Quality Management System (QMS)

An easy guide to a Quality Management System - definition of QMS, its benefits, purpose, history and more.

What is a Quality Management System (QMS)?

A Quality Management System is consolidation of QMS documents starting at strategic level down to working level to ensure quality of products/services and achievement of customer requirements. The benchmark for quality could vary depending upon the nature and complexity of products and services. In addition, QMS enables an organization to demonstrate due diligence by ensuring compliance with applicable statutory/regulatory requirements as well as applicable standards and codes of practice.

Sometimes there is lot of confusion between quality control, quality assurance and quality management system. Generally, quality control is the lowest form of control that applies to the shop floor or warehouse or distribution services. It is basically implementing pre-defined arrangements. On the other hand, quality assurance covers quality control plus design aspects. Finally, the quality management system applies to everyone in the organization starting at reception desk to leadership. Quality Management System covers every functional groups such as leadership, sales and marketing, project management, application engineering, engineering, supply chain, production/service delivery, shipping, installation, commissioning and warranty/servicing.

What is an ISO 9001 Quality management system?

The ISO 9001 Standard based Quality Management System fulfills the requirements of the ISO 9001 Standard. The ISO 9001 Standard is based on two fundamental concepts that include process approach/ PDCA cycle and risk-based thinking.  ISO 9001 based QMS applies to organizations of any size, nature, and complexity i.e. it applies to a candy store as well as GM corporation. The requirements of ISO 9001 Standard are not prescriptive in terms of products/services. In other words, it does not tell what to do but rather how to do it. ISO 9001 Standard does not dictate specific product/service requirements which is your organization`s job. ISO 9001 Standard spells out the process to get the job done.  The main clauses of the ISO 9001 based QMS include Organization Context, Leadership, Planning, Support, Operation, Performance Evaluation and Improvement processes.

Definition of quality?

Quality can be defined as one or all the following:

Fitness for purpose products or services must be capable of being used for the intended purpose for which they were purchased i.e. a car performing well in extremely hot or cold ambient temperatures, a toaster functioning without causing any health/safety concerns.

Conformance to customer requirementsProducts and services must conform to customer requirements which could include functional and performance requirements, health and safety concerns, environmental concerns, and compliance with applicable statutory/regulatory requirements.

Conformance to product characteristicsProducts must conform to various characteristics that could include attributes of the product itself that need to be controlled. Examples of product characteristics are size, shape, appearance, weight, color, gloss, quality, hardness, etc. The list of product characteristics depends on your product and its relationship with functional design requirements.

Conformance to product requirements related to applicable standards/codes/legislationDepending on the nature of products/services, the applicable statutory/regulatory could cover public safety legislation, environmental legislation, ethical legislation, technical standards, and codes of practices.

Recommend reading: 8 principles upon which ISO 9001:2015 Standard is based.

quality management systems

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Benefits of Quality Management System

The benefits of a quality management system include:

  • Job done right the first time.
  • Production cost reduction.
  • Customer loyalty enhancement.
  • Process improvements.
  • Stakeholder perception enhancement.
  • Due-diligence enhancement.
  • Increased profit margins.
  • Increased market share.

Why is QMS important?

  • It is important to run a disciplined, structured and systematic business to reap the benefits defined above,
  • to present a quality-oriented role model by the senior management,
  • to establish a bigger picture ‘strategic plan’ for your business,
  • to establish and make employees aware of expectations from them,
  • to establish and implement Key Performance Indicators for quality,
  • to identify, understand and mitigate high level risk posed to quality,
  • to understand and manage the needs and expectations of stakeholders.

Elements and Requirements of a QMS

Generally, a QMS is based on following PDCA cycle: Plan, Do, Check & Act.

Plan: Plan the QMS based on customer requirements, product specifications, product-related statutory/regulatory requirements, organizational context and stakeholders needs and expectations. This would include establishing Strategic Plan, QMS objectives/KPIs, Processes identification, Processes risk assessments, policies, procedures and supporting tools based on risk assessment.

Do: Cause awareness of and implement established policies, procedures/work instructions and supporting tools (defined above) using competent personnel and appropriate infrastructure/work environment. Retain appropriate records of product/process outputs.

Check: Monitor and measure all products and processes outputs and collect raw data. Develop trends for analysis of data and then evaluate the ups/downs of trends to identify process and product deficiencies. In addition, perform internal audits and management reviews to identify any gaps.

Act: Conduct root cause analysis on the identified gaps within QMS and develop and implement corrective action. Drive continual improvement based on management review and analysis of data/evaluation outputs. Revise the risk register as necessary. Revise the strategic plan if necessary, and revise the Quality Objectives and KPIs as appropriate.

What is the Purpose of a QMS?

The purpose is to deliver a message or perception to the current customer/potential customer that your organization is capable of meeting or exceeding their requirements as well as meeting applicable statutory/regulatory requirements related to products/services. In addition, your organization possesses human competence and an appropriate infrastructure/work environment to deliver their defined products and services.  

Different types of a Quality management systems

Quality Management system could cover the whole system or can be broken down into the following subsystems:

  • Product
  • Process
  • Supplier
  • Compliance (Statutory and Regulatory)
  • Customer
  • Leadership
  • Process Identification and Risk QMS

Core elements of an ISO 9001 quality management system

Core elements of an ISO 9001 based QMS cover:

  • Clause 1-Scope of ISO 9001 Standard
  • Clause 2 -Normative References
  • Clause 3-Terms and definitions
  • Clause 4-Organizational Context
  • Clause 5-Leadership
  • Clause 6-Planning
  • Clause 7-Support
  • Clause 8-Operation
  • Clause 9-Performance Evaluation
  • Clause 10-Improvement

How can a QMS software help your Business/Organization?

Quality Management Systems are designed to ensure that products or services meet specified requirements and standards while continuously improving processes. Various types of software can be used to manage Quality Management Systems, and these tools help organizations streamline their quality processes, ensure compliance, and drive continuous improvement. Here are some different types of software used for managing QMS:

1. Enterprise Resource Planning (ERP) Software:

  • Functionality: ERP systems often include modules dedicated to quality management. These modules help integrate quality processes with other business functions like production, inventory, and finance, human resources, manufacturing, supply chain, services, procurement, sales and marketing, design and development, quality, shipping, commissioning.
  • Features: Document control, corrective and preventive action (CAPA), non-conformance tracking, audit management, and integration with other business processes.

2. Document Management Software:

  • Functionality: Document control is a crucial aspect of QMS. Document management systems help organize, version, and control access to important quality documents.
  • Features: Version control, access permissions, electronic signatures, and audit trails.

3. Quality Management Software :

  • Functionality: Dedicated QMS software is designed specifically for managing quality processes. It provides a centralized platform for tracking and managing quality-related activities.
  • Features: CAPA, non-conformance tracking, risk management, audit management, training management, and reporting tools.

4. Compliance Management Software:

  • Functionality: Ensuring compliance with industry standards and regulations is a critical aspect of quality management. Compliance management software helps organizations stay compliant with relevant standards.
  • Features: Regulatory tracking, compliance monitoring, and reporting.

5. Statistical Process Control (SPC) Software:

  • Functionality: SPC software is used to monitor and control processes by analyzing statistical data. It is often employed in manufacturing environments to maintain product quality.
  • Features: Statistical analysis, control charting, and real-time monitoring of process data.

6. Customer Relationship Management (CRM) Software:

  • Functionality: Customer feedback and satisfaction are integral to quality management. CRM software can help manage customer interactions and feedback.
  • Features: Customer complaint tracking, feedback management, and integration with other quality processes.

7. Risk Management Software:

  • Functionality: Identifying and managing risks is a key component of QMS. Risk management software helps organizations assess and mitigate potential risks.
  • Features: Risk assessment, risk mitigation planning, and monitoring.

8. Training Management Software:

  • Functionality: Ensuring that employees are trained on quality procedures is essential. Training management software helps track and manage employee training.
  • Features: Training program tracking, certification management, and competency assessments.

Wrap Up When selecting software for managing a Quality Management System, organizations should consider their specific needs, industry regulations, and the integration capabilities of the chosen software with existing systems. It’s essential to choose a solution that aligns with the organization’s quality goals and facilitates continuous improvement.

Consult JSA today to get started!

History of Quality - Industrial influence on quality and standardization.

Quality evolution refers to the continuous improvement and development of products, services, or processes over time. It involves refining and enhancing various aspects to meet or exceed customer expectations and industry standards. The evolution of quality can be understood in chronological order through the following key stages:

1. Craftsmanship Era (Pre-Industrial Revolution):

  • Quality was primarily dependent on the skills and craftsmanship of individual artisans.
  • Inspection was often limited to the end product, and there was little emphasis on systematic quality control.

2. Inspection Era (Late 19th to Early 20th Century):

  • With the advent of mass production during the Industrial Revolution, product inspection became more prevalent.
  • Inspection was often performed at the end of the production process to identify and rectify defective products.

3. Quality Control Era (1920s-1940s):

  • Statistical methods, particularly those developed by Walter Shewhart, were introduced to control and improve the production process.
  • The focus shifted from mere inspection to actively managing and controlling the quality of processes.

4. Quality Assurance Era (1950s-1970s):

  • The emphasis moved beyond inspection and control to a broader approach involving the entire organization.
  • Quality assurance systems and standards, such as ISO 9000, gained prominence, focusing on preventive measures and documentation.

5. Total Quality Management (TQM) Era (1980s-1990s):

  • TQM became a significant management philosophy, emphasizing continuous improvement, employee involvement, and customer satisfaction.
  • Concepts like Six Sigma and Lean Manufacturing gained popularity during this period, aiming for zero defects and waste reduction.

6. Six Sigma Era (1986-Present):

  • Introduced by Motorola in the 1980s and popularized by companies like General Electric, Six Sigma focuses on reducing variation and improving process efficiency.
  • The DMAIC (Define, Measure, Analyze, Improve, Control) methodology is commonly used in Six Sigma projects.

7. Lean Manufacturing Era (1990s-Present):

  • Lean principles, derived from the Toyota Production System, gained prominence, aiming to eliminate waste and improve flow in manufacturing and service processes.
  • Lean practices often complement Six Sigma methodologies in pursuit of operational excellence.

8. ISO 9000:2000 and Beyond (2000s-Present):

  • ISO 9000 standards continued to evolve, with a focus on process approach, risk-based thinking, and customer satisfaction.
  • Integration of quality management systems with broader organizational processes became a key trend.

9. Industry 4.0 and Digital Quality (2010s-Present):

  • The integration of digital technologies, such as IoT (Internet of Things), big data analytics, and artificial intelligence, has transformed quality management.
  • Real-time monitoring, predictive analytics, and automation contribute to proactive quality control.

10. Agile and DevOps (2010s-Present):

  • In software development, Agile methodologies and DevOps practices emphasize collaboration, iterative development, and continuous integration, fostering a culture of continuous improvement.

Wrap Up The chronological evolution of quality reflects a shift from reactive approaches (inspection) to proactive and integrated strategies (TQM, Six Sigma, Lean, Industry 4.0). The modern approach to quality is dynamic, data-driven, and aligned with organizational goals and customer satisfaction.

QMS Resources

Courses
Blogs
  • What is ISO 9001? – Learn about ISO 9001 standard, its purpose, benefits, how to implement it, get certified and more.
  • Core elements – Learn about the 10 clauses of a Quality Management System in detail.
  • ISO 9001:2015 standard – Learn about ISO 9001 principles, how the structure has changed, risk based thinking and more.
Case Studies

Justice Institute of B.C.

(Post-Secondary Institute) Jack Sekhon and Associates assisted Justice Institute in achieving certification to ISO 9001 QMS Standard.

Baker Hughes

(Oilfield Servicing) - Jack Sekhon and Associates assisted Baker Hughes in achieving certification to ISO 9001 QMS Standard.

National Oilwell Varco

(Oilfield Equipment, Technologies, And Expertise) - Jack Sekhon and Associates assisted NOV in achieving certification to ISO 9001 QMS Standard.

Coast Testing

(Non-Destructive Testing, Inspection & Engineering) - Jack Sekhon and Associates assisted Coast Testing in achieving certification to ISO 9001 QMS Standard.
Frequently Asked Questions

Check out answers to Frequently Asked Questions.

The overall cost of quality consists of prevention cost, appraisal cost and failure cost. The overall cost of quality can vary between 3-25% of revenues for a quality pro and quality non-believer company respectively. There is an incentive to reduce the overall cost of quality by establishing/implementing a systematic, structured, and disciplined approach through a quality management system.

The overall cost of quality in an ideal company consists of 60-70% prevention, 20-30% appraisal and less than 10% failure cost. However, in a poorly run company the actual cost of quality could be 60% failure, 30-40 % appraisal and less than 10% prevention. Here is the opportunity to turn it around from failure to prevention model through ISO 9001 QMS based upon the process approach and risk based thinking.

he Prevention Cost of Quality covers the cost elements such as planning, training, designing, and implementing quality activities that prevent the occurrence of bad quality. 

Prevention costs are incurred to prevent or avoid quality problems. These costs are associated with the design, implementation, and maintenance of the quality management system. They are planned and incurred before actual operation, and they could include:

  • Product or service requirements: Establishment of specifications for incoming materials, processes, finished products, and services.
  • Quality planning: Creation of plans for quality, reliability, operations, production, and inspection.
  • Quality assurance: Creation and maintenance of the quality system.
  • Training: Development, preparation, and maintenance of programs.

Appraisal costs are the costs of reviewing, verifying, validating, inspecting, testing, auditing, and measuring quality to identify defects.

Appraisal costs are associated with measuring and monitoring activities related to quality. These costs are associated with the suppliers’ and customers’ evaluation of purchased materials, processes, products, and services to ensure that they conform to specifications. They could include:

  • Verification: Checking of incoming material, process setup, and products against agreed specifications.
  • Quality audits: Confirmation that the quality system is functioning correctly.
  • Supplier rating: Assessment and approval of suppliers of products and services.

The cost of failure includes internal and external failure costs.

Internal failure costs are incurred to remedy defects discovered before the product or service is delivered to the customer. These costs occur when the results of work fail to reach design quality standards and are detected before they are transferred to the customer. They could include:

  • Waste: Performance of unnecessary work or holding of stock as a result of errors, poor organization, or communication.
  • Scrap: Defective product or material that cannot be repaired, used, or sold.
  • Rework or rectification: Correction of defective material or errors.
  • Failure analysis: Activity required to establish the causes of internal product or service failure.

External failure costs are incurred to remedy defects discovered by customers. These costs occur when products or services that fail to reach design quality standards are not detected until after transfer to the customer. They could include:

  • Repairs and servicing: Of both returned products and those in the field.
  • Warranty claims: Failed products that are replaced or services that are re-performed under a guarantee.
  • Complaints: All work and costs associated with handling and servicing customers’ complaints.
  • Returns: Handling and investigation of rejected or recalled products, including transport costs.

The cost of quality can be measured through the design of the accounting system. The level of accuracy of the cost of quality measurement will depend on the depth of breakdown of the business to track cost. Mostly the ABC Activity Based Costing is used to track the cost. The term Activity should be defined precisely from the business standpoint to reflect the accuracy of the cost of quality. The deeper the breakdown of the business in terms of cost, the easier it will be to analyze and reduce the cost of quality through process improvements.

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