ISO 13485:2016 is an internationally recognized standard for Quality Management Systems (QMS) specific to the manufacturing of medical devices. This certification ensures that organizations produce medical devices that meet customer and regulatory requirements, offering reliable quality, safety, and performance.
Submit to get ISO 13485:2016 Certification
Improved operational efficiency
Systematic business management
Enhanced production, sales, and delivery processes
The 2016 version of ISO 13485 introduced several improvements to ensure better compliance and risk management, including:
Clear applicability for outsourced processes and external resources.
Enhanced risk management procedures.
Emphasis on software validation and regular updates.
Comprehensive guidelines for handling complaints, risk, and product measurement.
New chapters addressing communication with authorities and complaint resolution.
Transition from ISO 13485:2003 to ISO 13485:2016
Transitioning to the new version involves the following steps:
Planning the transition with a certified body.
Conducting a gap analysis and making necessary changes.
Preparing new documentation as per the updated requirements.
Undergoing an audit process to obtain certification.
Procedure to Obtain ISO 13485:2016 Certification
Collect and prepare all the documents
Then apply for the certificate with the product and all company details
Audit by authority
Addressing of non-conformities occurred.
After completion of all the formalities then certificate will be issued.
Now Let’s discuss in detail what is included in every step and how we proceed with that
Collect and prepare all necessary documentation.
Submit the application form with product and company details.
Audit Process:
Stage 1: Documentation review and on-site verification.
Stage 2: Implementation evaluation, performance review, and client response analysis.
Address nonconformities:
Major: Rectify within 60 days.
Minor: Rectify within 90 days.
Upon successful audit, the certificate is issued, valid for 3 years, with re-certification required every 3 years.
Time taken: -
Smaller organizations: It can take around 3 to 4 months to obtain certification.
Larger organizations: It can take up to a year to obtain certification.
Documents Deliverable: -
ISO 13485:2016 Certificate
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Eligibility
Organizations of any size and complexity, especially those involved in manufacturing or supplying medical devices, can implement this standard. However, individuals cannot use ISO 13485:2016 as it is designed for organizational use.
Documents Required for ISO 13485:2016 Certification
Now let’s Discuss about the documents need for ISO 13485:2016 Certification
Proof of Identity
PAN card of the Proprietor/LLP/Company.
Business Registration Documents
Certificate of incorporation (if applicable).
GST registration certificate (if applicable).
Operational Information
Business objectives to be printed on the ISO certificate.
Latest purchase bill in the name of the Proprietor/LLP/Company.
Cancelled letterhead with the ISO scope printed.
Compliance and Records
Signed and stamped attendance sheet.
Signed and stamped agreement.
NOC from the Pollution Board.
List of medical equipment with testing reports.
Benefits Of Getting Iso 13485:2016 Certification
Operational efficiency: - Improved operational efficiency and systematic business management.
Cost reduction: - It helps to reduce the cost and minimize the waste.
Increase productivity: - It helps to enhance productivity in production, sales, and delivery processes
Grow the business: - It helps to grow the business and provide the opportunity of expansion.
Brand image: - It helps to improves the brand image of the entity.
ISO 13485:2016 is an internationally recognized standard for Quality Management Systems (QMS) specific to the manufacturing of medical devices. This certification ensures that organizations produce medical devices that meet customer and regulatory requirements, offering reliable quality, safety, and performance.
There are various benefits of ISO 13485:2016 Certification some of them are i.e., it improved operational efficiency, provides systematic management of business, it also helps to grow business
While certification is not mandatory, ISO 13485:2016 is often required by regulatory bodies and clients in the medical device industry. Not being certified could limit your ability to enter certain markets, collaborate with clients, or meet regulatory requirements,.
If organization fail to meet the requirements of ISO 13485:2016 then during the audit the certification body will issue the non-confirmation report and the organization need to take the corrective action to address all the non-conformities raised by body.
Yes, ISO 13485:2016 is internationally recognized and accepted by regulatory bodies around the world. Certificate help organization to enter into global market.
Any type of business is eligible for ISO 13485:2016 certification irrespective of its size, complexity, etc.
It is only valid upto 3 years after that there is need to renew it or recertify the certificate again.
