ISO 13485
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
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 quality management system by monitoring, maintaining, and controlling the processes.
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. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. 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
CE Marking
CE Marking
Transparency and Safety on European Markets
CE Marking
Only safe, flawless, and quality goods should be available on the European market – at least, that’s the objective of the CE mark. The mark proves that the product in question conforms to EU health and safety standards, whether it’s toys or construction machines. Our experts conduct an audit on your products based on the appropriate EU regulations, such as the low-voltage or electromagnetic compatibility directive. Your CE declaration of conformity means your product now has right of way onto the European market.
Benefits at a Glance
A product audit by TÜV Rheinland and CE Marking helps you:
Stick to current EU guidelines
Reduce liability for your company with documented safety standards
Improve the quality and safety of your products
Take advantage of short audit times and our extensive experience
Four Steps to Your Product’s CE Marking
Step 1:
Our employees determine which directive are applicable to your product.
Step 2:
We carry out the conformity evaluation procedure and all required audits on your behalf. With a declaration of conformity, you demonstrate that your product complies with all valid regulations, such as health and safety product regulation or medical product regulations.
Step 3:
Some products or machines rated as dangerous need to have been initialized by an authorized body, such as TÜV Rheinland.
Step 4:
You can now label your product as CE Marking approved.
ISO/IEC 27001
Certification to ISO/IEC 27001 Information Security Management
Keep your information confidential with a certified ISO/IEC 27001 system and show that you have information security risks under control. Compliance with world-class standards can help you win customer trust and new business opportunities.
ISO 45001 health and safety management standard
ISO 45001 is an international standard for health and safety at work developed by national and international standards committees independent of government.
Implementing ISO 45001 may help your organisation demonstrate compliance with health and safety law. But, in some respects, it goes beyond what the law requires, so consider carefully whether to adopt it.
ISO 7001
Article Talk. ISO 7001 (“public information symbols”) is a standard published by the International Organization for Standardization that defines a set of pictograms and symbols for public information. The latest version, ISO 7001:2023, was published in February 2023. ISO 7001:2023.
ISO 8583
The ISO8583 standard specifies a message format that describes credit card and debit card data that is exchanged between devices and card issuers. The International Standards Organization (ISO) defines and publishes data standards that are used by many organizations in the public and private sectors.