ISO 13485:2012- Standard

QMS- Medical Devices


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BENEFITS OF ISO 13485

BENEFITS OF ISO 13485
Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:

  • Access to markets that recognize or require the certification including Canada and Europe.
  • Reduce operational costs by highlighting process deficiencies and improving efficiency.
  • Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints.
  • Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints.
  • Proven commitment to quality through an internationally recognized standard.
  • Adds transparency to the way complaints, surveillance or product recalls are handled.

APPLICABILITY OF ISO 13485

The standard is applicable to any organization that is into the design, development, Manufacturing of any type of Medical instrument/Machines or type services related to it.

APPLICABILITY OF ISO 14001

The ISO 14001 quality management standard applies to areas such as manufacturing, processing, printing, forestry, electronics, food processing, financial services, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gsm pulp and paper, publishing, petrochemicals, shipping, mining, telecommunications, plastics, metals, research health care, hospitality, utilities, aviation, machine tools, agriculture, government, education, fabrication, sanitation, consumer products, transportation, biotechnology, chemicals, and various other types of industries where any type of activity whose product or byproduct can affect environment in any way can opt to ISO 14001 certification.

How to Get ISO 14001 Certified Easily?

  • Go for the implementation as per the standards
    1. You know that implementing the system standards in your organization has many benefits as well as getting you ahead of the competition.
    2. You also know that being independently assessed and certified with various international system standards gives you credibility and helps attract new customers.
    3. However, you may not have the required resources and expertise and time In house to achieve this on your own.
    4. We can show how and where to get this required additional support.
  • Apply for Certification
    1. As you are ready with the implemented system, send the filled application form.
    2. The application form is forwarded to the accreditation board.
    3. The registration approval is received within 2 working days from the board.
    4. The financial decision is taken and the quotation and agreement is signed.
  • Get your system Audited
    1. As soon as the financial part is decided, you get ready to be audited for the certifications.
    2. Confirmation of the audit date is done and the auditor is chosen from the list of auditors by the board.
    3. The certificate valid for 3 years is released within 15 working days after the audit is performed successfully.
    4. A decided frequency of surveillance audit is decided by the board and the surveillance process is followed between the three years cycle of the certification.
    5. A recertification audit is conducted after the cycle of three years and the process continues.