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What are the audit stages involved in ISO 13485 Certification in UAE?

What is ISO 13485 Certification?

ISO 13485 Certification in UAE ISO is an internationally recognised standard that provides guidelines for the global standardisation of Quality Management System (QMS) requirements for companies that experience negative consequences on the longevity of medical devices. This covers design, development, production, maintenance, Installation and distribution. It adapts the ISO 9001 framework tailored specifically for medical equipment and its suppliers. It helps ensure that they’re fully in line with the needs of their clients and international standards.

Why ISO 13485 Certification is Important in UAE.

The UAE is fast becoming a centre of innovation in the medical and healthcare devices trade. With regulators such as the Ministry of Health and Prevention (MOHAP), Dubai Health Authority (DHA), and the Department of Health – Abu Dhabi (DOH) adhering to rigorous guidelines. ISO 13485 Certification in UAE is the first step to:

Product registration and approval from the regulatory authorities
Participation in tenders and public procurement
Building trust internationally and market access
Affirming their commitment to the safety of patients

Key Benefits of ISO 13485 Certification in UAE

Regulation Compliant: Helps meet local and international regulations for medical devices
Global Market Access: Enhances EU, USA, and GCC export eligibility
Operations Efficiency: Standardises procedures to lessen waste, errors and recalls
Risk Management: It emphasises the importance of risk-based decisions throughout a product’s lifecycle
Customer confidence: Establishes credibility among hospitals, clinics, and consumers.
Competitive Edge: It differentiates your company in a constantly changing market.
The eligibility for tenders: Opens opportunities in private and public sector tenders.

Who Needs ISO 13485 Certification in UAE?

ISO 13485 Certification in UAE is ideal for companies like:

Medical device manufacturers
Manufacturers of components and other materials
Contract manufacturers
Importers and distributors
Sterilisation service providers
Medical software developers create software
Testing and calibration laboratories for medical devices.

If you’re a start-up in Dubai, an established manufacturer in Sharjah, or an agent in Abu Dhabi, ISO 13485 Certification enhances your confidence in your business.

Key Audit Stages of ISO 13485 Certification in UAE

Acquiring ISO 13485 certification involves a controlled audit procedure performed by a third-party certification body. You should be aware of the most important audit phases:

1. Pre-Audit (Optional but Recommended): Also known as a gap analysis. This internal assessment evaluates whether your quality management system meets ISO 13485 requirements.

It helps identify any potential issues before the audit.
It provides a guideline for corrective actions.

2. Stage 1 Audit – Documentation Review: The certification body examines the documented QMS to ensure it complies with the specifications for ISO 13485. The focus is on:

High-quality manual
SOPs, or Standard Operating Procedures (SOPs)
Risk management processes
Documentation for regulatory purposes.

This assessment will determine your ability to move on to the next stage and could involve visits to your location or a remote evaluation.

3. Stage 2 Audit – On-site Implementation Review: The primary certification audit. Auditors visit your premises to ensure your facility’s QMS is properly implemented and complies with ISO 13485. Includes:

Interviews with staff
Observing work practices
Studying documents and examining evidence
Verifying corrective/preventive action (CAPA) processes.

Any irregularities discovered are recorded, and you must take corrective action within a specified time frame.

4. Issuance of ISO 13485 Certificate: When your organisation has eliminated any non-conformities and complies with the standards, the certification body will issue ISO 13485 certification. ISO 13485 certificate. The validity is up to three years, subject to surveillance audits.

5. Surveillance Audits (Typically Annually):

Continuously monitors compliance and improvement.
Each year, you will be able to evaluate the effectiveness of your QMS.
If there are serious issues, certification can be revoked or suspended.

6. Recertification Audit (Every 3 Years): A complete system audit was completed before the expiration of the three-year cycle for certification. Examines the ongoing compliance and effectiveness of your QMS.

What is the Cost of ISO 13485 Certification in UAE?

The Price is based on the following criteria:

Its size is business
The complexity of the operation.
Employees and the number of places
The certification scope is five.
Consulting and training requirements.

Factocert provides cost-effective solutions tailored to your requirements.

Steps to Achieve ISO 13485 Certification in UAE

Here’s a simple procedure:

1. Gap Analysis: Examine your current procedures and compare them to ISO 13485 requirements.

2. QMS Design and Documentation: Create guidelines, procedures, work instructions and records that align with the established guidelines.

3. Employee Training: The trainers will instruct staff on their roles, responsibilities and compliance with the QMS.

4. Internal Audit and Management Review: Conduct internal audits and management review meetings to ensure you are ready.

5. Stage 1 Audit: The body that certifies you reviews your documentation and preparedness.

6. Stage 2 Audit: An on-site audit to validate the QMS application and efficiency.

7. Certification: After the audit, ISO 13485 Certification will be given (valid for 3 years, with annually scheduled audits for surveillance).

Why Factocert for ISO 13485 Certification in UAE

We provide the best ISO 13485 Certification in UAE who are knowledgeable and provide the best solutions. Kindly contact us at contact@factocert.com. ISO 13485 Certification consultants in UAE and ISO 13485 auditors in UAE work according to ISO standards and help organizations implement ISO 13485 certification consultants in UAE with proper documentation.

For more information, visit ISO 13485 Certification in UAE.

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