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HOW LONG DOES IT TAKE TO ACQUIRE ISO 13485 CERTIFICATION ?

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How long does it take to acquire ISO 13485 certification

Global quality services have been giving the best quality ISO certifications to its customers. ISO 13485 certification is one of them. ISO 13485 confirmations is an overall term that is utilized for two primary things. To begin with, you can confirm an organization, i.e., ensure its clinical gadget Quality Management System. Certificate of the organization QMS includes carrying out each of the necessities in the ISO 13485:2016 norm, and afterward having reviewers from an autonomous outsider accreditation body come and check that your QMS processes meet every one of the prerequisites of the ISO 13485 norm. Your QMS is then ensured.

Second, you can affirm people since you will require individuals in your association to acquire information about ISO 13485 to execute and keep up with the fundamental cycles, including the basic course of inside evaluating your QMS on a continuous premise to confirm conformance and track down progress. These people might see that guaranteed preparing is useful in acquiring these abilities.

The organization ISO 13485 confirmation process is separated into three phases:

  • Stage one (documentation survey) – The reviewers from your picked certificate body will check to guarantee your documentation meets the necessities of ISO 13485. You’ll get a review report specifying the regions where you are consistent, just as those wherein you have issues. You will then, at that point, be offered a chance to execute the important remedial activities to determine the issues. This is frequently done during the equivalent time span given for the underlying activity of the Quality Management System.
  • Stage Two (primary review) – Here, the affirmation body examiners will check whether your real exercises are agreeable with both ISO 13485 and your own documentation by assessing archives, records, and friends rehearses. During this review, the accreditation body will send examiners to view the records you have gathered through the activity of QMS processes. These records will incorporate those from the executive’s survey, inward reviews, and restorative activities.
  • Stage Three (reconnaissance reviews) – The prerequisites of ISO 13485 command that the QMS be kept up with and improved, implying that your ISO affirmation isn’t just a one-time action. Normally, there is a three-year review cycle for ISO 13485, what begins with the underlying confirmation review, which will see all processes in the QMS. Over the course of the following three years the accreditation body will perform progressing reconnaissance reviews of the framework (now and again called upkeep reviews), where they just gander at a piece of the framework alongside basic cycles, for example, the inner review, the board audit, and restorative activity. The upkeep reviews occur, at least, when a year during the period in which the testament is substantial. The cycle will begin again after the three-year affirmation period is finished, in the event that the organization decides to keep up with the ISO 13485 confirmation and the advantages it gives.

Other than this for people, there are instructional classes that people can take to get the ISO 13485 testament. ISO 13485 courses are important to give the data, information, and abilities expected to involve the ISO 13485 norm for making and keeping a Quality Management System in an organization. Notwithstanding execution, people who will be evaluating the ISO 13485 QMS should figure out how to do as such, and taking an inspecting course can be a significant piece of this information securing.

Contact [email protected]  9845313910  for further information

Services Offered :-

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

What are Class 1, 2, 3 Medical Devices ?

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What are class 1, 2, 3 medical devices

It is highly important that the medical devices must be tested properly and proved safe!

The European Union (EU MDR) classification will bring you all about the classification of medical devices and this blog presents how it is being classified. This is not in accordance with the MDD 93/42/EC classification rather the “new one” EU medical device regulation 2017/745 or EU MDR 2017/745 and this seems to be mandatory from 2020 onwards. Also it is noticed that the status period is extended. Global quality services bring you this blog to make you aware of the classes of medical devices.

Number of classification that exists:

The EU MDR 2017/745 has categorized the medical devices into four main divisions and they include,

  • Class I
  • Class IIa
  • Class IIb
  • Class III

The products or the devices with the low risk will be put into class I and the products with higher risk stages are into class III. In order to be more specific, these main 4 divisions are further splitted into sub categories like class ls, class lm, and class lr.

Class ls: This comprises the class I products that are delivered as ‘sterile’

Class lm: This comprises the products or devices that are with a measuring function

Class lr: This is a new sub class that is mentioned for products that are reprocessed

Factors taken into account for classification:

Some of the factors that are being considered to undertake this classification include:

  • The duration by which the device is going to be used
  • Ensuring if the device is surgically invasive or not
  • Ensuring that the device is actively used or surgically implantable
  • If any medical substances are present in the device

Class I devices:

The medical devices those are considered to be the ‘lowest risk level’ comes under the class I classification. This complies only the lowest level of regulatory standards. In an overall analysis, 47% percent of the medical devices will fall under this category. And the remaining 95% of the medical devices will be an exemption from the regulatory processes. If any of the devices is identified to be in the general category of exempted class I devices, then the premarket notification and FDA clearance is not mandatorily required.  The examples of class I devices include elastic bandages, dental floss, enema kits, manual stethoscopes and bedpans.

Class II devices:

The devices or products that come under class II medical devices are the ones that come under the moderate to high risk to the patient or the user. Here in this category 43% of the medical devices will fall, and it is found that almost many of the medical devices fall into this category. They are more complicated than the class I devices and hence require stringent regulatory controls in order to provide the assurance and safety of the user. Examples of these devices include condoms, pregnancy testing kits, and powered wheelchairs.

Class III devices:

The class III devices are said to be the most complex devices and these are also considered to follow the more stringent regulatory controls. Some of the devices include implantable pacemakers and breast implants. These represent only 10% of the medical devices.

Based on the duration of use, the medical devices can be categorized into ‘Transient’, ‘short term’, and ‘long term’.

You need to keep track of your product’s life cycle and every device manufacturer must keep quality in the first place. Global quality services help you to track all the quality and the legacy approach along with the regulations.

Contact [email protected]  9845313910  for further information

Services Offered :-

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

Benefits of ISO:13485 Certification

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Benefits of ISO: 13485 Certification

ISO 13485 certificate is intended to be utilized by associations engaged with the plan, creation, establishment and adjusting of clinical gadgets and related administrations. Global quality services helps in the execution of a Quality Management System in view of ISO 13485 is one such venture, where it’s hard to put a dollar sum on the possible advantages.

The benefits of ISO 13485 couldn’t possibly be more significant. Organizations of all sizes have acknowledged critical reserve funds in cost and time, in addition to different enhancements that an effective Quality Management System normally achieve.

  • It works on your organization’s believability and picture: ISO 13485 is the inside perceived best quality level for quality in the clinical gadget industry. Certification to this standard shows customers and clients that your organization treats quality exceptionally in a serious way, and that you have a framework set up to guarantee it. Your QMS can be an incredible advertising instrument, and it has turned into a prerequisite in numerous nations for providers to show consistence. This means greater freedom.
  • It can further develop the consumer loyalty: The ISO 13485 standards are based on a bunch of value the board standards, one of which is guaranteeing consumer loyalty. This can be accomplished by surveying client needs and assumptions, and end eavouring to meet them. Clients know what they need, and what they need, and a large number of them won’t engage a provider that isn’t guaranteed. Past that, guaranteeing the fulfillment of your current clients keeps them returning, and assists you with offering your administrations to new clients. This makes an interpretation of straightforwardly to expanded income.
  • It works on your cycles:Utilizing the interaction approach illustrated in ISO 13485, it’s a lot simpler to find openings for upgrades. You’ll have the option to distinguish and dispose of waste inside and between processes, diminish mistakes, and keep away from revising organizations with more prominent productivity and cost reserve funds.
  • Further develop dynamic:One more quality administration standard of ISO 13485 respects the utilization of proof based dynamic. At the point when you use realities and information to drive your choices, those choices will generally be better lined up with the essential objectives of your organization. A special reward is the expanded knowledge into the wellbeing of your cycles, and any upgrades that are made, when you monitor the information.
  • Make a culture of persistent improvement:A third quality administration guideline making up the establishment of ISO 13485 is the idea of constant improvement. By building up precise cycles for lessening issues and alleviating their belongings, everybody will invest less energy tidying up botches, and additional time conveying quality items and administrations.
  • Better worker commitment: At the point when workers are approached to help search for ways of working on their own cycles, they will likewise be a lot more joyful and more put resources into the accomplishment of the organization. The more your representatives comprehend their jobs in conveying quality items and administrations, the more drawn in they are, which prompts expanded effectiveness and efficiency.

Global quality services emphasizeon ISO 13485 certification because of the global norm for Quality Management Systems in the clinical gadget industry. Organizations that have accomplished certification through GQS show confirmation to potential customers that they consent to best practices, and with administrative prerequisites. Furthermore, it enroots, your organization will normally appreciate better command over its cycles, and ceaseless improvement driving consistent ROI.

Contact [email protected]  9845313910  for further information

Services Offered :-

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

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 [email protected]  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 [email protected]  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 [email protected] 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 [email protected] OR call 98453 13910, 98450 78743

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