Crafting an Effective Quality Policy for ISO 13485 Compliance in a Medical Device Start-up

Posted: May 17, 2023

Crafting an Effective Quality Policy for ISO 13485 Compliance in a Medical Device Start-up

As a medical device start-up, adhering to the ISO 13485:2016 standard is crucial for ensuring the safety and effectiveness of your products. One of the key requirements of this standard is the development of a quality policy that outlines your organization’s commitment to quality management.

Crafting an effective quality policy can be a daunting task, but it is a critical step towards achieving ISO 13485 compliance. In this blog post, I will explore what a quality policy is, why it’s important, the ISO 13485 quality policy requirements, and how to write a quality policy that meets these requirements. I will also discuss common mistakes to avoid, how to communicate the policy to stakeholders, and the relationship between the quality policy and other key components of the ISO 13485 standard. Finally, I will cover how to keep your quality policy up to date and offer some concluding thoughts on the importance of this foundational document.

By the end of this article, I hope that you a clear understanding of how to craft an effective Quality Policy for ISO 13485:2016 compliance in your medical device start-up.

Table of Contents

What is ISO 13485:2016?

ISO 13485:2016 is an international standard that specifies the requirements for a quality management system (QMS) in the medical device industry. The standard sets out guidelines for organizations to follow when designing, developing, producing, installing, and servicing medical devices. Compliance with ISO 13485:2016 demonstrates a commitment to quality and safety, ensuring that medical devices meet regulatory requirements and are safe for patient use. For a medical device start-up, achieving ISO 13485:2016 compliance is critical to building a successful business, establishing credibility with customers and regulatory bodies, and ultimately ensuring the safety and efficacy of their products. An effective quality policy is a crucial component of a compliant QMS and plays a key role in demonstrating the start-up’s commitment to quality and safety.

Learn more about ISO 13485:2016 by taking our Introduction to ISO 13485:2016 Training Course.

What is a Quality Policy?

A quality policy is a formal document that outlines an organization’s commitment to quality management. It sets the tone for the organization’s approach to quality. The quality policy communicates the organization’s commitment to meeting customer requirements, complying with applicable regulations and standards, and continuously improving its processes and products.  It provides a framework for establishing and maintaining an effective quality management system that ensures the safety and effectiveness of medical devices.

A quality policy is a formal document that outlines an organization's commitment to quality management.

Why is a Quality Policy Important?

A quality policy is an essential requirement for a medical device manufacturer that is compliant with ISO 13485:2016. The quality policy serves as a framework for the organization’s quality management system, communicating the organization’s commitment to meeting customer requirements, complying with applicable regulations and standards, and continuously improving its processes and products.

When external audits are conducted on a medical device company, the quality policy is often one of the first things that is reviewed by the auditors. This is because the quality policy sets the tone for the entire QMS, and provides a framework for the company’s commitment to quality and compliance with ISO 13485:2016.

When external audits are conducted on a medical device company, the quality policy is often one of the first things that is reviewed by the auditors.

Having a strong quality policy in place can give a good “first impression” to auditors and regulators, demonstrating that the company takes quality seriously and has a robust system in place for ensuring compliance.

Having a written quality policy is critical for the following reasons:

  1. Demonstrates commitment to quality: A written quality policy demonstrates the organization’s commitment to quality management and ensures that all employees, suppliers, and customers understand the organization’s quality objectives.
  2. Provides a framework for decision-making: The quality policy provides a framework for decision-making processes, ensuring that all decisions are made in alignment with the organization’s quality objectives.
  3. Ensures compliance with regulations and standards: The quality policy ensures that the organization is compliant with applicable regulations and standards, including ISO 13485:2016.
  4. Facilitates continuous improvement: The quality policy sets the tone for the organization’s approach to quality and serves as a guiding principle for continuous improvement, ensuring that the organization is always striving to improve its processes and products.

Why the Importance of a Quality Policy can be Overlooked

 Medical device start-ups can sometimes overlook the importance of the quality policy in their pursuit of ISO 13485:2016 compliance. This can happen when the company views the quality policy as a mere document that needs to be created to satisfy the ISO standard, rather than an essential component of the company’s QMS.

However, the quality policy plays a central role in the design of a medical device company’s QMS because it provides a framework for the company’s quality objectives and establishes a clear direction for the organization’s quality efforts. The quality policy communicates the company’s commitment to quality to its stakeholders, including customers, regulators, and employees. It also sets the tone for the company’s quality culture and provides a foundation for continuous improvement.

When a company overlooks the importance of the quality policy, it can lead to a weak or ineffective QMS. This can result in a failure to meet customer requirements, increased product defects and recalls, and non-compliance with regulatory requirements. In addition, a weak quality culture can lead to employee dissatisfaction, low morale, and a lack of commitment to quality.

ISO 13485:2016 Quality Policy Requirements

The ISO 13485:2016 standard references the quality policy in various sections, and Table 1 provides a summary of the specific references to the quality policy within the standard.

ISO 13485:2016 Quality Policy Requirements

 Table 1 Where in ISO 13485:2016 the Quality Policy is referred to.

The following are the specific requirements that reference the quality policy.

In Clause 4.2 Documentation:

“4.2.1 General
The quality management system documentation (see 4.2.4) shall include:
a) documented statements of a quality policy and quality objectives”

 ISO 13485:2016 Clause 4.2.1 (a)

In Clause 5 Management Responsibility, in sections 5.1, 5.3, 5.4.1 and 5.6.1.

“5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintenance of its effectiveness by: ..
b) establishing the quality policy;”

ISO 13485:2016 Clause 5.1 (b)

“5.3 Quality policy
Top management shall ensure that the quality policy:
a) is applicable to the purpose of the organization;
b) includes a commitment to comply with requirements and to maintain the effectiveness of the
quality management system;
c) provides a framework for establishing and reviewing quality objectives;
d) is communicated and understood within the organization;
e) is reviewed for continuing suitability.”     

ISO 13485:2016 Clause 5.3

5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet applicable regulatory requirements and requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.”

 ISO 13485:2016 Clause 5.4.1

“5.6 Management review
5.6.1 General
The organization shall document procedures for management review. Top management shall review the organization’s quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.”

  ISO 13485:2016 Clause 5.6.1

In Clause 8 Improvement:.

“8.5 Improvement
8.5.1 General
The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the quality management system as well as medical device safety and performance through the use of the quality policy, quality objectives, audit results, post market surveillance, analysis of data, corrective actions, preventive actions and management review.”

ISO 13485:2016 Clause 5.5.4

 Understanding and adhering to these requirements is essential for a medical device start-up seeking ISO 13485:2016 compliance.

How to write a ISO 13485:2016 Complaint Quality Policy

I suggest taking the following steps when writing a quality policy that is compliant with ISO 13485:2016:

Understand the requirements of ISO 13485:2016: The first step in writing a quality policy that is compliant with ISO 13485:2016 is to understand the requirements of the standard. This includes understanding the purpose of the quality policy, as well as the requirements for its content and format.

Define the company’s mission and values: The quality policy should be aligned with the company’s mission and values. Define the company’s mission and values, and ensure that they are reflected in the quality policy.

Identify the intended audience: The quality policy should be written with the intended audience in mind. Identify the stakeholders who will be reading the quality policy and tailor the language and tone accordingly.

Consult with relevant stakeholders: Consult with relevant stakeholders, such as employees, customers, and suppliers, to ensure that the quality policy accurately reflects the company’s commitment to quality and meets the needs of all stakeholders.

Define the company’s commitment to quality: The quality policy should clearly define the company’s commitment to quality. This should include a statement of the company’s commitment to meeting customer needs and regulatory requirements, as well as a commitment to continuous improvement.

Define the scope of the quality management system: The quality policy should clearly define the scope of the company’s quality management system. This should include a description of the products and services covered by the system, as well as the processes and procedures that are used to ensure the quality of those products and services.

Obtain management approval: The quality policy should be reviewed and approved by top management to ensure that it accurately reflects the company’s commitment to quality and meets the requirements of ISO 13485:2016.

Communicate the quality policy: Once the quality policy has been approved, it should be communicated to all relevant stakeholders. This can be done through a variety of channels, such as company newsletters, employee meetings, and the company’s website.

Monitor and review the quality policy: The quality policy should be monitored and reviewed on a regular basis to ensure that it remains relevant and effective. This can be done through internal audits and management reviews.

Become an ISO 13485 internal auditor by taking our course Internal Auditor ISO 13485:2016 Training Course

When writing a quality policy, there are several common mistakes that can be made. Here are the top mistakes to avoid:

  1. Creating a policy that is too generic and lacks specific details.
  2. Creating a policy that is too complex and difficult to understand.
  3. Viewing the policy as a one-time document rather than a living, breathing document that needs regular review and update.
  4. Failing to communicate the policy effectively to all stakeholders, including employees, suppliers, and customers.

To avoid these mistakes, it is important to take the time to carefully craft a quality policy that is tailored to the organization’s unique needs and communicates a clear commitment to quality management. 

Here is an example of a quality policy that aligns with the ISO 13485:2016 standard.

At ABC Orthopedics, we are committed to providing safe, effective, and reliable orthopedic medical devices to our customers. Our mission is to improve the quality of life of patients with orthopedic conditions by providing innovative, high-quality products that meet their needs and exceed their expectations. We are dedicated to complying with the requirements of ISO 13485:2016 Clause 4.2.1, which requires the establishment, implementation, and maintenance of a quality management system.

Our quality management system is designed to ensure that our products meet the highest standards of quality and safety. We continually review and improve our processes to maintain compliance with regulatory requirements and industry standards. Our quality policy is communicated, understood, and applied throughout the organization, and we continually monitor and measure the effectiveness of our quality management system.

As a manufacturer of orthopedic medical devices, we are committed to:

Meeting the regulatory requirements and standards for our products and processes, including ISO 13485:2016.

Ensuring risk assessment and management is an integral part of our design and production processes. We assess and control risks throughout the product life cycle, from initial design to final distribution.

Continually improving the effectiveness of our quality management system by setting measurable objectives and targets.

Providing high-quality, reliable, and safe orthopedic medical devices that meet or exceed customer expectations.

Ensuring that all employees are trained and competent to carry out their responsibilities within the quality management system.

Ensuring that our suppliers and contractors are selected based on their ability to meet our quality requirements.

At ABC Orthopedics, quality is not just a priority; it is a core value that guides our every action. We are committed to providing exceptional orthopedic medical devices and ensuring that our customers are satisfied with our products and services.

Communicating the Quality Policy

Communicating the quality policy effectively is crucial for ensuring that everyone within the organization understands and adheres to it. The policy must be effectively communicated to stakeholders within and outside of the organization. The  effectiveness of the quality policy is limited if it is not effectively communicated to those who need to understand it.

Publish the Quality Policy on the Company Website: The Quality Policy can be published on the company website. This ensures that the Quality Policy is accessible to all stakeholders, including customers, suppliers, and regulatory authorities. The website can also include information about the company’s quality objectives, quality certifications, and quality metrics.

Display in the company premises: One way to communicate the Quality Policy is to display it prominently in the facility. The Quality Policy should be visible to employees, customers, and visitors. The manufacturer can display the Quality Policy on notice boards, posters, and signs in common areas such as the lobby, break rooms, and conference rooms.

Provide Training and Education on the Quality Policy: The manufacturer can provide training and education to employees, suppliers, and customers on the Quality Policy. This can be in the form of seminars, workshops, or online training courses. The training should focus on the importance of quality management, the role of the Quality Policy in the organization, and how stakeholders can contribute to the achievement of the company’s quality objectives.

Customer communication: The medical device manufacturer can communicate its quality policy to its customers through various communication channels, such as email, newsletters, or product packaging. This will ensure that customers are aware of the organization’s commitment to quality and can make informed decisions when choosing the organization’s products.

Supplier communication: The medical device manufacturer can communicate its quality policy to its suppliers through supplier agreements or other communication channels. This will ensure that suppliers are aware of the organization’s quality requirements and can meet these requirements when supplying raw materials or components.

Internal communication: The medical device manufacturer can communicate its quality policy through internal communication channels, such as staff meetings, intranet, or bulletin boards. This will ensure that all employees are aware of the organization’s quality policy and can contribute to achieving the organization’s quality objectives.

The  effectiveness of the quality policy is limited if it is not effectively communicated to those who need to understand it.

Updating the Quality Policy

The quality policy should be updated whenever there are changes to the company’s mission, vision, values, or business objectives that impact the QMS. It should also be reviewed and updated on a regular basis to ensure that it remains relevant and effective in meeting the company’s quality objectives.

Here are some examples of when a medical device company’s quality policy might be updated:

New product development: When a medical device company introduces a new product, they may need to update their quality policy to reflect any changes in quality objectives, processes, or procedures that are necessary to ensure the safety and effectiveness of the new product.

Regulatory changes: When there are changes to regulatory requirements or standards, a medical device company may need to update their quality policy to ensure compliance with the latest requirements. For example, the recent revision of ISO 13485:2016 may require companies to update their quality policy to reflect the new requirements.

Business expansion: When a medical device company expands their business into new markets or geographies, they may need to update their quality policy to reflect any new quality objectives, processes, or procedures that are required to meet the needs of the new market.

Continuous improvement: A medical device company may choose to update their quality policy as part of their ongoing efforts to improve the QMS and overall business operations. This may involve revising quality objectives, processes, or procedures based on feedback from customers, employees, or other stakeholders.

When there are changes to the regulatory environment: The medical device industry is heavily regulated, and companies must comply with a wide range of standards and regulations, including ISO 13485:2016. If there are changes to these regulations, the company’s quality policy may need to be updated to reflect these changes.

When the company introduces new products or services: When a company introduces new products or services, they may need to update their quality policy to ensure that it covers these new offerings. For example, if a company that previously only manufactured medical devices begins offering consulting services, they may need to update their quality policy to address the quality requirements of these services.

When there are changes to the company’s organizational structure: If the company undergoes a merger, acquisition, or restructuring, the quality policy may need to be revised to reflect the new organizational structure and ensure that all employees are aware of their roles and responsibilities.

Updating and revising the quality policy is a critical component of maintaining a compliant QMS. The standard requires that the quality policy be  reviewed regularly to ensure its ongoing suitability and effectiveness in meeting the company’s quality objectives. 

Conclusion

In conclusion, crafting an effective quality policy is a critical step towards achieving ISO 13485:2016 compliance and ensuring the safety and efficacy of medical devices produced by a start-up. A well-crafted quality policy serves as a statement of the organization’s commitment to quality and safety, guiding all aspects of the QMS. By understanding the requirements outlined in the ISO 13485:2016 standard and following best practices for writing and communicating the policy, a start-up can establish credibility with customers and regulatory bodies and build a successful business.

However, it’s essential to note that a quality policy is not a static document and should be periodically reviewed and updated to reflect changes in the organization’s operations, regulatory requirements, and customer needs. By maintaining a commitment to continuous improvement and updating the quality policy accordingly, a start-up can ensure ongoing compliance with the standard and enhance its reputation for quality and safety in the medical device industry.

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    Picture of Dr. Fiona Masterson

    Dr. Fiona Masterson

    With over 25 years’ experience in quality management, operations management,
    and higher education, Fiona combines technical expertise with highly engaging
    training. She has worked in fast-paced manufacturing environments including
    medical device companies, and lectures part-time in universities.

    She has Bachelor and Master of Science degrees, and a Doctorate in
    Mechanical Engineering. Fiona has published in peer reviewed journals on
    topics such as medical device and pharmaceutical regulatory affairs, on-the job
    training and innovative training technologies and strategies. .