NEU!! Entwickelt SxMDs mit einem strukturierten eQMS, einschließlich auditfähriger SxMD-Vorlagen, die an EU- und US-Standards angepasst sind. Mehr Erfahren!
ISO Standards Explained: Why They Matter for Your Business
Firstly, What is a Standard?
A standard is a set of agreed-upon guidelines, specifications, or criteria established by an authority or by consensus within a particular industry or field. Standards ensure that products, services, and processes are consistent, reliable, and safe. They provide a common language and framework that everyone can follow, which is especially crucial in tech and medical industries.
What are ISO Standards?
In the world of industries that are regulated, including businesses in the medical device industry, organizations must ensure their products comply with rigorous quality and safety standards.
Adhering to ISO standards is a key method to achieve this. But what exactly are ISO standards, and why are they crucial for quality compliance officers, regulatory professionals, and software developers? Let's delve into these questions.
The Objective of ISO Standards
ISO (International Organization for Standardization) standards are globally recognized guidelines developed to ensure the quality, safety, and efficiency of products and services across various industries.
These standards cover a wide range of sectors, from technology and manufacturing to healthcare and environmental management.
The primary objective of these standards is to provide a consistent framework that can be followed worldwide, reducing variability and enhancing overall quality. By adhering to ISO standards, companies can establish reliability, foster trust with consumers, and facilitate international trade by ensuring that products and services meet universally accepted benchmarks.
Overview of Different ISO Standards
ISO standards cover a wide range of industries and sectors, setting benchmarks for quality, safety, and efficiency. These international standards help organizations improve their processes and deliver better products and services. One way to look at this is firstly to distinguish between vertical and horizontal standards.
What are Vertical Standards?
These standards apply to a particular industry or sector. They address the specific needs, regulations, and practices of that industry.
They provide detailed guidelines that are unique to the industry, ensuring that all players in that sector adhere to the same requirements.
Looking vertically for medical device manufacturers, adhering to specific ISO standards is critical to ensuring product safety and efficacy. Several ISO standards are particularly relevant in this sector:
ISO 13485: Quality Management Systems for Medical Devices - Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Check out the key differences between ISO 9001 & ISO 13485 in our latest article and our video series.
ISO 14971: Application of Risk Management to Medical Devices - Establishes a process for a manufacturer to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
ISO 10993: Biological Evaluation of Medical Devices - Provides guidelines for evaluating the biocompatibility of medical devices to ensure they are safe for use in patients.
ISO 62304: Software Life Cycle Processes for Medical Device Software - Specifies life cycle requirements for the development of medical software and software within medical devices, ensuring it meets quality and safety standards.
Why This Matters For Vertical Standards:
Adhering to vertical standards shows your deep understanding and commitment to the specific industry, which can boost credibility and trust with industry stakeholders.
Many vertical standards are tied to regulatory requirements, so compliance is often mandatory to operate legally within the industry.
Horizontal Standards:
These standards are broad and apply across multiple industries. They are not specific to any one sector.
They establish general practices that can be implemented by various types of organizations, regardless of the industry they operate in.
Some common ISO horizontal standards include:
ISO 9001: Quality Management Systems - This standard provides a framework for organizations to ensure consistent quality in their products and services, enhancing customer satisfaction.
ISO 14001: Environmental Management Systems - Focuses on helping organizations improve their environmental performance through more efficient use of resources and reduction of waste.
ISO 27001: Information Security Management Systems - Provides requirements for establishing, implementing, maintaining, and continually improving an information security management system (ISMS).
ISO 45001: Occupational Health and Safety Management Systems - Aims to improve employee safety, reduce workplace risks, and create better, safer working conditions.
Why This Matters For Horizontal Standards
Implementing horizontal standards can make your company more versatile and capable of meeting broad, cross-industry best practices.
These standards often facilitate easier integration and interoperability between different sectors, making your product or service more adaptable.
Integrating both types of standards where relevant can provide a robust foundation for quality, compliance, and market competitiveness. It shows that you're not only meeting industry-specific needs but also aligning with broader best practices.
How to Know Which ISO Standards Relate to You
Determining which ISO standards apply to your organization can be challenging due to the broad range of standards available.
A good starting point is to understand your industry-specific requirements and your products' regulatory environment. Consulting with industry experts and regulatory bodies can provide valuable insights and help you navigate the complexities of standard compliance.
Additionally, exploring resources such as the ISO website can help you stay informed about relevant standards and best practices, offering practical guidance on implementation and compliance.
The Plan-Do-Check-Act Cycle within ISO Standards
The Plan-Do-Check-Act (PDCA) cycle is a core principle behind many ISO standards, mainly relevant for management system standards. It's a continuous improvement loop that helps organizations systematically plan, implement, monitor, and improve their processes. Here's a brief overview of the PDCA cycle:
Plan: Identify objectives and processes needed to deliver results.
Do: Implement the plan and execute the process.
Check: Monitor and measure the process against the objectives.
Act: Take actions to continually improve process performance.
Take a look at our recent article on the Plan Do Check Act cycle!
Why Consider ISO Standards from a Regulatory and Governing Body Perspective
Compliance with ISO standards is not just about maintaining high-quality products; it's also about adhering to regulatory requirements. Many governing bodies, including the FDA, recognize ISO standards as benchmarks for quality and safety. Adhering to these standards can simplify the regulatory approval process, reduce the risk of non-compliance, and demonstrate your commitment to maintaining high standards. This can also enhance your reputation and trustworthiness in the industry.
Harmonized ISO Standards with FDA and Other Regions
Some ISO standards are harmonized with regulatory requirements in different regions, meaning they are accepted and recognized across multiple jurisdictions. In the US we talk about recognized consensus standards. The situation with ISO 13485 harmonized with the FDA's Quality System Regulation (QSR) is slightly different as there the standard is being incorporated in the legislation.
Understanding these nuances for ISO Standards can streamline your compliance efforts, reduce duplication of regulatory submissions, and facilitate easier market access. This alignment can help you avoid costly delays and ensure smoother operations in international markets.
Notified Bodies and ISO Standards, Focus on Medical Devices
Notified bodies are organizations designated by regulatory authorities to assess the conformity of certain products before they can be placed on the market. For medical devices, notified bodies play a crucial role in evaluating compliance with relevant ISO standards. They conduct rigorous audits, review technical documentation, and ensure that your products meet all necessary regulatory requirements. Working with notified bodies is essential, as you need their approval to launch a Medical Device on the market in the EU (Except Class 1) and they will provide an additional layer of assurance of the quality and safety of your medical devices, helping you to confidently enter and compete in global markets.
What is an ISO Audit?
An ISO audit is a systematic, independent examination to determine whether activities and related results comply with planned arrangements. This process helps verify that standards are effectively implemented and maintained.
Types of ISO Audits for ISO Standards:
Internal Audits: Conducted by the organization's own staff to ensure internal compliance. Learn more about how Matrix Requirements can help you conduct an internal audit from our experts.
External Audits: Performed by independent certification bodies to provide an impartial assessment.
Surveillance Audits: Regular checks by a certification body to ensure ongoing compliance.
Top 5 Tips for ISO Standard Implementation
Implementing ISO standards can be a complex process, but the following tips can help you get started:
Understand the Requirements: Familiarize yourself with the specific ISO standards relevant to your industry and products.
Engage Stakeholders: Involve key stakeholders in the planning and implementation process to ensure buy-in and collaboration.
Conduct a Gap Analysis: Assess your current processes against the requirements of the ISO standards to identify areas for improvement.
Develop a Roadmap: Create a detailed plan outlining the steps needed to achieve compliance, including timelines and responsibilities.
Continuous Improvement: Use the PDCA cycle to continuously monitor, evaluate, and improve your processes to maintain compliance.
Conclusion
Incorporating ISO standards into your organization's operations is a strategic decision that can lead to significant benefits. By adhering to these internationally recognized benchmarks, you enhance product quality, ensure compliance with regulatory requirements, and demonstrate your commitment to excellence.
Whether you are in manufacturing, healthcare, or any other industry, understanding and implementing the relevant ISO standards can provide a competitive edge and pave the way for sustained success. Matrix Requirements can help you on your journey with our eQMS. Reach out to our team to learn more about how we can help you bridge the gap between Quality and Compliance.