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ISO 13485:2016
WHAT IS ISO 13485?
ISO 13485 ensures that medical devices meet the needs of the costumers, and fulfill regulatory requirements.
This standard was conceived to help medical device manufacturers to implement Quality Management Systems that establish and maintain the effectiveness of their process. It ensures the consistent design, development, production, installation and delivery of medical devices safe for their intended purpose.
This standard represents the need for a risk-based approach to the Quality Management System and enhances the approach to regulatory requirements and top management responsibilities, improved supplier controls and external activities. It makes an emphasis on risk management throughout the product life cycle.
WHAT ARE THE BENEFITS OF BECOMING ISO 13485 CERTIFIED?
Companies with this certification show a commitment to quality to both customers and regulators.
- Increased involvement of the company’s shareholders.
- Increased reputation of the company, brand and services.
- Improved competition.
- Clear customer satisfaction.
- Increased profitability by reducing material costs.
- Facilitates the achievement of delivery deadlines.
- Allows the Certification of Medical Devices for the CE Market.
HOW TO CERTIFY ISO 13485?
The ISO quality certification process starts when you decide to bring quality management for the medical device industry to your company. ISO 13485, due to its focus on quality processes for the medical device industry, is a tool for the execution of preventive actions.
WHO CAN BE CERTIFIED IN ISO 13485?
ISO 13485 applies not only to companies that produce and service medical devices but also to organizations that distribute and make use of them.
This standard can be used by an organization for the design and development, production, installation and service of medical devices, medical equipment and the design, development and provision of related services.
WHAT IS THE COST OF ISO 13485 CERTIFICATION?
The cost of certification depends on several factors such as the size of the company, the scope of the company and the number of employees, among other factors.
OTHER ISO STANDARDS
ISO 14001 is the international standard that focuses on the implementation of an environmental management plan where environmental risks are identified, catalogued and managed in any organization.
This standard is aimed at enabling organizations to manage occupational health and safety risks, improve the performance of occupational health and safety measures and integrate other aspects of employee health and well-being.
ISO 13485 is to ensure that medical devices meet customer needs and applicable regulatory requirements.
FREQUENTLY ASKED QUESTIONS
What is an ISO Standard?
ISO Standards are those models that serve as a reference for the manufacture and/or evaluation of a product, performance of a process or provision of a service.
The International Organization for Standardization (ISO: International Organization Standardization) is in charge of creating standards in order to unify them and make them international.
What is a Management System?
A Management System could be defined as the set of ordered and coordinated activities that allow offering quality products or services for customer satisfaction; that is, they are components susceptible to planning, control and continuous improvement, so that they meet the requirements and exceed expectations.
Does it apply to any company or organization?
Due to the wide scope and flexibility of ISO standards, any business can implement a Management System.
What are the requirements for certification?
To be eligible for ISO certification, 4 essential requirements must be met:
1. To have implemented the corresponding Management System.
2. To have at least 3 months of records
3. To have carried out at least one internal audit.
4. To have carried out a management review
What is the process and how long does Certification take?
The ISO certification process starts when you decide to boost your company’s Management Systems. The duration varies in relation to the time it takes to implement it.
We invite you to learn more about the Certification Process.
What is the cost of the Certification?
The cost of certification depends on several factors such as the size of the company, the scope of the company and the number of employees, among other factors.
We invite you to visit the QAlliance Quotation section.
News and Events
ISO 13485 and its application in the Healthcare Sector
ISO 13485 AND ITS APPLICATION IN THE HEALTH SECTOR The medical devices industry with its...
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