The International Standard Organization stated as the ISO 13485 is formulated as the Quality Management System (QMS) for Design and Manufacture of medical devices. The ISO 13485 is a certification provided to the medical device manufacturer and controls in the work to ensure the safety of the product. Global Quality Services (GQS) focuses primarily on auditing the risk management activities involved in the manufacturing activities and the design control activities. The leading consulting firm in India has provided the best ISO certification consultancy for a wide variety of clients across the countries and we will make internal audits on the proper integration of the customer-specific requirements. Since this is related to the medical field, we ensure that the people are highly benefitted without any miscarriages. The other important thing you need to make sure to get this certification is that you need to formulate the best risk management and contingency planning. In addition to this, you need to be able to formulate quality policies and objectives, set up a proper system for maintaining the documentation procedures, records and sustainability.
Who can avail of this?
All the medical design companies, the medical device manufacture companies, and the related industry sector can get this ISO 13485 certification to make their Medical devices approved to be the high standard quality.
The medical device manufacturers must know the reason for availing such cardinal certifications for their medical devices. The reasons include, they will get an opportunity to supply their medical devices for the top-notch industries; they can easily cater to the export market, the safety of the product or the devices will be highly ensured – thereby the people can trust the manufacturer easily, helps them to perform high traceability management, the entire business processes will be streamlined and also helps by improving the efficiency.
The ISO 13485 certification helps the medical device manufacturers in the proceeding of business process optimization. To make your business highly optimized, any manufacturer must focus on some of the mandatory things like – Technology, Re-engineering processes, Training (if needed), Strategic sourcing, supply chain design, Cost reduction, Quality control, High customer satisfaction and most primarily meeting the specific customer requirements. Global Quality Services (GQS), which strives as the best consulting firm for ISO certifications in Bangalore , will put all together and endeavors to make any organization fulfill these business optimization techniques to enhance their business. The medical device manufacturers must make themselves sustainable in the business arena and then they can create a large impact in their field. The highly sustainable business must be very strict in satisfying the needs in all areas like Environmental, Economic, Social, and Governance. Making your business sustainable and optimized will create a high impact among the public. The foremost thing that all manufacturers must keep in mind is the well-being of the public. Hence, make sure that the medical devices that you manufacture are meeting all the specific requirements and Global Quality Services (GQS) will help you by assisting the same.
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If Management conforms that they are meeting all the appropriate and international standards and also provides a proper endorsement that the system is in place, then the organization will be awarded a certificate of management system certification. Some of the examples include ISO 9001 , 14001, 27001, and 14001. Every ISO standard will reckon a different kind of intent. This ISO 13485 will draw the inference of supporting the standardized medical device manufacturers to design a qualified system thereby maintaining the effectiveness of the system process.
You need to get a clear picture that the management system certifications are meant to guarantee over the system and not any individual products or services that own them. In the case of product certifications, the expert team would focus on the product and they will analyze whether the product meets the international standard specifications and offers continual support to the users. You need to also make sure that the product which achieves the product certification must be different from the other usual products. This differentiation largely brings an impact on the product certification among the public. The design, development, production, and installation are completely analyzed and tested before offering the certifications. There are also certain certification schemes that the products under test must undergo. After the quality assurance test, if the product is meeting the standard regulations and norms under the certification, then such products will be certified. ISO 13485 comes under the management system certification and the accreditation body focuses mainly on the system that the medical device manufacturers follow to provide quality devices and deliver them properly for the intended purposes.
There are certain norms and standards that the certification schemes follow to test the quality of the intended product or service. This certification will do a write-up that includes both the performance test methods and practices of the product and the standard criteria that the product must meet to become certified. The issue of the certificate by a certification body is based on their clients who meet the ‘specific requirements and that will not come under the accreditation. The leading consulting firm, Global Quality services (GQS) finds that if a person gains good knowledge on the difference between the management system certification and the product certification, it will bring lots of benefits to the concerned organization. By doing proper audits, the product or the service will be tested if they are meeting that ‘specific requirements.
Figure out the product certification or the management system certification that best suits you with the best consulting firm in Bangalore – Global quality services (GQS). There is a lot of product certification but everything doesn’t suit you, so find the best place that’s worth your time for getting more ideas about the certification processes. It is meant like if a product or service is accredited once, it will be accepted everywhere.
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Achira a leading medical device research company has now been successfully recommended for ISO 13485 Certification by TUV.
The entire journey started with gap analysis, preparation of documentation, preparation of the design file, review of the management system, internal audits, stage 1 and stage 2 audit by TUV.
Risk assessment were carried out based on the special ISO standard for carrying out risk assessment for medical devices.
Wish to know more about ISO 13485-2016 Consulting for medical devices, ISO 13485 Certification for medical device research center, production center, service center..do drop an email to SHAKTI@GQSINDIA.COM or call on 9845313910, 9741501910.
What is new in ISO 13485 and how can GQS help ?
ISO 13485 training and certification to Achira a medical equipment company in Bangalore has been initiated since May 2018. The process of consultancy involves
Call us to know more about ISO 13485 Consultancy, ISO 13485 Certification and guidelines to prepare Medical device file.
9845313910, 9845078743, drop an email to firstname.lastname@example.org
CRITICAL STEPS TOWARDS ISO 13485 CERTIFICATION
Most medical equipment manufacturing companies are guided by GQS consultants and ISO certification body regarding the requirements to be implemented and complied to.
The statutory and regulatory requirements applicable for medical equipments have to be studied, reviewed and documented before the documentation kick starts. There are over 30 documented procedures and documents needed to roll out the same for implementation.
For these 30 documented procedures, mandatory records over 40 have to be implemented by various departments.
Clinical validation, Clean room validation, Advisory notices, Servicing instruction, Installation instruction, Technology handover post design, Risk assessment based on ISO 14971 covering all harms associated with the use of medical equipments have to be reviewed, documented and implemented.
During Design of these medical equipments, it is important to understand if there are samples or information from patients used are controlled and complied as per the latest EU regulation against Data Protection. The articles and recitals of the 99 GDPR Articles have to be studied and complied.
Should you require further information on ISO 13485 Consultants, ISO 13485 Certification, ISO 13485 Consultancy drop us an email at SHAKTI@GQSINDIA.COM
Call us 9845313910 / 9845078743