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The Need for ISO 13485 certification for your Medical devices

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The Need for ISO 13485 certification for your Medical devices

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 Reason:

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.

Contact shakti@gqsindia.com  9845313910  for further information

Services Offered :-

India – Bengaluru , Chennai, Hyderabad, Mumbai, Kolkata, Mysore, Belgaum

 

Difference Between Management System Certification and Product Certification: ISO 13485

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Difference between management system certification and product certification: ISO 13485

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 BangaloreGlobal 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.

Choose wisely!

Contact shakti@gqsindia.com  9845313910  for further information

Services Offered :-

India – Bangalore, Chennai, Hyderabad, Mumbai, Kolkata, Mysore, Belgaum

ISO 13485:2016-Quality Management System

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ISO 13485 Consultancy by IRCA Approved auditors

ISO 13485 Consultancy by IRCA Approved auditors with excellent experience in ISO 13485 audit experience in Medical devices such as Dental equipments, Elisa type readers, Trading companies, Servicing of Dental chairs, Surgical instruments, X Ray machines, CTScan, MRI manufacturing

 

ISO 13485 consultant, ISO 13485 Consultancy, ISO 13485 Certification,  ISO 13485 in Bangalore, Hyderabad and Chennai.

Please drop us an mail at SHAKTI@GQSINDIA.COM or call us on 9845313910

Remote Online ISO Certification due to Covid 19 Virus issue

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Online ISO

Online ISO

Remote Online ISO Certification due to Covid 19 Virus issue – valid until December 2021

GQS India becomes the first  ISO Certification body to announce remote ISO certification audits and Lead auditor trainings (by Third party IRCA and Non IRCA Approved training organisation), General awareness training, Internal audit training  2021  in the following

  1. ISO 22301 – Remote Online Business continuity management Certification audit
  2. ISO 13485 – Remote Online Medical equipment management Certification audit
  3. ISO 22000 – Remote OnlineFood safety management system Certification audit
  4. FSSC 22000 Version 5 – Remote Online Food Safety System certification Certification audit
  5. ISO 28000 – Remote Online Supply chain management Certification audit
  6. ISO 37001 – Remote Online Anti Bribery Management system Certification audit
  7. C-TPAT – Customs – Trade partnership Against terrorism – Remote consultancy, training
  8. SCAN – Supplier Compliance Audit Network – Remote consultancy audit
  9. BRC – British Retail Consortium – Remote BRC Consultancy audit
  10. ISO 50001- Remote Online Energy management system certification audit
  11. ISO 55001 – Remote Online Asset management system certification audit
  12. ISO 45001 – Remote Online Safety Management system certification audit
  13. ISO 14001 – Remote Online Environment Management system certification audit
  14. ISO 9001 – Remote Online Quality Management system certification audit
  15. ISO 27001 – Remote online Information Security Management certification audit
  16. ISO 13485 – Remote Medical device Management system certification audit
  17. ISO 41001 – Remote Facility Management system audit
  18. GMP – Remote Good manufacturing Practices audit

PLEASE NOTE THAT AS PER ACCREDITATION GUIDELINES,

  1. THIS SERVICE WILL BE CONTINUED UNTIL THE COVID 19 VIRUS ISSUE, AFTER THE ISSUE SETTLES DOWN THE ONLINE CERTIFICATION PROCESS WILL BE WITHDRAWN.
  2. FOR ALL SUCH REMOTE AUDITS – ON SITE AUDITS SHALL BE CONDUCTED ONCE THE TRAVEL RESTRICTIONS ARE LIFTED BY GOVERNMENT.
  3. CERTIFICATIONS ARE SUBJECT TO AVAILABILITY OF ALL RELEVANT DOCUMENTS AND REGULATORY COMPLIANCES.

Located for audits for 2021 any part of India– Best  training and certification experts in ISO Certification, drop an email to shakti@gqsindia.com OR call 98453 13910, 98450 78743

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What is new in ISO 13485 with free download

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ISO 13485 Download documents

ISO 13485 Download documents

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

  1. Preparation of Medical device file.
  2. ISO 13485 Certification steps
  3. ISO 13485 consultant support for preparation of Medical device file MDF
  4. Writing procedure with respect to Advisory services
  5. Writing procedure for Software validation
  6. What softwares are required to be validated ?
  7. How are the validation protocols to be documented and recorded

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 shakti@gqsindia.com

 

ISO 13485 Certification Bangalore, Hyderabad, Chennai

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ISO 13485 Certification

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

ISO 13485 Certification

ISO 13485 Certification

 

Ridiculous ISO 9001 Certificate in 1 to 7 days

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Dont get fooled by cheap and Fast ISO certificate- Approach QCI Approved consultant for ISO Certification to avail Government subsidy
for KOSHER, ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, FSSC 22000 Certificate and CE Mark for any
kind of company located in India.
Government subsidy starts from 1 lac(non food) until 50 lacs for food industry.
Non Food industry looking for infrastructure improvement can also apply for subsidy to an extent of
50 lacs.

Claims of certificate in Seven (7) days is ridiculous and fake. Do not fall prey to ‘fly by night’
certification and consultancy firms.

10 Check Points for Identifying the Right ISO consultant and ISO Certification body.

1. If the consultant is approved by Quality Council of India or NRBPT
2. if the certification body is approved by QCI or NRBPT or NABCB
3. if the consultant / Certification body is approved by APEDA for providing consultancy to food company
4. Avoid Free lance consultants who operate from their homes. You will never find a replacement for fixing
all the erroneous or shoddy work carried out by these Free Lance ISO consultant.
5. There are freshers from college who have started consultancy services without having work experience.
6. Check credentials of the consultant before you deploy him.
7. Check if the Accreditation logo provided on certificate are genuine. Call up their office to see if the phones are working !
Many certificates are printed in Bangalore or other cities in India with “Virtual address” of US or UK offices. When you call you get the following response
“This phone does not exist”
8. Check if Certification body is located in commercial Business centers.
If certificate have Virtual office address.. This is not permitted by Accreditation body.
9. Various ways you could get conned. Be aware, alert and wise in deciding your partner for your
quest in implementing ISO 9001, ISO 14001, OHSAS 18001, ISO 9001:2015, ISO 45001.
10. Check if auditor have their Lead auditor certificate and if its valid IRCA approved certificate.

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