A quality management system (QMS) offers a comprehensive tool kit to analyze risks, set quality objectives, implement workflows to achieve standards and audit for optimal performance. The ISO 9000 family of quality management systems is a set of standards designed to help organizations improve their product and service delivery by providing documented procedures and workflows.
QMS software is used in conjunction with other manufacturing software or MRP software options. These options may be general-use for all manufacturers or focus on quality management capabilities unique to specific manufacturing industries (such as pharmaceuticals or chemicals).
Enterprise-level quality systems (EQMS) have a greater scope than generic QMS solutions. EQMS assists business processes with globalization by enhancing their quality management practices across the supply chain. (See: What is EQMS?)
ISO 9001 is the international standard that specifies requirements for quality management software (QMS). Organizations use the standard to demonstrate the ability to provide products and services that meet customer and regulatory requirements.
Quality management systems are a set of documented policies, procedures, and responsibilities, organized into a structured system of processes to assist an organization to realize its quality vision goals and objectives. ISO standards led to ISO 9001 for quality management systems. This comprises a set of generic standard requirement standards that govern the quality management systems of certified companies or organizations.
Credited auditors, known as CB auditors, are authorized to award a certificate of compliance with the ISO 9001 standard. This certification must be reviewed annually and renewed every 3 years. One of the foundation requirements of this standard is that its implementation should be placed on a system of dynamic processes, rather than a set of static standards.
The ISO 9001 standard includes procedures for the following activities and has required documented procedures:
Maintaining compliance with ISO 9001 standards helps meet customer requirements and expectations, leading to an effective and efficient organization.
There are a total of 7 quality management principles that can help guarantee your organization will be successful. These fundamental beliefs, rules, and values are accepted as true and known to provide improvement to the quality management processes of an organization.
The core elements found and provided by a QMS include:
By harnessing the power of data management, organizations can drive continuous improvement and preventative quality control activities. Ineffective data management practices can lead to inconsistent product quality, operating inefficiencies, compliance risks, poor customer satisfaction, and lower profitability.
CAPA is a continuous improvement tool that collects and analyzes data to identify and eliminate product quality issues, process inefficiencies, and equipment issues. This helps prevent nonconformance from recurring by eliminating the cause of a nonconformity, while preventative action prevents nonconformance from occurring at all.
CAPA features within quality improvement processes will alert you to these potential issues through risk assessments and root cause analysis, which identify the underlying problem with a product or process. By finding out the root cause, you’ll be able to more easily resolve the issue, and actions can be taken to prevent the nonconformance from occurring again.
Total quality management can be achieved through a QMS implementation that focuses on audit management. This includes a preliminary evaluation of your site that details nonconformities. Then a registration audit occurs which includes a readiness audit and a certification audit. From there, a surveillance audit is conducted over time to measure continued conformance to ISO standards and any other additional regulatory programs.
Recertification audits are also common over a three-year registration cycle, called triennial audits. Finally, internal audits can occur at any time at recommended intervals from the QMS.
Risk management processes help quantify, minimize, mitigate, and build contingencies to deal with risks. Risk management within QMS will coordinate and optimize a reduction of harm to your organization’s earnings potential. This occurs by identifying and categorizing risk into types, origins, and ownerships.
Manufacturers use risk management to identify hazards associated with their own production process. They also use it for compliance regulations when estimating, monitoring, evaluating, and controlling risks across the product lifecycle.
Failure modes and effects analysis study the consequences of the ways something might fail, including errors and defects. This aims to decrease manufacturing costs by providing opportunities for preventative and corrective maintenance versus reactive maintenance.
FMEA processes include defining corrective actions, identifying causes and effects, improving economic production, avoiding defects, preventing failure, reducing product development time and costs, defining and minimizing risks, and improving the quality and reliability over time.
Statistical process control processes collect quality and performance data in real-time to be used for statistical analysis. Manufacturers use SPC software for identifying product quality issues and process variations in order to take corrective action before extensive issues occur, as well as improve process performance.
The data collected by SPC software is plotted onto user-friendly graphs, which include control charts, Pareto charts, and histograms. Having the data in an easy-to-read format allows you to see when data variations occur and how far the variations deviate from the expected value.