What is a Quality Management System (QMS)?

A QMS is a clearly defined set of business processes. It is a core tenet of the ISO 9001 standard for quality management. Together with the relevant documentation, it defines your organisation’s commitment to creating products and services in accordance with pre-defined quality standards.

A good Quality Management System should include detailed information about processes and responsibilities within an operational environment, such as an office or factory, and align with regulatory legislation. An effective QMS helps your organisation deliver products and services at a consistently high standard and helps to maintain and improve that quality over time.

Core elements of Quality Management Systems

A Quality Management System is a framework designed for consistently meeting client requirements and improving customer satisfaction with high-quality output. It is built on several core principles which are aligned with the ISO 9001 standard for Quality Management:

• Customer focus – The primary goal of a QMS is to meet customer needs and exceed their expectations, driving customer loyalty and attracting new business.
• Leadership – Clear guidance from leaders who prioritise quality management helps employees feel more involved in achieving the company’s quality goals.
• Employee engagement – Encouraging employees to participate in continual improvement activities, such as problem-solving teams or quality circles, can enhance their ownership and commitment to the QMS.
• Process approach – Understanding quality activities as processes that link together and function as a system can help efficiently produce consistent, predictable results.
• Improvement – Successful businesses strive to continually improve their QMS to consistently provide high-quality output and take advantage of new opportunities.
• Evidence-based decision-making – Effective decisions are based on the analysis and evaluation of data, which helps drive continual improvement.
• Relationship management – Fostering strong relationships between an organisation and its external providers requires a balanced approach to increase both parties’ ability to create value.

Quality management techniques

There are various quality management techniques that can help organisations improve their processes, products and services by reducing errors and inefficiencies. Here are some commonly implemented techniques:

• ISO 9001 is a globally recognised standard for a QMS. It provides a standardised framework for quality management. It follows a process approach focused on improving customer satisfaction through continual improvement.
• Total Quality Management (TQM) promotes a customer-focused, process-centred approach. It requires all employees to be involved in continuous improvement efforts to enhance the quality of products or services.
• Six Sigma is a data-driven methodology that uses statistical methods to improve process capability and effectiveness while reducing errors in quality management processes.
• Lean eliminates waste in all forms (time, effort, resources) to improve efficiency and streamline operations.

Choosing the right quality management techniques would depend on your organisation’s objectives, size, complexity and specific industry requirements.

What are the benefits of using a QMS?

Implementing a Quality Management System (QMS) can bring substantial advantages to your organisation, promoting efficiency, reliability, and customer satisfaction. The benefits can include:

Consistency

Companies that use a QMS have a clearly defined process for manufacturing products or delivering services that allows them to cope with staff changes, breakdowns, and even finding new outsourcing partners.

Because documentation is a key factor in the QMS, the information is readily available to deal with any changes, planned or not – the organisation is not reliant on individual skill and knowledge.

Reducing failures and dissatisfaction

An effective QMS should have an inbuilt reviewing process. Should a problem occur in a process, or if a customer is not satisfied with a service, then the errors that have led to this failure can be swiftly identified and the causes examined.

From the findings, the systems can then be updated and improved to prevent similar issues from occurring.

Regulatory compliance

A QMS may help you comply with product or service regulations that fall within the scope.

Pre-qualification for new business

A QMS such as ISO 9001 demonstrates your competency to new businesses and markets. Many types of organisation, from those that work in the public sector through to international corporations, will take your QMS as a mark of trust. Some industries may require your organisation to have an ISO certification in order for you to work with them.

Ensure you are certified through an appropriate channel, such as a UKAS accredited certification body, to maximise this benefit.

Evidence-based decision making

Without clear results and data, deciding what changes to make in a business would be guesswork.

A QMS can generate a real picture of operational weak points and potential risks, providing the data needed to reflect and inform meaningful change within the business.

Risk management

Implementing a QMS helps your organisation to manage risks by identifying any potential issues before they become problems. A proactive approach can help your business avoid costly errors.

Customer satisfaction

By using a QMS, you are making a statement about your reliability and ability to deliver on your contractual responsibilities to your customer, making your dedication to meeting their needs clear.

Cost reduction

A well-implemented QMS can help your organisation reduce costs by streamlining processes, reducing waste and improving resource use. This can translate to better profitability and competitive advantage.

Attracting customers and investors

Using a QMS can make your company attractive to potential investors. It confirms that the promises made by your sales and marketing materials can be more than adequately fulfilled by your operational capacity – this can be attractive to investors who want to align themselves with organisations that prioritise strict quality management.

Continual improvement

Going forward, a QMS will provide a business with a framework for implementing change within procedures, complete with a full documentation process that allows businesses to plot the evolution of different approaches.

The continual refinement of the system allows organisations to improve every aspect of their business.

Why you should choose ISO 9001 as your QMS

ISO 9001 is an internationally recognised standard and one of the most popular for quality management. It is possible for a business to implement a QMS and still experience a disconnect between policy and procedure across the operational capacity. This is not the case with ISO 9001.

No other standard has the history of ISO 9001. The roots of the standard can be traced back to the World War II era and it was introduced as a standard in the 1980s. Since then, it has undergone continual revision on the worldwide stage and has become the world’s best-known quality management system.

There are three reasons why the ISO 9001 standard has developed this reputation for delivering real results:

1. Credibility

ISO 9001 certification requires a third party to assess an organisation against the required standards. This ensures that the organisation meets a high level of consistent quality assurance and that the certification itself is unbiased and trustworthy.

2. Universality

Because ISO 9001 is a standard that can be applied across a wide variety of sectors, it can be adopted by vast numbers of companies. With such a wide reach, it has become the simple way for procurement teams to rate companies.

3. Success

When an organisation implements ISO 9001 effectively, it can assist in delivering three things – generating results, improving efficiency and providing a framework for continual improvement. The standard’s reputation is based on a consistently high level of return on investment, making it an extremely attractive proposition for business.

As an accepted framework for a successful QMS, ISO 9001 reduces the workload for business directors and senior management. Rather than having to construct an entire approach from the ground up, this standard allows businesses to make the decision and accelerate towards certification and a better operational structure.

Requirements of an ISO 9001 QMS

The ISO 9001 standard is based on several quality management principles, including a strong customer focus and continual improvement. It’s structured around ten main clauses structured to follow the Plan, Do, Check, Act (PDCA) cycle:

• Clause 1: Scope – Defines the purpose and scope of the standard.
• Clause 2: Normative References – Provides details of the reference standards or publications relevant to this particular standard.
• Clause 3: Terms and Definitions – Explains the terms and definitions applied within the ISO 9001 standard for clear understanding and consistency.
• Clause 4: Context of the Organisation – Requires the identification of any internal/external issues, interested parties and their requirements to determine the processes needed for the QMS.
• Clause 5: Leadership – Explains the need for senior management to demonstrate leadership and commitment to the QMS, customer focus and quality – and outlines organisational roles and responsibilities.
• Clause 6: Planning – Details requirements for addressing risks and opportunities, QMS objectives and plans to achieve them.
• Clause 7: Support – Covers resources, competence, awareness, communication and documented information.
• Clause 8: Operation – Focuses on operational planning and control, customer communication, design, controlling external provisions, production and service provision, release of products and services and nonconformity controls.
• Clause 9: Performance Evaluation – Involves monitoring, measurement, analysis, evaluation, internal auditing and management reviews of the QMS and your products/services.
• Clause 10: Improvement – Emphasises the need for improvement by highlighting nonconformity and potential risks and embracing continual improvement.

Other quality management standards

Besides ISO 9001, there are a number of other standards related to quality management. Two examples include:

• ISO 13485 – This is a standard specifically designed for Quality Management Systems related to medical devices. This standard places a greater emphasis on risk management and risk-based decision-making, aligning with the sector’s strict regulatory requirements.
• AS9100 – This is a Quality Management System standard for the aerospace industry. It includes additional requirements not covered in ISO 9001, addressing the sector’s specific safety and reliability demands.

Steps to ISO 9001 certification 

There are a number of steps an organisation should take before becoming ISO 9001 certified.

First, you will need to have a comprehensive understanding of ISO 9001 and the wider role a Quality Management System plays in an organisation. This includes familiarity with the standard’s clauses and core elements.

You will then undergo a Stage 1 assessment. This assessment is primarily a gap analysis to identify what is missing in your existing quality management process. After this analysis, a report is issued to highlight the actions needed for your organisation to acheive ISO 9001 certification.

Based on these findings, you may need to take additional steps to make your QMS ISO 9001 compliant before the Stage 2 assessment.

The Stage 2 assessment is an in-depth review of your Quality Management System. An auditor will conduct a full assessment to determine whether your management systems and processes meet the standard’s requirements. A critical part of your Stage 2 assessment is reviewing real examples of the delivery of your products and services.

Once your organisation has passed the Stage 2 assessment, you will be awarded your ISO 9001 certification.

Your QMS will need an annual reassessment to keep its ISO 9001 certification. These audits verify that the QMS continues to comply with ISO 9001 requirements and demonstrate continual improvement.

Get started on your ISO 9001 certification journey

If you’re ready to start your ISO 9001 certification journey and want to take your organisation to the next level, contact British Assessment Bureau.

Our website provides a comprehensive overview of all the ISO standards your organisation may need, including ISO 9001. We also offer a comprehensive library of ISO resources, including The Ultimate Guide to ISO 9001, a downloadable ISO 9001 checklist and ISO 9001 training courses.

Business is always becoming increasingly competitive. With more than 4.8 million companies currently active in the UK, how can your organisation stand out from competitors in your sector? Implementing a QMS and becoming ISO 9001-certified can give you a competitive edge in a clear, discernible way that your customers can understand.

Get started on your journey to ISO 9001 certification – get a quote today or contact our team to discuss your needs.