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A quality management system (QMS) is a collection of business processes and procedures which aims to ensure that the quality of products or services meets - or exceeds - customer expectations. Such systems are typically repeatable and measurable, and rely on continuous improvement. ISO 9001 is an example of a quality management system.

Types of quality management systems

There are many different types of quality management systems, each with their own advantages and disadvantages. Some of the most common ones are:

Standardised systems

These rely on established standards and follow agreed codes and regulations. Examples include ISO certifications such as ISO 9001. To pass the ISO standards, a business needs to satisfy all the requirements relating to quality and documentation, as well as audits. ISO certification is voluntary for most businesses. However, it may be a legal or contractual requirement in certain sectors and industries. See more on quality management standards.

Total quality management (TQM)

TQM is a management framework that relies on continuous, organisation-wide efforts to ensure long-term customer loyalty and success. It places a strong focus on process measurement and controls as means of continuous improvement. See more on .

Continuous quality improvement

This system, also known as CQI, focuses on continual incremental improvements, rather than processes and functions. The emphasis is on teams and individuals, and their importance in ensuring the quality of products and services. One of the most popular continuous improvement tools is a four-step quality model, the Plan-Do-Check-Act (PDCA) cycle. See more on .

Six Sigma

This is a data-driven methodology that focuses on process improvement. Under this approach, the processes are defined, measured, analysed, improved and controlled to achieve maximum quality. See more on .

Core elements of quality management systems

At their core, most quality systems will have several key elements:

• quality policy
• quality objectives
• quality manual
• quality procedures, instructions, and records
• document control
• organisational structure and responsibilities
• data management
• processes
• customer satisfaction
• continuous improvement

Put together, these elements make up a system which defines expectations, responsibilities and actions needed to achieve the expected quality of products or services.

Find out more about the advantages of quality management systems.

Which quality management system to choose?

Choosing the right quality system depends on the needs of your business. Your business will have a unique set of products, goals, values and quality objectives, therefore certain quality systems may suit better than others.

An ideal quality management system should be easy to integrate and use, it should meet the desired quality standards and demonstrate compliance with policies, procedures etc. It should also be flexible enough to change and adapt as your processes improve.

In most cases, you can tailor any quality management approach to satisfy the specific needs of your business. See how to implement a quality management system.

Implementing a quality management system, such as ISO 9001, offers numerous benefits to business owners. It typically increases efficiency and productivity, and is likely to give you an edge over your competitors.

Below are some of the business benefits you should consider.

Advantages of ISO 9001

Using ISO 9001 can help ensure that your customers get consistent, good quality products and services. This can, in turn, lead to new business, as well as:

• greater efficiency and less waste
• better and consistent control of major business processes
• a better understanding of customer needs
• regulation of successful working practices
• improved risk management
• increased customer satisfaction
• improved participation of employees
• better internal communication
• greater consistency in the quality of products and services
• differentiation of your business from its competitors
• increased profits
• reduction of costly errors
• exploitation of new markets, both in the UK and overseas
• managing growth more effectively
• an embedded culture of quality

The ISO 9001 certification is a globally recognised achievement and, as such, may help you raise your international profile and increase business overseas.

Benefits of ISO 9004:2018 to your business

ISO 9004 standard focuses on the quality of the organisation, rather than the quality management of products and services as set out in ISO 9001.

The standard gives recommendations for achieving long-term, sustained success and focuses on meeting the needs and expectations of all relevant interested parties, rather than just customers.

ISO 9004 is applicable to any organisation regardless of size, type and activity. Its latest revision includes an enhanced self-assessment tool which can help you:

• assess the level of maturity of the different components of your system
• identify and prioritise potential areas for improvement

ISO 9004 is intended as guidance only. It is not intended for certification, regulatory or contractual use. Read more about the .

Disadvantages of ISO implementation

Despite the many benefits, possible challenges to implementing the ISO standards include:

• the cost of getting and keeping the certification (in the case of ISO 9001)
• the time involved
• resistance to change from within the business

You can adapt the standard to your business needs and resources, although you may need the help of a consultant, which can come at an additional cost.

Certification to ISO 9001 isn't mandatory, but in some cases may be a prerequisite to working with certain clients such as public bodies. You should evaluate carefully if certification makes sense for your business. Many organisations benefit from using the standard without actually seeking certification.

Find out how to implement a quality management system.

Quality management standards establish a framework for how a business manages its key activities. They identify an agreed way of doing something, either making a product, managing a process or delivering a service.

What are quality standards?

Quality management standards are details of requirements, specifications, guidelines and characteristics that products, services and processes should consistently meet in order to ensure:

• their quality matches expectations
• they are fit for purpose
• they meet the needs of their users

Standards are an essential element of quality management systems.

Purpose of quality management standards

Businesses use standards to satisfy their customers' quality requirements and for a range of other reasons, such as:

• ensuring the safety and reliability of their products and services
• complying with regulations, often at a lower cost
• defining and controlling internal processes
• meeting environmental objectives

Businesses committed to following quality management standards are often more able to:

• increase their profits
• reduce losses or costs across the business
• improve their competitiveness
• gain market access across the world
• increase consumer loyalty

Read also about the advantages of quality management systems.

Examples of quality management standards

ISO international standards are by far the most widely accepted set of quality standards in the world. ISO 9001:2015 specifies the requirements for a quality management system that businesses can use to develop their own quality agenda.

Read about the ISO 9001 quality management standard.

Other standards related to quality include:

• the remaining ISO 9000 family, including ISO 9000 and ISO 9004
• the ISO 14000 family for environmental management systems
• ISO 13485 for medical devices
• ISO 19011 for auditing management systems
• ISO/TS 16949 for automotive-related products

Standards can be very specific, applying to a particular type of product, or general such as wide-ranging management practices. Find a .

Use of standards may be voluntary, but certain groups of customers or stakeholders may expect it. Also, some organisations and government bodies may require suppliers and partners to comply with standards as a condition of doing business.

Other types of best practice standards

Standards can help you to achieve best practice in a wide range of business activities, not just quality management. For example:

• accessibility standards - can help make services or premises accessible to disabled users
• - can help reduce accidents in the workplace
• - can help keep sensitive information secure
• food safety standards - can help prevent food from being contaminated
• - can reduce environmental impact and waste
• energy management standards - can help cut energy consumption

See how to make best use of standards.

ISO 9001 is the most popular and most used standard for quality management systems in the world. It is the only standard within the ISO 9000 series to which organisations can certify.

The ISO standards are published by the .

What is ISO 9001?

The ISO 9001 standard is an internationally-agreed set of documented rules and guidelines that provide clear criteria for implementing and maintaining a quality system in your business.

The latest version of the standard is ISO 9001:2015. Its criteria are based on seven quality management principles:

• customer focus - to understand and fulfil customer needs
• leadership - to increase employee motivation
• involvement of people - to recognise, empower and enhance the competence of people in the organisation and their role in delivering quality products or services
• process approach - to identify your essential business activities and consider each one as part of a process
• continuous improvement - to make improvement a permanent business objective
• evidence-based decision making - to use analysis of data to inform decisions
• relationship management - to recognise the interdependence of your business and its suppliers

The principles describe which requirements your products, services and organisation have to meet in order to comply with the standard.

Key requirements of ISO 9001

The ISO 9001:2015 standard is broadly divided into ten sections (called ISO clauses).

Clauses 1, 2 and 3 deal with the scope of the standard, normative references, terms and definitions contained in the standard. Clauses 4 to 10 specify the requirements for the different areas of the quality management system:

• Clause 4 - establishes the context of the organisation and requires you to determine external and internal issues, the needs and expectations of interested parties, the scope of the quality management system and its processes
• Clause 5 - requires top management to demonstrate leadership and customer commitment, establish and communicate a quality policy, and assign responsibilities
• Clause 6 - emphasises the importance of planning and requires you to address organisational risks and opportunities, changes and establish quality objectives
• Clause 7 - requires that you provide resources and 91Ï㽶»ÆÉ«ÊÓƵ that are needed, including infrastructure and skilled staff, and document information to 91Ï㽶»ÆÉ«ÊÓƵ the quality management system
• Clause 8 - requires planning for product or service provision, to ensure that you deliver what customers want, looking at areas such as sales processes, design and development, purchasing, production or service activities
• Clause 9 - requires that you carry out performance evaluation, and monitor, measure, analyse and evaluate your quality management system
• Clause 10 - requires continual improvement of your quality management system, including taking preventive and corrective actions, addressing non-conformities, etc

Find out more about the .

These requirements can apply to any business in any industry and can guide any organisation in the implementation of quality management.

ISO 9001:2015 documentation requirement

To comply with the ISO 9001:2015 standard, you must maintain the following documentation:

• your quality policy
• your quality objectives
• the scope of the quality management system

The ISO 9001:2015 no longer requires any documented procedures or a quality manual, but refers to 'documented information' instead, as the information that the organisation has to retain, control and maintain.

The standard requires you to maintain documented information 'to the extent necessary to 91Ï㽶»ÆÉ«ÊÓƵ the operation of processes'. You have the flexibility to work out what you need and how you want to document it.

Bear in mind that documented information is used as evidence of conformance, can help provide consistency in processes, help with staff training and preservation of knowledge.

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ISO 9004:2018 standard

If you have implemented ISO 9001 in your business, and you wish to go further, consider the . It helps businesses achieve sustained success by using a quality management approach based on continuous improvement. The standard sets out voluntary guidelines and recommendations, and you cannot certify as achieving it.

Find out more about the advantages of quality management systems.

ISO certification is the official recognition by a certification body that your business has achieved an ISO 9001 quality management standard. You can choose to implement a quality management system without seeking ISO certification.

While certification has its benefits, and might reassure your customers that your products and services will meet their expectations, many businesses can benefit from using the standard without actually getting ISO certified.

Steps to ISO 9001 certification

ISO 9001:2015 certification process typically involves the following steps:

1. Start by establishing your baseline status

Find out where you are and where you need to be to become certified. Consider your objectives and determine which benefits you expect to gain by certification. Carry out an ISO 9001 gap analysis. You can use the results of this analysis to create a plan and schedule for your compliance project. See our project plan for ISO 9001 implementation.

2. Develop your quality system

Improve the existing processes and procedures based on the findings from your gap analysis. You may also need to develop new processes, quality controls or documentation to fulfil the requirements of the standard. Be prepared to incorporate quality management systems into every area of your business. See how to implement a quality management system.

3. Audit your system internally

Check that your new or improved processes, procedures and documentation meet the ISO 9001 requirements. A thorough audit will enable you to identify problems or weaknesses in your system, so make sure that you address these before engaging an external auditor.

4. Choose an auditor

You will ideally want an accredited certification body to audit your business. Accreditation is not compulsory; however, it offers independent reassurance that the auditors are competent, impartial and using relevant standards. Using an accredited certification body reduces the risk of selecting an incompetent evaluator and paying for, or more seriously, acting upon invalid results. .

5. Assessment process

Some certification bodies may carry out a pre-audit assessment to ensure that you have the required documentation in place or to highlight areas in need of improvement. The formal assessment involves a visit from a representative of the certification body, who will check that you have developed the necessary ISO 9001 procedures and controls in your business, and assess their implementation to make sure they are working effectively.

6. Certification

If you meet the requirements, the certification body will issue you an ISO 9001 certificate, which is valid for three years. During this period, the auditor will return at scheduled intervals to ensure that your system remains compliant and continually improves. If your ISO audit was unsuccessful, the auditor will suggest corrective action to address any problems and arrange a further assessment if necessary.

Find out more about ISO 9001 quality management standard and remember to take into account the ISO 9001 certification costs.

What is ISO accreditation?

Accreditation isn't the same as certification. Accreditation is a licence that certification bodies gain in order to carry out ISO certification audits and be able to issue certificates.

Accreditation isn't mandatory, but it shows that the certification body is compliant with international standards. United Kingdom Accreditation Service (UKAS) is the accreditation body for the United Kingdom.

There are no typical ISO 9001 costs. If you're budgeting for an ISO 9001 project, you should take into account certification costs, as well as the actual costs of implementation of the standard in your business.

Different factors will affect the price of ISO implementation and certification. These include:

• the size of your business
• the number of employees you have
• your industry or sector
• your business' operational structure
• the extent of existing quality management systems
• the complexity of the audit required

If you are looking for a 'ballpark' figure, many consultancy businesses offer 'no obligation' quotes online. To find an accredited certification body, .

How much does it cost to get ISO certified?

Certification bodies operate a three-year ISO certification cycle. This cycle involves:

• initial audits and certification
• surveillance audits (during first and second year)
• re-certification audit (at the end of the third surveillance year)

The costs of ISO certification will be spread across these stages. Certification bodies may exercise discretion over how they break these down.

Example of ISO certification costs

Typical ISO certification costs may involve the following:

Implementation costs

These will depend on whether you are doing the implementation yourself in-house, or hiring a consultant. If you're doing it yourself, you should estimate the costs of staff, time and resources needed for the project, for staff training, developing documentation, and so on. If you are hiring consultants to help with implementation, expect to pay at least £300 per day for a consultant.

Certification fees

These will depend on the size of your business, the number of operational sites you have and the level of risk associated with the product or service you provide. As an example, if you have two or three employees, operate at one site and provide low risk product or service, you can anticipate initial assessment fees in the region of at least £1400.

Post-certification costs

ISO certificates are issued for a period of three years. You will have to undergo six-monthly or annual surveillance audits to determine ongoing conformance to the standard. In the example given above, you would need to allow for:

• annual audit costs of approximately £1000
• 're-certification' audit, which can cost around 60 per cent of the initial assessment fees

In addition, some certification bodies also charge an annual registration fee of £100-400. For the example above, this could bring the total anticipated costs to £3500-4500 for three years ISO certification, and an additional £1200 for re-certification.

This is an indication of the costs only. There is no such thing as a fixed ISO price list. You can request quotations for certification services to give you better idea of the costs. You may also want to speak to more than one certification body in order to determine the full costs for certification over three years, as well as the costs for re-certification.

Keep in mind that adding other standards, such as those relating to environmental or health and safety systems, can significantly increase the costs of ISO certification.

Costs and benefits of ISO certification

Although the costs of ISO certification may initially put you off, it's important that you weigh them carefully against the potential savings and improvements your business could make and the additional business you could win. See advantages of quality management systems.

You can try several things to reduce the costs of ISO 9001 certification:

• Get quotes, including the cost of surveillance visits, from several certification bodies and compare them for best deals.
• Ask your certification body if they offer special rates for smaller businesses.
• Minimise the amount of paperwork in your system.
• Get a copy of the relevant standard to make sure that any work you do towards the standard meets its requirements. Prices start from around £85.
• Check if your business qualifies for financial assistance with system or quality management software implementation. Search Northern Ireland business 91Ï㽶»ÆÉ«ÊÓƵ finder.

Remember, you can choose to implement a quality management system without seeking ISO certification. See how to implement a quality management system.

Implementing a quality management system (QMS) into a business is not always a simple task. Here are some key guidelines to getting a QMS started.

Steps to quality management system implementation

Creating a quality management system requires input from employees at all levels of an organisation, starting with top management. Their firm commitment to change and improvement is vital to the success of system implementation.

After securing the 91Ï㽶»ÆÉ«ÊÓƵ of top management, you should follow these key steps to implement a quality management system:

1. Analyse your business by breaking it down into key areas. These will often be areas that are crucial to your customers' satisfaction. Senior staff should determine the needs of the business and design the system around these.

2. Plan your approach by deciding which resources you need and discussing the effectiveness of existing processes with staff. Conduct a gap analysis to determine what the current processes are and how they need to change. Assemble your team and develop an implementation plan. See project plan for ISO 9001 implementation .

3. Inform and train employees. Decide if new processes are necessary and tell staff about them. Provide training and explain how the new system will benefit both staff and customers.

4. Consider 91Ï㽶»ÆÉ«ÊÓƵing documentation, such as quality policies, procedures, training materials, work instructions, etc. Use version control documents to keep your documentation in order. If you are seeking ISO certification, you will have to keep specific documentation to meet the requirements. .

5. Deploy the system and check that the processes are working. Give someone the responsibility for the system and ensure that proper procedures are followed. Set targets for how each process contributes to the success of business goals. Control, measure and monitor your outputs to ensure that they meet the expected quality levels.

6. Review and revise processes where necessary. Schedule routine product or process audits to monitor compliance with policies and procedures, and any certification requirements. Continue to audit and review regularly to ensure continuous improvement.

The British Standards Institution (BSI) offers guidance to help you determine if you're ready for ISO 9001 certification :

See also ISO 9001 certification.

Implementing a total quality management system

Unlike the ISO 9000 standards, which are usually restricted to specified business processes, a applies to the whole business. It addresses work culture, the working environment and the ethics of the business, and aims to ensure complete customer satisfaction.

Our free planning template for ISO 9001 implementation will help you prepare and effectively manage all aspects of your ISO project. Use this sample document to:

• plan your ISO 9001 project milestones and timescales
• assign roles and responsibilities to individuals and teams
• oversee and manage your ISO 9001 implementation

You should develop your project plan based on your gap analysis. Decide in advance the extent of documentation you will need to demonstrate control. See how to implement a quality management system.

…

Project Plan: ISO 9001:2015

Project goals

Start date: ______________________________________

Target registration date: _______________________

Responsibilities

Project manager: _____________________________________________________

Management representative: _________________________________________

Person ultimately in charge: ____________________________________________

ISO 9001:2015 team: ____________________________________________

Project timeline:

See more on the ISO 9001 quality management standard.

A balanced scorecard is a strategic management tool which you can use to manage and measure your business performance in areas that are crucial to its success.

What is a balanced scorecard?

A balanced scorecard is a framework for an organisational appraisal that allows you to look at your business from four perspectives:

• Learning and growth - it considers the infrastructure that 91Ï㽶»ÆÉ«ÊÓƵs your employees' skills, capabilities and knowledge. Two common elements are employee training and education.
• Internal business processes - it takes into account the procedures that drive your business forward, such as the number of new products or services you create and new product development time. These activities aim to maintain good relationships with your stakeholders, as well as your customers.
• Customer perception - it studies the satisfaction levels of your product or service, eg using surveys, focus groups and hard data. It evaluates a variety of factors such as cost, quality, availability, time management, service and innovation, which can help you to add value and make your business stand out from the competition.
• Financial health - it provides analysis and monitoring measures that 91Ï㽶»ÆÉ«ÊÓƵ profitability, growth, value creation and risk assessment.

For each of these areas, the balanced scorecard allows you to develop metrics, set performance targets, and collect and analyse data.

Purpose of the balanced scorecard

Balanced scorecard helps managers keep track of progress towards organisational and strategic targets. It provides a structured report that allows you to:

• communicate the activities you need to implement for success
• align the day-to-day work of your staff with your strategy
• determine objectively if the strategy is working
• prioritize projects, products, and services
• measure and monitor progress towards targets, as well as efficiency and effectiveness
• reduce uncertainty

Balanced scorecard combines financial measures with other key performance indicators (KPIs) to give you a snapshot of how well your business is doing now and how it may perform in the future. See how to decide which KPIs to measure.

The scorecard can also help you to review your strategy implementation, or implementation of a new quality management system, based on measured and verified data. See how to implement a quality management system.

A quality policy statement is a brief document developed as part of a business' quality management system. It declares what you consider 'quality' in your organisation and outlines the processes you have in place to ensure that you meet the agreed standards.

What is the purpose of a quality policy?

Quality management policy is important for several reasons. Most importantly, it articulates:

• your intentions regarding quality of your products or services
• your commitment to continuous improvement in quality management
• responsibilities of all staff, especially those with key roles, for maintaining quality of products and services

A written, well-defined quality policy is also required by the ISO 9001 standard and is essential to creating an effective quality management system.

Sample quality policy statement

Below is a template for a typical quality management policy statement which you are welcome to customise for your business.

Sample company name (XYZ Limited)
Quality policy statement

Company XYZ Limited was established in [year] to provide [describe goods, works, services] to the [describe] industry. We are based in [city/town/region] and employ [number] people.

Quality is important to our business because we value our customers. We strive to provide our customers with products and services which meet and even exceed their expectations.

We are committed to continuous improvement and have established a Quality Management System which provides a framework for measuring and improving our performance.

We have the following systems and procedures in place to 91Ï㽶»ÆÉ«ÊÓƵ us in our aim of total customer satisfaction and continuous improvement throughout our business:

• regular gathering and monitoring of customer feedback
• a customer complaints procedure
• selection and performance monitoring of suppliers against set criteria
• training and development for our employees
• regular audit of our internal processes
• measurable quality objectives which reflect our business aims
• management reviews of audit results, customer feedback and complaints

Our internal procedures are reviewed regularly and are held in a Quality Manual which is made available to all employees.

This policy is posted on the Company Notice Board and can also be found in the staff handbook.

Although the Managing Director has ultimate responsibility for Quality, all employees have a responsibility within their own areas of work to help ensure that Quality is embedded within the whole of the company.

The policy review date is [date].

Signed:................................. (Chief Executive)

Date:.................................

Please note: It is good practice to review your quality policy regularly to ensure that it remains suitable and appropriate to your organisation.