ISO 13485

Medical Devices

Continually improve your business with the international standard on medical devices

ISO 13485 is an internationally recognized standard, first adopted in 1996, and refers to the requirements of a quality management system for the manufacture of medical devices. The latest version of this standard, offered by our company, was adopted on March 1, 2016.

Although often implemented independently of other standards, ISO 13485 is essentially fully aligned with the ISO 9001 quality management system and demonstrates the commitment of the manufacturer to the maximum correctness and quality of its medical devices.

ISO 13485 brings many benefits to any firm or organization that decides to implement this standard into its business, and some of these benefits are:

  • Increase in placements on world markets;
  • Improving the way of reviewing and improving the process in the organization;
  • Increase efficiency, reduce costs and monitor the efficiency of the supply chain;
  • Increasing production and sales of safer and more effective medical devices;
  • Fulfillment of legal regulations and customer expectations.

Regardless of whether you are still considering implementing the ISO 13485 standard or have already started this process, our company can help you complete it quickly and easily.

Just select the phase in which you are and start already today with creating a better future for your business.

1. Introduction

Find out what the ISO 13485 really is and what makes it suitable for your business.

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2. Implementation

Find out the best way to implement ISO 13485 and how our company can help you with this.

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3. Certification

Make an independent assessment of the standard implemented and obtain certification for your system.

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4. Maintenance

Make sure your system is constantly growing and evolving to deliver the best solutions for your business.

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1. Introduction

ISO 13485 is a standalone standard for Quality Management Systems (QMS), derived from the internationally known and accepted ISO 9000 series of quality management standards.

ISO 13485 is adapted to the ISO 9000 model for use in a regulated environment for the production and sale of medical devices. Although ISO 13485 is based on the ISO 13485 process model with the concept “Plan, Do, Check, Work”, it is also designed to meet legal requirements. In this way, the standard becomes enhanced and requires a thoroughly documented quality management system.

ISO 13485 is written to support manufacturers of medical devices during designing quality management systems that establish and maintain effectiveness in their processes. It ensures the consistency of the design, development, manufacture, installation and delivery of medical devices that are safe for their intended use.

2. Implementation

When implementing ISO 13485, our team of consultants will help you to familiarize yourself with the requirements of the standard, with a view to its successful implementation.

ISO 13485 is an important tool for improving your business, as well as considering and adopting a way to manage business processes. Employee engagement is also very important during the implementation of ISO 13485, and special attention is given to those who will lead the quality system of medical devices. They must be sufficiently trained so that the system could be effectively implemented.

Mobes Group is here to help you eliminate all difficulties during implementation of the ISO 13485 standard, with a simple set of tools and services offered by our company.

ISO 13485 Implementation Tips:

1. Ensure the support and commitment of senior management;

2. Ensure good internal communication in the overall business;

3. Compare your existing quality systems of medical devices with the requirements of ISO 13485;

4. Establish and determine a team for implementation;

5. Plan and assign roles, duties and timetables for implementation;

6. Adapt ISO 13485 requirements to your business;

7. Motivate the involvement of employees with various training;

8. Share your knowledge of ISO 13485 with your employees and encourage them to train for internal auditors;

9. Continualy evaluate your ISO 13485 system to make sure it is constantly improving.

3. Certification

Once you reach the ISO 13485 certification level, you will be able to show your customers and stakeholders how committed you are to the quality of the products you offer. This is a good opportunity to promote your business and show that you are a trusted partner, which can open up new business opportunities for your company.

Certification steps ISO 13485:

1. Analysis of nonconformity

The non-compliance analysis is an optional activity that is carried out before the assessment itself. We will closely look at your existing quality system of medical devices and compare it with the requirements of ISO 13485. It is a cost-effective way to check if there are areas that need to be improved before a formal assessment is made.

2. Formal assessment

A formal assessment is a two-step process. First, a consultant will review the readiness of your organization for the assessment, by checking the necessary procedures of the ISO 13485 standard and the control methods developed therein. Details of our analyzes will be shared with you and in case of discrepancies, you will have the opportunity to solve them. In case all requirements are fulfilled, it goes to the assessment of the level of implementation of procedures and control within the organization, according to the requirements of ISO 13485 certification.

3. Certification

Once the level of certification is achieved, you will receive the ISO 13485 certificate, which has a validity of three years, but subject to an annual check. With this certificate, you have formal evidence that your organization operates in accordance with quality requirements and thus takes care not only of internal resources and processes, but also of the requirements of clients and other stakeholders.

4. Maintenance

Implementation of ISO 13485 standards is done just because of the certification, but also because it provides guidelines on how to constantly improve your organization. Maintaining the quality system of medical devices is carried out by regular visits by a consultant, in order to make sure that you are implementing the requirements of the system, improving the system and thus giving added value to your company.

Some of the basic activities in maintaining the ISO 13485 system are:

• Revision of your documentation and ongoing harmonization, both with the applicable legal regulations, and with the latest issues of international standards;

• Training of new employees for implementation and maintenance of the implemented standard;

• Analyzes of data obtained using ISO 13485;

• Conducting internal audits;

• Advising and participating in proposing corrective measures;

• Customer satisfaction analysis;

• Consulting and participating in the review of ISO 13485 by management.

Popular courses and training for ISO 13485

We use accelerated learning techniques to make sure that you fully understand all the requirements of ISO 13485. This type of training consists of lectures and workshops of interactive parts, which allow you to gain knowledge, give your opinion and present your views, practical examples and the like.

Learn more about ISO 13485 training.