What Is The Difference Between ISO 13485 And ISO 9001?

calendar22 May, 2023
timeReading Time: 4 Minutes
ISO 13485 and ISO 9001

Establishing a strong quality management system is vital when creating a medical device (QMS). Adhering to the pertinent national and international regulatory regulations is crucial while developing your QMS. The two most important ISO standards in terms of quality management are ISO 13485 and ISO 9001. Although ISO 9001 served as the foundation for ISO 13485, it’s crucial to keep in mind that there are some significant distinctions between the two standards.

What is a Quality Management System?

A codified system known as a Quality Management System[1] (QMS) is used to record processes, procedures, and roles for consistently providing high-quality goods and services that satisfy customer and regulatory criteria. The goal of it is to give your company a structure that enhances collaboration, communication, and consistency throughout the entire business while simultaneously cutting waste and encouraging continuous development.

It is kind of a platform for quality management that enables you to automate and streamline quality management procedures throughout your business. Adopting such QMS tools can lower operational expenses while simultaneously enhancing quality and compliance. They may be applied throughout a company as a whole or in certain divisions, such as quality, regulation, product development, and others.

Importance of Quality Management System (QMS)

Many organizations mistakenly believe that large corporations are the only ones who need a quality management system. Any size organization in any industry can gain from using a quality management system. A quality management system enables businesses to maintain continuous improvement, establish regulatory compliance, and make sure that quality is incorporated into every facet of the good or service.

Different Types of Quality Management Systems

Several kinds of quality management systems exist. The best option for your company will depend on a variety of elements, including your industry, your needs for quality, and others. 

The most widely used and recognized quality management system standard in the world is ISO 9001:2015. Organizations can use the specifications for a QMS in ISO 9001:2015 to create their programs.

The remaining ISO 9000 series (including ISO 9000 and ISO 9004), the ISO 14000 series (environmental management systems), ISO 13485 (quality management systems for medical devices), ISO 19011 (auditing management systems), and IATF 16949 are additional standards of quality management systems (quality management systems for automotive-related products).

What is ISO 13485 and ISO 9001?

Let’s understand the meaning of ISO 13485 and ISO 9001:

ISO 3485

Like other ISO certifications, ISO 13485 enables a company to demonstrate that it can consistently and completely meet the needs of clients and governing bodies. ISO 13485 specifically pertains to medical devices and associated services. The ISO 13485 guidelines can be used to develop a quality management system (QMS) that ensures best practices. Businesses in the medical device sector have the ability to use ISO 13485 at any stage of the product life cycle. Adopting this standard gives users access to a detailed framework for developing a QMS, allowing them to identify weaknesses in the existing quality management system and more effectively track where and how changes may be made. Although ISO 13485 certification is not required, there are numerous advantages that cannot be ignored.

ISO 9001

The international standard known as ISO 9001 is used to describe the specifications for a quality management system (QMS). The standard is used by businesses to show that they can consistently deliver goods and services that adhere to legal and customer standards. It is the most widely used standard in the ISO 9000 series and the only one to which enterprises can receive certification. ISO 9001 was released initially in 1987. In September 2015, the most recent edition of ISO 9001 was made public.

Similarities and Differences between ISO 13485 and ISO 9001

Following are the similarities and differences between ISO 13485 and ISO 9001:


  • Risk-based strategy: Both standards stress the importance of approaching both business and production from a risk perspective and basing critical choices on a risk analysis.
  • Process strategy: Both standards follow the Plan-Do-Check-Act (PDCA) process methodology.
  • Customer Focus: Both standards are focused on making sure that the needs of the consumer are addressed.
  • Infrastructure: Both standards demand that the infrastructure required for business operations be identified.
  • Employee Competency: Under both standards, an organization is required to assess each employee’s proficiency in order to ensure that they are capable of doing the tasks allocated to them in compliance with regulatory requirements.
  • Organization’s role: Both standards demand that the organizational structure specify employee functions.


  • Scope

The scope of these quality standards, which differs between ISO 13485 and ISO 9001 for medical devices, is their main distinction. The international standard ISO 9001 outlines requirements for a quality management system that can be implemented at any organization, independent of the sector, the scope of goods or services, or the scale of business.

A thorough management system designed exclusively for the production of medical equipment is ISO 13485. It gives less organizational process freedom and places a greater emphasis on regulatory compliance.

  • Documentation control

In terms of documentation, ISO 13485 is more stringent than ISO 9001 since it calls for the inclusion of regulatory documents—including full product specifications, descriptions of production processes, and instructions for installation and maintenance—in the system documentation.

  • Distribution of duties

While ISO 13485 mandates that a medical device maker choose a specific individual from the management to be accountable for QMS, ISO 9001 permits businesses to distribute the duties for quality control without being connected to specific managers.

The ISO 13485 standard focuses on the creation of risk management paperwork and mandates that a manufacturer of medical devices keep track of the risk management procedure throughout medical device production. Additionally, the standard requires medical device manufacturers to examine customer complaints and set up post-sale oversight of the product’s adherence to the stated quality.

  • Risk management
  • Quality requirements

Customer satisfaction is a sign of a quality-oriented culture according to ISO 9001. Customers’ safety is the primary focus of ISO 13485, which also defines particular safety requirements for manufacture (including sterility), assembly and packaging of each medical device, installation, inspection, and shelf life of medical devices, among other areas.

  • Resource management

Both standards define resources as the diverse tools, structures, people, and IT resources needed to produce high-quality goods. The business that is involved in the whole manufacturing cycle of medical devices is required by ISO 13485 to document the standards for the hygiene and cleanliness of employee uniforms, keep an eye on the working environment, and create methods for the containment of contaminated products.


Since ISO 13485 and ISO 9001 don’t have the same structure, most organizations would find it difficult to adhere to both standards. Since ISO 13485 is heavily based on ISO 9001, it makes more sense for the majority of firms to pursue the one that fits them best rather than both. For any company that distributes internationally, ISO 13485 is a superior option because of the advantages it provides. Customers from other countries will be looking for partners who have ISO 13485 accreditation.

Read our Article:How To Get ISO 13485 Certificate?

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