11/13/2022 0 Comments Iso 13485:2016 free download![]() It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's QMS by monitoring, maintaining, and controlling the processes. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type, except where explicitly stated. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including QMS-related services to such organizations. It may also include peripheral design and development or provision of associated activities (e.g. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage, distribution, installation, and servicing of a medical device. The new ISO 13485:2016 standard specifies the requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This update will require the whole family of ISO 9001 QMS-based quality standards to update, including the automotive, aerospace, environmental and occupational health standards, all of which were based on the older ISO 9001:2008 Standard. Take a look at our new client area, bringing together useful tools and information.Īre you a consultant wanting to join our ACR? Or are you client looking for a reputable consultant to help you implement your management system? We are always looking for talented people to join our team.Īs a valued NQA client we want to ensure we support you at every step of your certification journey. Working for NQA is extremely rewarding as we work with a wide variety of interesting clients around the world. We provide accredited certification, training and support services to help you improve processes, performance and products and services. That's why it's our policy to achieve accreditation for our services wherever possible. We believe in the integrity of standards and rigor of the certification process. Certification audits should help to improve your organization as well as meet the requirements of your chosen standard. 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.Īt NQA we believe our clients deserve value for money and great service. ![]() The requirement for delivering customer value for money is of critical importance. ![]() With the broad range of activities and sums of money spent the public services sector is subject to close control. NQA is particularly well-positioned to help interpret the standards and has auditors familiar and comfortable with service environments. We can assist with construction industry certification and training related to ISO and other standards. We are one of the world's leading certification bodies for the aviation and aerospace industry - serving Lockheed, Boeing, Raytheon, NASA, European Space Agency and many more. We are the leading automotive sector certification body for IATF 16949 in China and have global experience across the automotive supply chain. ![]()
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