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What do you want to know about QC 080000 ?

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QC080000

QC 080000 also called as international IECQ technical specification for risky substance measure the executives. It is a proactive, powerful, and cost-productive way to deal with overseeing, limiting, and wiping out risky substances in electronic and electrical items and their creation measures. QC 080000 gives an establishment to the complete, efficient, and straightforward administration and control of the cycles intended to meet client, legal, and administrative HSF (Hazardous Substance Free) necessities. It guarantees the worth-added the board of HSPM measures from idea through item the acknowledgment to item end-of-life.

QC 080000 provides a design and specification and it helps in the following ways:

  • Fulfil both client HSF necessities and worldwide HSF administrative necessities,
  • Decides and record the specialized parts of the perilous or limited substance levels in items and cycles.
  • Foster the strategies and cycle controls to guarantee specialized consistence with perilous substance limitation necessities, and
  • Gives the fundamental preparing, measure instruments, and framework to guarantee maintainability.

QC 080000 and ISO 9001

  • QC 080000 was composed to relate to the structure of ISO 9001:2000, the global norm for quality administration frameworks.
  • While ISO 9001 gives a reason for the advancement of business frameworks, QC 080000 makes it a stride further to underline the administration of dangerous substances.
  • Close by ISO 9001, QC 080000 gives the particulars of interaction the board for dangerous substance limitation:
    • Zeroed in on unsafe substance measures for conveying items consistent with WEEE, RoHS, as well as Green Process prerequisites
    • Must have recorded the board for specialized verification of consistence
    • Must have estimation and testing constrained by the association
    • Continuous improvement of dangerous substance cycles to drive authoritative and item acknowledgment measure improvement
    • Must show conformance with scope objective

QC 080000 Benefits

QC 080000 can demonstrate to controllers that a producer’s cycles are successfully controlling dangerous substances. It demonstrates that the association has measures set up to appropriately oversee item acknowledgment explicitly for HSF.

  • Guarantees continuous admittance to worldwide business sectors
  • Ensures a supported upper hand
  • Provides a solid appearance of consistency with material laws
  • Assists in driving business mix and progression of cycle control all through the inventory network

QC 080000 PROCESS

Prior in looking for certification to QC 080000, the association should be ensured to ISO 9001 or one of its subordinates, (for example, ISO/TS 16949, ISO 13485, TL 9000, or AS9100). The two norms might be surveyed simultaneously. The review interaction for QC 080000 is basically the same as that of ISO 9001, with yearly evaluations and a declaration legitimacy of three years. Some of them are:

  • There can be no Opportunities for Improvement (OFIs), just major or minor dissensions.
  • All necessities and capacities will be covered during the yearly reconnaissance review. No testing evaluations are permitted; all destinations should be surveyed during each review.
  • Technical item and cycle factors will be assessed, for example, material/item hazard investigation, testing reports, production network the board, hazard control, or estimations for similarity.
  • The degree articulation on the testament will cover pertinent lawful and other necessities (RoHS, WEEE, Batteries, Packaging, and so forth) notwithstanding an item scope, (for example, “plan and production of… “) like what might be displayed on an ISO 9001 declaration.
  • When your association is confirmed, the endorsement will be posted on IECQ’s site.
  • The auditing services emphasize minimizing business risk while evaluating the efficiency of the HSPM procedures in achieving the HSF goals.
  • With a high level of technical knowledge and an unmatched emphasis on customer fulfilment, it is keen to support throughout the life of the QC 080000 certification and in the future.

Contact shakti@gqsindia.com to know more about HSF Hazardous Substance free, HSPM Hazardous substance Process management, QC 080000 Consultancy, QC 080000 Certification, QC 080000 Training if your factory is located in  India – Bangalore, Chennai, Hyderabad, Mumbai, Kolkata, Mysore, Belgaum

Mobile :- +91- 9845313910

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

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

 

ICMED 13485 QCI Certification for Medical products consultancy by GQS

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CE for Medical products

CE for Medical products

With the launch of Medical Product Regulations since 2017, all medical products falling under

CLASS 1, CLASS2 and CLASS 3 shall have to undergo certification to Quality Council of India QCI accredited ICMED Indian Certification for Medical devices.

The legal requirements will be in force w.e.f 2018 and shall comply to all the specifications and requirements for factories manufacturing, trading or supplying medical products falling under CLASS 1, CLASS 2 or CLASS 3 type.

QCI has launched ICMED in 3 categories for certification

  • ICMED 9000 –  based upon ISO 9001  plus additional requirements
  •  ICMED 13485  — based upon ISO 13485  plus additional requirements
  • ICMED 13485 Plus  – based upon ICMED 13485 pluS Product specifications prescribed by MoH

All organisations supplying, trading or manufacturing have to mandatorily achieve certification by QCI accredited Notified body.

GQS was one of the first to attend major seminars on this subject and has been in the field of Medical product certification since 2001 and registered by QCI since its inception.

Drop in an email to SHAKTI@GQSINDIA.COM or RAJ@GQSINDIA.COM to know more details about ICMED, QCI, Certification, Consultancy, ISO 13485.

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