ISO 13485 Quality System for Medical Device

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ISO 13485 Certification Quality System for Medical Device :

ISO 13485 Certification Quality System for Medical Device  For details visit Here:

ISO 13485 Certification:

ISO 13485 Certification We provide ISO 13485 certification , an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector. For details visit Here:

ISO 13485 Requirements:

ISO 13485 Requirements In order to achieve ISO 13485 certification, you must develop written policies for the following functions : ·       Document and record controls ·         Internal auditing procedures ·         Controls for non-conformance ·         Corrective and preventative actions ·         Process and design controls ·         Record retention ·         Accountability and traceability For details visit Here:

 Planning the Quality System:

 Planning the Quality System ISO 13485 Standard includes a requirement for Quality Planning. Writing a Quality Manual is not sufficient to meet this requirement. You need documented Quality Plans for implementing changes to your Quality Management System, and creating a new Quality System from scratch is a big change. There is no required format for quality plans. Spreadsheets and Gantt Charts are the most common tools for quality planning. For details visit Here:

How is ISO 13485 recognized worldwide? :

How is ISO 13485 recognized worldwide? ISO 13485 focuses on the harmonization of the Quality Management Systems in the framework of Medical Device regulatory requirements. It is not surprising to see that many jurisdictions recognize or even require that Medical Device manufacturers obtain ISO 13485 certification in order to access their market. For details visit Here:

Contact details:

Contact details URS CERTIFICATION F-3, Sector 06 Noida - 201301, India Tel: 91-120-4516264 - 65 Mobile: +91-9650807813 Email: [email protected] W:-



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