ISO 13485 Consultants Bangalore

ISO 13485 is an ISOstandard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture ofmedical divices.

Other specific differences include: » the promotion and awareness of regulatory requirements as a management responsibility, will providing resources and during reviews » controls in the work environment to ensure product safety » focus on risk management activities and design transfer activities during product development » specific requirements for documentation and validation of processes for sterile medical devices Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device is assessed before sale is permitted.

ISO 14001 Consultants Bangalore

The ISO 14001 is a standard for environmental management systems that is applicable to any business, regardless of size, location or income. The aim of the standard is to reduce the environmental footprint of a business and to decrease the pollution and waste a business produces. The ISO 14000 environmental management standards help organizations minimize the negative effect on the environment.

Benefits of Certification
	ISO 14001:2004 is a tool that can be used to meet  Internal & External Objectives  » Provide assurance to management that it is in control of the organizational processes and activities having an impact on the environment » assure employees that they are working for an environmentally responsible organization. » provide assurance on environmental issues to external stakeholders – such as customers, the community and regulatory agencies » Comply with environmental regulations » support the organization's claims and communication about its own environmental policies, plans and actions » provides a framework for demonstrating conformity via suppliers' declarations of conformity, assessment of conformity by an external stakeholder - such as a business client - and for certification of conformity by an independent certification body

ISO 9001 Consulting Service Bangalore

Benefits of ISO 9001 include
	» Needs to demonstrate its ability to consistently provide product or         » Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system. » Driving down costs, reducing rejections » Managing risk more effectively »  Improving customer satisfaction » A quality management system gives you the framework you need to monitor and improve performance in any area you choose Some of the requirements in ISO 9001 include » A set of procedures that cover all key processes in the business     » Monitoring  & measuring processes to ensure they are effective » keeping adequate records for different processes » checking output for deficiencies, with appropriate corrective & preventive action where necessary » regularly reviewing individual processes and the quality management system itself for effectiveness » facilitating continual improvement

ISO 9001 Consultants Bangalore

ORBIT QMS, with headquarters in Bangalore provides superior consulting services for implementation of quality & management standards, serving both the manufacturing and service sectors. ORBIT brings a fresh and innovative approach to consulting services.

 Our goal is to exceed the expectations of every client by offering outstanding customer service, increased flexibility, and greater value, thus optimizing system functionality and improving operation efficiency. Our associates are distinguished by their functional and technical expertise combined with their hands-on experience, thereby ensuring that our clients receive the most effective and professional service.