ISO 13485:2016
Certification
Medical devices — Quality Management Systems
ISO 13485 is an internationally recognized quality management system (QMS) standard specifically designed for medical devices and related services. It is published by the International Organization for Standardization (ISO) and provides a framework for organizations to ensure compliance with regulatory requirements for medical devices.
Streamline legal and regulatory requirements in multiple countries
Enhances product safety and reliability
Improves credibility and trust in medical device products
Streamlines processes and reduces risks
Supports compliance with MDR (EU), FDA (US), and other global standards
Why Should Your Company Have ISO 13485 Certification?
ISO 13485 certification is essential for companies in the medical device industry as it ensures compliance with international regulations, improves product quality, and enhances credibility with customers and regulatory authorities. It provides access to new markets, reduces operational risks, and strengthens process efficiency. By obtaining this certification, companies demonstrate their commitment to safety and reliability, minimizing product recalls and non-conformities. Additionally, it helps build trust among clients and partners, offering a competitive edge in the industry. Investing in ISO 13485 certification is a strategic decision that contributes to long-term business growth and sustainability.
QMS and the ISO 13485 Certification
Integrated
Management
QMS offers a wide range of ISO certifications, making it easier for companies to streamline integrations of medical devices quality management system with other management systems
Agile
Process
We have a structured, validated, and constantly improved process on an international level. This process streamlines communication, question resolution, scheduling, and certificate issuance
Qualified
Auditors
QMS has highly qualified ISO 13485 auditors who have been auditing medical devices for many years
How to obtain ISO certification?
Step 1
Working with a consultant
Some companies decide to hire a consultant to help them with the process of implementing a management system. Through their expertise, this consultancy can guide them through the requirements of the ISO Standards and help them develop the necessary tools. Please note that hiring a consultant for this purpose is optional and this service is not offered by QMS.
Stage 2
Pre-audit
Once you have completed the implementation of your management system and before the certification audit, you can request a pre-audit if you feel it is necessary. In this process, a certification body such as QMS will carry out a prior, independent assessment of your management system in order to check that all the requirements comply with the criteria of the ISO standard you have adopted. It is important to note that this step is optional for any organization that has applied for certification and that the pre-audit can be offered by QMS.
Stage 3
Suitable for ISO certification
At this stage, you need to apply for ISO certification through a third-party certification body. The certification body will conduct an audit of your company’s documents and management system against the requirements of the standard and determine whether it is ready for certification. During the audit, it is essential to demonstrate the effectiveness of your management system. If you wish, you can contact QMS for a no-obligation quote.
Stage 4
ISO recertification
Each certification is valid for 3 years. However, every year, the certification body carries out a surveillance audit to ensure that your management system continually adheres to the requirements of the ISO standard.
What is ISO certification?
ISO is the International Organization for Standardization. It was created with the aim of facilitating international coordination and the unification of industrial standards that contribute to the development of trade.
Standards are made up of documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for purpose.
Each standard represents a different good, service or process, and it is up to the company to decide which standard best meets its needs.
What are the benefits of being certified to an ISO standard?
Among the numerous benefits, certification can help you win contracts. If you are looking to bid for and win tenders, for example, being certified can increase your chances of being chosen as a supplier, especially for work in the public sector. In addition, certification adds credibility to your business, boosting customer satisfaction and confidence in your brand. Other benefits include cost savings and increased market share.
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