ISO 13485:2016
Medical Devices
Quality Management System


When it comes to patient care, the medical field is quite delicate. The medical devices sector has its own set of standards, laws, and certifications that it must adhere to. Each step was taken to ensure quality, safety, and, most importantly, legal conformity.

The particular steps that medical device manufacturers must take are not spelled out in the ISO 13485 certification. Nonetheless, the certification ensures the public that rigorous standards are maintained throughout the production of medical equipment.

There are several advantages to adopting ISO 13485 for your company. Maintaining an ISO 13485 quality management system will require some more work up front, but the payoff is greater efficiency and happier clients.

HISTORY OF ISO 13485:2016

The latest version of 13485:2016

ISO 13485:2016 is compliant with the requirements of ISO 9001:2008. This is due to the fact that the most recent version of ISO 9001 does not follow the high-level structure (Annex L) (which is 9001:2015). ISO 9001:2015 focuses on customer satisfaction and continual improvement, whereas ISO 13485:2016 prioritises the documentation and safety of a product.

More attention has been paid to risk in the latest version of ISO 13485, and the facility requirements, design and development requirements, supplier control, complaint management, etc., have all been improved. In addition, it lays down the standards for product cleanliness, facility upgrades, and the allocation of responsibility for training employees.

The Intent of ISO 13485:2016

Organizations that are involved in the conception, manufacturing, installation, and servicing of medical devices and services linked to them are the intended users of the ISO 13485 standard.

Moreover, both internal and external parties, such as certification organisations, can utilise it as a tool to assist them in the conduct of their auditing procedures. It guarantees the safe design, development, manufacture, installation, and delivery of medical equipment at every stage of the process, from the beginning to the conclusion of their useful lives. The importance of ISO 13485 lies not only in its implementation, but also in the fact that it provides a mechanism for conducting in-depth audits in order to determine whether or not the system is working effectively. It instills a greater level of trust in the manufacturer’s capacity to continuously achieve and maintain compliance with regulatory standards. It can also assist to avoid surprises and failures, both of which have the potential to have a negative impact on patient safety as well as the reputation of the manufacturer. Manufacturers may show their dedication to medical device safety and quality by adopting ISO 13485, which offers a realistic basis for addressing the EU Medical Device Directive (MDD) and the EU Medical Device Regulation (MDR), among other requirements.

ISO 13485:2016 Structure

Requirements of ISO 13485

Medical equipment and services must be manufactured in accordance with ISO 13485:2016, which details the standards for a Quality Management System to ensure that these needs are always met. Unless where otherwise noted, the requirements of ISO 13485:2016 are universal and can be applied to organisations of any size or kind. Whenever a condition is stated to apply to medical equipment, it also applies to any related services provided by the company.

The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System. Here is what the five main sections are about:


Know all about ISO 13485

  • Advisory Notice – notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the use of a medical device, modification of a medical device, return of the medical device to the organization that supplied it, or destruction of a medical device.

Note: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.

  • Medical Device – An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means*.
  • Active Medical Device – An active medical device is a device that-to operate-uses and converts energy in a significant way. For a device to be an active device, the form of energy does not include gravitational or directly provided human energies.
  • Medical Equipment – Medical equipment means equipment used in a patient care environment to support patient treatment and diagnosis. Medical equipment manufacturers range from businesses that produce basic supplies like bandages, forceps, scalpels, and gloves to those that do cutting-edge research and create sophisticated apparatus like surgical robots, CAT scans and MRI machines.

Mandatory Documentations for ISO 13485:2016

Download PDF For Complete Documentation

  • 1. Functions performed by the entity to satisfy relevant legislation
  • 2. Documentation and process for verifying software use claims
  • 3. Guide to Excellence in Quality
  • 4. Registration of a Medical Device
  • 5. Methodology for Keeping Tabs on Paperwork
  • 6. Methodology for Maintaining Records
  • 7. Strategic Approach to Quality Assurance
  • 8. Aims for Quality
  • 9. Authorizations and Duties
  • 10. Management review process documentation
  • 11. Instructional Methods
  • 12. Prerequisites for building upkeep and repair
  • 13. Prerequisites for the Office Setting
  • 14. Plans for the management of potentially hazardous materials
  • 15. Methodology for Managing Dangers During Product Development
  • 16. outcomes of product realisation planning
  • 17. Documentation of the Customer Requirements Review and Any Further Actions
  • 18. Planning for interaction with clients
  • 19. The Design and Development Process
  • 20. Preliminary Design and Development Scheduling

The QMS documentation is there to make sure that the most important procedures are well-understood and can be carried out exactly the same way every time. For this to succeed, the requisite procedures should be as straightforward and straightforwardly explained as feasible. In many cases, a graphic flow chart is all that’s needed to clearly and concisely convey the necessary details. Having straightforward documentation for procedures makes it simpler to train and test workers to consistently provide high-quality results.

ISO 13485:2016 Standard Process

Benefits of ISO 13485

The ability to enter new markets is the certification’s most obvious practical value. Without this accreditation, the firm cannot legally sell its goods or even function in the medical device industry in most countries. The biggest obstacle to entering a market is generally something like this.

Besides the most apparent advantage, firms having ISO 13485 certification can also:

1. Enhance the credibility of an organization and identity

In terms of quality control in the medical device sector, the ISO 13485 certification is the gold standard. Customers can be certain that they are receiving a product of the highest quality thanks to this certification, which also notifies them that the company has a quality assurance standard in place.

ISO 13485 certification is vital for medical device makers to demonstrate quality and safety, and it also serves as a potent marketing tool for any business.

2. Decision-making based on evidence

The company’s dedication to quality has been validated by ISO 13485 accreditation. Management receives data on a consistent basis, which they may utilise to make choices that are more in line with the company’s long-term objectives.

There will be consequences if management notices a lag in attaining the targets.

3. Continual improvement

One of the tenets of ISO quality management systems is the continual improvement. The adoption of a QMS causes a shift in perspective amongst an organization’s leadership and workforce, who now actively seek for ways to enhance operations.

High performance, strategic leadership, and employee engagement may all result from the implementation of systematic procedures that are designed to limit the occurrence of errors and the volume of labour required. It in turn means better final results for consumers.

4. Boost involvement of employees

Employees are better equipped to play their part in ISO 13485 implementation when processes are well-documented and controlled. Employees are overjoyed when they are given the opportunity to contribute to the company’s success by looking new ways to improve existing procedures.

Employees are more invested in the company when they feel they have a meaningful role to play. Because of this, productivity and efficiency are improved.

5. Satisfaction of customers

The pursuit of 100% customer satisfaction is key to the ISO 13485 implementation process. Customers have more trust in businesses that have earned the ISO 13485 standard certification. Customers have high expectations since they know the organisation has a solid quality management system.

Relevant Industries For ISO 13485

Medical device developers, factories, and retailers can all benefit from ISO 13485 certification. Moreover, certification can increase a company’s marketability because more and more manufacturers are insisting on it as a prerequisite for doing business with a supplier or service provider.

ISO 13485 is the worldwide standard for quality management systems (QMS) in the medical device industry. It specifies the minimum standards for a QMS in these fields.

The MDR 2017/745 mandates that all businesses operating inside the European Union have a Quality Management System (QMS) that is ISO 13485:2016 certified. Companies that fall under this category include:

  • Manufacturers of Medical Devices– producers of all devices specified under Annex XVI of the MDR, which includes both in vitro diagnostic and medicinal devices.
  • Developers of healthcare technology, especially software used in medicine
  • Manufacturers of medical equipment
  • Parts and component makers for medical devices, as per Article 23 of the MDR and Article 20 of the In Vitro Diagnostic Medical Device Regulation
  • Installers, repairmen, and maintainers of medical equipment
  • Distributors and importers in the European Union who perform similar tasks to manufacturers

FUTURE of ISO 13485

Predicting what the future version of ISO 13485 will entail is always challenging. This relates to the Quality System’s emphasis on preventative measures. The current placement of preventative activities in ISO 13485’s last chapter is, to be frank, a little unusual, given that these actions are fundamentally connected to the QMS risk-based approach that serves as a foundation of ISO 13485:2016.

Take ISO 9001:2015 as an example, where preventative activity has been all but eliminated. Each and every quality management system should use a risk-based approach, and preventative measures are an integral element of this strategy.

Joining Over SIS Certifications Best ISO Certification Agency

  “We do not sell, We certify.”