ISO 13485:2016 (Medical Devices)

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ISO 13485:2016 (Medical Devices)

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LIST OF DOCUMENTS REQUIRED FOR ISO 13485:2016:

  • PAN card of the Proprietor/LLP/Company

  • Certificate of incorporation, if having

  • Business objective of the Proprietor/LLP/Company that need to be print of the ISO certificate

  • Latest purchase bill in the name of the Proprietor/LLP/Company

  • GST registration certificate, if having

  • Cancelled Letterhead having scope of ISO to be printed on ISO certificate

  • Signed and stamped attendance sheet attached

  • Signed and stamped agreement.

  • NOC from pollution board.

  • List of medical equipment with their testing report.

DELIVERABLE UNDER ISO 13485:2016:

  • Soft copy of ISO 

  • Courier hard copy of ISO certificate

  • Online verification of ISO certificate

PROCESS OF ISO 13485:2016:

  • Step-1 Collection of Documents mentioned in below checklist

  • Step-2 Providing draft ISO certificate for approval

  • Step-3 After approval generation of final certificate.

  • Step-4 Verification of ISO certificate online

  • Step-5 Courier of hard copy of certificate

SERVICE DELIVERY TIME:

  • Soft copy of ISO shall be provide within 2 working days

  • Hard copy shall be courier within 5 working days

  • Certificate shall be verified online within 48 hours from generation time.

ISO 13485:2016- Quality Management System for manufacturing medical devices.

What are medical devices?

Medical devices are tools, instruments that are used for medical purposes. The manufacturers should ensure that the tools which are produced are useful for customers. In order to improve your business and maintain a good management system, it is required to implement some international standards such as ISO Standard For Medical Devices 13485:2016. 
This standard helps in maintaining the quality of products, consistent services, the good process from production to delivery of goods which attracts more customers to the organization and thus moves forward in the market.
Organizations of any size, complexity, and especially medical device companies can implement this standard. An individual cannot use the standard. ISO 13485:2016 version was published on 1 March 2016. The previous version of ISO 13485 was ISO 13485:2003

 

What are the changes that can be seen in ISO 13485 new version 2016?

The changes in the new standard gave us a different dimension to look into it.

  • The new standard is clearly applicable for sources from outside which are used in the organization.
  • It also improvised its application for regulating necessary requirements, improved the risk managing process.
  • It also says that the required software used in business must be updated and validated for avoiding any obstacle in process of the organization.
  • The management system should consider handling any complaints, risk management, notifying its authorities, product measurements, etc.
  • It so focuses on the design and development of devices, the procedure for designing, new ingestions, and validation of software for designing.
  • New chapters have been added such as addressing complaints and communication with authorities.

 

Iso Medical Devices New Version is Helpful?

Yes, it is. The work is getting easier. As it covers the requirements of 21 CFR part 820. This new version covers a lot of new topics which were not in previous ones and also gives a broader view for understanding the standard.

 

How to convert from the old version to the new version standard for medical devices

The new version was published in 2016 so the given transition period is 3 years, 2019 you have to convert to the new version 
Things should be kept in mind before transitioning to the new version.

  • Plan your transition with a certified body.
  • Do gap analysis and implement any changes required to your system.
  • List out new requirements needed as per standard and make necessary documents ready.
  • Plan for audit procedure to obtain your certificate.

 

Is it compulsory to obtain ISO 13485:2016 certificate for your organization?

No, it is not mandatory to have a certificate until you have included the Quality Management system and implemented some legal requirements to your organization. But EU MDR wants you to include ISO standard and for medical devices, the only standard listed in EU MDR is ISO 13485:2016 standard. Many companies would like to implement this ISO standard as it is listed in MDR, which shows you have the best QMS system to meet your customer's requirements.

 

Few Steps to Certification Process ISO 13485:2016

Because the new ISO 13485 is based on ISO 9001 previous version, it contains combined documents of both standards.

  • Quality manual.
  • Quality policies and procedures.
  • Software validation process.
  • Medical device file.
  • Record of management participation.
  • Employees record
  • Infrastructure and maintenance.
  • Pollution control.
  • Supplier documents
  • Documentation of measures taken.

 

After collecting all the required documents of ISO 134585 Medical Devices, you must

  • Fill up basic requirements about the product and the company prescribed in the form.
  • After applying for certification, the team of auditors will review your documents given, on-site verification, and provide any suggestions to improve before another audit.
  • In 2nd audit, the auditor evaluates any implementation made against standard, performance, reporting, clients response. Makes sure that the internal audit system and management system have been effectively performed.
  • If any documentation is against the standard, whether it is major or minor the time period is given 
  1. For major nonconformity 60 days
  2. For minor nonconformity 90 days 
  • After being satisfied with all the verification processes. The certificate is issued.
  • The issued certificate is valid for 3 years and for every 3 years it should be re-certified.
  • For re-certification, the audit will be conducted as done in the stage 2 audit.

 

Five Benefits of ISO 13485:2016 certificate.

  • It provides a method to implement, measure, and analyze the operation of the business.
  • It provides a systematic approach toward reducing wastage and costs
  • It also improves the 3 stages of a manufacturing business that is
  1. Production process
  2. Sales process.
  3. Delivery process.
  • It encourages to growth and expansion of business.
  • It provides a competitive market.
  • Improve Your Company's Image 
  • It Provides the utilizing resources properly.
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