ISO 13485 for business

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.


Product conformity is important across all industries, but it's especially crucial when it comes to the design and manufacturing of medical devices. Consistent product quality is an issue of patient safety, regulatory compliance and a company's ability to succeed in the industry. To ensure the appropriate level of quality control, it's essential to comply with the relevant standards.


One of these standards is ISO 13485, a quality management system (QMS) standard designed specifically for medical device manufacturers. At Aequalis, we have extensive experience with ISO 13485 and other standards relevant to the medical device manufacturing sector.


The following step-by-step guide to implementing ISO 13485 will walk you through how to become certified with the help of the experts at Aequalis.


ISO 13485 is a quality management standard that is designed specifically for the manufacturing of medical devices. The standard is based on ISO 9001 but contains additional requirements that relate specifically to manufacturing, installing and servicing medical devices. ISO 13485 calls for:

  • Implementing a quality management system
  • Taking a risk management approach to product development
  • Validating processes
  • Complying with regulatory and statutory requirements
  • Establishing effective methods for product traceability and recall


ISO 13485 also helps companies that manufacture, install and service medical devices with process improvement, operational efficiency and product improvement.


Benefits Of ISO 13485

Complying with ISO 13485 and achieving certification to it can provide numerous benefits to medical device companies. Some of the benefits of ISO 13485 certification include:

  • Legal Compliance: ISO 13485 certification requires compliance with all legal and regulatory requirements. It also helps you to improve your understanding of how these requirements impact your organization and your customers.
  • Enhanced Risk Management: Certification to ISO 13485 also helps you to manage risks by increasing the traceability and consistency of your products and services.
  • Reduced Operating Costs: ISO 13485 helps you to continually improve your processes and make them more efficient over time, saving your organization money.
  • Improved Customer Satisfaction: A medical device QMS helps you to provide more consistent quality in your products and services, making your products more reliable and better able to meet customers' needs. This enhanced quality increases customer satisfaction.
  • Better Access to Information: The documentation that ISO 13485 requires can assist your organization in creating a consolidated knowledge base, which can help you to identify issues and improve your products and processes. Documentation also helps you to ensure that team members have access to accurate information whenever they need it.
  • Improved Business Reputation: Certification to ISO 13485 is recognized internationally as a sign of a reputable business and high-quality products, so it can improve your business's reputation among current and potential customers, investors, partners, suppliers, and other stakeholders.
  • Ability To Win More Business: Many businesses prefer to work with medical device organizations that have ISO 13485 certification, and some require that all the companies they partner with have it. This is due in part to the fact that, under the latest version of ISO 13485, companies are responsible for ensuring any subcontractors they work with conform to ISO 13485 requirements. Because of these preferences and requirements, ISO 13485 certification enables you to win more business.
  • International Expansion Opportunities: ISO 13485 is internationally recognized as a sign of product quality and is the first step to regulatory approval in many major markets. These qualities mean ISO 13485 certification can help you to expand your business into new markets.
  • Assistance With ISO 9001 Certification: Achieving ISO 13485 certification can make it easier to earn certification to ISO 9001, as the two standards share many requirements. Keep in mind that there are some differences in requirements that you will need to account for.

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We are British business helping other businesses in the UK. I started out running from a small, rented room in Blackpool with an entrepreneurial spirit, and a desire to help. Today, we help hundreds of businesses achieve certification and improve their processes every year.

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