ISO 13485:2016 has been based on the ISO 9001 process model perspective is a management systems standard specifically created for the manufacture of medical devices. Its main objective is to facilitate harmonized medical device’s regulatory needs. This standard allows organizations to lower safety and legal risks while creating more economical work environments. Once in 5 years, it is reviewed and revised, to make sure it aligns with industry needs.
Benefits of ISO 13485 Certificate
Some of its key features are
- It provides defining terms.
- It does not replicate the ISO 9001:2015 changes.
- It mandates more inputs for the analysis of data.
- It strengthens controls of non-conforming products.
- Clarifies and strengthens the validation requirements.
- It requires more input to the risk management processes.
- It includes newer sub-clauses and new additional clauses.
- It helps in managing contamination and in preserving a product.
- There is higher importance given to Complaints and their management.
- There is a vast difference in the format and clauses, and how it gets documented.
- It necessitates the need for a system based on risk management, which will manage the process.
- There is a lot of significance in ensuring proper regulations and regulatory requirements in place, which get compiled throughout the deployment of QMS and its associated services.
- There is an impact on the design and development aspect. Any minor improvement which raises concerns on traceability needs to be analyzed. There could also be a requirement to transfer design, design files, and more emphasis on design change and its considerations.
- There is higher control given to providers who are external to the organization. It is especially true when they increase product risk when more records are needed when it needs increased action required on verification, and when the supplier of the equipment does not comply with the requirements.
How to Register for ISO 13485 Certification?
The ISO accreditation measures contain a couple of principle steps, like applying, the survey of reports, and the definite inspecting methodology. The steps or the phases that are a part of completing the ISO certification issuance process are
The candidate needs to fill in an application for the registrar after selecting a proper ISO accreditation for a product or business.
Includes an exhaustive assessment by auditor on the existing and improved quality controls, covering the detections of non-conformances.
Document Required for ISO Certification
2. GST Registration
3. MSME Registration
2. Two Purchase Invoices
2. Visiting Card
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There should be a written audit on the control of quality agreements.
There is also an additional need to have all the roles in the organization in a document.
Analyze the impact on Medical Devices and QMS before making any change to the QMS process.
It requires applying a “risk-based approach to the control of appropriate processes needed for the QMS.
Added requirements associated with validation of the appliance of computer software utilized in the QMS.
It considers the role of the people in the organization, and it determines their responsibility and accountability.
Execute control over outsourced processes, based on the risk involved and the ability of the external provider, to meet requirements.
Cleanliness of product
Any mishandling complaints
Design and development (D&D) planning
Practicing internal assessment through auditing
Inspecting products that don’t meet the required design
The process should enhance continually by analyzing data created