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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!

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GDPR Compliance for ISO 27001, ISO 20000, ISO 13485

GDPR ISO 27001, GDPR ISO 20000, GDPR ISO 13485

GDPR ISO 27001, GDPR ISO 20000, GDPR ISO 13485

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


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