quality initiatives support the organization’s overarching strategy.
- Define Clear Quality Objectives: Develop specific, measurable, achievable, relevant, and time-bound (SMART) quality objectives that align with the strategic direction. These objectives should be focused on enhancing processes, products, and services to meet or exceed customer expectations.
- Reflect Core Values and Culture: Incorporate the organization’s core values, culture, and principles into the Quality Policy. This ensures that the policy resonates with employees and stakeholders.
- Tailor to the Organization’s Needs: Customize the Quality Policy to address the unique needs, characteristics, and challenges of the organization. Avoid generic statements and focus on aspects that are relevant to the organization’s industry and context.
- Regular Review and Revision: Establish a mechanism for periodic review and revision of the Quality Policy to ensure its continued relevance. As the organization’s strategic direction evolves, update the policy accordingly.
- Communication and Awareness: Clearly communicate the Quality Policy to all employees and stakeholders. Make sure everyone understands the policy’s importance and relevance. Provide training and awareness programs to ensure employees know how to implement the policy in their daily tasks.
- Cascade Down to Operational Level: Translate the high-level Quality Policy into actionable steps for different departments and teams. Each operational area should understand how its activities contribute to the broader Quality Policy objectives.
- Monitor and Measure: Implement a system for monitoring and measuring the effectiveness of the Quality Policy and its associated objectives. Regularly assess whether the policy is driving desired outcomes and if adjustments are needed.
- Continuous Improvement: Encourage a culture of continuous improvement by using feedback, data analysis, and lessons learned to refine the Quality Policy and related processes.
- Document and Display: Document the Quality Policy in a clear and easily accessible format. Display the policy prominently in the workplace to reinforce its importance.
By following these steps, an organization can ensure that its Quality Policy is not only appropriate to its purpose and context but also actively supports its strategic direction for long-term success.
3) Quality Policy should provides a framework for setting quality objectives
The Quality Policy should indeed provide the overarching framework within which an organization sets its quality objectives. Here’s a more focused explanation of how the Quality Policy accomplishes this:
- Guiding Principles: The Quality Policy outlines the organization’s fundamental principles and commitment to quality. It sets the tone for the entire quality management system.
- Direction and Purpose: The policy provides the overall direction and purpose of the organization’s quality efforts. It should articulate how the organization aims to meet customer requirements and enhance customer satisfaction.
- Context and Relevance: The Quality Policy is tailored to the organization’s context, taking into account its industry, customer needs, regulatory environment, and strategic direction. This context shapes the focus of the quality objectives.
- Strategic Alignment: The Quality Policy should align with the organization’s strategic goals and objectives. Quality objectives are then derived from these overarching strategic aspirations.
- Commitment to Improvement: The policy should emphasize the organization’s commitment to continuous improvement. Quality objectives play a crucial role in driving this improvement.
- Foundation for Objectives: Quality objectives are specific targets and outcomes that the organization strives to achieve to enhance its products, processes, and services. These objectives are directly linked to the principles and commitments outlined in the Quality Policy.
- SMART Criteria: The Quality Policy helps ensure that quality objectives are set using the SMART criteria—Specific, Measurable, Achievable, Relevant, and Time-bound.
- Reinforcing Culture: The Quality Policy reinforces the organization’s culture of quality by stating its importance and value. Quality objectives should reflect this culture and contribute to its development.
- Hierarchy of Objectives: The Quality Policy guides the formulation of quality objectives at various levels of the organization. These objectives cascade down from the policy, ensuring alignment and consistency.
- Review and Revision: As the organization’s context and strategic direction evolve, the Quality Policy provides a foundation for reviewing and updating quality objectives to remain aligned and relevant.
- Measuring Success: Quality objectives serve as key performance indicators (KPIs) for measuring the organization’s progress toward fulfilling its Quality Policy commitments.
- Accountability and Responsibility: The Quality Policy, along with its associated quality objectives, clarifies who is responsible for achieving these objectives within the organization.
In essence, the Quality Policy acts as the overarching framework that sets the direction and tone for the organization’s quality efforts. Quality objectives, derived from this policy, provide specific, measurable targets that drive continuous improvement and align with the organization’s purpose, context, and strategic direction.
4) Quality policy includes a commitment to satisfy applicable requirements;
A commitment to satisfy applicable requirements is a fundamental element of a Quality Policy. This commitment demonstrates the organization’s dedication to meeting the expectations of customers, stakeholders, and regulatory bodies. Here’s how this commitment is integrated into a Quality Policy:
- Clear Statement: The Quality Policy explicitly states the organization’s commitment to satisfying applicable requirements. This can include legal regulations, industry standards, customer specifications, and any other relevant obligations.
- Customer Focus: The commitment to satisfying applicable requirements is closely tied to customer satisfaction. By adhering to requirements, the organization ensures that its products, services, and processes meet or exceed customer expectations.
- Regulatory Compliance: The commitment acknowledges the importance of complying with relevant laws and regulations that govern the organization’s industry and operations. This reflects the organization’s responsibility and integrity.
- Quality Management System: The Quality Policy can highlight the role of the Quality Management System (QMS) in ensuring that all applicable requirements are identified, understood, and consistently met.
- Continuous Monitoring: The commitment to satisfying requirements implies an ongoing process of monitoring changes in regulations and standards. This ensures that the organization remains up to date and compliant.
- Risk Management: The commitment can emphasize the organization’s proactive approach to risk management, identifying potential gaps in meeting requirements and taking corrective actions to mitigate risks.
- Employee Awareness: The Quality Policy communicates the organization’s expectation that all employees understand and work towards satisfying applicable requirements in their roles.
- Accountability: The commitment holds all levels of the organization accountable for fulfilling requirements, from top management to frontline workers.
- Transparency: By publicly stating the commitment to satisfying requirements, the organization demonstrates transparency to customers, stakeholders, and regulatory bodies.
- Continuous Improvement: The Quality Policy can emphasize the organization’s commitment to continuously improving processes, products, and services to ensure ongoing compliance with evolving requirements.
- Documentation: The Quality Policy can reference the importance of documenting processes, procedures, and practices to ensure traceability and evidence of compliance.
- Communication: The commitment can extend to effective communication with stakeholders regarding the organization’s efforts to meet requirements and maintain compliance.
Incorporating a commitment to satisfy applicable requirements in the Quality Policy reinforces the organization’s dedication to quality and compliance. This commitment should be reflected in the organization’s actions, decisions, and day-to-day operations, contributing to its reputation and long-term success.
4) Quality Policy includes a commitment to continual improvement of the quality management system.
A commitment to the continual improvement of the quality management system (QMS) is a crucial element of a Quality Policy. This commitment reflects the organization’s dedication to refining its processes, products, and services over time. Here’s how this commitment is integrated into a Quality Policy:
- Explicit Statement: The Quality Policy explicitly states the organization’s commitment to the continual improvement of the QMS. This communicates the organization’s dedication to ongoing enhancement.
- Culture of Improvement: The commitment reflects the organization’s culture of seeking better ways to operate and deliver value. It encourages a mindset of innovation and progress.
- Quality Objectives: The commitment aligns with quality objectives, which should include improvement-related targets. This ensures that improvement is a measurable and prioritized goal.
- Process Optimization: The commitment emphasizes the importance of regularly reviewing and optimizing processes to enhance efficiency, effectiveness, and overall performance.
- Customer Satisfaction: Continual improvement directly impacts customer satisfaction by delivering higher quality products and services that better meet customer needs and expectations.
- Employee Engagement: The commitment encourages employees at all levels to contribute ideas and suggestions for improvement, fostering a sense of ownership and engagement.
- Adapting to Change: The commitment acknowledges the dynamic nature of business environments and the need to adapt to changes in technology, market trends, and customer preferences.
- Innovation: The commitment encourages a culture of innovation, where new ideas and practices are explored to drive improvements in quality, processes, and outcomes.
- Feedback Utilization: Continual improvement involves actively seeking and utilizing feedback from customers, employees, and stakeholders to identify areas for enhancement.
- Learning from Mistakes: The commitment embraces a perspective that mistakes and failures provide valuable learning opportunities for refining processes and preventing future issues.
- Benchmarking: Continual improvement may involve benchmarking against industry best practices or competitors to identify areas where the organization can excel.
- Top Management Support: The commitment is reinforced by the involvement and support of top management, demonstrating that improvement is a strategic priority.
- Documented Processes: The commitment can involve the documentation of improvement processes, including how improvement ideas are identified, evaluated, and implemented.
- Review Mechanisms: The Quality Policy may indicate regular management reviews to assess the progress and impact of improvement efforts.
- Measurement and Reporting: Continual improvement efforts should be tracked and measured, with progress and outcomes reported to stakeholders.
- Integration with QMS Elements: The commitment to continual improvement should be integrated into various QMS elements, such as corrective and preventive actions, risk management, and process control.
Including a commitment to the continual improvement of the QMS in the Quality Policy demonstrates the organization’s dedication to staying competitive, maintaining high-quality standards, and evolving to meet changing customer and market demands.
5) The quality policy shall be available and be maintained as documented information;
It is a requirement that the Quality Policy is documented and made available for reference. Here’s how this requirement is typically fulfilled:
- Documented Information: The Quality Policy is formally documented, meaning it is written down and recorded in a clear and understandable manner.
- Accessibility: The documented Quality Policy is accessible to all relevant personnel within the organization. This can be achieved through physical copies posted in common areas, electronic copies on the company intranet, or other appropriate means.
- Maintenance: The Quality Policy is regularly reviewed and updated as needed to ensure its continued relevance and alignment with the organization’s objectives and direction.
- Version Control: If there are updates or revisions to the Quality Policy, a version control mechanism is employed to track changes and maintain a history of previous versions.
- Inclusion in Quality Management System: The Quality Policy is an integral part of the organization’s Quality Management System (QMS) documentation.
- Communication: The existence and availability of the Quality Policy are communicated to employees, stakeholders, and relevant parties.
- Training and Awareness: Employees are made aware of the Quality Policy during onboarding and ongoing training programs to ensure that they understand its content and significance.
- Integration with Processes: The Quality Policy is integrated into various QMS processes, such as setting quality objectives, performing risk assessments, and conducting management reviews.
- Alignment with Objectives: The Quality Policy supports the organization’s quality objectives and overall strategic direction, ensuring that the entire organization is working toward a common goal.
- External Communication: The documented Quality Policy can also be shared with customers, partners, regulators, and other external parties to showcase the organization’s commitment to quality.
- Auditing and Assessment: During internal or external audits, the availability and adherence to the Quality Policy are assessed to ensure compliance.
- Continuous Improvement: The documented Quality Policy is subject to the organization’s culture of continuous improvement, and any necessary updates are made to enhance its effectiveness.
By maintaining the Quality Policy as documented information that is easily accessible and up-to-date, the organization ensures that its commitment to quality, along with its strategic direction, is effectively communicated, understood, and consistently applied throughout the organization.
6) The Quality Policy should be communicated, understood and applied within the organization;
Communicating, ensuring understanding, and applying the Quality Policy within the organization are essential steps to ensure its effectiveness and alignment with the organization’s objectives. Here’s how this can be achieved:
- Clear Communication: The Quality Policy should be communicated to all employees across the organization, regardless of their level or department. This can be done through various channels such as company meetings, intranet, posters, emails, and orientation programs.
- Simplified Language: Use clear and concise language in the Quality Policy to make it easily understandable by all employees, including those who may not have a deep understanding of quality management terminology.
- Training and Education: Provide training sessions or workshops to help employees understand the Quality Policy, its significance, and how it relates to their roles and responsibilities.
- Integration with Onboarding: Include the Quality Policy as part of the onboarding process for new employees to familiarize them with the organization’s commitment to quality from the beginning.
- Regular Communication: Reinforce the message by periodically discussing the Quality Policy during team meetings, performance reviews, and other relevant interactions.
- Two-Way Communication: Encourage employees to ask questions, seek clarifications, and provide feedback about the Quality Policy. This fosters a sense of ownership and engagement.
- Departmental Alignment: Ensure that each department’s objectives and activities align with the principles and commitments outlined in the Quality Policy.
- Visual Reminders: Display the Quality Policy prominently in common areas and workspaces to serve as a visual reminder of the organization’s quality commitment.
- Leadership Role Modeling: Leaders and managers should actively demonstrate their commitment to the Quality Policy through their words and actions.
- Link to Performance: Tie the understanding and adherence to the Quality Policy to performance evaluations and recognition systems.
- Provide Examples: Use real-world examples or case studies to illustrate how the Quality Policy translates into daily work and decision-making.
- Feedback Mechanism: Establish a mechanism for employees to provide feedback on how the Quality Policy is being implemented and whether improvements are needed.
- Encourage Ownership: Empower employees to take ownership of the Quality Policy by encouraging them to suggest ways to align their work with its principles.
- Regular Reinforcement: Continuously reinforce the importance of the Quality Policy as an integral part of the organization’s culture.
- Incorporate in Processes: Integrate the Quality Policy into relevant processes and procedures to ensure that it guides decision-making and actions at every level.
- Auditing and Monitoring: Regularly audit and monitor how well the Quality Policy is being communicated, understood, and applied across the organization.
By ensuring that the Quality Policy is effectively communicated, understood, and applied throughout the organization, you create a culture where quality is valued, practiced, and woven into every aspect of the business.
7) The Quality Policy shall be available to relevant interested parties, as appropriate.
Making the Quality Policy available to relevant interested parties is an important aspect of transparency, accountability, and demonstrating the organization’s commitment to quality. Here’s how this can be accomplished:
- Identify Interested Parties: Determine who the relevant interested parties are. These may include customers, suppliers, regulatory agencies, shareholders, employees, partners, and the general public.
- Communication Channels: Choose appropriate channels to share the Quality Policy with these interested parties. This could be through the company website, brochures, presentations, annual reports, or direct communication.
- Customer Communication: Share the Quality Policy with customers to assure them of the organization’s dedication to delivering high-quality products and services that meet their needs.
- Supplier Engagement: Communicate the Quality Policy to suppliers to establish clear expectations for quality standards in the products and services they provide.
- Regulatory Compliance: Share the Quality Policy with regulatory bodies to demonstrate the organization’s commitment to complying with relevant regulations and standards.
- Internal Communication: Make the Quality Policy accessible to employees through intranet portals, internal communication platforms, and employee handbooks.
- Stakeholder Engagement: Engage with stakeholders through regular communication to provide updates on the organization’s quality efforts, aligned with the commitments in the Quality Policy.
- Transparency and Trust: Sharing the Quality Policy with interested parties builds transparency and trust, showcasing the organization’s values and dedication to quality.
- Regular Updates: Keep interested parties informed about any updates or changes to the Quality Policy, ensuring that they are aware of the organization’s evolving commitment to quality.
- Open Dialogue: Encourage interested parties to provide feedback and ask questions about the Quality Policy, fostering open dialogue and demonstrating receptiveness.
- Demonstrate Compliance: Sharing the Quality Policy with relevant parties demonstrates the organization’s intention to comply with industry best practices and legal requirements.
- Alignment with Branding: The Quality Policy can be incorporated into the organization’s branding efforts, illustrating its commitment to quality to the public and stakeholders.
- Supplier Agreements: Include references to the Quality Policy in supplier agreements or contracts to establish shared quality expectations.
- Incorporate in Reports: Integrate the Quality Policy into corporate reports, such as sustainability reports or annual reports, to show the organization’s holistic commitment.
- Social Responsibility: Sharing the Quality Policy can be part of the organization’s corporate social responsibility efforts to promote ethical and responsible business practices.
By making the Quality Policy available to relevant interested parties, the organization demonstrates its commitment to quality, accountability, and transparency. This helps build stronger relationships with customers, suppliers, stakeholders, and the public at large.
Example of Quality Policy
QualityTech Solutions Quality Policy
“At QualityTech Solutions, our commitment to quality is the cornerstone of our success. We are dedicated to providing innovative technology solutions that exceed the expectations of our clients and stakeholders. Our Quality Policy embodies our values and guides our actions in delivering exceptional products and services.”
- Customer-Centric Excellence: We strive to understand and anticipate our clients’ needs, delivering solutions that drive their success. Customer satisfaction is our ultimate goal.
- Continuous Improvement: We foster a culture of continuous improvement, where every employee is empowered to contribute ideas and solutions that enhance our processes, products, and services.
- Adherence to Standards: We adhere to industry best practices and relevant regulations to ensure the highest quality standards in all aspects of our operations.
- Innovation and Creativity: We encourage creativity and innovation in our solutions, constantly seeking new ways to add value and stay ahead in a rapidly evolving technological landscape.
- Team Collaboration: We collaborate across teams, departments, and functions, leveraging diverse skills and perspectives to drive effective problem-solving and innovation.
- Employee Development: We invest in the development of our employees, ensuring they have the skills, knowledge, and resources to excel in their roles and contribute to our shared success.
- Environmental Responsibility: We are committed to minimizing our environmental impact by adopting sustainable practices in our operations and promoting eco-friendly solutions.
Our Quality Objectives:
- Achieve a customer satisfaction rating of at least 95% based on regular feedback surveys.
- Reduce project delivery time by 15% through process optimization and streamlined workflows.
- Maintain a 99% on-time delivery rate for our products and services.
- Implement at least two innovative solutions each year that enhance client outcomes.
- Ensure that all employees receive a minimum of 20 hours of training annually to enhance their skills.
Communication and Ownership:
This Quality Policy is communicated to all employees during their on boarding and is available on our company intranet. We encourage each employee to understand and apply these commitments in their daily work. Leadership at all levels is responsible for promoting a culture of quality and supporting our commitment to excellence.
The Quality Policy is subject to regular review by our management team to ensure its continued relevance and alignment with our strategic goals. Any necessary updates are made to reflect changes in our industry and business environment.
Please note that this is a fictional example and should be customized to fit the specific nature, industry, and values of your organization.
Documented Information Required:
The only mandatory document is to prepare the documented statement of the Quality policy. As part of your Quality Management System (QMS) documentation, you’ll need to ensure that certain documents and records are in place to fulfill this requirement. Here’s what’s typically required:
- Quality Policy Document: This is the formal document that outlines your organization’s Quality Policy. It should include the organization’s commitment to quality, customer satisfaction, continual improvement, and relevant requirements. The policy should be clear, concise, and easily understandable.
- Documented Information Control: Procedures should be in place to control the creation, approval, distribution, and revision of the Quality Policy document. This ensures that the policy remains accurate and up to date.
- Communication Plan: This plan outlines how the Quality Policy is communicated within the organization, including the channels used (email, intranet, meetings) and the frequency of communication.
- Training and Awareness Records: Keep records of employees’ training on the Quality Policy, ensuring that they understand its content and significance. These records demonstrate that employees are informed about the policy.
- Management Review Minutes: In your management review meetings, document discussions related to the Quality Policy, including its relevance, effectiveness, and alignment with the organization’s strategic direction.
- Evidence of Distribution: Maintain records that show the distribution of the Quality Policy to relevant parties, such as employees, customers, and suppliers. This can include acknowledgment of receipt or usage.
- Evidence of Understanding: Record mechanisms that indicate employees understand the Quality Policy. This could include quizzes, surveys, or signed acknowledgments.
- Records of Updates or Revisions: If the Quality Policy undergoes revisions, keep records of these changes, including reasons for the changes, who approved them, and when they were implemented.
Remember that while these are common documents and records associated with Clause 5.2 of ISO 9001:2015, the specific requirements might vary based on the size of your organization, its industry, and the complexity of your Quality Management System. Always tailor your documentation to suit your organization’s needs while adhering to the standard’s requirements.