Quality Management System Audits

Pro QC’s Comprehensive QMS Audit Services

Pro QC offers a wide range of QMS audits tailored to meet the specific needs of different industries. Our audits assess the supplier’s quality management system by reviewing their policies, procedures, and critical documentation. It assesses the implementation of procedures on the shop floor along with the associated documentation. Below is an overview of our primary QMS audit services:

ISO 9001:2015 Quality Management System Audit

The ISO 9001:2015 is the most recognized and widely implemented QMS standard globally. It serves as the foundation for other industry-specific standards and applies to any organization, regardless of its size or sector. Our ISO 9001 quality management system audit ensures supplier processes are capable of consistently delivering quality products and services.

IATF 16949:2016 Quality Management System Audit

Specifically designed for the automotive industry, IATF 16949:2016 builds upon the ISO 9001 standard with additional requirements specific to automotive production and relevant service part organizations. Pro QC’s IATF 16949 audits help automotive suppliers meet stringent industry demands, ensuring that their QMS aligns with the highest quality standards.

ISO 13485:2016 Quality Management System Audit

For the medical device industry, ISO 13485:2016 sets the requirements for a QMS that consistently meets customer and regulatory requirements. Our ISO 13485 audit assesses a supplier’s ability to produce safe and effective medical devices, ensuring compliance with international standards.

AS9100 Quality Management System Audit

The AS9100 standard is specifically designed for the aerospace industry. It incorporates ISO 9001 while adding additional requirements relevant to aerospace manufacturing and defense organizations. Pro QC’s AS9100 audits help aerospace suppliers ensure that their QMS meets the rigorous demands of the industry, including product safety, risk management, and reliability.

VDA 6.3:2023 Potential Analysis & Process Audit

VDA 6.3 is a process-based auditing standard used primarily in the automotive industry. It evaluates and improves controls related to new product introduction and manufacturing processes. Pro QC’s VDA 6.3 audits focus on ensuring supplier processes are capable of delivering products that meet the required specifications consistently.

MDSAP (Medical Device Single Audit Program)

MDSAP allows medical device manufacturers to undergo a single audit that covers the regulatory requirements of multiple countries, including the US, Canada, Japan, Brazil, and Australia. Pro QC’s MDSAP audits help streamline compliance for medical device suppliers, reducing the burden of multiple audits and ensuring global market access.

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When to Use Pro QC’s QMS Audits

Quality Management System audits are essential at various stages of the supplier relationship:

• Qualification and Onboarding of New Suppliers: Before onboarding a new supplier, a quality management system audit can verify their ability to meet the strictest quality standards.
• Ongoing Supplier Evaluation: Regular audits help maintain supplier performance and address any issues that arise over time.
• Post-Corrective Actions: After a quality issue has been identified, a QMS audit ensures that corrective actions have been effectively implemented.
• Preparation for Certification: For suppliers seeking to achieve or renew certifications, a QMS audit can help identify areas for improvement before the official certification audit.

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Pro QC’s Quality Management System Audit Process

Our approach to Quality Management System (QMS) audits is designed for efficiency and effectiveness, as outlined below:

1. Initial QMS Audit Assessment: Conduct a comprehensive evaluation to identify strengths and areas for improvement.
2. Corrective Action Plan: Develop a tailored plan to address any non-conformities or gaps discovered during the audit.
3. Implementation Verification: Ensure corrective actions are effectively implemented through thorough follow-up activities.
4. Ongoing Monitoring: Schedule annual follow-up visits, adjusted according to supplier risk levels, to maintain continuous improvement.
5. Performance Tracking: Provide a detailed supplier portfolio dashboard and performance analysis to monitor progress and outcomes.

Our supplier management team can customize checklists to meet the specific requirements of our clients. By partnering with us, companies can reduce overhead, streamline quality management, and ensure all necessary actions are efficiently executed.

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The Benefits of Working with Pro QC for QMS Audits

Choosing Pro QC for QMS audits offers numerous advantages:

Stability and Expertise

Founded in 1984, over 40 years of experience make Pro QC a trustworthy and dependable quality partner.

Expert-Led Solutions

Technical expert advice from first contact ensures reliable solutions are executed with precision.

Qualified Resources

Resource transparency and the right qualifications safeguard your interests on every project at every supplier.

Single Contact Point

A single contact point for quality services globally simplifies your supply chain.

Stringent Technical Oversight

Meticulous technical preparation, guidance throughout the engagement, and report review by senior engineers.

Advanced Quality Analysis

Industry-leading quality dashboard, analytics, and supplier performance analysis tools and framework.

Global Aligned Operations

Operational processes are optimized and aligned for a seamless cross-regional experience.

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