ISO 13485 – MDQMS
Medical Devices Quality Management System
What is ISO 13485?
Why is ISO 13485 important?
What are the benefits of ISO 13485 – Medical Devices — Quality Management System?
Adherence to appropriate medical devices quality management principles will aid your organization in achieving business objectives and goals, whereas a poorly designed quality management system would result in a huge overall deterioration of your company’s structure.
What is difference between ISO 9001 and ISO 13485?
The mandatory compliance requirements around the Documented Information, Internal Audit, Nonconformance, Corrective Actions, Management Review, Risk Management are the same for both standards.
ISO 13485 focuses on the specific Medical Device product/service which is identified per the scope. Additionally, Regulatory requirements, health and safety, device master records, and device history files need to be defined and addressed.
So short answer is, if you have a strong ISO 9001 framework, you are halfway there in meeting the ISO 13485 requirements.
Please contact us at [email protected] for PPT for ISO 9001 VS ISO 13485
What are the practical steps for ISO 13485 Certification?
Stage 1: Discovery
Stage 2: Documentation & Implementation
Documenting Management System procedures, WI-based on document structure most suitable and value adds to the Organization.
Once documents are drafted, reviewed, and approved, process owners, will implement the documented processes. Management involvement for in-depth product /service-related risk assessment and management of DMR, DHF, and Medical Device Reporting process.
Stage 3: Audit (Internal and External)
This entire process can take up to 6-8 months depending on the number of locations, employees, scope, number of processes, and resource commitment by the organization.
Is the ISO 13485 certification applicable to distributors or merchant exporters?
How long will it take to get certified?
Scope and Complexity
Number of Locations
Number of employees
Resource allocation
Timeline for certification ranges from 6-8 months depending on the factors above. Additionally, if the core process & standard operating procedures are defined, that makes the process go faster and the timeline of implementation is shorter. For a small size, organization certification can be achieved in 6 months. During the external audit, it will be very important that every process owner is able to demonstrate competence and awareness of their processes. Auditor will want to see a system that has been implemented for at least 3-4 months.
What additional cost are associated with ISO certification and maintenance?
These costs include:
1st Year Cost
2nd Year Cost
Recertification cost( every 3 years)
What is difference between ISO 9001 and ISO 13485?
The mandatory compliance requirements around the Documented Information, Internal Audit, Nonconformance, Corrective Actions, Management Review, Risk Management are the same for both standards.
ISO 13485 focuses on the specific Medical Device product/service which is identified per the scope. Additionally, Regulatory requirements, health and safety, device master records, and device history files need to be defined and addressed.
So short answer is, if you have a strong ISO 9001 framework, you are halfway there in meeting the ISO 13485 requirements.
Please contact us at [email protected] for PPT for ISO 9001 VS ISO 13485
What are the practical steps for ISO 13485 Certification?
Stage 1: Discovery
Stage 2: Documentation & Implementation
Documenting Management System procedures, WI-based on document structure most suitable and value adds to the Organization.
Once documents are drafted, reviewed, and approved, process owners, will implement the documented processes. Management involvement for in-depth product /service-related risk assessment and management of DMR, DHF, and Medical Device Reporting process.
Stage 3: Audit (Internal and External)
This entire process can take up to 6-8 months depending on the number of locations, employees, scope, number of processes, and resource commitment by the organization.
Is the ISO 13485 certification applicable to distributors or merchant exporters?
How long will it take to get certified?
Scope and Complexity
Number of Locations
Number of employees
Resource allocation
Timeline for certification ranges from 6-8 months depending on the factors above. Additionally, if the core process & standard operating procedures are defined, that makes the process go faster and the timeline of implementation is shorter. For a small size, organization certification can be achieved in 6 months. During the external audit, it will be very important that every process owner is able to demonstrate competence and awareness of their processes. Auditor will want to see a system that has been implemented for at least 3-4 months.
What additional cost are associated with ISO certification and maintenance?
These costs include:
1st Year Cost
2nd Year Cost
Recertification cost( every 3 years)
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