ISO 9001 Implementation Guide

A guide to ISO 9001:2015

ISO 9001:2015 is the most widespread standard for managing quality, with over 1 million organisations worldwide having certification. ISO 9001 is an internationally agreed framework, outlining all the elements of best practice an organisation should employ. Its purpose is to:

a) help businesses to build strong quality management systems

b) create a benchmark against which the performance of companies can be judged

c) help businesses satisfy customers through improved products and services



Why is ISO 9001 certification so important?

There are a number of benefits to having a well implemented ISO 9001 Quality Management System:


It strengthens your image and credibility, helping you to win projects

Without a doubt, the ability to show clients that you have a certified quality management system in your business is one of the most powerful arguments for achieving certification. Having an independent third party verify your organisations processes sends a strong message to clients and prospective clients that you mean business and will deliver time after time.


It aids the repeatability of processes

Having standardised ways of working is essential when you are looking to provide the same quality of service or product time after time. Avoiding variation is essential in any organisation, particularly when you are either looking to scale up or are already at a good size. Standardisation should occur to the level that is beneficial. Where creativity or flexibility is a key element, this should be recognised by writing processes that allow room for creativity but still define inputs and outputs.


It is an enabler of scalability

If you are looking to grow the business, at some point it becomes essential to start documenting how processes work. ISO 9001 gives a framework for this, and helps you to think about both the key operational processes that generate your product and service, but also the critical support processes like HR and supplier management.


It can help you save money

Running a good quality management system does require financial outlay, however if implemented correctly your business will make a net saving. A quality management system ensures that you have competent staff to do the work, defined processes to prevent errors and a framework in place to catch errors when they do occur and prevent them occurring again. We have seen a good quality management system reduce costs associated with errors by over £100,000 in a business with a turnover of £10m.


It's the basis for creating a quality culture

The process of implementing and maintaining a good quality management system will engage all staff. It is easy to overlook the significant impact that a workforce united to producing quality work can have. If every member of your team takes accountability for their work and actively looks for ways to improve how things are done, the ability of your business to learn and improve will set it above and beyond the reach of your competitors.



How is the standard structured?

When you first look at the standard, the layout and terminology can be confusing. However, as you understand further how the ISO 9001 standard is structured the logic starts to appear.


The 10 Clauses

The ISO 9001:2015 standard is written around 10 clauses. Of the ten clauses, it is clauses 4-10 that are audited. Clause 1-3 are used to set the scene of the standard but are less important when it comes to your ISO 9001 implementation.


Clause 4 - Context of the Organisation

Your organisation must identify, monitor and review external and internal issues that are relevant to your business and its strategic direction, especially those that will impact quality. You can use tools like PESTLESWOT and Porter's 5 Forces to consider all the factors shaping your business. You should document your findings and review them regularly. This clause also asks you to document all the interested parties who have needs and expectations of your business. Finally, this is the clause that suggests that you should have documented processes and procedures. How you document these processes and procedures is up to you, however typical ways include swimlane diagrams, turtle diagrams, standard operating procedures, or simply writing down how each process in your business occurs.


Clause 5 - Leadership

Leadership involvement is a critical component in making a quality management system work, and for this reason the standard makes it a requirement. Leadership are required to create your Quality Policy, set quality objectives, be present in the quality reviews and communicate the importance of quality throughout the organisation. Some of the ways leaders are involved will be tangible, e.g. the writing of the quality policy, but in other ways their involvement will be intangible, e.g. by acting in a way that positively promotes a quality culture.


Clause 6 - Planning

In Clause 6 of ISO 9001:2015 you need to demonstrate that actions to ensure quality are planned and do not occur by chance. The standard asks you to document the major risks facing your organisation and any business opportunities you believe that you have. These risks & opportunities should be linked to the contextual issues and expectations of your interested parties (Clause 4). This clause also requires you to set and document quality objectives, and to have a way to plan for changes in your business that may impact the quality of your output.


Clause 7 - Support

This section of the standard is about all the pieces of a management system that act like the oil, allowing everything else to run smoothly. We are talking about making sure you have the right people in place, the right infrastructure (physical and digital), a good working environment and sufficient knowledge (both individual knowledge and organisational). You are also required to have a way to monitor how well your organisation and the processes are working, e.g. with KPIs. If you have machinery or equipment that needs to be calibrated this also needs to be done regularly and documented.


Clause 8 - Operations

This is both the longest clause in the standard and the clause which can be the hardest to neatly define. It requires your organisation to carry out your operations in a controlled manner, applying the factors you have identified in clauses 4 to 7. You need to consider aspects such as; how you communicate with customers; determining the customer and legal requirements for your products and services; how you design and develop a product and service; how you control suppliers; how you follow up after delivering products and services; and what you do if there are issues during production, delivery or use. Evidencing this clause to an assessor is usually done through a walk through your workspace, observation of a job or project from end-to-end and interviews with staff.


Clause 9 - Performance evaluation

There are three main components of performance evaluation. Firstly you will need to demonstrate how you get feedback from customers and ideally have a way of documenting this feedback. Secondly is the important business of internal auditing - you will need to demonstrate that you regularly audit all the key components of the management system to review performance. Lastly, you will need to hold periodic 'management reviews' in which the person responsible for the daily running of the management systems reports back to the leadership team against a set agenda.


Clause 10 - Improvement

The key mechanism for continual improvement is a 'nonconformance process'. Although this sounds a bit foreboding, it is actually a constructive way to review your systems when something goes wrong and address the root cause of the issue. It is not about finding fault with individuals, rather the focus is on understanding why a process has broken down. The other half of improvement is the general way in which your business continually improves how it operates, either through small incremental changes or larger step changes.



Need more guidance?

Our experienced consultants are available to support you through the process. We can help you perform a gap analysis to understand where your strengths and weaknesses are, host educational sessions to talk you through the requirements of the standard or help you with a full implementation.

How do your customers benefit?

  • Gain confidence that you will deliver to specification time after time

  • Streamline their own due diligence & tender process if you are certified

  • Will receive goods and services which are continually improved

How does your company benefit?

  • Streamlined tendering processes and point of competitive advantage

  • Cost savings from reduced wastage and returns by getting it right first time

  • Sense of pride that you run your business to international best practice

What are the key components of a QMS?

  • An analysis of the internal and external issues that can impact your business

  • A well utilised risk management process

  • Documented and communicated business processes

  • A well deployed process for training staff

  • Utilisation of well chosen indicators (KPIs) to monitor business performance

  • A process for managing the relationship with suppliers

  • A process for addressing errors, complaints and unexpected circumstances

  • Consistent approach to calibration and equipment maintenance

  • Checks on product output/service delivery to check you have met your product & customer requirements

  • Internal audits to check processes are working as intended

  • Documented management meetings to make key quality and business decisions


ISO 9001 is based upon a 'Plan-Do-Check-Act' Cycle to drive continual improvements

Three important aims of ISO 9001

Continual improvement

  • Empower your team to continually participate in improving operations
  • Utilise well-chosen objectives to bring about step-change improvements
  • Reframe undesirable situations to become learning opportunities

Process approach

  • Understand and optimise every customer touch point
  • Prioritise the planning of your organisation's processes and how they interconnect
  • Standardise procedures to boost efficiency and beat your competitors

Customer focus

  • Proactively engage with your customers to learn how they feel about your organisation
  • Use this knowledge to improve your systems in the most impactful way
  • Continually review the needs and expectations of clients and adjust your product or service

What does it take to be successful?

Here are what we consider to be the key ingredients to make a really strong quality management system. It is also important to recognise that ISO is a journey and no company will have a perfect system in the first few years. It takes learning and continual improvement to embed quality in the business:


Senior manager involvement

Senior management must be involved to give legitimacy to the quality system, ensure the team buy in & provide the resources needed


Engagement of staff

Staff should be asked to help write the processes in the first instance and then be actively approached to make suggestions for improvements as the system matures


Thirst for continual improvement

Ideally the whole organisation, or at least a number of influential members must have a real desire to push the business to continually improve, learning from mistakes and seeking suggestions from all team members for improvements


Consistency & discipline

A QMS should not be a consideration once a year just before the auditors come in - instead work should be carried out on the management system little and often (e.g. spreading the internal audits throughout the year; or arranging quarterly quality meetings)


Collaboration with suppliers

The role suppliers play in your success shouldn't be underestimated - the best companies develop strong mutually beneficial relationships with suppliers and speak regularly with them to see how both parties can make improvements to their relationship

How does the certification process work?

The certification process can be confusing when you first research it.

Here, we will throw light on how the process works.


Case Study view all

Meet a Consultant view all

Lucy Trimmer
Management Systems Consultant
Lucy Trimmer

Frequently asked question view all

How much does ISO certification cost?

At 2SB our implementation costs are calculated by the number of days the implementation will take, and are based on the number of standards which you wish to implement at the same time.

The first part of the process is for us to understand how much you already have in place. Once contacted, we will ask a few key questions to understand your business before creating a proposal outlining costs and timeframes. Costs can range from £3000 to around £10000 depending on the size of your organisation, how many standards you require, the complexity of your processes and the amount of internal resource you can allocate.

In addition to consultancy costs there are the costs of certification. These are calculated on a daily rate by the Certification Body and depend on the size of your organisation, the complexity of your activities and the number of standards you want certified.

In order to remain certified you will have to pay for annual surveillance visits as well as every third year for the costs of recertification. Costs from a certification body can vary from around £800 upwards per day.

Contact an ISO Consultant