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Standardization Alert: Boon For A Company

You are here: Home / as9100 consultants / Standardization Alert: Boon For A Company
ISO-13485-certificate-consulting

April 21, 2020 By //  by Dave

Ever wondered what’s this entire buzz going around for getting ISO certifications?

Well there is plethora of ISO certifications and some companies ought to get those certifications in order to ensure their effectiveness. Hurry up and get to the nearest consultancy or look for an auditor.

But what is ISO?

The international organization for standardization is an international standard setting body. ISO standards are designed to ensure the quality management system and to make companies, governments and other organizations more efficient. Some standards are designed for the specific industries or designed to help the environment.

ISO9001 & ISO13485

ISO9001 focuses more in customer satisfaction and it’s more efficient and quality driven. These set of standards helps organizations ensure that they meet customers and other stakeholders needs within regulatory requirements. ISO9001 certification is mostly going to bring more companies means more business and more business readily depict more enhance productivity and accountability. It is a tremendous marketing tool.

The certification is issued by the registrar and it is not a single person certificate rather whole institution or company has to apply for it.

Similarly ISO13485 a certificate issued for design and manufacturing of medical devices. It is written to support the medical device manufacturers in designing quality management systems that establish and maintain effectiveness of the processes. It helps through the consistent design development, production, installation and delivery of the medical devices. Contact ISO 13485 Certification Consulting to get ISO13485.

ISO13485 basically is addition to the ISO9001 and additional medical requirements. The latest issue of ISO13485 was published on 1 march 2016 and it’s important because it is long overdue with the previous version being released 13 years earlier in 2003. Meet the needs of the ISO 9001 Certification Programs.

Documentation requirements

  • Quality manual
  • Medical device file
  • Document control
  • Control of records

 

Filing these internal audits isn’t an easy task and requires supervision and consulting auditors who specialize in handling in quality management. It comes with its own cost and expenditure and not forget about the various processes the company has to undergo before you actually get a certification.

Now there are many options available online as well as offline. But why to waste time when you can go digital mode. Choices people! You can actually learn these certification courses on your own and can become a personal auditor on platforms like udemy. And when it comes to professionalism you can always look for better options for consulting visit www.barileiso9001consulting.com which offers you a wide range of ISO certifications best suitable for your company or industry. So check up your company progress who knows it just lacks some quality management shine and get started on.

Filed Under: as9100 consultants

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