Healthcare and Medical Devices
Hospitals ; Health Care services are important elements of any well-ordered and humane society, and will indisputably would play key role in nurturing of society. That hospital should be places of safety, not only for patients but also for the staff and for the general public. Quality of hospitals and healthcare services is also of great interest to many other bodies, including governments, NGOs targeting healthcare and social welfare, associations of doctors and patents, medical insurance companies, shareholders of companies providing healthcare services, etc.
Services for the Healthcare Industries
In today’s marketplace of changing technology and stringent regulatory requirements, time to market and product quality are essential in developing a competitive advantage.
At Nucleus Consultants, our fluency in the industry helps you gain the competitive edge you need. Our industry experts, supported by qualified personnel, reducing your time to market.
Our quality systems consultancy services guide your team through the ISO 13485, ICMED 13485, MDSAP, NABH, ISO 9000, ISO 14001, and ISO 45001 certification process, providing your company a competitive advantage through improved processes, continuous improvement, and market recognition.
Nucleus Consultants Healthcare Industry services include:
- ICMED 13485, ISO 13485 Consulting, Implementation and Training
- NABH Consulting, Implementation and Training
- ISO 9000 and ISO 14000 Consulting, Implementation and Training
- ISO 45001 Consulting, Implementation and Training
- Other ISO Management System Consulting, Implementation and Training
- Clinical Evaluation Documentation, Implementation and training
- Medical Devices Regulatory Approvals Documentation, Implementation and training
For more information regarding our full suite of services for the Healthcare Industry, contact us.
About ISO 13485
ISO 13485 is the most accepted standard world-wide for manufacturers of medical devices (e.g. in the US, Japan, Canada, EU). This standard includes requirements specific to this business sector and defines terms such as medical device, active medical device, active implanted medical device, sterile medical device, and many more. ISO 13485 supports the reduction of unexpected risks for companies who construct, manufacture or use medical products and services, both during fabrication as well as for later use. It aims to increase reputation in the eyes of customers and authorities. It will be an independent standard which can be used without consideration of ISO 9001, provided a company works only within the medical industry. (See more about ISO 13485.)
About ISO 9001
Originally published in 1987 by the International Organization for Standardization, ISO 9001 is a generic quality systems standard that specifies, in very broad terms, the necessary components of a quality management system. Rather than being specific to any one industry, ISO 9000 details the basic requirements of the quality function for all industries. ISO 9001 gives you the tools to grow a better business through continuous improvement and refined processes. The latest version of ISO 9001 is ISO 9001:2015. Today more than 500,000 businesses have achieved ISO 9001 certification throughout the world, making it by far the most recognized symbol for quality in the global marketplace.(See more about ISO 9001.)
About ISO 14001
Protection of the environment is one of society’s key goals. A significant increase in environmental awareness and stricter environmental regulations has led many organizations to integrate environmental protection into their corporate management systems structure.
Leading corporations have been utilizing environmental management systems (EMS) for years to help them reach defined environmental objectives. Now, a streamlined environmental management tool is available to all corporations in the form of ISO 14001, an internationally recognized environmental management system conformance standard. Very similar in structure to the ISO 9001 quality management system standard, ISO 14001 outlines key requirements to which companies should comply in order to operate in an environmentally responsible manner.
The ISO 14000 elements provide diverse organizations a framework for managing and continually improving their environmental programs. Many companies already monitor air and water permits, or toxic use reduction programs. Utilizing ISO 14001, companies can now merge environmental programs into one coherent system to efficiently manage all environmental activities.
In short, ISO 14001 can provide your company a competitive advantage, by demonstrating to your customers that your environmental processes and impact is effectively managed, continually improving, and part of the corporate management system. (See more about ISO14001…)