ISO Certification for medical services

SIS Certifications Pvt. Ltd is Best ISO Certification body in India. We provide ISO Certification for Medical services  in India at the best price. We have well qualified auditor team. They have more experience in their field.

ISO Certification stands for international organization for standardization. The purpose of ISO in any stream is to make the process and the result successful be it in terms of quality, security, food , social accountability for others.

The specialty of ISO is it is valid and meaningful to all the sectors, especially where the customers are important and the organization runs to be best in the market by maintaining the trust and accountability. So, being meaningful in Health care sector as well, the following standards are good to go with :

1. ISO 9001: 2015 – Quality Management System (QMS)

ISO 9001 Certification is a Quality Management System standard that consists of principles that help ensure standardized levels of quality are applied across all organizations and sectors of the Healthcare Industry including Pharmaceutical Companies, Ambulatory Care, Long-term Care Facilities, Hospitals, among others. Healthcare service providers often choose ISO 9001 as their primary management system registration and then evaluate how other standards may be of benefit to the organization, possibly through an integrated approach.

With the implementation of a Quality Management System using ISO 9001, a health service provider can implement a process for continual improvement, as well as reduce inefficiencies and waste, thereby experiencing a significant cost savings, while maintaining a focus on patient/client satisfaction.

2. ISO 13485:2016

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.

3. ISO 2157:2016

ISO 2157:2016 specifies the nominal diameters of the working parts of dental rotary instruments, for example burs, laboratory burs, grinding instruments, diamond instruments, mandrels and the corresponding designation.

Excluded are the diameters of endodontic instruments and scaler tips.

4. ISO 7153-1:2016

ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopedics and dentistry.

While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.

From monitoring vital signs to  the signage and symbols that help prevent accidents at work or at home, there are more than 1000 ISO Standards that keep people healthy and safe.

Trusted by manufacturers, practitioners, regulators and patients, ISO Standards go beyond tangible objects like monitors and syringes. Countless health professionals rely on ISO management systems help deliver quality healthcare with total confidence. While ISO symbols work as a universal language that can warn people of potential hazards and help them to stay safe.


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|ISO Certification for Medical SERVICES |