ISO 13485:2016 certification in Sri Lanka, Maldives, India and Oman is one of the Quality Management standards for medical devices and related services companies it has been published by international organization for standard which outlines the requirement on safeguarding all of that business information. Due to Covid-19 pandemic situation most of the companies are moving towards manufacturing medical or personal protective equipment’s (PPEs) products.

ISO 13485:2016

What is 13485:2016 in Sri Lanka, India, Maldives, India?

Let us know some of the important details and learnings about ISO 13485:2016 certification in Sri Lanka, Maldives, India and Oman. With the new business strategy of the Sri Lankan government. They plan to expand the export and manufacturing industry. Currently there is a big demand for Medical device which can be manufacture at the garment factories and new innovative products are coming up.

ISO 13485:2016 in Sri Lanka, Maldives, India and Oman just like other quality standard for cousins majorly on customer satisfaction and continual improvement ISO 13485:2016 is quality management system for medical devices what is termed as medical devices quality management system this was written and published by international organisation for standardization this was published for the first time in 1996 and it is revised several times the latest version of ISO 13485 is 2016.

Halcyon for ISO 13485:2016 in Sri Lanka, India, Maldives, India

If you are thinking about how to get ISO 13485:2016 certification in Sri Lanka, Maldives, India and Oman then all you have to do is to contact us and get one of our consultants do a gap study and explain the implementation process towards achieving ISO 13485:2016 requirements

There are 8 clauses depending on which is the implementation of ISO 13485:2016 in Sri Lanka, Maldives, India and Oman carried out following are the eight clauses,

    1. First one is scope
    2. Normative reference
    3. Terms and definitions
    4. Quality management system requirements
    5. Management responsibilities
    6. Resource Management
    7. Product realisation
    8. Measurement, analysis and improvement

First three clauses mentioned above or non-editable and are generic classes which are present in each and every ISO standard the most important classes are clause number 4 and clause number 5. Major agenda of ISO 13485:2016 audit services in Sri Lanka, Maldives, India and Oman is to make sure that the medical devices which are being manufactured in an organisation are up to the mark and follow every quality aspect and are safe to use.

Close number for is quality management system requirements and its nothing but the quality management system standard which defines that each and every process it is followed in the organisation has to be neatly documented into policies procedures and also objective have to be defined to make sure that there are no shortcomings to any of the requirements which are stated in the ISO 13485:2016 certification Sri Lanka, Maldives, India and Oman. Our team of consultants will assist you to understand and implement all the requirements status by the ISO 13485:2016 standard.

There is one closer it is really important which is nothing but management responsibilities which covers each and every aspect of having all the required things in place which are essential to make sure that the management system and the products which are being manufactured are safe and secure.

Resource management, product realization and also measurements, analysis and improvements are the next following classes which by name we can understand that every single and every small thing which is being performed has to be taken care and to implement the standard by keeping each and everything in place and by making sure nothing is missed. It is really difficult for an organisation solely by itself so it is always recommended that you choose and ISO 13485:2016 certification consultant in Sri Lanka, Maldives, India and Oman who will help you in all possible ways to implement ISO 13485:2016 the organisation

Halcyon ISO 13485:2016 provides in Sri Lanka, India, Maldives, India,

  1. Total documentation and training for the client

  2. Internal audit conduct by qualified lead auditor

  3. Support to complete the corrective action after the certification audit

Benefits of getting ISO 13485:2016 certification in Sri Lanka, India, Maldives, India