“At the end of 2009, over one million certificates to ISO 9001 had been issued throughout 178 countries and economies.”
In this current economic climate one of the key issues in business survival is ensuring that we satisfy the needs of our customers and improve the products and services that we provide to them.
To achieve this, an organisation needs to adopt and utilise a management system to manage all the elements in the business and their interaction, elements such as policies, objectives human resources, processes, materials, equipment, etc.
There are a number of models and frameworks that you can use to develop and improve your management system. ISO 9001:2008 provides one of the most widely known and used model frameworks describing what an organisation should consider when planning and implementing the management system.
It describes activities and processes that are important to your business and how these should be collectively managed as a management system. It does not tell you how to run your organisation - because that is your business. It does however ask you to implement a management system to help you ensure your business consistently delivers what your customers expect.
Before going any further, it is worth reading the International Organization for Standardization (ISO) document: “Guidance on the Process Approach to quality management systems” (PDF Download) to get a feel for the main concepts of ISO 9001:2008. You can purchase a copy of the ISO 9001 Standard here (please note this will take you to an external website).
Also, it is becoming increasing important to manage systems in a sustainable manner to ensure the continued success of the business. ISO 9004:2009 provides guidance on how to manage the sustained success of an organisation utilising the Management System Approach.
This article provides some practical guidance and advice for those who have been tasked in gaining certification for their organisations and complements the article: ‘Implementing a management system – a consultant’s viewpoint.’ If you are starting to implement your management system, we would advise you to read both.
ISO 9001:2008 is based on 8 management principles. These are described in ISO 9000:2005 and are regarded as key elements in facilitating the achievement of an organisation’s quality objectives. These key themes should be very visible within the management system.
Organisations depend on their customers and therefore should understand current and future customer needs, should meet requirements and strive to exceed customer expectations.
Leaders establish unity of purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives.
People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit.
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Identifying, understanding and managing interrelated processes as a system contributes to the organisation’s effectiveness and efficiency in achieving its objectives.
Continual improvement of the organisation’s overall performance should be a permanent objective of the organisation.
Effective decisions are based on the analysis of data and information.
An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
“Forewarned, forearmed; to be prepared is half the victory.”
Miguel de Cervantes Saavedra, Spanish writer and author of Don Quixote (1547 - 1616).
Taking responsibility for your organisation’s management system is no easy task and a project through to certification is going to take a lot longer than a couple of weeks. Ensure your organisation plans for, and provides adequate resources (people) because it will not evolve by itself. It will also require the senior management to support and lead this project because it will affect the work of your whole organisation
If you are still feeling a little unsure how to approach the implementation, talk to others in your industry’s and trade associations to explore how they approached the project and how much work was involved. Also, think about attending an LRQA one-day awareness training event where you will be able to talk to other people implementing management systems and talk through aspects of the process with your tutor.
To help you in planning your project, we have developed an implementation planner defining the typical key stages and activities leading to your certification.
Firstly, you should identify the basic processes of your management system, such as:
At no point in the implementation of a management system based on ISO 9001:2000 will it ask you to do anything that will not benefit your business, because every decision of how to implement the management system arrangements is yours.
The system should be appropriate to your needs and right for your people, work environment, industry norms, etc. The focus is on implementing a system to help you consistently deliver products and services to meet your customer’s needs and expectations and to review and improve the performance of these working practices.
The best place to start is to understand what you already do as an organisation and how work happens in a systematic way, find out how your organisation carries out the following:
A good way to do this is to think about workflows in your organisation. How do the core processes flow in logical/chronological sequence, what are the sub-processes within them and how the support processes and their sub processes link-in.
One tried and tested technique is to capture this information using process maps and/or flowcharts ensuring you use the terms and language of your organisation to describe what happens where. Another technique is to use a large clear wall and a pack of sticky notes. Write on the sticky those activities that happen in your organisation and then organise the notes into logical chains of events. Make sure you capture the work you have done for later use;, standard Microsoft packages have the capability to help you here. You do not need special software.
Involve other people in this process - if you have done it yourself let other people see it. Consider and incorporate their comments to make sure it is a true representation of what happens.
Now, take a copy of your process map and write on the clauses of ISO 9001 to identify which areas of your organisation relate to the requirements contained in ISO 9001. Do not worry about the detail at this stage - this comes next.
If there is a requirement in ISO 9001:2008 that you have not covered, you will now have to think about where and how your organisation will address this. Remember ISO 9001:2008 is based on proven good management practices and how you address the requirement should provide benefit for your organisation. You should never find your organisation having to do something only because you believe the standard asks you to.
One of the most significant problems third party assessors encounter when auditing, is that the knowledge and ownership of the management system is not shared throughout the organisation.
One of the biggest issues you can create is trying to do everything yourself without telling your colleagues what’s going on. Set up a project team to help plan the project, complete project tasks and review progress.
Make sure that your senior managers are aware of their role and responsibilities, what is expected of them now and in the future. Ensure you plan in review meetings – either, for example a monthly meeting - or at key stages of your plan with the senior management team.
Ensure you plan to educate all people in your organisation. Even better, get senior managers involved in doing this, to make people aware of why your organisation is doing this and why it is important. Keep all people involved wherever possible with the development of systems.
When writing procedures, use the experience and expertise of those actually carrying out the tasks to help inform the content and format. People who carry out tasks on a regular basis often know best but they may not know the importance or impact of what they do further down the process.
Keep people informed of the progress of the project - what’s done, what’s next and how the project is progressing against plan. Make this process transparent and visible to all concerned – for example, progress charts on the walls and notice boards. Remember, this is the organisation’s project not yours.
For all the processes you have identified in your organisation you need to determine the activities involved, who does what (responsibilities) and what resources are required in respect of people and equipment. Also what controls are in place to ensure that work is carried out in a planned way and the required output is achieved (measurement and analysis).
Identify who is the best person to define the management system requirements and arrangements. If the procedures are written by people who are not directly involved in the process, ensure that people directly involved have an opportunity to comment and review before the procedures are implemented. If this is not done, it can lead to non acceptance and even rejection.
How much documentation you need is up to you. Remember the forms you currently use are also part of the system documentation. Avoid including the obvious unless you consider it important and avoid duplication. It is important that the documentation reflects and controls what you currently do.
It is often best to implement those parts of the system as they are ready, rather than head towards a big launch date. This helps people accept the system as part of their day to day working rather than a new initiative starting on a specific date.
It is important for your organisation to understand how well the system is working and what your customers think about the products and services you provide.
Your management system is your planned approach for how work in your organisation is carried out. You need confidence that people are continuing to implement the system as planned to ensure the best possible chance of satisfying your customers. Therefore, you need to review on a regular basis, how well the system is implemented. The most common way to do this is to conduct what are called internal audits.
The LRQA Internal QMS Auditor course is an ideal training event for anyone required to perform internal quality audits.
View the course page for more information.
Internal audits are planned reviews of areas of your organisation to assess the compliant and effective implementation of your management system. It’s important that the people you choose to carry out these audits have a good understanding of what should happen and good overall knowledge of your organisation.
You also need to plan what information you will monitor to understand how well the system is performing and who will review this information. Typically information reviewed relates to:
Regular meetings often review information such as this. It is often beneficial to map out what these meetings cover and how this relates to the management system.
Top management have a critical role to play in all organisations. In respect of management sysstems, top management’s role is to review how well it is supporting the business in achieving its overall objectives. Typically, this requires performance information to be gathered and reviewed against the organisation’s policies and objectives.
Conducted on a regular basis, which is dependant on business needs, development and changes. It is recommended that they look at the longer term (strategic view) rather than the day to day specific activities. The purpose of this review is to establish whether or not the system is really supporting and helping the delivery of the required products and services. Such reviews are often combined with reviews of performance against business and operating plans.
One of the main outcomes from this meeting is to look at what needs to be changed and how the change will happen.
Key questions that need to be asked at this stage include:
Not all certification bodies are made the same. When selecting the body you want to work with ensure they are accredited by a national body. In the UK, this is the United Kingdom Accreditation Service.
Visit UKAS website for further information on accreditation.
Certification is an external validation of your quality management system, to ensure that it meets the requirements of the internationally recognised, quality management system standard: ISO 9001:2008.
For more information on ISO 9001 visit the ISO website.
Your choice of certification body says a lot to your customers about how seriously you take management systems. You need to choose a certification body that can help you develop your management system to realise its potential. With LRQA you will be allocated an account manager - or business advisor if on the small business’ scheme - who will discuss the best way to approach certification for you.
All LRQA assessors go through a rigorous selection and training programme followed by continual professional development and are all registered Lead Auditors with IRCA, (International Register of Certificated Auditors) the UK’s premier auditor registration body, providing you with the best the certification industry has to offer.
This gives you the assurance that by choosing LRQA as your certification body you will get a thorough but fair assessment supporting the ongoing development of your management system. In addition, as the LRQA brand is recognised globally, it will provide purchasers – wherever in the world they are based - with the confidence that your management system meets the requirements of ISO 9001.
For UK based organisations employing less than 30 employees, LRQA can also offer you the option of our Small Business Scheme allowing you the option of monthly direct debit payments to aid cash flow.
Since 1985, we have been designing our services with you in mind. This means we take your individual needs and requirements into account when shaping our service offer. Also our complementary support package has been developed to help you make the most from your management systems and includes:
For information on gaining ISO 9001 certification with LRQA, visit our ISO 9001 information page.
LRQA also provide a number of engaging and informative courses, in respect of developing implementing, auditing, managing and improving your quality management system. Visit the training section to learn more.
To learn more about LRQA products and services, contact our business advisors on 0800 783 2179
Page last modified on 07 February 2007
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