What is a Quality Management System (QMS)? - ISO 9001 Processes

By Russ Davidson • Updated on July 21st, 2022

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?)

uniPoint Key Indicators Dashboard
Key indicators on the uniPoint dashboard.

What are the Benefits of Quality Management Systems?

  • Ensuring regulatory compliance: Stay compliant with regulatory standards such as ISO 9001, Title 21 CFR Part 11, NERC, SSOP, HAACP, and more. QMS helps demonstrate compliance and is almost always required for permitting, which can be an eligibility condition for bid consideration or help avoid penalties and other legal action.
  • Analyzing and reducing risk: QMS identifies the cost of quality management improvements versus the likely impact of reduced financial liability. This includes analysis tools for quantifying the financial risks related to quality exceptions.
  • Increase customer satisfaction: Show customers that your products are constantly evaluated for reliability and ease of use. Help keep promises to customers that determine your ability to gain future business, upsell products, and generate enthusiasm for your goods and services.
  • Eliminate inefficiencies: Create quality products efficiently and eliminate manual paperwork with an electronic quality control system.
  • Document Control: Document quality policies and objectives. Includes quality manuals, procedures, and other documents needed for effective planning.

ISO 9001 and Other Certifications, Standards, and Compliance

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:

  • Control of documents and records, such as the gathering of customer requirements and the recording of product history
  • Control of non-conforming products, to prevent defects and rejects from being sent to customers
  • Continually improvement through corrective and preventive actions, to prevent mistakes from happening again
  • Internal audits, to show the organization is committed to quality and conformance to the ISO 9001 standard

Maintaining compliance with ISO 9001 standards helps meet customer requirements and expectations, leading to an effective and efficient organization.

Other Certifications and Standards

  • API Q1/Q2: Standards specific to the oil and gas industry that are similar in nature to ISO 9001. API W2 has the explicit requirement for contingency planning. Both API Q1/Q2 makes the distinction between corrective and preventative action (something ISO 9001 does not)
  • 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 environmental concerns vs product quality
  • ISO 17025: Laboratory testing and calibration
  • IATF 16949: Automotive quality management standard similar to ISO 9001 with additional requirements
  • AS 9100: Aerospace quality management standard similar to ISO 9001 with additional requirements

Quality Management Principles

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.

  1. Customer Focus: Meet customer expectations and the needs of all interested parties
  2. Leadership: Create conditions in which people are engaged achieving the organization’s quality goals. Communicate the strategic direction and objectives throughout the organization. Encourage the organization’s commitment to quality.
  3. Engagement of people: Enhance the capability to create and deliver value through competent, empowered, and engaged employees.
  4. Process Approach: Focus on key processes, align systems through these processes, optimize the performance of resources, reduce cross-functional barriers, and uphold a sense of consistency, effectiveness, and efficiency.
  5. Improvement: Maintain an ongoing focus on improvement. Monitor, audit, and review the completion and results. Promote and establish improvement objectives at all levels of the organization. Improvement will help identify risks and handle root cause elimination.
  6. Evidence-Based Decision Making: Make decisions based on analysis and evaluation of data. Determine and monitor what your key data sources are. Understand the cause-and-effect relationships. Make decisions and take actions based on evidence.
  7. Relationship Management: Identify and build relationships with the relevant stakeholders that influence the performance of an organization.

Elements of a Quality Management System

The core elements found and provided by a QMS include:

Continuous Improvement

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.

Corrective and Preventive Action (CAPA)

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.

Root cause investigation results in MasterControl Qx
Root cause investigation results in MasterControl Qx.

Audit Management

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

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.

BPA Quality Risk Assessment
Monitor risks in BPA Quality.

Failure Mode and Effects Analysis (FMEA)

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 (SPC)

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.

An example X-Bar and S control chart in Enact
An example X-Bar and S control chart in Enact measuring the length of a machined component.
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