Definition:

Medical devices are instruments, devices, machines, implants, in vitro reagents, or other similar items that are intended for the diagnosis, prevention, and treatment of diseases or other medical conditions. There are many varieties of medical equipment, ranging from hand tools to complex computer-controlled machines. These include wound dressings and scalpels; durable equipment such as wheelchairs or dental chairs; implantable equipment such as pacemakers and monitors, artificial legs/hands and artificial joints; life support equipment such as respirators and lung ventilators; sophisticated software-controlled equipment such as CT scanners and MRI machines; and in vitro diagnostic reagents and test kits.

Medical devices that are produced and circulated are expected to guarantee safety, quality, and benefits. To fulfill these requirements, the production must meet the guidelines for Good Medical Devices Manufacturing Practices (CPAKB). The guidelines have been prepared by the Directorate of Medical Device Production and Distribution in 2006 based on the ISO 13485 reference: Medical Device—Quality Management System—Requirements for Regulatory Purposes by involving all relevant stakeholders so that it is expected that the CPAKB guidelines can be used as a reference for all parties.

ISO 13485 certification is an international standard published in 2016 that is a specialized quality management system for the medical device industry. The standard was recently revised with a new version published in March 2016. ISO 13485 was originally derived from ISO 9001 and has the same basic principles, but requires greater documentation and places additional emphasis on areas such as work environment, risk management, design control and regulatory requirements.

The main purpose of the standard is to facilitate quality management system requirements in line with regulatory objectives in the medical device sector. The standard is based on ISO 9001, but includes additional requirements specific to the medical device business sector. Implementation of ISO 13485 can help reduce unexpected risks and can improve company management.

Medical device manufacturers operating an ISO 13485 quality management system tend to demonstrate a philosophy of prevention rather than error containment; with continuous review of critical process points and regulatory requirements; corrective actions and results; consistent communication within processes, and among facilities, suppliers, and customers; thorough record keeping and efficient control of critical documents; total quality awareness by all employees; and high levels of executive management trust and support.

Principal:

ISO 13485:2016 guides the medical industry on how to manufacture and maintain quality medical equipment. In particular, it helps managers ensure that medical equipment remains in good condition. The requirements of ISO 13485: 2016 apply to organizations regardless of size and type unless explicitly stated.

This ISO 13485 certificate is issued by certification bodies that have been accredited by applying ISO 17021 to be able to conduct compliance audits in accordance with the ISO 13485 standard. These accreditation bodies are KAN, UKAS, ANAB, JAS-ANZ, and many others.

Broadly, ISO 13485 requires a management system such as SOP and its derivatives. Infrastructure according to established standards and compliance with laws and regulations related to operations and medical equipment products provided.

Processes required by ISO 13485: 2016 that apply to the organization, but are not performed by the organization, are the responsibility of the organization and are recorded in the organization's quality management system by monitoring, maintaining, and controlling the process.

To make the preparation process more effective towards ISO 13485 certification, the things that companies need to do are as follows:

1. Conduct a self-assessment to see how far the current gap is with ISO 13485 requirements.

2. Form a team of representatives from each section so that the process facilitates communication in making the management system and effectiveness during implementation.

3. Provide training to the team in the hope that the appointed team has the same goals and mindset.

4. Periodically review the consistency of the implementation of the system that has been created.

5. Conduct internal audits and management reviews before submitting to the Certification Body.

ISO 13485 is not mandatory. You can create a QMS that suits your organization's needs, as long as the QMS process meets the legal and regulatory requirements for medical devices where you intend to manufacture and sell them. Although ISO 13485 is not required for EU MDR compliance, EU MDR regulations require you to have a QMS, and the ISO 13485:2016 standard is the only QMS standard listed in the EU harmonized standards list, so most companies will use ISO 13485 requirements to implement their QMS.

By using ISO 13485 requirements to create your QMS, you can ensure that you have a world-class system in place to meet the needs of customers and legislators for your medical devices. ISO 13485 gives you more than just the minimum requirements to meet legal requirements; it provides an entire system that is specialized to help you make your quality processes better.

Benefit:

The expected benefits of ISO 13485 include:

1. Improved safety and effectiveness in the manufacture and use of medical devices.

2. Reduced regulatory liabilities and issues.

3. Improved relationship between you and your customers.

4. Standardization of quality management system requirements.

5. Efficient management of external audits and site visits.

6. Overall cost reduction and improved competitiveness.

7. Improved management and enhancement of your performance.

Another major benefit of becoming an ISO 13485 certified company is that it will set your company apart from your competitors. ISO 13485 is an ideal quality management system standard to compete in business because it aims to control quality and regulatory compliance costs, increase productivity, and reduce waste. It is also customer-driven. When implemented correctly, the elements of ISO 13485 work together meticulously to ensure that the required quality levels are met, and that customer and regulatory needs are met. It can be a powerful strategic tool.

Contributor: Lestari Chandra N