Iso certificate no 13485

Your Email required. Phone :. Your Message. I am not a Spammer! What is ISO Certification? Some benefits of ISO Certification are: 1. Legal compliance in quality. Improved technology and quality. Time-saving process. Accurate results. Customer satisfaction. Gaining the trust of stakeholders. Proven business creditability. Increased sales revenue and opening of new markets. What are the requirements of ISO Certification?

Determining the plan and need in the medical devices. Identification of quality management system in the medical process and procedures. Documentation is required to fulfil the need of the standard. Regular maintenance of medical devices. Timely sanitization of devices. Management system standards Providing a model to follow when setting up and operating a management system, find out more about how MSS work and where they can be applied.

ISO Medical devices. Manage quality throughout the life cycle of a medical device with ISO What is a medical device?

Who is ISO for? Certification to ISO Like other ISO management system standards, certification to ISO is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. Why was ISO revised and what are the main improvements? ISO - Medical devices - A practical guide Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO ISO certification is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements and by organizations whose services support medical device manufacturers.

These companies need to get certified to ISO Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing. Further, there are many terms in ISO unique to medical devices. ISO also retained the role of a quality representative to top management, where ISO removed this in many aspects.

Interestingly, ISO has a lot more requirements for monitoring external providers for performance than the old version, and this is something always required by ISO ISO is also ideal for companies that provide parts and services for medical device manufacturers.

The standard has requirements for traceability, identification, risk assessment, cleanliness and documentation of procedures, all of which position these enterprises to be strong sources for medical components. Since there are many regulatory requirements by which medical device manufacturers must evaluate and monitor their suppliers, the presence of ISO certification will help medical device manufacturers feel confident about working with these parts and services providers.

Apart from medical devices, businesses in the aerospace industry seek to get certified to ISO to diversify. ISO is a standard that focuses on the importance of the lifecycle of a medical device, including its design, development, production, storage, distribution, installation, servicing and final decommissioning. The standard is designed to assist organizations in focusing their management system and therefore practices on strengthening its risk management approach and meeting regulatory requirements.

The following is a major revision of the ISO standard. It also may carry more favor with medical device manufacturers if you have the standard as a supplier of components for them. No, but as above, it closer meets requirements in the regulation and may better meet the requirements of your customers if they manufacture medical devices.

EN is the Euro Norm, and virtually the only difference is the inclusion of the Z Annex, which highlights which of the regulation elements the standard helps to achieve. Class III medical devices are the highest risk level of medical devices and typically include devices that support or maintain life.

These require a notified body to review the technical file and permit sale by application of a CE mark, amongst other activities. To implement a QMS with a higher level of control, focus on safety and tougher requirements and standards which can benefit the manufacture of medical devices or components for them.

Complete a Quote Request Form so that we can understand your company and requirements. You can do this by completing either the online quick quote or the online formal quote request form.

We will use this information to accurately define your scope of assessment and provide you with a proposal for certification. This assessment consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.

Following a successful two stage audit, a certification decision is made and if positive, then certification to the required standard is issued by NQA. You will receive both a hard and soft copy of the certificate. Certification is valid for three years and is maintained through a programme of annual surveillance audits and a three yearly recertification audit.

Contact us Client area Consultant area Careers Newsletter sign up. All standards. Industries Automotive We are the leading automotive sector certification body for IATF in China and have global experience across the automotive supply chain.

Construction We can assist with construction industry certification and training related to ISO and other standards. Service Industry NQA is particularly well-positioned to help interpret the standards and has auditors familiar and comfortable with service environments. Public Sector With the broad range of activities and sums of money spent the public services sector is subject to close control.

Information Technology Organizations must be vigilant with the security of their systems and data, while ensuring efficiency of service and customer satisfaction, to survive in an ever growing and advancing marketplace. More industry sectors. What is a gap analysis? Certification process Need a consultant? Environmental Management System The proven way to improve environmental impacts, energy efficiency and sustainability. Certification Process The process for management systems certification is straightforward and consistent for ISO management systems standards.

Looking for a consultant? What's the certification process? Resources Blog Regular updates on standards, events and best practice for quality, aerospace, safety, energy and environmental practitioners. Case Studies We've helped thousands of organizations from a wide range of sectors to improve their management systems and business performance with certification.