What is an ISO 13485 Quality Management System?

ISO 13485:2013 Medical Devices (QUALITY MANAGEMENT SYSTMS)

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What is an ISO 13485 Quality Management System?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of being certified to ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

Increase access to more markets worldwide with certification
Outline how to review and improve processes across your organization
Increase efficiency, cut costs and monitor supply chain performance
Demonstrate that you produce safer and more effective medical devices
Meet regulatory requirements and customer expectations

ISO 13485, CMDR, FDA and CE marking services from a Notified Body

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the Health Canada Canadian Medical Device Regulations CMDCA What is an ISO 13485 Quality Management System?

What are the benefits of being certified to ISO 13485?

Increase access to more markets worldwide with certification
Outline how to review and improve processes across your organization
Increase efficiency, cut costs and monitor supply chain performance
Demonstrate that you produce safer and more effective medical devices
Meet regulatory requirements and customer expectations

ISO 13485, CMDR, FDA and CE marking services from a Notified Body

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the Health Canada Canadian Medical Device Regulations CMDCAS programme.
Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the European Commission. As one of the leading notified bodies for CE marking, we can support you on selecting the most efficient conformity assessment routes to achieve CE marking.
BSI ISO 13485 Certification is one component of the comprehensive portfolio of quality management assurance services that we provide, together with our toll
Popular services that compliment ISO 13485 include:
Programme.
Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the European Commission. As one of the leading notified bodies for CE marking, we can support you on selecting the most efficient conformity assessment routes to achieve CE marking.
BSI ISO 13485 Certification is one component of the comprehensive portfolio of quality management assurance services that we provide, together with our BSI Excellerator tool.
Popular services that compliment ISO 13485 include:

Time Frame

The work related to preparation & implementation of QUALITY Management Systems can be completed in a period of approximately 10 to 15 DAYS. However for this purpose, it is essential that your management responds favorably to our consultant’s advice and is able to take recommended actions within the prescribed time-frame.

Terms & Conditions

1. We shall be charging our total fee (consultancy fee and certification fee).as per as follows

S. no. Fees Certification Board Scope

01. 25,000 13485:2013 UK (Q.M.S)

Note:-

We will charge extra /- per man days for implement of Your Company.

1. The fee shall be payable by you in installments as per the completion of work in different modules.

1. Advance with application 50%

2. After getting softcopy of the certificate 50%

1. We shall be charging a fee of /- as Surveillance audit fees per annum.

1. You will organize your own computer, photocopier, stationary and other related facilities for the preparation of documents.

1. Any other expenditure to be incurred on development of QMS, like procurement of any machinery, test equipment, calibrations, materials, etc. shall be borne by .