![]() See all the changes here: Infographic: What’s new in the 2016 revision of ISO 13485. Among the additions to this update are included: a focus on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facility requirements, better alignment of design and development requirements to many regulations, more emphasis on control of suppliers, requirements for traceability procedures, addition of complaint handling, and enhancement of product cleanliness requirements. The latest revision of ISO 13485 for ISO medical devices is from March 2016. For a good explanation on this, take a look at the article List of mandatory documents required by ISO 13485:2016.Ī survey of ISO 13485-certified companies shows that the number of companies that have implemented an ISO 13485 Quality Management System still shows a general positive trend worldwide (the drop in 2018 was mainly due to a different measurement methodology).ĭata taken from 2018 ISO Survey What is the current version of ISO 13485? Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service. Together, these define the overall scope and implementation of the Quality Management System. Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. It does not store any personal data.Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. The cookie is used to store the user consent for the cookies in the category "Performance". This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. The cookies is used to store the user consent for the cookies in the category "Necessary". ![]() The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". ![]() These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly. We can be reached at 1-60 or by email at Please let us know if you have any further questions regarding the processing and use of your information. We will remove persons from any future emails if they choose to opt out of future emails. We do not expect individuals to object with the use of this data to fulfill an action that they requested of ControlAir. Is the intended use likely to cause individuals to object or complain? Receive follow up emails to gauge your customer experience and alert you to product information. You may receive emails to alert you of order, quote or shipment status. The purpose of transferring this information to these individuals/companies will be to fulfill your request for product information and quotation. What will be the effect of this on the individuals concerned? Your information maybe shared with one of our local partners (distributors and/or local field agent) so we can fulfill your request ![]() Your information will not be sold to a third party. This information will be entered into a CRM database, so we can contact you via email, phone or mail to fulfill your request and follow up with appropriate product information. This information may be used to contact you in the future regarding This information is being collected for the purpose to respond to your request and for later follow up to ensure that we provided you with a good customer experience. We do use a Customer Relationship Management system to process this information.ĭata is collected using our Webforms (Get a Quote, Ask the Expert, White Paper Sign Up, etc), via phone calls, incoming emails and during any email campaigns that are sent to you for marketing purposes. Here are some relevant questions and answers regarding our collectionĬontrolAir will collect names, email addresses, phone numbers and local addresses so we may fulfill your request for product help, quotes or order shipment.ĬontrolAir has a sales and marketing department that oversees the collection and use of this data. ControlAir’s purpose to collect any personal data is to respond to your request for product help, quotation and processing of orders. ![]()
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