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What is an ISO 13485 certificate?

by | Aug 3, 2023

ISO 13485 (ISO standard for quality management of medical equipment)

The benefits of obtaining the ISO 13485 certificate

  • Ensuring the health of medical products and equipment
  • Globalization and creation of competitive advantage in exports
  • Receive a valid international certificate with a register code
  • Creating a sense of confidence in customers
  • More and more effective sales due to brand strengthening
  • Suitable conditions and standards for medical products

What is ISO 13485 standard and certification?

In order to obtain the ISO 13485 certificate, Isosystem is ready to provide services to companies and organizations. (Receiving ISO 13485 – Issuing ISO 13485 – Obtaining ISO 13485 – Obtaining ISO 13485)

ISO 13485 standard and certificate is a specialized standard for companies that produce medical and surgical equipment and instruments.

The companies that succeed in receiving this certificate indicate that they have met the quality requirements approved by the ISO international organization in the production of their medical products.

All manufactured products related to medicine, from consumables such as sutures and bandages to medical devices, can receive the certificate of this standard by complying with the requirements of the ISO 13485 standard.


The importance of obtaining ISO 13485 certification in the medical industry

ISO 13485 certification (quality management system in medical equipment) focuses on a quality management system in the design, development, production, assembly, after-sales service and distribution of all types of medical equipment and makes the process of obtaining the CE mark easy for export to Europe. .

Products that get ISO 13485 certificate and CE mark will be able to export to Europe.

Currently, Iran’s General Directorate of Medical Equipment has determined a limited number of approved companies, and ISO System is also a contracting party with some of these centers.

Therefore, if you wish, you can get the ISO 13485 certificate and the CE mark approved by the General Directorate of Medical Equipment through the ISO system collection.

The purpose of implementing and obtaining ISO 13485 certification

The purpose of implementing and implementing the ISO 13485 standard is to create harmony in the requirements and implementation of quality management rules and regulations for the medical equipment industry.


Using ISO 9001 and ISO 13485

This standard is very complementary to the ISO 9001 standard (quality management system) or the IMS integrated management system and will bring the excellence of medical equipment manufacturing companies.

Unlike ISO 9001, in the international standard ISO 13485, the emphasis on continuous improvement and customer satisfaction has been removed, and instead on things such as compliance with customer needs, risk management and maintenance of effective processes such as special processes such as safe design, production and The distribution of medical equipment has been emphasized.

The ISO 13485 certificate is useful for creating a management system that meets the requirements of customers and especially global laws.

Of course, it should be noted that despite the differences mentioned between ISO 9001 and ISO 13485, the nature of these two standards is based on the Deming cycle and process-based.

Obtaining ISO 13485 – Issuing ISO 13485 – Receiving ISO 13485

In order to obtain ISO 13485 (receiving ISO 13485 – issuing ISO 13485), you can proceed through Isosystem. Isosystem is the best center for obtaining ISO 13485 (receiving ISO 13485 – issuing ISO 13485) in the country with the official license of the Organization of Industry, Mining and Trade.

To obtain ISO 13485 certificate (receiving ISO 13485 – issuing ISO 13485) through the certificate request link on this page, you can also quickly apply for obtaining ISO 13485 (receiving ISO 13485 – issuing ISO 13485) through this link. register.

ISO 13485 and CE mark

ISO 13485 is the internationally accepted best practice model that a medical device organization can implement to help demonstrate compliance with medical device industry rules and regulations. This ISO is a QMS standard that has been accepted as the basis for CE marking of medical devices under the UK European Directives and Regulations.

What are the benefits of getting the ISO 13485 certificate?

High performing organizations expect an ISO 13485 audit to be thorough, competent, relevant and challenging. Effective auditing provides significant benefits to the manufacturer. The beneficial outputs of an effective audit are:

  • Meaningful feedback on quality effectiveness
  • Management system
  • Confidence in complying with regulations
  • Identify areas that need attention
  • Identify areas of non-compliance and risk
  • Receive a valuable and recognized certificate

The relationship between ISO 13485 and ISO 9001

The requirements of the ISO 13485:2016 standard correspond to the ISO 9001:2008 version. ISO 9001 is a recognized international standard for quality management systems (QMS) published by ISO (International Organization for Standardization).

The requirements of this standard are recognized worldwide as an acceptable basis for QMS implementation. Although ISO 13485:2016 was published after the original update of ISO 9001:2015, it is not compliant because the latest changes to ISO 9001:2015 are not necessary for medical devices.

What is the difference between ISO 9001 and ISO 13485?

Although ISO 13485 is an independent standard, it is based on ISO 9001:2008 as mentioned above.

While ISO 9001 is a recognized international standard for any organization and industry, ISO 13485 includes additional requirements specific to companies that manufacture medical devices.

What are the requirements of ISO 13485?

ISO 13485:2016 specifies the requirements for a quality management system for manufacturing medical devices and related services that consistently meet customer regulatory requirements. Requirements of this standard b The vote of organizations can be applied regardless of their size and regardless of their type.

The structure of ISO 13485 is divided into eight parts, the first three parts are preliminary and the last five parts contain mandatory requirements for the quality management system.

What is the difference between ISO 13485 and EN ISO 13485?

As mentioned above, ISO 13485 is an internationally recognized standard set of requirements issued by the International Organization for Standardization (ISO) to establish a quality management system in the medical device industry.

The EN ISO 13485 standard is a parallel standard issued to establish a QMS in the medical device industry for use in the European Union. The requirements of these two standards are the same and the entire ISO 13485:2016 standard is included in the EN ISO 13485:2016 document.

However, the European version of the standard (EN ISO 13485) contains several valuable tables that align the requirements of ISO 13485:2016 with the three EU directives for medical devices.

ISO 13485 life cycle

The latest revision of ISO 13485 for medical devices is in March 2016. Among the items added to this update are:

Focusing on risk, clarifying management responsibilities, clarifying training responsibilities, improving facility requirements, better alignment of design and development requirements for many regulations, greater emphasis on supplier control, requirements for traceability procedures, added complaint handling, and increased product cleanliness requirements.

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