ISO 13485:2016 Certification

Achieving ISO 13485 certification is pivotal for companies in the medical field. It demonstrates a commitment to producing medical devices that meet the highest standards of quality, safety, and regulatory compliance. Manufacturers adhering to ISO 13485 ensure that their products are not only effective but also safe for patients’ use, fostering trust among healthcare professionals and end-users.

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Benefits of ISO 13485:2016
Implementation

Risk Management

Identify, assess, and mitigate risks effectively, ensuring product safety and customer satisfaction

Competitive Advantage

Differentiates businesses from competitors, where quality is a critical factor

Increased Customer Confidence

Products with a certification that guarantees adherence to stringent quality standards.

Enhanced Product Quality and Safety

Guarantees the production of high-quality, safe, & effective medical devices, instilling confidence in healthcare.

How to Register for ISO 13485 Certification?

ISO certification services refer to the professional assistance provided by certification bodies or agencies to help businesses achieve certification for various ISO standards. These services are designed to guide organizations through the complex process of implementing ISO standards and preparing for certification audits.

Applying

The application can be submitted either in hard copy via post or soft copy via email. It should contain all the basic information about the organization.

Review of Documents

The inspector audits the reports based on the quality control practices and strategies implemented in the organization.

Pre-Evaluation

At this phase, the auditor determines if there are any flaws in the existing quality control measures which is already in place in the organization.

Action Plan

Once the auditor completes the initial survey, the issues in the organization’s existing quality control guidelines are audited.

First Audit

Includes an exhaustive assessment by auditor on the existing and improved quality controls, covering the detections of non-conformances.

Final Audit

By the last stage of review, the applicant would have handled most of the significant non-conformities.