Contact +91-9845313910, shakti@gqsindia.com
Banashankari Stage II, Bengaluru, Karnataka, India

Open Hours
Mon - Sat: 8 am - 5 pm, Sunday: CLOSED

Difference Between Management System Certification and Product Certification: ISO 13485

|
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

CE Certification for Technical Products

|
CE Certification for Technical products

Ten Steps for CE Certification for Technical products by Notified body

We provide complete solution for CE certification :-

1. technical support in preparation of product technical file, CE Risk assessment of the product and process
2. Identifying the right Notified body suitable for the product you manufacture. Be it Engineering or Non engineering product, do let us know to help you identify the right international standards required for inspection / testing
3. Support in B (Technical file preparation) + C (Process Inspection) + D (Inspection of process)
4. Coordination with European notified body for conducting on site CE audits
5. Coordination with customer after the “Open market Pick and Test qualification report” issued by the Notified body
6. Coordination for B2 CE certificate which is issued after the online audit of the Technical file. This is being carried out only due to the current travel restriction. Online audit will be revoked, and offline audit will be carried out once travel restrictions are lifted
7. Coordination of C2 CE Certificate – which is issued only after the Offline (Onsite) audit is carried out by approved auditor from Notified body
8. Support in issuance of the 5 year Valid CE Certificate from Notified body
9. Support during CE Surveillance audit which is carried out by Notified body every year.
10. Support in closure of any NC identified by Notified body auditor during CE Process and Product audit.

Contact shakti@gqsindia.com 9845313910  for further information

Services Offered :-

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

Data Sanitizing in SERI R2 Version 3

|
Data Sanitizing in SERI R2 Version 3

What is Data Sanitizing in SERI R2 Version 3 ?

Many recycling vendors do have doubts and queries related to logical sanitizing process.

• Does it require all facilities to apply the Appendix B for Data sanitizing ?
• How do you secure your environment for Data sanitizing ?
• What should be the competency of the Data sanitizers ?

These facilities not only will have to get the vendor performing sanitizing approved but also apply for R2 SERI Version 3.

Interested to know more about R2 Version 3 certification, R2 Version 3 experts and agency for R2V3 Certification Contact shakti@gqsindia.com 9845313910  for further information

Services Offered :-

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

AS 9145 – APQP For AS 9100 Aerospace

|
AS 9145 - APQP For 9100 Aerospace

Many Aircraft Component Manufacturing Companies seldom overlook implementation of AS 9145 during AS 9100 Certification .

Interested in AS 9145 implementation for aircraft component manufacturing, drop us an email shakti@gqsindia.com  9845313910

Services Offered :-

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

AS 9145 – Aerospace Standards for Advanced Product Quality Planning.

|
AS 9145 – Aerospace standards for Advanced

AS 9145 – Aerospace Standards for Advanced Product Quality Planning

GQS supports in AS 9145 implementation, training and consultancy during AS 9100 certification process for Aircraft component manufacturing companies.

The 5 Steps for AS 9145 implementation are illustrated in the image. Implementation of AS 9145 APQP in line with the AS 9100 standards requires hands-on domain experience.
Do email us shakti@gqsindia.com  9845313910  for AS 9145 implementation, training and consultancy during AS 9100 certifications.

Services Offered :-

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

Environment Site Assessment as per ASTM E 1527

|
Environment Site Assessment as per ASTM E 1527

Green field projects requiring Phase 1 Environment Site Assessment as per ASTM E 1527 – Part 13

Be it Green field or brown field projects, GQS can support in conducting Phase 1 ESA Environment Site Assessment based on ASTM-E Part 13 covering

1. Soil investigation
2. Ambient air quality
3. Water pollution
4. Noise levels
5. Mercury poisoning
6. Lead contamination
7. Hazards due to Earthquake
8. Public hearing where required
9. Due diligence by interviewing interested parties
10. Risk evaluation of neighboring properties.

Looking for ESA Environment Site assessment consultants – Contact shakti@gqsindia.com 9845313910  for further information

Services Offered :-

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

ENVIRONMENT IMPACT ASSESSMENT (EIA)

|
ENVIRONMENT IMPACT ASSESSMENT (EIA)

GQS has the expertise and professionalism in EIA studies for new industries / capacity expansion of existing industries based on the Environment Protection Act 1986 and notification in 2006 thereafter. Irrespective of the Category A or Category B of industries, we will help

  1. To review the Terms of Reference TOR
  2. Central Government / State government clearances
  3. Public consultations (Public Hearing) with NGO / Experts / General Public
  4. Notification in Newspaper
  5. Communication with relevant authorities

Note – Category B1 requires preparation of EIA report while Category B2 does not require EIA report.

For further information please contact shakti@gqsindia.com 9845313910

Electronic Recycling

|
Electronic Recycling

Electronic Recycling

Recycling of electronic products involve lot of responsible care with respect to Quality, Health and Safety, Ethical regulations and GQS has it all.

From identifying the right R2 SERI Certified facility with complete Life cycle assessment to getting the products repaired / recycled using approved legal and scientific methods of recycling, GQS does it all for you.

Should you have I.T Assets and looking for R2 Certified vendor to recycle / repair Laptops, Desktops, IPads, Servers, CRT, UPS Batteries, Printers, Printed circuit boards, Capacitors, Data Sanitizing using NIST standards drop us an email to  SHAKTI@GQSINDIA.COM or call us on 9845313910

Destruction / Repair Reports shall be issued to all assets containing unique numbers.

Geographical collection feasibility

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

 

ISO 45001 Controls to Prevent COVID-19

|
ISO 45001 Controls to prevent COVID 19

ISO 45001 Controls to prevent COVID 19 Infections

1. Conduct HIRA

2. Consider COVID as a SignIficant Risk

3. Follow the 5 steps Hierarchy for Virus control 4. Record any incidents and report to Regulatory body. Contact SHAKTI@GQSINDIA.COM for Hazard and risk assessment and Virus control procedures in line with regulatory bodies and ISO 45001 requirements.

 

ISO 45001 Certification, ISO 45001 Consultancy, ISO 45001 consultant  in Bangalore, Hyderabad and Chennai.

 

Categories

Search by Tags

Clients