Quality management software, also known as QMS, offers a comprehensive tool kit to analyze business risks, set quality objectives on product development, implement workflows to achieve these standards, and audit the product lifecycle for optimal performance. This integrated approach allows your company to craft standard operating procedures (SOPs) to optimize your business processes.
In particular, QMS helps businesses meet the regulatory requirements of ISO and FDA, in addition to compliance standards set by other government and industry-specific agencies.
Note: Enterprise quality management systems (EQMS) have a greater scope than generic QMS solutions. EQMS automates globalization by enhancing quality management practices across the supply chain. Many of these QMS products use the two terms interchangeably.
Quality management systems offer a wide variety of functionality. Modules often include the following core functions:
Quality management systems assist all types of manufacturers in meeting some of their most critical business challenges:
Managing the product lifecycle for regulatory compliance is complex work. To start, manufacturers are often subject to an alphabet soup of regulatory standards (FDA, ISO 9001, Title 21 CFR Part 11, NERC, SSOP, HAACP, and more). Compliance can be required for permitting, an eligibility condition for bid consideration, or a business necessity to avoid penalties or other legal action. A quality system provides the monitoring and reporting tools you need to simplify the complexity.
Different types of manufacturers need to comply with different regulations. For instance, manufacturers of medical devices, food, cosmetics, and chemicals all have unique, strict regulations to abide by. Selecting an industry-specific QMS system can help you control compliance for your industry.
Every business faces risk: production errors, product defects, unexpected service work, and more pose a threat to the financial health of your company. Improved quality management offers a chance to mitigate these business risks and smooth out the variance in your financial projections. QMS with quality standards and audit management tools provide an effective way to identify the root cause of any issues, allowing you to provide corrective action and enjoy higher quality results.
Analysis tools can quantify the financial risks related to quality exceptions. Identifying the cost of quality management improvements versus the likely impact of reduced financial liability is one of the more challenging business issues facing manufacturers.
Customer satisfaction is key to the success of every business model. Your customers are continually evaluating your products for quality, reliability, and whether or not they do what they are supposed to do. Quality assurance modules provide ways to review products for defects before they get sent to retailers or consumers, giving you the opportunity to make corrections. Fewer defective products on the market mean happier customers.
ISO standards include:
|ISO 9001||Sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity|
|ISO 13485||Similar to ISO 9001 but for medical devices. Has the specific requirement for software validation and requires validation reports to verify for the auditor that it will work as intended. Includes requirement for CFR 21 specific electronic signatures|
|ISO 50001||Energy management standard for addressing the energy consumption and use of an organization|
|ISO 27001||Information security, similar to ISO 9001 but with a change in focus to data security and integrity vs product quality|
|ISO 45001||Health and safety, similar to ISO 9001 but with a change in focus to employee safety vs product quality|
|ISO 14001||Health and safety, similar to ISO 9001 but with a change in focus to environment concerns vs product quality|
|ISO 17025||Laboratory testing and calibration|
FDA certifications include:
|FDA 21 CFR Part 11||Electronic records and electronic signatures|
|FDA 21 CFR Part 211||Drug and pharmaceutical manufacturing|
|FDA 21 CFR Part 820||Medical device manufacturing and distribution|
Other common QMS standards include:
Pricing of quality management systems depends on several factors: number of users, required functionality, and additional integrations. Another variable to consider is whether you want an on-premise or cloud-based system. Generally, an on-premise software will have a one-time perpetual licensing fee while a cloud platform will be part of a monthly or annual subscription. The one-time fee and setup often results in a higher cost of entry while SaaS QMS can be more expensive over time.
With all these factors taken into consideration, costs range from $50 to $2,000 per user per month.
Quality management software incorporates information from across the enterprise. Very often, QMS systems are found within larger ERP software solutions.
Because QMS systems typically operate best when they are taking a holistic approach to the enterprise challenge of optimizing quality, you may need to manage integrations with other information systems, such as: