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Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to customer success.
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Empowering Excellence: Redefine Supplier Audit Practices with Strategic Thought Leadership.
In today’s globalized market, organizations work with suppliers from around the world. However, ensuring that suppliers meet all the quality standards set by your company can be challenging. This is where supplier quality audits play a critical role. Supplier quality audits help businesses address these challenges by providing insight into whether a supplier’s products, services, and processes consistently adhere to defined quality standards, making them an essential part of any manufacturer’s quality management practices. Request an Online Demo
A supplier audit is performed by businesses to ensure that the external supplier meets the organization’s quality standards. In a supplier audit, the supplier auditor inspects whether the supplier is adhering to industry regulatory practices, such as health and safety measures and correct manufacturing processes. There are various types of supplier audits to ensure Quality Assurance is consistent. The most common types of supplier audits are system audits, compliance audits, process audits, and product audits, all of which support effective auditing suppliers across the supply chain.
Remote audit is not an entirely new concept. ISO 19011:2018 Annex A1 already makes provisions for it and acknowledges its…
With manufacturing and supply chain processes becoming more complex, critical aspects of a product are being outsourced to external global…
The pandemic has accelerated the adoption of remote audits, even in highly regulated industries like manufacturing and medical devices. With…
Having better visibility into a supplier’s processes and Quality Management System (QMS) allows manufacturers to avoid the risk of products that do not meet business quality standards. Supplier audits are a key part of structured supplier audit management and are often included in the quality team’s due diligence or annual review activities. Supplier auditing will enable businesses to evaluate a supplier’s products and processes based on the defined quality standards at the time of onboarding. Supplier audits are also usually requested when
Typically, a supplier audit process is initiated by an internal team of the buyer organization. The person leading the supplier audit is usually a qualified supplier auditor from the procurement or quality department. Once the audit date is set, the internal audit team creates a checklist of items or information that must be collected from suppliers. Based on this scope, the organization decides whether auditing suppliers should be conducted in-house or by an external audit partner.
Some of the benefits of implementing a supplier audit are:
Supplier audits review onboarding and performance processes, helping identify gaps, risks, and improvement areas while strengthening supplier audit management.
To maintain customer satisfaction, it is essential to keep the quality standards of the product. A supplier audit helps ensure the suppliers follow the quality standards and maintain Quality Control.
Helps improve and maintain communication with suppliers as regular audits ensure quality objectives are consistently met and enhanced to meet the organization’s ever-changing needs.
A supplier quality audit, when conducted successfully, will help a business identify, remedy, and prevent problems in a supplier’s product quality or processes. The audit also helps from the quality issue creating major problems while ensuring quality consistency. Before performing a supplier audit, consider the following points.
Conduct pre-audit research before reaching the audit site
In this step, it is important to understand the parties’ expectations. Similarly, the audit committee must prepare a prioritized checklist of items to review along with a list of products or services supplied. Other pre-audit research items include a review of:
Do thorough research on the supplier's reputation online
Leverage online research, regulatory databases, and compliance history to investigate the supplier. Review the supplier’s website and digital channels, read feedback from Consumer Reports and the Better Business Bureau, and search FDA records for CGMP compliance information or warning letters—insights that support effective, risk-based supplier audit management.
Investigate customer complaints
Customer complaints are a source of information about the performance and quality of products. To that end, looking into each complaint with a fine toothcomb is important. If there is repetitiveness in the type of complaint, understand the root cause for the same. This helps understand if the supplier is at fault, and this information can become part of the supplier audit process for further investigation.
Know your supplier's activity
If a part of the products your business procures comes from your supplier’s supplier, it is mandatory to be notified of the fact. Their relationship also impacts the quality of your products; hence, all parties involved with the company must adhere to the supplier quality agreements. Request your immediate supplier to furnish an audit report or any other documentation that validates their claim to meet your quality standards. This process is paramount to the overall quality output of your business.
Ensure Supplier Quality Audits Stay on Track
During a supplier quality audit, it is essential to actively review processes and documents while listening carefully to the supplier. The supplier’s responsibility is to follow established protocols and provide the auditor with full access to all quality-related records and processes. If the supplier or their team provides incomplete or evasive responses, this should be documented in the supplier quality audit report, as it may indicate issues such as deviations, non-conformances, or failed lots.
We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.
Lia Budiman,Solution Consultant, Continental Contitech
Suppliers Activities Impacting Manufacturer Regulatory Compliance (EU IVDR): in-vitro diagnostic
Checklist | October 4th, 2021
Supplier Audit Checklist
Checklist | October 26th, 2022
Suppliers Activities Impacting Manufacturer Regulatory Compliance (EU MDR): medical device
Your Roadmap for Purchasing Controls and Supplier Evaluation based on FDA’s Recommendations
Checklist | November 12th, 2021
A neutral third-party inspection company conducts external supplier audits by assessing the supplier’s compliance based on specific quality standards and business requirements. To ensure that the supplier quality standards are met consistently, it is recommended that supplier audits are conducted every two years.
ComplianceQuest EQMS includes a dedicated portal called Supplier Central, designed to support organizations in managing supplier quality audits effectively. Quality and supply chain leaders can:
rack all supplier-related data in real-time to prepare for audits
Submit requests to suppliers, contract manufacturers, dealers, or partners for audit-related information
Respond to supply chain issues with agility during supplier quality audits
Gain end-to-end visibility of any supplier’s quality performance
Communicate and collaborate with key stakeholders to address audit findings
By centralizing supplier data, companies can ensure a smoother, more efficient supplier quality audit process.
The ComplianceQuest Supplier Management solution provides the Supplier Readiness app, which helps auditors capture all supplier-related information in a structured way. Auditors can:
Use a customizable auditing checklist tool tailored for supplier quality audits
Adjust the checklist based on the risk levels of each supplier
Collect evidence and document findings in real time for compliance verification
Streamline audit execution, reporting, and follow-up actions
This ensures that supplier quality audits are consistent, thorough, and fully aligned with organizational quality standards.
To centralize supplier quality and audit management, the most effective approach is to consolidate all supplier data, audits, certifications, nonconformances, and CAPAs into one cloud-based platform.
A solution like ComplianceQuestprovides a unified Supplier Quality Management and Audit module, eliminating fragmented spreadsheets and manual tracking. Standardized checklists, automated scheduling, escalations, and digital CAPA workflows ensure consistent, risk-based supplier evaluations. Real-time dashboards track performance trends, closure rates, and recurring issues, improving visibility and accountability. Supplier portals streamline collaboration, document exchange, and corrective actions.
With centralized workflows, organizations gain stronger oversight, faster response cycles, continuous improvement, and better long-term supply chain reliability.
ComplianceQuest automates supplier audit scheduling, findings, and corrective actions. Issues are routed to suppliers, tracked to closure, and linked to CAPA, ensuring accountability and continuous improvement.
In this blog, we emphasize the importance of building a strong foundation with a robust supplier information system that ensures…
A couple of months ago, at ComplianceQuest, we published a…
Just recently, at ComplianceQuest, we published a blog titled ‘Supplier Metrics:…
Every manufacturer faces a unique set of challenges: supply chain…
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