Understanding the Need for Quality Management Systems in Australia

Quality is the degree to which a product or service meets the customer's needs or expectations. In simple words, quality is about meeting or exceeding expectations. Therefore, a Quality Management System (QMS) is needed to achieve and retain quality in an organisation.

What is Meant by a Quality Management System?

A quality management system (QMS) is a set of guidelines that dictate how an organisation produces and delivers its products and services. A QMS is an essential tool for any organisation or business that wants to ensure the delivery of high-quality products and services to its customers.

Your organisation or business already has several systems to keep them in operation. A QMS is one more system that, when followed, will help ensure your success.

Organisations use QMSs to document their quality policies, objectives, and responsibilities to:

• guide their decision-making
• communicate to employees, suppliers, customers, and other interested parties what the organisation does
• ensure that its products or services meet the needs of employees, suppliers, customers, and other interested parties.

QMS is often referred to as ISO 9000, the standard published by the International Organization for Standardization (ISO). The latest revision standard in Australia is AS/NZS ISO 9001:2016.

Components of the Quality Management Process

The idea behind a QMS is to have one source that can provide all your needs for quality management. They simplify and streamline supply chains by maintaining four main components of a quality management process: quality planning, quality control, quality assurance, and quality improvement.

1. Quality Planning

Quality planning is the stage wherein the quality standards are set and how the product or service will meet them. It also assigns responsibilities to specific members of the organisation. This planning stage must consider all quality aspects, including design, customer requirements, processes, and delivery.

• Strategic Goal-Setting: This isn't just about product features. It ties into higher-level business goals: increasing market share, improving customer retention, reducing warranty costs, etc. A strong quality plan should answer "How does better quality help us achieve our overall business vision?"
• Resource Allocation: Quality isn't free. Plan for the needed budget for personnel (quality engineers, inspectors), testing equipment, training, and potential software tools.
• Risk Analysis: Proactively use tools like FMEA (Failure Mode and Effects Analysis) to identify potential points of failure before they happen. Prevention is always cheaper than fixing problems after they reach customers.

2. Quality Control

Quality control is the stage that involves setting up procedures to test products or services to see if they meet the quality standards set in quality planning. This is done during and after production.

Organisations use quality control to find product errors or defects before reaching the customer. As a result, businesses can save time and money by reworking the product or service before it is delivered by catching these errors early.

• Product Inspection: The most basic form is visually examining items for defects, misalignments, etc. This can be done at various production stages: raw materials, mid-process, and final product.
• Statistical Sampling: When testing every single item is impractical, use statistically valid sampling plans to represent the whole batch. This saves time and still gives a high degree of confidence in overall quality.
• Performance Testing: Does the product do what it's supposed to? This might involve lab simulations, destructive testing (finding the point of failure), or real-world trials.
• Durability Testing: How long will the product last under expected use? Accelerated lifespan tests can simulate years of usage in a short time.

3. Quality Assurance (QA)

Quality assurance is the stage that ensures that all quality control procedures are being followed and that products or services are up to the set standards. This is usually done by auditors checking to see if businesses follow their quality plans.

Quality assurance aims to verify that quality standards are being met at every stage of production. QA can help improve the overall quality of a product or service by catching errors and correcting them.

Quality assurance and quality control help businesses identify potential issues and take corrective and preventive measures to address them.

• Internal Audits: Teams within the company periodically check if processes and procedures are being followed according to the QMS. It's a self-assessment that helps to maintain consistency.
• External Audits: Third-party auditors, often needed for certifications like ISO 9001, provide an independent, unbiased view. This demonstrates to customers that your quality system is rigorous.
• Process Audits: Focus on the efficiency and correctness of how things get done – are instructions clear, and are resources used wisely?
• Product Audits: A deep dive into a specific product/service to ensure it consistently meets quality standards.

4. Quality Improvement

Quality improvement is the stage that continually looks at ways to improve quality control and assurance procedures. This is done by constantly monitoring products or services for sustained success and changing how they are produced.

Businesses can give their customers the best product or service possible by constantly looking for improvement opportunities. In addition, quality improvement can help enterprises save money by preventing errors and reducing waste.

• Root Cause Analysis (RCA): Don't just fix the symptom of a problem; find the underlying cause so it doesn't happen again. Tools like '5 Whys' or fishbone diagrams help.
• Pareto Charts: The principle that 80% of problems come from 20% of causes. This tool visually ranks issues so you target the most significant areas for maximum impact.
• Corrective & Preventive Action (CAPA): A systematic way to address quality issues – containment, correction, then preventing it from recurring.
• Statistical Process Control (SPC): Using control charts to track process stability over time. You can spot trends and deviations before problems reach the customer.

Key Elements in a QMS

A number of key elements make up a quality management system and are needed for achieving the company's goals. They are:

1. Quality Policy

The quality policy sets out the organisation's commitment to quality, its overall intentions, and direction concerning quality. It's usually drafted by top management and communicated throughout the organisation. It should be a guiding principle infused into the company culture. Think beyond "We strive for quality."

Make It Meaningful:

• Tie it to your company's mission/values.
• Use straightforward language everyone understands.
• Keep it short and prominently displayed.

Examples:

• "Customer satisfaction is our driving force, and we achieve it through continual improvement in our products and services."
• "Innovation and excellence are at the heart of everything we do. We deliver reliable solutions that exceed expectations."

2. Quality objectives

Quality objectives are specific targets that the organisation wants to achieve to improve its quality. They should be SMART (specific, measurable, achievable, relevant, and time-bound). They cover aspects such as product quality, customer satisfaction, and process improvement.

• Link to Business Results: Quality isn't its own reward; it must support the bottom line.
• Specific and Measurable: Avoid vague goals like "be better."
• Examples:
  • "Reduce product defects by 20% within the next fiscal year."
  • "Increase on-time delivery rate to 98%."
  • "Improve customer satisfaction survey scores by an average of 10%."

3. Quality Manual

There is no requirement in ISO 9001-2015 for a written manual, but many companies find that having one can be helpful. A manual can provide an overview of the quality management system and its procedures. It can also be a valuable resource for employees, helping them understand how the system works and their roles and responsibilities.

In addition, a manual can be used to communicate the company's commitment to quality to customers and other stakeholders and is useful for any organisation seeking to implement or improve its quality management system.

4. Organisational Structure and Responsibilities

"Organisation" in a QMS describes people and structures. This element outlines the roles and responsibilities of each department and individual. This includes understanding how each works together to achieve the organisation's goals.

5. Data management

The success of a QMS is reliant upon the data that it contains. This data must be high-quality and readily available for the QMS to drive continuous improvement and preventative quality control activities. Without accurate and up-to-date data, the QMS will be unable to identify areas for improvement or potential sources of issues.

• Types of Data:
  • Customer feedback (surveys, complaints, returns)
  • Process data (yield rates, cycle times, defect rates)
  • Supplier quality data
  • Audit results (internal and external)
  • Calibration and maintenance records for equipment
• Software Solutions:
  • Basic spreadsheets (for small operations)
  • Specialised QMS software (larger companies, complex needs)
  • Statistical analysis tools (Minitab, JMP, etc.)
  • Document management systems for secure storage
• Data Analysis:
  • Focus on trends, not just single data points.
  • Utilise visualisation tools (charts, graphs) for easy insights.
  • Look for correlations between data sets (Does supplier quality impact your defect rates?)

6. Processes and Procedures

The QMS framework defines processes as using any resource to transform inputs into outputs. While procedures are specific instructions that detail how a process is to be carried out.

7. Continual Improvement

The notion of continual improvement is imbued in the QMS framework. As the name suggests, businesses must continually look for ways to improve their quality. This is done through the implementation of corrective and preventive actions.

8. Customer Satisfaction

The goal of any quality management system is to provide products or services that meet the needs and expectations of customers. Businesses need to constantly monitor customer satisfaction levels and take action to address any issues.

9. Management Review

A vital element of a quality management system is the need for regular management reviews. Management reviews provide an opportunity for senior management to assess the performance of the QMS and identify areas for improvement. Management review meetings should be held at least once a year.

• Meeting Structure:
  • Defined frequency (at least yearly)
  • Clear agenda distributed in advance
  • Attendees: Senior management, department heads, quality reps
• Key Areas of Evaluation:
  • Performance against quality objectives
  • Customer feedback analysis
  • Audit findings and status of corrective actions
  • Process performance trends
  • Resource needs for the QMS
  • Opportunities for improvement
• Outcomes: Not just a report out, but action plans with owners and deadlines.

10. Document Control

Document control ensures that all relevant documents are up-to-date and easily accessible to those who need them. It also keeps people from making changes to documents without following the right steps.

11. Audit

Auditing is a key part of any quality management system. It provides a way to check that the QMS is followed and effectively meets the organisation's quality objectives. Audits can be internal or external, or can be conducted by employees or third-party organisations.

Importance of a QMS

Organisations face many challenges in today's fast-paced and competitive business environment. QMSs are essential because they provide a framework for businesses to continuously improve the quality of their products and services. This is the role of a QMS.

The primary purpose of a QMS is to help you avoid mistakes, reduce waste and rework, and improve efficiency and effectiveness. A QMS allows organisations to:

• identify and control the risks associated with their products and services
• improve customer satisfaction by consistently meeting their needs
• reduce waste and costs by improving efficiency and effectiveness
• identify areas in need of improvement and implement corrective actions to address any deficiencies
• improve communication and collaboration between departments, as well as with external suppliers and partners.

Managing a QMS

Various methods of managing a QMS enable businesses to reflect their unique goods, objectives, principles, and beliefs in their quality management systems. The most used are listed below.

Standardised Systems

Standardised systems follow federal codes and regulations for quality management. One of these is ISO 9001. It is part of the ISO 9000 family that guides businesses on how to set up and operate an effective QMS.

When it comes to quality management, four key components need to be addressed: quality planning, quality control, quality assurance, and quality improvement. Each component plays a vital role in ensuring that products and services meet or exceed customer expectations.

Quality planning involves setting quality objectives and developing a plan for achieving them. Quality control is all about monitoring and measuring the performance of products and services against those objectives. Quality assurance provides confidence that the quality control process is working as intended. And finally, quality improvement is about continuous improvements to the overall system.

By addressing these four components, businesses can build a strong foundation for delivering high-quality products and services. These principles can improve their performance and make them more competitive in their respective markets. As a result, businesses that are ISO 9001 certified may be viewed favourably by potential customers and partners.

Six Sigma

The Six Sigma approach is another popular quality management system. Motorola developed it in 1986 and focused on reducing product and service defects. Six Sigma is a process improvement methodology that seeks to find and remove the causes of errors and defects in the processes.

One advantage of this approach is that it helps businesses improve their bottom line by reducing waste and increasing efficiency. In addition, it can also lead to improved customer satisfaction. It also emphasises the importance of measuring, analysing, improving, and controlling process variables.

Total Quality Management (TQM)

Total Quality Management (TQM) highlights an organisation's requirement to continuously monitor and improve product quality. The principle behind it is simple—ensure that rate is considered at every stage, from development to delivery. This way, not only are customers satisfied, but companies also save on costs associated with rework and replacement.

TQM must adopt all levels of the organisation to be successful. It is only then that businesses can hope to reap its benefits.

Continual Quality Improvement (CQI)

Continual quality improvement, or CQI, is a quality management system that focuses on continual and constant improvement. Its focus is on teams and individuals rather than processes and functions, making it an adaptable strategy for different industries.

The "Plan, Do, Check, Act" approach, also known as the Deming Cycle, is the approach used for continuous improvement. With its emphasis on quality at every level, CQI is a system that never stops working with improvements.

QMS In Various Industries

Choosing the method to implement for your business depends on budget, industry, and specific needs and goals. However, all quality management systems share one common goal: to help businesses provide consistently high-quality products and services. Here are some examples of how QMSs are used in various industries:

Automotive industry

Safety is of paramount importance in the automotive industry. One defect or error in the manufacturing process can lead to severe accidents. To avoid such disasters, automotive manufacturers use QMSs to ensure their vehicles are safe and meet all regulatory requirements.

Some tools you can use in this industry include failure mode and effects analysis (FMEA) and design of experiments (DoE). These tools help identify and correct problems in the manufacturing process, preventing defects in the final product.

Healthcare industry

As with the automotive industry, quality in healthcare is also highly regulated. Hospitals and other healthcare organisations must meet uncompromising quality standards to be licensed and accredited.

The lives of patients and consumers are at stake, so healthcare organisations must have a QMS in place. It will help them deliver high-quality care and medications. It improves patient safety, reduces medication errors, and improves the quality of care.

Food Industry

Nourishment poisoning, food-borne illnesses, and other health hazards are significant concerns in the food industry. To ensure the safety of consumers, food manufacturers must adhere to strict quality standards set by state laws. A QMS can help meet these standards and protect the public from harm.

Using a QMS, food manufacturers can avoid costly recalls and other problems associated with poor quality. It is implemented using tools like Hazard Analysis, and Critical Control Point (HACCP) plans in the food industry. These plans help identify and address potential hazards in the food manufacturing process.

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. The TGA implements quality systems to ensure the safety, quality, and efficacy of therapeutic goods.

Information technology (IT) industry

With the ever-changing landscape of technology, IT companies need to have a QMS in place. The goal of a QMS in the IT industry is to help organisations develop and deliver quality software products.

It will help IT companies improve their software development process, reduce product defects, and meet customer expectations. The tools you can use for a QMS in the IT industry include software testing, configuration management, and project management.

Implement a QMS with SafetyDocs

Whichever industry your business is in, a QMS can help you improve the quality of your products and services. Implementing a QMS can help ensure compliance with relevant regulations, drive profitability through improved process efficiency, and support the development of new products and services.

To get started with your QMS, SafetyDocs can provide you with the necessary policies and procedures or full management systems to ensure your system is effective. SafetyDocs by SafetyCulture can help your business develop a QMS tailored to your needs. You can use the following documentation to guide you in starting:

• Quality Management System
• Quality Project Management Plan
• Quality Evaluation Plan

Contact us today to learn more about how we can help you improve the quality of your organisation.

Our team of experts is dedicated to providing accurate and informative content. Craig Cruickshank, our senior HSEQ advisor at SafetyDocs by SafetyCulture has reviewed this blog post to ensure the highest level of quality.

Learn more about Craig's work on LinkedIn for more industry insights.

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Please note that the above information is provided as a comment only and should not be relied on as professional, legal or financial advice.