ISO 13485 Certification – Basics Of ISO 13485 Quality Management System For Medical Devices

ISO 13485 Certification – Basics Of ISO 13485 Quality Management System For Medical Devices

ISO 13485 Certification

In the majority of ISO management standards, certification in conformity to ISO 13485 doesn't constitute a requirement for the standard. Companies can reap the benefits of following the measures without going through the certification process. Third-party certification will prove to authorities that you have met the standard's requirements. 

Important "ISO 13485 Certified" means an organization has adopted the ISO 13485 Quality Management System and successfully fulfilled the requirements of the standard. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while focusing on the safety and effectiveness of medical devices.

Regulatory requirements are progressively demanding throughout every level of a product’s life cycle, consisting of service and delivery. It has gradually become important for companies in the industry to demonstrate and implement best practices in their quality management processes.
Designed specifically for the medical device industry, ISO 13485 is an international standard that specifies how a quality management system should work. Safety and quality in this industry are not negotiable, which is why ISO developed the standards.

What is ISO 13485 Certification For Medical Devices?

The ISO 13485 quality management system standard is a stand-alone version of the ISO 9000 series of quality management standards, which is internationally recognized and accepted. ISO 13485 complies with the preceding version of ISO 9001.  ISO 13485 relies on the ISO 9001 process model perception of Plan, Do, Check, and Act. ISO 13485 is developed for regulatory compliance, so it is more prescribed in nature and requires an extensive quality management system (QMS).

Certification ISO 13485 For Medical Devices

ISO 13485 is the medical industry's top medical device standard that ensures that all medical equipment complies with the appropriate regulations and compliance requirements. ISO 13485 certification is an important credential established to help keep patients and professionals safe in hospitals, clinics, and other medical facilities.
A QMS that ensures the efficiency and effectiveness of the medical device. It guarantees the consistency of design and development, production, delivery, and installation, all the way to the disposal of devices for medical use that is suitable for the intended use.
The Medical Device ISO 13485 standard contains specific requirements for the manufacture, installation, and servicing of medical devices and calls for:
Implementation of a Quality Management System with several enhancements
Risk Management approach to product development and product realisation
Validation of processes
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems



Who Is ISO 13485 Designed For?

ISO 13485 is designed to be used by companies who are involved in the development of, manufacturing, installation, and maintenance of medical devices as well as related services. ISO Certification 13485 is also utilized by external and internal parties, including certification bodies, to assist them in their auditing processes.

ISO 13485 Quality Management System Standard

Scope

ISO 13485 Quality Management System applies to all organizations that participate in the life-cycle of the medical device. In this article on MDR, the life cycle encompasses all stages, from the initial concept to decommissioning and removal. Organizations involved in the design and development of manufacturing storage distribution, installation servicing, or any other associated activities can opt to implement the ISO 13485 Quality Management System.
This means that legal manufacturers and subcontractors can use it to manufacturers, importers, distributors, and other companies that provide related services. By defining the scope for the ISO 13485 Quality Management System, the most crucial question will be, "What are the consequences of this process on your safety and the protection of the equipment?" If the outputs from the process impact the safety of medical devices, ISO 13485 would be the most effective method to manage it.
“ISO 13485 defines what to do to ensure the safety of a medical device. In terms of the law, it's simply a list of requirements. It doesn't define the method of implementing those requirements and how to manage the processes. "How's" should be defined in accordance with a variety of company-specific aspects like the kind and specification of medical device, the level of staff competence complexity of processes, the culture of the company and any relevant regulations. In order to establish a reliable ISO 13485 Quality Management System an approach that is custom-made for each company will be employed by analyzing the process.”

Normative references

Clause 2 of ISO 13485 lists ISO 9000 Quality management systems Basics and vocabulary as examples. It is important to note that ISO 13485:2016 does not fall compatible with the "High Standard Structure" (HLS) that ISO developed.

Terms and definitions

ISO 13485, which includes the terms "quality management systems" and "regulatory purposes" in its title, clearly aims to assist manufacturers by meeting the legal requirements of each country where they plan to market their products. Paragraph 3 of ISO 13485 lists 20 terms compatible with most medical device regulations worldwide. These terms and definitions will help you understand clauses 4-8 before implementing the standard in your company.

Quality management system

Clause 4 outlines the requirements for a risk-based process and includes documentation and record-keeping measures.
A risk-based approach to each product realization is key to a successful implementation. It is easy to transform the results of the process risk management plan into an implementation plan. The process inputs, outputs, and responsibilities will help determine the needed control methods. To define the limits of each process, you should ask the magic questions: "What happens if I don't control this step?" and "What effect will it have on medical device safety?" It is necessary to keep the note that clause 4.1 would demand a process risk management procedure.

Management responsibility

Top management support is crucial for a successful ISO 13485 Quality Management System implementation. This is why clause 5 of the standard outlines the main principles: customer focus and management commitment.
The quality policy should provide a framework to establish the quality goals. You must set "SMART" goals and create detailed action plans according to PDCA (Plan - Do - Check - Act). Management review procedures must conform to clause 5.6 of the standard as part of the PDCA Cycle.
SMART - Specific, Measurable, Attainable, Realistic, Time-dependent

Resource Management

In Clause 6, the standard lists the requirements regarding human resources, infrastructure, and work environment. To ensure safety, medical devices must have sufficient resources to address these three areas.
The standard stipulates that employees responsible for ensuring product quality must be qualified based on appropriate education, training, and experience. Training must be planned to achieve the required competency level. The manufacturers should assess the effectiveness of their actions and, if necessary, plan new PDCA-related actions.
The 2016 version of this standard features a better structure that specifies the requirements for cleanliness/sterility. If medical device specifications require it, cleanliness must be achieved by implementing contamination control requirements parallel to ISO 14644/ISO 14698.

Product Realization

Clause 7 of this standard outlines the classic quality control approach used to ensure the safety of medical devices. Converting the product specification into quality plans using a risk-based approach is a good confirmation method.
The standard's clause 7.2 shall govern the requirements for customer-related processes. Documented processes for designing, developing, and purchasing must be documented and implemented. These procedures will ensure that the medical device conforms with regulatory requirements and meets specified product data.
Similar to design and development, production and service provisions should be planned, executed, monitored, and controlled to ensure compliance with specifications. A risk-based approach must be used to define the limits for the control methods required. The standard must be traceable and identified by clearly defined manufacturing and quality control procedures.

Measurement, analysis, and improvement

Monitoring, measuring, analyzing, and improving product conformity and quality management systems shall be made. These processes must also maintain the effectiveness and efficiency of the quality management system.
These methods will be used to manage customer complaints and feedback. These tools, which include internal audits, nonconformity procedures, and corrective and preventive actions, shall be integrated into every quality system process. This will allow the organization to achieve high levels of effectiveness and ensure compliance with regulatory requirements.
A medical device manufacturer can comply with legal and regulatory requirements by implementing ISO 13485 2016 requirements. This will improve the process efficiency and lead to safer medical devices. Thorough gap analysis against the requirements above would be extremely helpful in ensuring a successful preparation phase. A robust risk management process compliant with ISO 14971 should also be implemented.

Please contact us to get more information on a particular standard clause and ask for a preliminary meeting. We would love to discuss possible roadmaps for a successful ISO 13485 implementation. 

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