ISO stands for International Organization for Standardization.
Medical devices have their own standard for QMS called ISO 13485. It is published by ISO.
It gives makers of medical devices a framework for creating, implementing, and maintaining a quality management system.
Developing and keeping up a strong quality management system (QMS) for your medical devices, products, and services is crucial for establishing a solid basis for your business. By obtaining EN ISO 13485 certification for your QMS, you showcase your dedication to meeting international standards.
The certification process for EN ISO 13485 involves conducting audits on-site to ensure that your quality management system is capable and reliable. Our team of experts evaluates how well you apply your QMS in real-world situations and assesses its effectiveness in key areas such as design, development, production, and customer care.
STEPS TO FOLLOW
The certification body offers your organization an ISO 13485 certificate if the external audit is successful.
Key requirements of ISO
It’s crucial to be aware that gaining ISO 13485 certification can be a difficult and time-consuming procedure that may call for consulting assistance.
Choose certification organisation: Pick a certification authority that is authorised to certify businesses in accordance with ISO 13485.
Plan a third-party audit: Set up a third-party audit with the selected certification body. The auditor examine your QMS and makes sure it complies with ISO 13485 criteria. Determine how the requirements of ISO 13485 apply to the products and services that your business provides after analysing the requirements.
Educational Qualification Details of Competent Technical Staff
Establish a quality control system: Put in place an ISO 13485 compliant quality management system. To do this, the system’s scope must be determined, the processes necessary must be identified, and written policies, procedures, and
Brief Description on Other Activities Carried Out by Applicant records must be maintained.
Conduct an internal audit to verify that your quality management system complies with ISO 13485 requirements and to identify areas that need to be improved.
Obtain certification: The certification body offer your organisation an ISO 13485 certificate if the external audit is successful.
Maintain certification: To keep your ISO 13485 certification current, you must undertake routine internal audits, rectify any non-conformities that are discovered, and submit to routine external audits by the accrediting organisation.
It’s crucial to be aware that gaining ISO 13485 certification can be a difficult and time-consuming procedure that may call for consulting assistance.
How we can assist you?
- Regulatory guidance
- Gap analysis
- Drafting of documents
- Evaluation of data
- Application submission
- Responding to quer