Consulting
ISO Standards and CE Marking
ISO 9001
ISO 9001: 2015 Quality Management System
ISO 9001:2015 is a standard developed by the International Organization for Standardization, which can be used by any organization irrespective of its type or size; the products and services it provides.
This standard can provide organizations with a framework to implement and continually improve an implemented quality management system.
The QMS will enable organization to review, control, monitor and improve their processes and thereby reliably provide products or services that achieve customer satisfaction and comply to regulatory regulations.
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ISO 9001:2015 is a standard developed by the International Organization for Standardization, which can be used by any organization irrespective of its type or size; the products and services it provides.
This standard can provide organizations with a framework to implement and continually improve an implemented quality management system.
The QMS will enable organization to review, control, monitor and improve their processes and thereby reliably provide products or services that achieve customer satisfaction and comply to regulatory regulations.
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 product life-cycle, including production, storage and distribution, installation and / or servicing of a medical device and design & 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.
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Such organizations can be involved in one or more stages of the product life-cycle, including production, storage and distribution, installation and / or servicing of a medical device and design & 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.
ISO 14001
ISO 14001 sets out the criteria for establishing and implementing an environmental management system.
It maps out a framework that a company or organization can follow to set up an effective EMS (environmental management system).
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It maps out a framework that a company or organization can follow to set up an effective EMS (environmental management system).
ISO 27001
ISO 27001: 2013 Information Security Management Systems
ISO 27001 concerns international best practices that organizations follow for the secured management of information. It specifies controls & measures, what effects they have and how to implement them.
The standard defines the desired best practice methods for controlling (Protecting) information - Confidentiality, Integrity & Availability and it requires to be audited and registered by a third party Certification Body. In today's IT driven world, organizations are seeking to demonstrate to their stakeholders, business partners and customers, some form of 'fit for purpose' assurance regarding their information security.
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ISO 27001 concerns international best practices that organizations follow for the secured management of information. It specifies controls & measures, what effects they have and how to implement them.
The standard defines the desired best practice methods for controlling (Protecting) information - Confidentiality, Integrity & Availability and it requires to be audited and registered by a third party Certification Body. In today's IT driven world, organizations are seeking to demonstrate to their stakeholders, business partners and customers, some form of 'fit for purpose' assurance regarding their information security.
ISO 45001
ISO 45001: 2018 Occupational Health and Safety Management System
ISO 45001:2018 is a standard that helps an organization to control occupational health and safety risks. It was developed as a response to widespread demand for an Internationally recognized standard against which the company needs to be assessed and certified.
OHSMS, essentially helps organizations in a number of ways like:
it helps in minimizing risk to employees, improve existing OH&S management system, demonstrate diligence, gain assurance besides a number of other benefits.
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it helps in minimizing risk to employees, improve existing OH&S management system, demonstrate diligence, gain assurance besides a number of other benefits.
CE Marking
EU MDR 2017/745
The manufacturers, authorized representatives, importers or distributors of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices need to know how to comply. The step by step guide to complying with the European Union's Medical Device Regulation of 2017/745: Decide the intended use and classification of your medical device Establish the necessary processes and resources Minimize the risks and fulfill the general safety and performance requirements Complete the clinical evaluation Compile the technical documentation Register the device and the manufacturer Complete the conformity assessment Fulfill the ongoing obligations in the post launch phase
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The manufacturers, authorized representatives, importers or distributors of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices need to know how to comply. The step by step guide to complying with the European Union's Medical Device Regulation of 2017/745: Decide the intended use and classification of your medical device Establish the necessary processes and resources Minimize the risks and fulfill the general safety and performance requirements Complete the clinical evaluation Compile the technical documentation Register the device and the manufacturer Complete the conformity assessment Fulfill the ongoing obligations in the post launch phase