Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
Discover your potential savings with our ROI Calculator
Middle Office Platform
The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environment and Sustainability
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Self-guided Product Tours
Product Demo Videos
Pricing
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
Safety 2025 Conference & Expo
22 Jul, 2025
Orlando, FL
About
About ComplianceQuest
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.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplianceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
A quality audit is a systematic and independent examination or assessment of an organization's QMS.
It is done to evaluate the effectiveness of an organization's quality controls, identify areas of improvement, and ensure all areas are quality-compliant.
Quality audit is a verification effort intended at evaluating the degree of conformance to meet a standard specification or procedure of the product, design, process, or system. The quality audit has two components: one is the analysis of the system within which the items of product or service are brought into being and is called the quality system audit. The other one is an analysis of the items themselves, which is called product or service quality audit.
A quality audit is typically conducted by an external or internal quality auditor or audit team at agreed time intervals, ensuring that an organization has a clearly defined system for quality monitoring. It is an essential element of the ISO 9001 quality system standard.
Quality auditing is the systematic, independent, and documented review and evaluation of an organization’s Quality Management System (QMS) to determine whether quality activities and results comply with a strategic arrangement that is effectively implemented and appropriate to achieve the objectives.
Unlock the Future of Quality Audits with AI In today's fast-paced world, traditional audit processes are riddled with inefficiencies, human…
Maintaining compliance is crucial in the highly regulated life sciences industry. Audit Management Software System for Life Sciences provides a…
What is Audit Reporting? Audit reporting is the formal process of documenting the results of an audit, detailing the findings,…
To ensure the greatest benefit for an organization, audits are crucial for assessing the success of processes, products, and systems whether it is existing or newly-implemented. This is an important tool for:
Determining the conformity or nonconformity of the quality system elements with specified requirements
Verifying objective evidence of processes
Providing evidence for the reduction and elimination of any problem areas
Ensuring whether the products are fit for use, safe for the consumers and regulations are being followed
Identifying whether the quality policies of organizations meet quality standards adequately
Taking corrective action for deficiencies
Recognizing improvement opportunities
An auditor is a person who understands the business and industry standards and conducts an audit as per the standards. Quality auditors can be one of two categories, external or internal. An internal auditor is an employee of the company being audited whereas an external auditor is a third party hired from an approved agency, customer or client to evaluate the quality system or products.
There are different types of quality audits, broadly categorized as follows:
Process audit
A process audit specifies whether a company’s processes are working within defined limits. It measures conformance to any predefined requirements or industry standards along with the effectiveness and adequacy of the process controls as established by procedures, work instructions, training, and process specifications.
Product audit
Product audit inspects whether a particular product or service complies with customer requirements, specifications, and performance standards.
System audit
A system audit confirms that all elements of a management system are effective and appropriate, and have been developed, implemented, and documented as per the specified requirements. A quality management system audit measures an organization’s existing quality management system to assure its conformance with contract commitments, company policies, and regulatory requirements.
First-party, second-party, and third-party audits
A first-party audit is an internal quality audit designed to measure the performance of the organization’s objectives, identification of problem areas, and to find opportunities for continuous improvement. This audit is conducted by auditors who are employed by the organization being audited.
A second-party audit is an external audit conducted by auditors who are hired from outside the organization to conduct an independent audit. Second-party audits are more conventional than a first-party audit as the audit results may impact the buying decisions of the customer.
A third-party audit is performed by an external independent organization without conflict of interest resulting in recognition, certification, license approval, a penalty, or a fine being issued by the third-party organization.
Audit is carried out either by trained members of an organization’s own staff (internal quality audit) or by hired professional auditors from outside the organization (external quality audit). The process of quality audits can be divided as follows:
The initial step in the quality audit process is starting the quality audit. Initiating quality audits involves a preliminary discussion between the three parties concerned, the client, the auditee, and the auditing organization. The three parties discuss the objective of the proposed audit, the reference standards against which documentation and activities are compared, the auditors to be used, and the time of the audit. They can speak for and take decisions on behalf of the managers of their organization during the discussion. Mutual understanding and agreement will enable the auditee and the auditing organization to execute their activities efficiently.
Audit planning by the auditing organization comprehends several activities by implying actions and reactions from the three involved parties in the audit including scheduling the audit, the number of resources needed for the audit, gathering working papers for the audit, reporting the results, determining the sampling procedures in the audit and following up on corrective actions.
After the quality audit initiation and planning, the auditor starts to undertake various activities including evaluating process and system controls, interviewing employees, on-site audit management, and regular communication with other relevant parties within the organization. Audit execution is often called ‘fieldwork’ and it concludes with the final discussion between the auditor and the auditee.
The audit report outlines the results of an auditor’s observation made, inspection, or test results obtained providing accurate data on management, conformances, and nonconformances found along with any recommended corrective actions that need to be taken. It also allows an organization to track performance and quality effectively, find out areas for continuous improvement, and emphasize any achievements.
Customer Success
Organizations implement the ISO 9000 group of standards to achieve compliance for their commitment to quality management. Often, manufacturers, large and small-sized businesses, and other companies address potential quality gaps to provide the best possible product or service to customers and clients. While many companies are making the move towards compliance, many do not. Here are some of the most common reasons for quality audit failure:
Unsatisfactory documentation
To organize, store, and manage data simply and effectively, Document Management is needed for a quality management system audit without which compliance audits can easily be failed.
Lack of ISO Understanding
Lack of understanding ISO compliance and standardization are a common mistake because many think that ISO grants companies with certification, but actually independent certification bodies are there for certifying companies.
Poor Enforcement Strategies
It is always a good idea to have a clear understanding of enforcement strategies within your specific industry and determine a good strategy that properly handles non-conformance within your company.
Insufficient Competency Testing
Employee competency testing, another essential aspect of ISO 9001 quality management standard, is something that many ignore or leave out. Training should be done each year with a focus on promoting awareness of quality goals.
Poor Auditor Selection
Poor auditor selection is another mistake that affects compliance. If auditors are selected too quickly or not carefully enough, then it could impact the auditing process.
ComplianceQuest is widely recognized as a top choice for businesses looking for reliable quality inspection & audit management software. Designed to streamline the audit process, its cloud-based platform allows teams to collaborate in real time, improving the overall efficiency of audit and quality assurance. With a robust suite of quality audit management software, organizations can conduct audits effortlessly and ensure compliance across multiple functions.
What sets ComplianceQuest apart from competitors like MasterControl and Intelex is its user-friendly interface and seamless integration with other business systems. This makes it especially popular among industries that prioritize both quality and safety. Its quality inspection & audit management software supports businesses in staying on top of regulatory requirements, while its advanced quality assurance audit capabilities help reduce risks, ensure smooth operations, and maintain high standards of compliance.
ComplianceQuest will provide your company with the opportunity to reach a new level of Quality Management. Everything from the well thought out and configured out of the box solution, to the system validation scripts, tractability matrix and end user guides, ComplianceQuest sets the standards high! Their customer service is superb, their employees are dedicated to the success of your project and learning about your company to ensure appropriate and effective solutions are provided. All quality leaders at Aphria Inc. have been very pleased and excited to launch all the capabilities ComplianceQuest has to offer to ensure quality remains our highest priority!
Amy McCrindle,Project Manager
Quality audit software is an effective management tool conducted to check the causes of poor quality, corrective action taken, and the confirmation or verification activities undertaken related to quality. It not only detects the problems and defects in the quality management system but also helps improve and resolve them based on broad findings and recommendations. The principles behind quality audit management system are as follows:
Ethical standards
Accurate presentation
Professional support
Independence
Objectivity
Assessment based on evidence
Proficiency
Collaboration
Confidence
Quality Control Area Safety Audit Checklist for Pharmaceutical Companies
Checklist | April 22nd, 2022
Quality Assurance Checklist – Part A (Project Management)
Checklist | September 7th, 2022
Quality Assurance Checklist – Part B (Project Deliverables)
There are various advantages of implementing quality audits properly in organizations.
Internal quality audit improves the quality of the system as well as the quality of the product.
Internal and external quality audits assess the cost-effectiveness of the quality systems and measure the effectiveness of the quality programs.
Quality audit management system increase productivity in the organization, which increases uniformity of output of product, reduces mistakes and wastages of manpower, machine, and materials.
Quality audits encourage employees in the organizations to disclose inadequacies in the interpretation of the basic quality requirements.
Auditors should have the knowledge and skills in audit principles, procedures and techniques, organizational understanding, quality management systems, and social interaction.
Manual IQC methods belong in the past. Here’s how to leap ahead. The Problem with Traditional Incoming Quality Control (IQC) Walk…
A 20% time saving on regulatory audits and a 10%…
In Jan 2022, McKinsey Quarterly published an article titled “Embedding…
This document has been prepared by Study Group 4: Auditing…
Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive demo video.
Please confirm your details
By submitting this form you agree that we can store and process your personal data as per our Privacy Statement. We will never sell your personal information to any third party.
Enter Captcha
