Indonissin Noodles and Raghu Packaging has kick started implementing the SMETA 6.0, SEDEX, SA 8000 Social accountability standards.
The focus of these standards are on
From forming committees to implementing regulatory compliances with respect to these standards, it is a very challenging task since these involve implementation of good practices in Human relations and Industrial relations.
Call on 9845313910, 9741501910 or drop an email to SHAKTI@GQSINDIA.COM if you are looking at SMETA 6.0 Audit, SMETA 6.0 Certification, SA 8000 Certification
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.
Oneworld located in Gandhidham, Gujarat has kick started R2 SERI Certification. The company with its Head office in Penang, Malaysia is a pioneer in Plastic recycling. The company is also well known in the business of cloth recycling in Gujarat.
With state of art technology the company has invested in Special economic zone SEZ Kandla for import and export of Printers, Laptops, Desktops, Mobile phones and tablets.
From Receiving, storage, repair, dismantling, Security, Transportation of hazardous waste to approved recycler, the company has planned to implement a robust Environment, Health and Safety systems by applying for the ISO 9001, ISO 14001, OHSAS 18001 Certification.
Interested to know about R2 SERI, R2 Certified supplier, R2 Certificate, R2 SERI Audit, SERI License, R2 SERI Certified facilities in Bangalore, Chennai, Kolkata, Hyderabad, Delhi and in any state such as Tamil Nadu, Karnataka, Gujarat, Kerala..drop an email to SHAKTI@GQSINDIA.COM or call us on 9845313910, 9845078743.
Taj computers, Delhi involved in repair, dismantling, refurbishment of laptops, desktops have now been recommended for R2 SERI Certificate.
R2 SERI Licensing and certification requires recyclers to maintain high level of integrity and traceability of products right from receiving until dispatch. Further to the repair and refurbishment process, Cradle to Grave of the focus material have also to be documented and controlled to avoid misuse or abuse of the wastes.
If Finding a R2 Recycler SERI Certified is a challenge..you don’t have to feel so. Call us on 9845313910, 9845078743 or email to SHAKTI@GQSINDIA.COM to know more about R2 SERI, R2 Certified supplier, R2 Certificate, R2 SERI Audit, SERI License,
ECO RECO Andheri Mumbai, has started the SERI standards on Responsible recycling. The company is involved in recycling of electronic wastes such as Batteries, Laptops, Desktops, Lamps and Printed circuit boards.
With license from SERI Sustainable Environmental Recycling International USA, the organisation has moved one step above the rest in implementing a strong Environment, Health, Quality, Security management system. The recycled products have been successfully disposed using the state of the art technology at various down stream vendors located in India and abroad.
Located in Mumbai, Kolkata, Delhi, Chennai and wish to apply for SERI License and R2 Certificate,R2 SERI, R2 Certified supplier, R2 Certificate, R2 SERI Audit drop an email to SHAKTI@GQSINDIA.COM or call 9845313910, 9845078743
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 email@example.com
General Data Protection Regulation GDPR was published by the European Union to ensure that Data is secure and used for the right business purpose.
Although the compliance has to be met by organisations, there is no need for any certification by any third party.
To comply to the GDPR and meet the certification requirements for ISO 27001 Information Security Management, ISO 20000 IT Service management, ISO 13485 Medical devices management system, there are 99 articles and 173 recitals to be complied.
Certain additional ISO Standards which can be referred while implementing ISO 27001, ISO 20000, ISO 13485 are ISO 8000-8 Data Quality, ISO 29124 Information Technology security techniques guidance for Data privacy, BS 10012 Personal Information Management system.
The following details have to be known for organisations who implement GDPR, DS – Data Subject, DP – Data processor and DC -Data controller. All the key companies involved in Data processing be it in Europe or any other part of the world have to comply to GDPR.
The word “Third country” is used many times in the GDPR. This refers to the organisations located in other countries other than the European Union EU, who are a party to this and have to comply to GDPR
Upon knowing a Breach, the DS Data subject have to notify the National regulator within 72 hours of such a breach. The guilty could be penalised anywhere between 10 million Euros to 20 million Euros.
Organisations have to deploy as Data Processing Officer who is referred to DPO to monitor the GDPR Compliance.
Wish to implement GDPR along with ISO 27001, ISO 20000, ISO 13485 – Do call us on 9845078743, 9845313910 or just drop an email to SHAKTI@GQSINDIA.COM
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
Learn and document how to identify Risks and opportunities in the latest High Level structure published by the International organisation for standardization.
The 4 step method to identify, assess and mitigate risks and opportunities as per iso-9001-2015-iso-45001-2018-iso-22000-2018-iso-14001-2015 are illustrated in the image above.
The advantages of these 4 step method is to assure the organisation that all the high risks are identified, assessed as per the documented procedure, mitigated and controlled as per the feasibility and budgets allocated to each and every process by the Leadership team.
Whether it is ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 22000:2018, ISO 27001:2013, the process of identifying, assessing and mitigating Risks in line with ISO 31000 requirements remains the same.
Should you be interested in consultancy, certification of ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 22000:2018, ISO 27001:2013, ISO 50001, ISO 55001 Drop an email to SHAKTI@GQSINDIA.COM, 9845313910.
Six Ways to upgrade to ISO 22000:2018 by focussing on Interested parties
Located in Bangalore, Singapore, Malaysia, Indonesia, Sri Lanka, Maldives, UAE – Do let us know as your organisation decides to upgrade / migrate to ISO 22000:2018 Certification.
Call 9845313910 or drop an email to SHAKTI@GQSINDIA.COM