ISO 13485 audits are crucial for organizations in the medical device industry to ensure they meet quality management system (QMS) requirements. Qualitcert, a leading certification provider in Bangalore, offers comprehensive audit services to help businesses comply with ISO 13485 standards.
Types of Audits:
Pre-Audit Assessment: Qualitcert conducts an initial assessment to evaluate your organization's readiness for the ISO 13485 certification. This helps identify any gaps in compliance and allows you to make necessary adjustments.
Stage 1 Audit: This audit focuses on reviewing your organization’s documentation. Qualitcert's auditors assess your QMS policies, procedures, and records to ensure they align with ISO 13485 requirements.
Stage 2 Audit (On-Site Audit): The second stage involves a more in-depth review of your operations. Qualitcert auditors visit your site to examine processes, interview staff, and check for proper implementation of QMS practices.
Surveillance Audits: After certification, annual surveillance audits are conducted to ensure ongoing compliance. Qualitcert helps businesses maintain the standards required for ISO 13485, reducing the risk of non-compliance.
What to Expect During the Audit:
- Document Review: The auditors will review all relevant documents related to your QMS.
- Process Evaluation: Your manufacturing, testing, and quality control processes will be closely examined.
- Staff Interviews: Auditors will interact with employees to understand how well they follow QMS procedures.
- Non-Conformities: If any gaps are identified, a report will be provided, and your organization will be given time to address the issues.
Why Choose Qualitcert?
- Expert Guidance: Qualitcert offers professional audit services led by experienced auditors who understand the intricacies of ISO 13485 standards.
- Comprehensive Support: From pre-audit assessments to post-audit follow-ups, Qualitcert supports you through every step of the process.
- Local Expertise: With a strong presence in Bangalore, Qualitcert ensures personalized and efficient audit services.
