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October 17, 2023

ISO 13485 vs. ISO 9001 - A Comparison Panel

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Quality management systems (QMS) are essential for organizations across various industries to ensure product and service quality, compliance with regulations, and customer satisfaction.

Two prominent international standards that address quality management are ISO 9001 and ISO 13485.

While both standards aim to enhance quality, they serve different purposes and cater to distinct sectors. In this extensive comparison panel, we will delve into the key differences and similarities between ISO 9001 and ISO 13485, shedding light on their applications, requirements, and benefits.

Understanding ISO Standards

ISO 9001: The Universal QMS Standard

ISO 9001, officially known as “ISO 9001: Quality Management Systems - Requirements”, stands as the pinnacle of global recognition when it comes to quality management standards. This internationally acknowledged framework, established by the International Organization for Standardization (or ISO), plays a pivotal role in guiding organizations, regardless of their industry or size, in developing, implementing, and sustaining an efficient and effective QMS.

At its core, ISO 9001 essentially revolves around one objective: elevating customer satisfaction by consistently meeting their requirements and relentlessly improving operational processes. It’s not confined to any specific industry, making it truly universal and adaptable.

This adaptability makes ISO 9001 an invaluable tool for organizations across sectors and geographies.

Key Principles of ISO 9001:

  • Process-Based Management: ISO 9001 places a strong emphasis on a process-oriented approach to management. This means organizations are encouraged to view their operations as a series of interconnected processes, each contributing to the overall efficiency and quality of the product or service. By analyzing and optimizing these processes, organizations can enhance their performance and deliver consistent results.
  • Customer Focus: ISO 9001 places customers at the center of its philosophy. Meeting and exceeding customer expectations is a core goal. This not only involves understanding customer needs but also actively seeking feedback and using it to drive improvements. By maintaining a customer-centric approach, organizations can build trust and loyalty among their clientele.
  • Leadership Involvement: Effective leadership is a critical component of ISO 9001. Leaders within the organization are expected to provide clear direction, establish a culture of quality, and actively engage in the QMS implementation. Their commitment and support are essential in ensuring that quality objectives are met and sustained.
  • Data-Driven Decision-Making: ISO 9001 emphasizes the importance of data and evidence-based decision-making. Organizations are encouraged to collect and analyze data related to their processes and performance. This data-driven approach allows for informed decision-making, helping organizations identify areas for improvement and make changes that lead to greater efficiency and quality.

In essence, ISO 9001 stands as a shining example of excellence in quality management that knows no boundaries or industry restrictions. It equips organizations with the tools to create a structured and systematic approach to quality, leading to ongoing improvements, delighted customers, and sustained success. By embracing the principles of ISO 9001, organizations not only meet international standards but also position themselves for success in today’s competitive, customer-centric business world.

ISO 13485: Quality Management for Medical Devices

ISO 13485, formally known as “ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes,” stands as a highly specialized standard tailored exclusively for organizations engaged in the intricate realms of medical device production, distribution, and servicing.

Published by the International Organization for Standardization (ISO), this standard not only sets the benchmarks for excellence but also serves as the cornerstone for compliance with stringent regulatory bodies such as the U.S. FDA and the European Union’s MDR.

The significance of ISO 13485 is rooted in its unwavering dedication to safeguarding the well-being of patients and healthcare practitioners. Here, we delve into the core tenets of ISO 13485 and explore why it is indispensable for those navigating the complex landscape of medical devices:

  • Product Safety at the Forefront: ISO 13485 places an unshakable emphasis on the paramount importance of product safety. Given the critical role medical devices play in healthcare, this standard sets rigorous criteria to ensure that every aspect of design, production, and distribution prioritizes the safety of patients and users. This focus extends to risk management, where potential hazards are assessed and mitigated to prevent harm.
  • Regulatory Compliance as a Cornerstone: In the realm of medical devices, adherence to regulations is non-negotiable. ISO 13485 aligns seamlessly with the requirements of regulatory authorities worldwide. It provides a robust framework to ensure that organizations meet and exceed the regulatory expectations and legal obligations specific to medical devices. This alignment simplifies the process of obtaining necessary approvals, including CE marking in Europe or FDA clearance in the United States.
  • Holistic Quality Management Systems: ISO 13485 mandates the establishment and maintenance of comprehensive QMS that are specially tailored for the unique challenges of the medical device industry. These systems encompass every facet of an organization’s operations, from design and development to manufacturing, testing, and post-market surveillance. The standard provides a systematic approach to quality assurance, emphasizing the consistency and traceability of processes.
  • Continuous Improvement: Beyond compliance and safety, ISO 13485 promotes a culture of continuous improvement. Organizations are encouraged to monitor and evaluate their QMS regularly. By analyzing data, soliciting feedback from users and stakeholders, and conducting internal audits, they can identify opportunities for refinement and enhancement, ensuring that their products and processes evolve in tandem with technological advancements and changing healthcare needs.

In conclusion, ISO 13485 epitomizes the pinnacle of quality management for the medical device industry. It offers a robust foundation upon which organizations can build their commitment to patient safety, regulatory compliance, and operational excellence.

By adhering to the principles and standards set forth in ISO 13485, organizations can not only thrive in the highly regulated medical device sector but also contribute to the betterment of healthcare worldwide by delivering reliable, safe, and effective medical devices.

Key Differences

When comparing ISO 9001 and ISO 13485, it becomes evident that these standards are tailored to different industries and have distinct emphases. Let’s dive deeper into their key differences.

Industry Focus

  • ISO 9001: ISO 9001 serves as a generic standard with broad applicability. It extends its reach across a wide spectrum of industries, spanning manufacturing, services, education, finance, and many more.

The central objective of ISO 9001 is to bolster the overall quality and enhance customer satisfaction. It provides a versatile framework for organizations to develop quality management systems, fostering operational excellence and customer-centric approaches.

  • ISO 13485: In stark contrast, ISO 13485 is a specialized standard exclusively designed for the medical device industry.

This standard addresses the intricate challenges, nuances, and regulatory requirements inherent to the design, production, and distribution of medical devices. Compliance with ISO 13485 is often a legal mandate for medical device manufacturers, ensuring that products are developed and distributed with the utmost safety and effectiveness in mind.

Regulatory Requirements

  • ISO 9001: ISO 9001 serves as a foundation for organizations to demonstrate their dedication to quality, but it refrains from specifying detailed regulatory requirements. Instead, it adopts a flexible approach to implementation, permitting organizations to adapt their Quality Management Systems according to their unique needs and contextual factors. ISO 9001 encourages a proactive stance towards quality but leaves room for adaptation.

  • ISO 13485: ISO 13485 embeds more rigorous and specific regulatory requirements, especially geared towards the medical device industry. It aligns with regulatory frameworks like the FDA’s Quality System Regulation and the European Medical Device Regulation. For organizations in this sector, ISO 13485 compliance is not just a matter of best practice but a mandatory step for legal compliance, ensuring that medical devices meet the highest standards of quality and safety.

Risk Management

  • ISO 9001: While risk management is indeed important within ISO 9001, its emphasis is more generalized. It encourages organizations to identify, assess, and manage risks to improve overall efficiency and effectiveness.

The focus extends beyond product safety and regulatory compliance, aiming to enhance operational performance across various industries.

  • ISO 13485: ISO 13485 places a strong focus on risk management due to the critical nature of medical devices. This standard necessitates organizations to meticulously identify, assess, and mitigate risks associated with both their products and the processes involved in their creation.

This approach ensures that medical device manufacturers prioritize the safety of patients and users, as well as compliance with stringent regulatory requirements.

Thus, ISO 9001 and ISO 13485 represent two distinct approaches to quality management tailored for different sectors.

ISO 9001 offers versatility and broad scope, fostering quality and customer satisfaction across diverse industries.

In contrast, ISO 13485 specializes in the medical device realm, incorporating strict regulatory adherence and a heightened focus on risk management to guarantee the safety and effectiveness of medical products.

Understanding these differences is essential for organizations to select the right standard that aligns with their industry, objectives, and compliance requirements.

Key Similarities

While ISO 9001 and ISO 13485 cater to different industries and have distinct areas of emphasis, they also exhibit significant commonalities that underscore their shared commitment to quality management.

These key similarities include:

1. Process Approach:

  • ISO 9001: ISO 9001 advocates a process-based approach, emphasizing the need to define, document, monitor, and continually improve processes. This approach allows organizations to manage their operations systematically and with a focus on efficiency and quality.
  • ISO 13485: Similarly, ISO 13485 also places a strong emphasis on a process-oriented approach, particularly when it comes to the design, production, and distribution of medical devices. It encourages organizations to define and control processes to ensure product safety and effectiveness.

2. Management Commitment:

  • ISO 9001: Both standards require active leadership involvement in quality management. In ISO 9001, top management plays a crucial role in setting quality objectives, allocating resources, and fostering a culture of quality throughout the organization.
  • ISO 13485: ISO 13485 shares this requirement for management commitment. In the medical device industry, the role of leadership is pivotal in ensuring that safety and regulatory compliance are at the forefront of organizational priorities.

3. Continuous Improvement:

  • ISO 9001: Continuous improvement is a fundamental concept in ISO 9001. Organizations are urged to monitor performance, gather data, and use this data to drive ongoing enhancements to their processes, products, and overall quality management systems.
  • ISO 13485: ISO 13485 also embraces the principle of continuous improvement. In the medical device industry, it’s essential for organizations to evolve with advancements in technology and the changing landscape of healthcare. Regular assessments and improvements are vital to maintaining the safety and efficacy of medical devices.

4. Customer Focus:

  • ISO 9001: Customer satisfaction is a central theme in ISO 9001. Organizations are expected to identify customer needs and expectations and then work diligently to meet or exceed them. A satisfied customer base is a key indicator of a well-implemented quality management system.
  • ISO 13485: Similarly, ISO 13485 underscores the importance of understanding and fulfilling customer requirements in the medical device context. Ensuring that medical devices meet the specific needs and expectations of healthcare professionals and patients is paramount to the standard’s objectives.

These shared elements emphasize that both ISO 9001 and ISO 13485 are built on a foundation of systematic quality management principles.

Regardless of their industry-specific nuances, these standards prioritize processes, leadership involvement, ongoing improvement, and, most importantly, the satisfaction of their end users. This alignment in core principles underscores the universal importance of these quality management standards in enhancing operational efficiency, product safety, and customer-centricity.

Benefits of ISO 9001 and ISO 13485

Benefits of ISO 9001

  • Enhanced Customer Satisfaction: ISO 9001 provides organizations with a robust framework for consistently delivering high-quality products and services. This, in turn, leads to increased customer satisfaction as customers receive products that meet their expectations and requirements.
  • Improved Operational Efficiency: ISO 9001 encourages the identification and optimization of processes, resulting in reduced waste, enhanced productivity, and cost savings. Streamlining operations and reducing errors leads to a more efficient and effective organization.
  • Increased Competitiveness: Organizations certified to ISO 9001 often enjoy a competitive advantage in the market. Customers and partners view ISO 9001 certification as a mark of commitment to quality, which can open doors to new opportunities and partnerships.
  • Greater Consistency and Traceability: ISO 9001 enforces a process-based approach, which enhances consistency in operations and enables traceability of processes, making it easier to identify and rectify issues.
  • Improved Risk Management: The data-driven decision-making encouraged by ISO 9001 helps organizations make informed choices and mitigate risks. This proactive risk management approach enhances the organization’s ability to weather unexpected challenges.
  • Enhanced Communication and Alignment: ISO 9001 fosters a culture of quality that encourages open communication and collaboration within organizations. This improved communication enhances teamwork and alignment with the organization’s quality objectives.

Benefits of ISO 13485

  • Compliance with Regulatory Requirements: ISO 13485 is a cornerstone for compliance in the highly regulated medical device industry. Organizations that adhere to this standard can navigate the complex web of regulations, including the FDA’s Quality System Regulation (QSR) and the European Union’s Medical Device Regulation (MDR), ensuring that their products meet the highest standards of safety and quality.
  • Enhanced Product Safety and Patient Outcomes: ISO 13485 places patient safety at the forefront by requiring rigorous risk management and quality control measures. This focus on safety directly contributes to improved patient outcomes, as it ensures that medical devices are reliable, effective, and safe to use.
  • Improved Risk Management in a Highly Regulated Industry: Given the critical nature of medical devices, ISO 13485’s stringent focus on risk management ensures that organizations in this sector identify, assess, and mitigate risks associated with their products and processes.
  • Greater Traceability and Control: ISO 13485 mandates comprehensive documentation and traceability throughout the product lifecycle, from design and development to production and post-market surveillance. This level of control assures the quality and safety of medical devices.
  • Increased Market Access and International Recognition: ISO 13485 certification is globally recognized and often a requirement for market access. It opens doors to international markets, giving organizations a competitive edge and broader reach.
  • Enhanced Organizational Reputation and Stakeholder Trust: Organizations certified to ISO 13485 demonstrate their unwavering commitment to quality, safety, and regulatory compliance. This builds trust among stakeholders, including healthcare professionals, patients, and regulatory authorities, enhancing the organization’s reputation and credibility.

That way, both ISO 9001 and ISO 13485 offer a wealth of benefits, but they are tailored to the specific needs and regulatory requirements of different industries.

The choice between these standards depends on the organization’s industry, objectives, and compliance needs.

Conclusion

In summary, ISO 9001 and ISO 13485 are both valuable quality management standards that serve different purposes.

ISO 9001 is a generic standard applicable to organizations across various industries, emphasizing customer satisfaction and process improvement. ISO 13485, on the other hand, is specific to the medical device industry and places a strong emphasis on regulatory compliance, risk management, and product safety.

Organizations should carefully assess their industry, objectives, and regulatory requirements to determine which standard is most suitable for their needs. In some cases, organizations may choose to implement both standards, leveraging the benefits of each to enhance overall quality and compliance.

Ultimately, the choice between ISO 9001 and ISO 13485 will depend on an organization’s specific context and goals, with the overarching aim of delivering high-quality products and services while meeting industry-specific requirements.

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Privacy Policy

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iCure SA (iCure) is incorporated in Geneva, Switzerland, with a registered office at Rue de la Fontaine 7, 1204 Geneva, Switzerland registered in the commercial registry under CHE-270.492.477.

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The original language of this Privacy Policy is English. In the case of other translations provided by iCure, the English version shall prevail.

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1. Definitions

Administrative Data: means Personal Data such as the Name, Email, and Phone in order to perform administrative tasks like Invoicing or contacting the Client (if support is needed).

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For this website, iCure collects and determines the use and the purpose of any Personal Data uploaded by the visitor, therefore iCure is defined as the Data Controller according to the GDPR.

2.1 Contact Form

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Please contact us with any questions or comments about this Policy, your Personal Data, and our use and disclosure practices by email at privacy@icure.com If you have any concerns or complaints about this Policy or your Personal Data, you may contact our DPO at privacy@icure.com.

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Last update: July the 26th, 2023.

Information Security Policy

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1. Introduction

The iCure universe is built on trust. Guaranteeing the confidentiality of the data that are entrusted to us is our highest priority.

The Information Security Policy of iCure abstracts the security concept that permeates every activity and abides by the ISO 27001:2013 requirements for Information Security, so that we ensure the security of the data that iCure and its clients manage.

Every employee, contractor, consultant, supplier and client of iCure is bound by our Information Security Policy.

2. Our Policy

iCure is committed to protecting the confidentiality, integrity and availability of the service it provides and the data it manages. iCure also considers protecting the privacy of its employees, partners, suppliers, clients and their customers as a fundamental security aspect.

iCure complies with all applicable laws and regulations regarding the protection of information assets and voluntarily commits itself to the provisions of the ISO 27001:2013.

3. Information Security Definitions

Confidentiality refers to iCure’s ability to protect information against disclosure. Attacks, such as network reconnaissance, database breaches or electronic eavesdropping or inadvertent information revealing through poor practices.

Integrity is about ensuring that information is not tampered with during or after submission. Data integrity can be compromised by accident or on purpose, by evading intrusion detection or changing file configurations to allow unwanted access.

Availability requires organizations to have up-and-running systems, networks, and applications to guarantee authorized users’ access to information without any interruption or waiting. The nature of data entrusted to us requires a higher-than-average availability.

Privacy is the right of individuals to control the collection, use, and disclosure of their personal information. Our privacy policies are based on the GDPR(https://gdpr-info.eu/) and can be augmented by added requirements of specific clients or law areas.

4. Risk Assessment

The main threats iCure is facing as a company are:

  1. Data Theft;
  2. Data Deletion;
  3. Denial of Service attacks;
  4. Malware;
  5. Blackmail and Extortion.

As providers of a solution used by developers active in Healthcare, we also have to anticipate the risks of:

  1. Attacks on our clients’ data, which could lead to major social damages and a loss of trust in our solution;
  2. Abuse of our solution by ill-intentioned clients, that could impact the quality of the service provided to the rest of our clients.

The motivation of the attackers in the latter cases can range from financial gain to political or ideological motivations.

A last risk is linked to the nature of the healthcare data we handle. We must ensure, that the data we handle are not used for purposes other than those for which they were collected:

A piece of data collected from a patient for the purpose of a medical consultation should not be available to third parties, not even a government agency.

5. Risk Management

The main principles we apply to manage the risks we face are:

  1. Confidentiality by design: All sensitive data is encrypted end-to-end before being stored in our databases. We do not have any access to the data we store. Our client’s customers are the only ones who can decrypt the data we store.
  2. Anonymization by design: Healthcare information that has to be stored unencrypted is always anonymized using end-to-end encryption scheme. This means that the link between the healthcare and administrative information must be encrypted.

Those two principles allow us to minimize the risks of data theft, blackmail, extortion, and coercion by government agency.

  1. Multiple real-time replicas, with automatic failover: We use a distributed database architecture to ensure that our data is available at all times. We use a master-master architecture, each data is replicated at least 3 times. Snapshots are taken every day to ensure that we can restore the data in case of a malevolent deletion event.
  2. Automatic password rotations: no single password can be used for more than 48 hours. Passwords are automatically rotated every 24 hours. In case of a password leak, we can limit the window of opportunity for an attack.

Those two principles allow us to minimise the risks of data deletion, denial of service attacks, and malware.

  1. Minimization of the attack surface: we deploy our systems in the most minimal way. We only expose the network services that are strictly necessary.
  2. Strict dependency management: we only use open-source software that is regularly updated and audited by the community. We favor dependency management software and providers that minimize the risk of supply chain poisoning.

Those two principles allow iCure to minimise the risks of intrusion by vulnerability exploit or supply chain attacks, two risks that could lead to data theft or data deletion.

6. Further Information

This policy is valid as of November 10th, 2022. For futher information please connect with us at privacy@icure.com

Impressum

iCure SA

Rue de la Fontaine 7, 1204 Geneva, Switzerland

CHE-270.492.477

Website: https://icure.com/

Contact email: client@icure.com

Privacy request: privacy@icure.com

This website uses cookies

We use only one cookie application for internal research on how to improve our service for all users. It is called Matomo, and it stores the information in Europe, anonymized and for limited time. For more details, please refer to our and .

Cookie Notice

www.iCure.com

1. Cookies basic information

Cookies are text files placed on your computer to collect standard Internet log information and visitor behavior information. When you visit our websites, we may collect information from you automatically through cookies or similar technology (for further information, visit allaboutcookies.org.)

You can set your browser not to accept cookies, and the above website tells you how to remove cookies from your browser. However, in a few cases, some of our website features may not function as a result.

2. Types of cookies

Types of cookies depending on the organisation managing them:

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3. How and what cookies do we use

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Analytical cookies (with your consent): collect information about how visitors use a website and help website owners improve site performance. They don’t collect information that identifies a visitor.

4. Cookies used on our website

Our web analytics open-source program, Matomo, uses two types of cookies for analyzing page usage: a session cookie ("MATOMO_SESSID") that lasts for 30 minutes and a persistent cookie ("_pk_id.xxx") that remains beyond the browsing session, allowing anonymous tracking of website usage for up to 13 months (without collecting personal information). Matomo temporarily stores user data, including IP addresses, on our server in anonymized form for evaluation before deletion. This data is solely used for our personnal analysis, with no sharing with third parties.

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  • Expiration: Session 30 min

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  • Expiration: 13 months

For the purposes of analyzing website usage and to optimize its services. The legal basis for the use of Matomo is Article 6, 1 (a) of the GDPR (consent).

5. Users preference

The user can, at any time, allow, block or delete the cookies installed on his/her device by changing the settings on the browser installed on his/her computer:

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6. Withdrawing consent

The user may withdraw his/her consent relating to the Cookies Policy at any time, and may delete the cookies stored on his/her device by adjusting his/her internet browser settings, as described above.

7. Cookie settings

This Cookies Policy may be modified when required by the legislation in force at any time or when there is a change in the type of cookies used on the website. For this reason, we recommend that you review this policy every time you access our website so that you are appropriately informed of how and why we use cookies.

8. Contact

Please contact us with any questions or comments about this Policy, your Personal Data, and our use and disclosure practices by email at privacy@icure.com

iCure SA

Contact: contact@icure.com

Last update: September 13th, 2023

Quality Policy

www.iCure.com

At iCure SA, we are committed to excellence in all aspects of our work. Our quality policy is designed to provide a framework for measuring and improving our performance within the QMS.

1. Purpose of the Organization

The purpose of the QMS is to ensure consistent quality in the design, development, production, installation, and delivery of Data processing, security, archival, technical support and protection solutions for medical device software, while ensuring we meet customer and regulatory requirements. The document applies to all documentation and activities within the QMS. Users of this document are members of the iCure Management Team involved in the processes covered by the scope.

2. Compliance and Effectiveness

We are committed to complying with all applicable regulatory and statutory requirements, including ISO 13485: 2016 and ISO 27001:2013. We strive to maintain and continually improve the effectiveness of our quality management system.

3. Quality Objectives

Our quality objectives are set within the framework of this policy and as defined by our Software Development Lifecycle and are reviewed regularly to ensure they align with our business goals. These objectives serve as benchmarks for measuring our performance and guide our decision-making processes.

4. Communication

We ensure that our quality policy is communicated and understood at all levels of the organization. We encourage every member of our team to uphold these standards in their daily work whether they are employees, contractors, consultants, suppliers, clients or any other person involved in building our medical data management software.

5. Continuing Suitability

We regularly review our quality policy to ensure it remains suitable for our organization. This includes considering new regulatory requirements, feedback from customers, and changes in our business environment. By adhering to this policy, we aim to enhance customer satisfaction, improve our performance, and contribute to the advancement of medical technology

iCure SA

Contact: contact@icure.com

Last update: April 17th, 2024