ISO 13485 Certification in Delhi

ISO 13485 Certification in Delhi

ISO 13485:2003 is the international standard that defines quality management system requirements for organizations that design and develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices. The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector.

It is derived from the same basic principles as ISO 9001, but places additional emphasis on areas such as documentation, the work environment, risk management, design control and medical device reporting to meet regulatory requirements

ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Our ISO 13485 Certification:

·         is recognized globally as the best quality practices within the medical device industry

·         • meets regulatory requirements in many countries, as well as contractual obligations of many organizations, enabling you to do business with new customers

·         helps create a systematic framework in which organizations monitor, measure and analyze their processes and customer feedback

·         helps provide a framework for implementation of actions (where necessary) to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with applicable customer, quality and regulatory requirements

·         can provide improved performance in areas such as sales, product delivery, and process efficiency

·         can reduce costs as a result of minimizing product failures

 

The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic). The standard can be used by an organization for the design, development, production, and installation and servicing of medical devices as well as for the design, development and provision of related services.

ISO 13485 can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements. The standard is published by ISO, the International Organization for Standardization, and is available through National Standards Bodies.

Benefits of ISO 13485 Certification

·    Implementing a Quality Management System, in general, helps to motivate staff and provide a better definition of roles and key responsibilities.

·    Implementing a Quality Management System specifically tailored for the medical devices industry helps the organization to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, meet applicable regulatory requirements (compliance) and safety standards.

·    Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted and corrected.

·    Improvements can be developed on a systematic and monitored base, resulting in less waste, less inappropriate or rejected work, and fewer complaints.

·    Provides a systematic approach to risk management.

·    Systematic, smoother, transparent and documented handling of activities required by regulation such as post-marketing follow-up and surveillance, complaints handling, CAPA implementation, field actions or product recall handling, vigilance and competent authorities reporting, and clinical experience enrichment.

·    Systematic incorporation, at an early stage and within the design and development process, of the regulatory requirements impacting on the product itself and its technical features.

·    Help creating a systematic vision embracing the medical device lifecycle, medical device packaging, its labeling, its installation, its servicing, and its usability. This includes the information provided together with the medical devices, the commercial claims, the unspoken user expectations, the feedback from users or patients, the risks associated with use, the benefits brought to the single patient and to the Community, the costs and the disposal of the medical device.

In other words the real benefit that should be pursued and that can be gained by the use of ISO 13485:2003 is the creation of a company’s culture based on the understanding that the regulatory compliance of a medical device is "within" the medical device, intrinsically bound to the “physicality” of the medical device from the moment it is conceived (designed) until it is manufactured.

A medical device is simply an object; it can be material (tube, scalpel or machine) or immaterial (software). It is important to understand that such an object becomes a medical device, acquires the dignity of a medical device because it answers to a certain definition given by a regulation, the same regulation that gives the requirements the medical device must satisfy.

 Contact CDG for ISO 13485 Certification in Delhi

Phone: 9999974494, 9654656507, 9555577722