A quality policy is a formal, documented statement issued by an organization’s top management that defines its commitment to quality, regulatory compliance, and continual improvement. Quality policy forms the foundation of a Quality Management System (QMS) and aligns with the organization’s strategic objectives.
Quality policy examples vary depending on industry, organization size, and regulatory context. For example, pharmaceutical companies may emphasize compliance with FDA regulations and Good Manufacturing Practices, while Contract Research Organizations may focus on data integrity and client satisfaction. Despite these differences, all effective quality policies share core attributes: a commitment to quality, focus on customer needs, regulatory compliance, continual improvement, and alignment with business strategy.
A quality policy is expected to meet requirements defined by international standards and regulatory frameworks. These include ISO 9001:2015 for general quality management, ISO 13485:2016 for medical devices, FDA 21 CFR Parts 820 and 211 for U.S. medical and pharmaceutical manufacturers, EU MDR 2017/745 for European medical devices, and ICH Q10 for pharmaceutical quality systems. Additional frameworks such as EU GMP, AS9100 (aerospace), ISO 22000 (food safety), and ISO/IEC 27001 (information security) outline sector-specific quality policy expectations.
Developing and implementing a quality policy involves a structured process. Key actions begin with understanding applicable regulations, engaging leadership, and analyzing the organizational context to ensure alignment with strategic and compliance priorities. This is followed by defining core quality commitments and aligning them with measurable quality objectives to guide the organization’s direction. The final steps involve drafting and approving the policy, communicating it effectively, integrating it into QMS processes, and reviewing it regularly to ensure continued relevance and effectiveness.
QMS software plays a strategic role in quality policy management by streamlining key processes such as document control, training assignment, policy distribution, and traceability. The QMS software helps ensure the policy is consistently communicated, accessible, and aligned with both organizational goals and regulatory requirements. Integration with quality objectives enables organizations to measure compliance and track quality performance.
SimplerQMS provides QMS software for life science companies, supporting the management of quality policies as active, integrated components of the QMS. By centralizing processes and streamlining compliance tasks, SimplerQMS helps organizations uphold high standards, reduce risk, and drive continuous improvement.
What Is a Quality Policy?
A quality policy is a formal, documented statement developed and issued by an organization’s top management. The quality policy outlines the organization’s commitment to quality, regulatory compliance, and continual improvement, and forms a foundational element of the quality management system (QMS). Aligned with the organization’s strategic direction, the policy guides achieving quality objectives and process consistency.
In business and quality management contexts, the quality policy defines how the organization intends to meet customer requirements and regulatory obligations while fostering a quality culture across operations.
The primary purpose of a quality policy is to clearly communicate the organization’s dedication to delivering compliant, high-quality products or services.
Top management is responsible for developing, implementing, and maintaining the quality policy. This includes ensuring the policy is relevant to the organization’s context, well-communicated, understood across the organization, and regularly reviewed for ongoing effectiveness.
What Is the Importance of a Quality Policy?
A quality policy is important for organizations striving to deliver consistent, high-quality products or services, maintain regulatory compliance, and build customer trust. Quality policy forms the foundation of the QMS by establishing a clear direction and aligning all departments around shared quality objectives.
The policy communicates expectations across the company, supports the consistent execution of processes, and ensures employees understand how their roles contribute to organizational quality goals. This clarity enhances accountability, boosts productivity, and fosters a culture of continuous improvement.
By aligning with international standards such as ISO 9001 and ISO 13485, a documented quality policy demonstrates leadership commitment and provides a framework for setting and reviewing quality objectives. Documented quality policy is also a key component during audits and inspections.
Organizations operating without a clearly defined quality policy face increased risks of non-compliance, poor internal communication, and inconsistent performance. The absence of a unified quality direction can lead to customer dissatisfaction, reputational harm, and reduced competitiveness in regulated markets.
What Is The Role of a Quality Policy in Quality Management Systems (QMS)?
A quality policy plays a central role in a quality management system by guiding how quality is defined, managed, and improved across the organization. Quality policy serves as a strategic directive that reflects the organization’s commitment to quality, compliance, and customer satisfaction.
Within a quality management system, the quality policy provides a clear foundation for process design, implementation, and ongoing improvement. Quality policy helps shape internal procedures, assign responsibilities, and establish measurable quality objectives aligned with the company’s strategic goals. These objectives directly influence how quality performance is monitored and improved over time.
The policy is closely tied to international quality standards such as ISO 9001 and ISO 13485. These standards require organizations to define, document, and maintain a quality policy. The quality policy has to align with the organization’s context, support continual improvement, and be effectively communicated and understood across all levels of the organization.
A well-established quality policy ensures consistent decision-making, supports a culture of accountability, and maintains alignment between business strategy and operational execution. Quality policy should be actively applied in daily operations and reviewed regularly, typically during management reviews, to ensure it remains relevant and effective as the organization evolves.
What Are Quality Policy Examples?
Quality policy statements can vary significantly depending on several factors. These factors include the industry, applicable regulations, organizational size, and strategic direction.
The structure and intent of a quality policy remain consistent. Typically, such policies express a clear commitment to quality, regulatory compliance, and continual improvement. However, each quality policy should be uniquely crafted to reflect the specific context and goals of the organization.
SimplerQMS Quality Policy Statement Example
Below is an example of the SimplerQMS A/S quality policy statement, demonstrating how a QMS provider may structure its commitment to quality, compliance, and customer satisfaction.
The quality policy of SimplerQMS A/S is to maintain a total quality management system within the entire organization by implementing the relevant regulatory requirements.
The Quality Policy is to prioritize quality first, always.
We will endeavor to:
a) Maintain an effective Quality Management System complying with relevant regulations for
the supply of an electronic QMS dedicated to the life science industry.
b) Ensure compliance with relevant statutory and safety requirements.
c) Achieve and maintain a level of quality which enhances the company’s reputation with customers.
d) Maintain a high level of information towards the customer.
e) Endeavor, at all times, to maximize customer satisfaction with products and services provided by SimplerQMS A/S.
f) Establish and continually review measurable objectives for the QMS.
Pharmaceutical Manufacturing Company Quality Policy Statement Example
Below is an example of a quality policy statement for a pharmaceutical manufacturing company. This illustrative example reflects the essential regulatory and operational elements typically found in pharmaceutical quality policies.
The quality policy of [Company Name] is to consistently manufacture pharmaceutical products that are safe, effective, and compliant with applicable regulatory standards, while meeting or exceeding customer expectations.
We are committed to:
a) Maintaining a robust Quality Management System in compliance with cGMP principles, including FDA 21 CFR Parts 210 and 211, and aligning with ICH Q10 and other applicable global pharmaceutical regulations.
b) Ensuring strict adherence to all statutory, regulatory, and safety requirements governing pharmaceutical development, manufacturing, and distribution.
c) Fostering a culture of continuous improvement through proactive process optimization, risk management, and innovation in manufacturing technologies.
d) Maintaining comprehensive and accurate documentation, including batch records, deviations, and change control, to ensure traceability and regulatory readiness.
e) Setting, monitoring, and reviewing quality objectives to enhance operational efficiency, minimize product defects, and ensure audit preparedness.
f) Investing in employee competency through targeted training and development programs to uphold high-quality standards at every level.
Quality is the foundation of our pharmaceutical manufacturing operations, driving patient safety, regulatory compliance, and sustained business success.
Contract Research Organization (CRO) Quality Policy Statement Example
Below is a sample quality policy statement for a Contract Research Organization (CRO) providing research services to the pharmaceutical and life sciences industries.
At [Company Name], our quality policy is to deliver scientifically sound, regulatory-compliant, and client-focused research services that accelerate the development of safe and effective pharmaceutical and biotechnology products.
We are committed to:
a) Operating a robust Quality Management System in alignment with ISO 9001:2015, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other applicable GxP guidelines.
b) Ensuring full compliance with international regulatory requirements, including FDA, EMA, and ICH standards, as well as client-specific protocols.
c) Conducting clinical trials, laboratory testing, and data analysis with precision, transparency, and traceability to ensure data integrity and regulatory acceptance.
d) Continuously enhancing our research methodologies, quality oversight, and operational tools based on performance metrics, client feedback, and regulatory updates.
e) Promoting a culture of client partnership through clear communication, proactive issue resolution, and a commitment to meeting project timelines and deliverables.
f) Establishing and reviewing quality objectives that drive scientific excellence, compliance assurance, and business improvement.
Our dedication to quality supports our clients’ success in drug development and contributes to advancing global health through reliable, trusted research outcomes.
What Are the Core Elements of a Quality Policy?
The core elements of a quality policy that contribute to a clear, effective, and compliant statement are listed below.
- Commitment to Quality: The policy should clearly express the organization’s dedication to delivering high-quality products or services that meet defined standards.
- Customer Focus: The policy needs to reflect a commitment to understanding customer needs, fulfilling expectations, and enhancing customer satisfaction.
- Compliance with Requirements: A quality policy should affirm the organization’s obligation to comply with all applicable regulatory, statutory, and contractual requirements.
- Continual Improvement: The policy should promote continual improvement of the QMS and its supporting processes.
- Alignment with Business Strategy: The quality policy needs to support the organization’s broader strategic objectives and long-term direction.
- Framework for Quality Objectives: The policy should provide a basis for setting, reviewing, and achieving measurable quality goals across relevant functions.
- Leadership and Responsibility: The policy should demonstrate top management’s accountability and clarify the organizational roles that support a quality-driven culture.
- Communication and Accessibility: The policy shall be communicated effectively, understood by employees, and accessible to relevant internal and external stakeholders.
- Review and Suitability: The policy is required to be reviewed at planned intervals- typically during management review, to ensure continued relevance, adequacy, and alignment with current business needs.
What Are the Regulatory and Standard Requirements for Quality Policy?
A quality policy should meet specific requirements outlined in international standards and regulatory frameworks that are applicable to the company.
Below are key regulations and standards in the life sciences industry that include expectations for a quality policy.
- ISO 9001:2015: Requires a documented quality policy that aligns with the organization’s strategic direction and supports the establishment of quality objectives.
- ISO 13485:2016: Specifies quality policy requirements for medical device organizations, emphasizing regulatory compliance and the effectiveness of the QMS.
- EU MDR 2017/745: Mandates a documented quality policy as part of a compliant quality management system for medical device manufacturers operating in the EU.
- FDA 21 CFR Part 820: U.S. medical device regulations that require a quality policy demonstrating top management’s commitment and alignment with defined quality objectives.
- 21 CFR Part 211: U.S. pharmaceutical GMP regulations that imply the need for a structured quality approach, consistent with the purpose of a quality policy.
- ICH Q10: A global pharmaceutical quality system framework that recommends a quality policy focused on regulatory compliance, product lifecycle management, and continual improvement.
- EU GMP: Requires manufacturers to define, document, and apply a quality policy that supports GMP compliance, product safety, and quality system maturity.
ISO 9001:2015
ISO 9001:2015 is an international standard for quality management systems applicable to organizations of all types and sizes.
Section 5.2 of the ISO 9001:2015 outlines quality policy requirements. The policy is expected to align with the organization’s context and strategic direction, support the QMS, enable the establishment of quality objectives, and be communicated, understood, and reviewed for continued relevance.
ISO 13485:2016
ISO 13485:2016 is a globally recognized standard for quality management systems specific to the medical device industry.
Clause 5.3 of ISO 13485:2016 identifies quality policy expectations. Clause 5.3 requires the policy to demonstrate commitment to regulatory compliance and QMS effectiveness. The policy shall be documented, communicated, understood by personnel, and reviewed periodically.
EU MDR 2017/745
The EU Medical Device Regulation (MDR) 2017/745 governs the marketing and performance of medical devices in the European Union.
Article 10(9) and Annex IX of EU MDR 2017/745 require manufacturers to establish a comprehensive QMS, including a documented quality policy. The policy should ensure compliance with safety, performance, and regulatory requirements across the product lifecycle.
FDA 21 CFR Part 820
FDA 21 CFR Part 820 is the U.S. Quality System Regulation for medical device manufacturers.
Section 820.20 (Management responsibility) of FDA 21 CFR Part 820 includes the requirement for a quality policy. The policy is expected to express top management’s commitment to quality and regulatory compliance and shall be implemented and maintained throughout the organization.
21 CFR Part 211
21 CFR Part 211 outlines current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals in the U.S.
Although 21 CFR Part 211 does not explicitly require a quality policy, it mandates quality control responsibilities and documentation that imply the need for a structured quality approach. These expectations are consistent with the purpose and function of a quality policy.
ICH Q10
ICH Q10 is a pharmaceutical quality system framework developed by the International Council for Harmonisation.
Section 2.1 from ICH Q10 emphasizes the importance of a quality policy as part of management responsibility. The policy should foster a culture of quality, support regulatory compliance, and drive continual improvement across the product lifecycle.
EU GMP
The EU Guidelines for Good Manufacturing Practice (GMP), outlined in EudraLex Volume 4, apply to medicinal products in the EU.
Chapter 1 of the EU GMP of the pharmaceutical quality system requires a documented quality policy that reflects management’s commitment to GMP, continuous improvement, and patient safety. The policy is a foundational component of the QMS.
Other Industry-Specific Requirements
Beyond the main life science QMS requirements, various industry-specific standards, guidelines, and regulations define quality policy requirements.
Listed below are key requirements outlining these expectations.
- ISO 22000: This standard focuses on food safety management systems and requires a quality policy that supports safe food practices, regulatory compliance, and continual improvement.
- HACCP (Hazard Analysis and Critical Control Points): HACCP-based systems require documented policies and procedures to manage food safety hazards, emphasizing a strong commitment to quality and safety.
- FDA Food Safety Modernization Act (FSMA): FSMA shifts the focus from reactive to preventive food safety. FSMA emphasizes the need for a documented food safety plan supported by a top-level quality and safety policy.
- AS9100: Designed for the aerospace industry, AS9100 requires a quality policy that demonstrates top management’s commitment to product conformity, operational safety, and customer satisfaction.
- ISO/IEC 20000: This IT service management standard includes requirements for a service-oriented quality policy that drives service effectiveness, continual improvement, and customer value.
- ISO/IEC 27001: As an information security management standard, ISO/IEC 27001 requires a policy framework that supports data protection, regulatory compliance, and risk mitigation.
How to Develop and Implement a Quality Policy?
To develop and implement a quality policy, organizations should follow a structured process that ensures alignment with regulatory requirements, reflects organizational goals, and embeds the policy effectively into the QMS.
The key steps involved in developing and implementing a quality policy are outlined below.
- Understand Regulatory Requirements
- Engage Top Management
- Assess Organizational Context
- Define Core Quality Commitments
- Align with Quality Objectives
- Draft the Quality Policy Statement
- Review and Approve the Policy
- Communicate the Policy
- Train Employees on the Policy
- Integrate into the QMS
- Use It in Objective Setting
- Control and Maintain Documentation
- Evaluate Understanding and Compliance
- Review and Update Regularly
1. Understand Regulatory Requirements
Identify applicable standards, guidelines, and regulations applicable to your industry, such as ISO 9001, ISO 13485, FDA 21 CFR Part 820, or EU MDR.
Understanding these requirements ensures that your quality policy meets external compliance requirements and forms a solid foundation for audits and certifications.
2. Engage Top Management
Involve senior leadership in setting the direction and tone of the quality policy from the beginning.
Top-level involvement reinforces the importance of quality and drives company-wide engagement.
3. Assess Organizational Context
Analyze internal and external factors that influence the organization’s quality approach, including customer needs, risks, and market conditions.
Understanding the context ensures the policy is relevant, practical, and tailored to the organization’s actual operating environment.
4. Define Core Quality Commitments
Clearly articulate your organization’s commitment to quality, regulatory compliance, customer satisfaction, and continual improvement.
These commitments act as guiding values for the entire QMS and influence every quality-related decision.
5. Align with Quality Objectives
Ensure the quality policy supports the development of measurable quality objectives consistent with strategic goals.
This connection ensures that the policy translates into actionable goals and continuous improvement efforts.
6. Draft the Quality Policy Statement
Write a clear, concise statement that incorporates regulatory, strategic, and operational priorities.
A well-drafted quality policy communicates expectations clearly and serves as a reference point across the organization.
7. Review and Approve the Policy
Have top management formally review and sign off on the final version of the quality policy.
Formal approval signifies leadership accountability and fulfills applicable requirements for management commitment.
8. Communicate the Policy
Distribute and communicate the quality policy throughout the organization using accessible channels such as training, onboarding, and internal platforms.
Effective communication ensures that employees are aware of the policy and understand its significance to their role.
9. Train Employees on the Policy
Ensure that all personnel understand the policy, their role in upholding it, and how it applies to their responsibilities.
Employees have to understand the quality policy to apply it in daily operations and uphold quality expectations consistently.
10. Integrate into the QMS
Embed the quality policy into QMS documents, procedures, forms, and workflows across all departments.
Integration ensures the policy is not a standalone document but actively influences how quality is managed across the organization.
11. Use It in Objective Setting
Develop quality objectives that directly reflect and support the commitments outlined in the quality policy.
This creates traceability between strategy and action, a key expectation in quality audits.
12. Control and Maintain Documentation
Store the quality policy in a controlled document format, and ensure proper version control and accessibility.
Document control ensures traceability, accuracy, and readiness for audits and inspections.
13. Evaluate Understanding and Compliance
Periodically assess employee understanding and implementation of the policy through audits, surveys, or training assessments.
Regular evaluation confirms whether the quality policy is effectively understood and implemented across the organization.
14. Review and Update Regularly
Reevaluate the policy during management reviews to ensure it remains relevant, effective, and aligned with organizational changes.
Scheduled reviews ensure that the quality policy evolves with the business and remains compliant with updated regulations.
What Is the Difference Between a Quality Policy and a Quality Manual?
The primary difference between a quality policy and a quality manual lies in its purpose, scope, and level of detail. The quality policy provides a high-level statement of intent, whereas the quality manual is a comprehensive document that describes the structure and functioning of the organization’s quality management system.
A quality manual is a structured guide explaining how the organization meets QMS requirements. A quality manual typically includes the scope of the QMS, descriptions of core processes, roles and responsibilities, interactions between processes, and references to supporting procedures and records.
The purpose of the quality policy is to set direction and communicate quality objectives, while the quality manual documents how those objectives are implemented through the QMS. The policy provides the “why”; the manual provides the “how.”
Quality policy and quality manual are closely connected. The quality policy is often embedded in the opening section of the quality manual, reinforcing leadership commitment and strategic alignment. Together, they form the foundation for certification and compliance with standards such as ISO 9001 and ISO 13485.
The quality policy is frequently referenced during audits, training sessions, and strategic planning. The quality manual is used more operationally, serving as a resource for staff, auditors, and regulators to understand how the QMS is structured and maintained.
What Is the Difference Between a Quality Policy and Quality Objectives?
The primary difference between a quality policy and quality objectives lies in their role within a QMS. The quality policy defines the direction, values, and intent of the organization regarding quality. Quality objectives translate that intent into specific, measurable targets.
Quality objectives are quantifiable goals derived from the quality policy. These objectives may relate to customer satisfaction, defect reduction, audit outcomes, training effectiveness, or process improvement.
In terms of format, the quality policy is typically a concise narrative document. Quality objectives, on the other hand, are data-driven, time-bound, and often tracked in dashboards or performance reports and reviewed at regular intervals.
Within the QMS, the quality policy and objectives are tightly connected. The policy establishes the organizational intent, and the objectives translate that intent into measurable outcomes. For example, if the policy emphasizes customer satisfaction, an objective might be to “achieve ≥95% customer satisfaction rate per quarter.”
Together, the quality policy and objectives drive quality performance across the organization. The policy supports alignment and leadership direction, while the objectives provide a framework for accountability, progress tracking, and continuous improvement.
What Is The Role of QMS Software in Quality Policy Management?
QMS software is a digital solution designed to automate, manage, and streamline quality-related processes across an organization. In the context of quality policy management, QMS software plays a strategic role by ensuring that the quality policy is not only documented and controlled but also effectively communicated, implemented, and monitored throughout the organization.
An effective QMS software supports the entire lifecycle of the quality policy, from initial drafting and version control to training, distribution, and ongoing reviews. QMS software helps ensure that the policy remains accessible to all employees, traceable in audits, and aligned with evolving regulatory requirements.
Key features of QMS software in quality policy management include the following.
- Document control for managing policy versions, approvals, and change history.
- Automated distribution to notify relevant personnel of new or updated policies.
- Training management to assign policy-related training and verify comprehension.
- Audit trails and traceability to demonstrate compliance during internal and external audits.
- Integration with quality objectives to connect the policy with measurable goals and QMS performance indicators.
SimplerQMS is a life science QMS software tailored for regulated industries such as medical devices, pharmaceuticals, and biotechnology. SimplerQMS software offers comprehensive support for managing controlled documents, training records, CAPAs, audits, and more. These elements are all essential to effective quality policy execution.
Through its validated, cloud-based platform, SimplerQMS helps organizations manage their quality policy as a living, integrated component of their QMS. SimplerQMS software supports compliance with key standards, regulations, and guidelines, including ISO 9001, ISO 13485, FDA 21 CFR Part 820, 21 CFR Part 211, EU MDR, and ICH Q10, among others.
By automating and centralizing these processes, SimplerQMS ensures that quality policies are consistently controlled, understood, and aligned with strategic and regulatory requirements – reducing risk and enhancing audit readiness.
