Auditing & Compliance

Overview

Regulatory compliance is not achieved through documentation alone. It requires verification that your quality management system is effectively implemented, that your processes are consistently followed, and that your device meets all applicable requirements. Auditing is the mechanism that provides this verification.

At Veritas Quality Solutions, we provide professional auditing and compliance verification services on behalf of clients across Pakistan, the Kingdom of Saudi Arabia (KSA), the United Arab Emirates (UAE), and Turkey. Our audits are designed to assess regulatory readiness, verify implementation of ISO 9001, ISO 13485, and EU MDR requirements, and identify gaps before they become findings during Notified Body, regulatory authority, or customer audits.

Why Auditing Matters

Regulatory Requirement

Under ISO 13485 Clause 8.2.4, organizations must conduct internal audits at planned intervals to determine whether the quality management system conforms to planned arrangements and the requirements of the standard. Under EU MDR, Notified Bodies conduct audits during initial certification, surveillance, and unannounced visits. The SFDA in Saudi Arabia conducts routine, follow-up, and unannounced inspection visits. The UAE has introduced on-site audit requirements for higher-risk device manufacturers.

Proactive Risk Management

Audits identify gaps and weaknesses before they become nonconformities during external inspections. A finding during a Notified Body audit can delay certification, jeopardize market access, and require costly remediation. Proactive auditing identifies and resolves issues early.

Continuous Improvement

Auditing is not about finding fault. It is about identifying opportunities for improvement and ensuring that processes are effective. A well-conducted audit provides valuable insights that strengthen your quality system and business operations.

Customer Confidence

Many customers require evidence of effective auditing as part of supplier qualification. Demonstrating a robust audit program and a history of effective corrective actions builds customer confidence and supports long-term business relationships.

Our Auditing Services

1. Internal Audit Program Development

We help you establish a risk-based internal audit program that satisfies ISO 13485 Clause 8.2.4 and supports ongoing compliance.

What We Deliver:

Audit Procedure: Development of an internal audit procedure defining scope, responsibilities, methodology, and reporting requirements

Risk-Based Audit Schedule: Establishment of an audit schedule based on the risk and importance of each process, as required by ISO 13485

Auditor Qualification Criteria: Definition of the qualifications, training, and competencies required for internal auditors

Audit Checklists and Templates: Development of audit checklists and report templates that ensure consistency and completeness

Auditor Training: Training for your internal auditors on audit principles, techniques, and regulatory requirements

2. Internal Audits

We conduct internal audits on your behalf, providing an independent and objective assessment of your quality management system.

Our Audit Approach:

Preparation: Review of applicable procedures, standards, and previous audit findings to develop a tailored audit plan

Opening Meeting: Confirmation of audit scope, objectives, and methodology with your team

On-Site Assessment: Through document review, interviews, and operational observation, we verify that processes are effectively implemented and compliant

Findings Classification: Classification of findings as nonconformities (major or minor) or observations, with clear evidence

Closing Meeting: Presentation of findings with agreed corrective action timelines

Audit Report: Comprehensive report documenting findings, evidence reviewed, and recommendations

Areas of Focus:

Quality Management System documentation and records

Management responsibility and review

Resource management and training

Design and development controls

Purchasing and supplier controls

Production and process controls

Risk management (ISO 14971)

Nonconforming product and CAPA

Complaint handling and vigilance

Internal audit and continuous improvement

3. Pre-Certification Audits

For organizations preparing for ISO 13485, ISO 9001, or MDR certification, we conduct pre-certification audits that simulate the approach used by Notified Bodies.

What We Do:

Stage 1 Readiness Review: Documentation review to confirm that your QMS meets the requirements of the applicable standard and that you are ready for the Stage 2 certification audit

Stage 2 Mock Audit: A full on-site assessment simulating the certification audit, covering all applicable processes, records, and operational areas

Gap Identification: Identification of gaps between your current system and certification requirements

Remediation Support: Support in developing and implementing corrective actions to close identified gaps

4. MDR Compliance Verification

For clients pursuing or maintaining EU MDR certification, we conduct audits that verify compliance with the specific requirements of Regulation (EU) 2017/745.

Areas of Focus:

Technical documentation completeness and currency

Clinical Evaluation Report adequacy

Post-Market Surveillance plan implementation

Vigilance and incident reporting procedures

UDI assignment and EUDAMED registration

General Safety and Performance Requirements (GSPR) compliance

Person Responsible for Regulatory Compliance (PRRC) responsibilities

5. Unannounced Audit Readiness

Under MDR, Notified Bodies conduct unannounced audits on manufacturers and, where applicable, their suppliers and subcontractors. These audits assess whether day-to-day operations consistently reflect the approved quality management system and technical documentation.

What We Do:

Surprise-Readiness Assessments: Conducting unannounced or short-notice assessments to test your readiness

Operational Record Verification: Verifying that production, quality, and training records are current and accessible

Personnel Preparedness: Ensuring that personnel understand their roles during an unannounced visit

Practice vs. Procedure Review: Identifying areas where day-to-day practice may deviate from documented procedures

Corrective Action Support: Addressing gaps identified during readiness assessments

6. Supplier and Subcontractor Audits

We conduct audits of your suppliers and subcontractors on your behalf, verifying compliance with quality requirements and regulatory standards.

What We Do:

Supplier Risk Assessment: Evaluation of supplier risk based on criticality, performance, and regulatory impact

On-Site Supplier Audits: Audits of supplier facilities to verify QMS compliance, process capability, and regulatory adherence

Audit Report and Findings: Documentation of findings with clear evidence and corrective action requirements

Follow-Up Verification: Verification of corrective action implementation and effectiveness

Note: Under FDA QMSR, supplier audit reports are now inspectable by FDA. Our audit reports are structured to satisfy this requirement.

7. Customer Audit Support

We support clients who are subject to customer audits, helping them prepare and respond effectively.

What We Do:

Pre-Audit Preparation: Review of customer requirements and preparation of documentation and personnel

Mock Customer Audits: Simulation of customer audit approach to identify potential findings

On-Site Support: Attendance during customer audits to provide technical support and guidance

Response Management: Support in developing responses to customer findings and corrective action plans

Regions We Serve

Our on-site audit teams operate across:

Our Audit Methodology

Our audits are conducted by qualified lead auditors with direct experience in medical device regulations and quality management systems. We follow a structured, risk-based approach:

Common Findings We Help You Avoid

Based on our experience and regulatory guidance, the most common audit findings include:

Discrepancies Between Documented Procedures and Actual Practice: Processes are documented but not followed consistently

Incomplete or Missing Records: Production, quality, or training records are incomplete, illegible, or unavailable

Unapproved Changes: Changes to processes, materials, or suppliers made without regulatory impact assessment

Inadequate Training Records: Training not documented or personnel not trained on current procedures

Risk Management Gaps: Risk management not integrated throughout the product lifecycle

CAPA Ineffectiveness: Corrective actions address symptoms rather than root causes, without verification of effectiveness

Supplier Control Weaknesses: Inadequate supplier evaluation, monitoring, or documentation

Outdated Technical Documentation: Technical files not updated to reflect current device, processes, or standards

We structure our audits specifically to identify and address these common deficiencies.

Why Choose Veritas Quality Solutions

Regulatory Expertise

Our auditors understand the specific requirements of ISO 9001, ISO 13485, MDR, and regional regulatory frameworks. We know what Notified Bodies, FDA investigators, and regulatory authorities look for during audits.

Practical Approach

We focus on identifying actionable findings that strengthen your quality system, not just documenting deficiencies. Our audit reports provide clear evidence and practical recommendations.

Regional Presence

We have the capability to conduct on-site audits across Pakistan, KSA, UAE, and Turkey, providing local support for manufacturers in these key markets.

Client-Focused

We work on your behalf, tailoring each audit to your specific objectives whether that is certification readiness, supplier qualification, or regulatory compliance verification.

Proven Track Record

We have supported manufacturers across device classes and therapeutic areas in achieving and maintaining compliance with ISO 13485, MDR, and other regulatory requirements.

Get Started

Whether you are preparing for your first Notified Body audit, seeking to verify supplier compliance, or responding to a customer audit request, Veritas Quality Solutions is your trusted partner in quality assurance.

Veritas Quality Solutions, Your Partner in Quality Assurance