ISO 9001 Quality Management How it works

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1 ISO 9001 Quality Management How it works raising standards worldwide

2 Some background What is ISO 9001? ISO 9001 is the world s most popular quality management system standard. It covers how organizations should manage their activities to be as efficient as possible, and it concentrates on what organizations should do to make sure that their customers requirements are met consistently. Why use this standard? ISO 9001 saves and makes you money. There is a great deal of evidence to show that ISO 9001 helps organizations improve customer satisfaction, reduce costs and operate more efficiently with more involved and motivated staff. Also companies can attract new business because a lot of organizations look for ISO 9001 certification as evidence that their suppliers are well-run companies. Additionally, most organizations are interested in growing. ISO 9001 puts robust structures in place to manage how everything is done, and strip out wasted effort. This gives managers more time to invest in making money. BSI Quality ROI Calculator showing the financial benefits of ISO 9001 certification ISO 9001 can help you save and make money and BSI s new, unique and free Return on Investment (ROI) calculator can show you how. The tool is based on the findings of independent academic research which shows that organizations with ISO 9001 certification financially outperform those without. Such financial benefits are supported by the experiences of thousands of BSI s customers. The tool enables you to compare the cost of certification with the financial benefits you could expect from it. Support your business case for investing in ISO Request a FREE ROI calculation from BSI. Call now. 2

3 Understanding the basics ISO 9001 has been designed so that it can be used by any organization, large or small, whatever its products or services. Here we explain some of the basics. Management systems A management system is simply the way an organization manages it processes, people and other resources so that its products or services meet organizational objectives and customer requirements. For example, your objective may be to satisfy your customers quality requirements; or to comply with statutory regulations; or to achieve specific turnover or productivity targets. A management system is usually a combination of policies, processes, procedures, training, forms and records that enable your business to operate effectively to meet its objectives. The ISO 9001 standard ISO 9001 provides a set of requirements to be met when you set-up and operate a quality management system. These requirements constitute international best practice for managing quality. Plan Do Check Act The Plan-Do-Check-Act (PDCA) cycle is the operating principle of all ISO management system standards. By following this cycle, you can manage and continually improve your organization s effectiveness. Plan establish objectives and make plans (analyse your organization s situation, establish overall objectives, set interim targets and develop plans to achieve them). Do implement your plans. Check measure/monitor your actual results against planned objectives. Act correct and improve your plans to get better results. Whether you are the managing director setting the direction of the business, or an individual carrying out a specific task, the PDCA cycle is very useful in achieving continual improvement. The requirements are a distillation of all the best ideas from hundreds of experts and users for more than 30 years. The standard is very well tried and tested and regularly updated. How organizations meet the requirements is entirely up to them, depending on what works best for the individual company. 3

4 The principles behind ISO 9001 ISO 9001 is built around eight management principles that guide and inform everything in it. They are: Customer focus You need to understand current and future customer needs. You should meet customer requirements and strive to exceed customer expectations. Leadership Leaders establish unity of purpose and the direction of the organization. Leaders should create and maintain an environment where people can become fully involved in achieving the organization's objectives. Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. System approach to management When you identify, understand and manage interrelated processes as a system, it contributes to the organization's effectiveness and efficiency in achieving its objectives. Continual improvement Continually improving your organization's overall performance should be a permanent objective. Factual approach to decision making Effective decisions are based on the analysis of data and information. Mutually beneficial supplier relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. Process approach Your desired result is achieved more efficiently when activities and related resources are managed as a process. 4

5 ISO 9001 in more detail Plan management responsibility This part of ISO 9001 gives management a powerful planning tool. The starting point is for managers to show commitment to the successful operation of the management system through being involved. The individual requirements take managers through the following sequence of activities: Customer focus. Find out what the customer s current and future needs and expectations are at a strategic level. How you do this is up to you. Quality policy. Use the information gathered from the customer to write a quality policy that is relevant to the purpose of your organization. Objectives. Establish measurable objectives for the organization to help you achieve the aims of the quality policy. Plan the system. Allocate responsibilities and establish effective processes to achieve your objectives. Review the operation of the system at regular intervals. Improve it where necessary. Ensure appropriate resources are provided. CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM MANAGEMENT RESPONSIBILITY CUSTOMERS CUSTOMERS RESOURCE MANAGEMENT MEASUREMENT, ANALYSIS AND IMPROVEMENT SATISFACTION REQUIREMENTS INPUT PRODUCT REALIZATION PRODUCT OUTPUT Quality Management System Model reproduced with permission from ISO 5

6 ISO 9001 in more detail Plan resource management The resource management part of the standard makes sure that you review and provide the resources needed to implement and improve the system. Resources are looked at in three ways: people, infrastructure and work environment. People Decide the competencies and skills needed within the organization. Infrastructure This involves the facilities and equipment you need to perform effectively. Start by determining and providing what is needed. Review this regularly. Work Environment Here you look at the conditions under which work is performed and ensure that this is appropriate for meeting customer s requirements. Again, review this regularly. Then look at the people that you have and identify gaps in existing competencies. Fill those gaps by providing training and coaching or encouraging self-learning. Review how effective the actions taken have been in helping you achieve the required competancies for the business. Through these techniques you always know whether the training you provide is actually adding value to the organization and contributing to results. 6

7 ISO 9001 in more detail Do product or service realization You now have the commitment and direction from management and the necessary resources to do the job. ISO 9001 goes on to give you a set of requirements for managing the work you do. Start with planning. Plan the journey from the point where the customer asks for something, right through to delivery (and beyond if necessary). Typically this involves defining the processes for: Don t worry if some of the topics here do not relate to you. Remember, ISO 9001 is designed to be used by all types of organizations. You simply concentrate on the areas relevant to you. Make sure at each stage that people understand their role and are competent to carry out tasks in line with business policies, procedures and objectives. Sales Design and development Purchasing Production / operational / service activities Delivery 7

8 ISO 9001 in more detail Check and act measurement analysis and improvement Don t stop once you deliver to the customer. Go on to find out whether the customer is satisfied. Take other measurements of the system s performance, analyse these and identify the areas for improvement. Again, the standard provides you with a set of requirements for achieving this using tried and tested techniques. Customer satisfaction This involves the monitoring of customer perception. It does not mean that you have to send questionnaires to your customers. There are many different ways of monitoring perception. You can use methods relevant to your business. Analysis of data Using the standard effectively will produce data on how effective your systems are. Use the data to find improvements. Continual improvement One of the key objectives of ISO 9001is to make sure that your organization improves. Using the results of the analysis will help you to determine where those improvements can be made. Internal audit Conduct reviews of your system to make sure that things are going to plan. Monitoring and measurement of products and processes Individual processes drive the system and it s important that they are operating effectively and efficiently. Products should also be measured and monitored to ensure that you are meeting the customer s requirements. Control of non-conforming products If something goes wrong, procedures should be in place to ensure that the problem is controlled and dealt with appropriately. 8

9 Ten tips on making ISO 9001 effective for you Top management commitment is vital if the system is to be implemented successfully. Make sure senior managers are actively involved, approve resources and agree the key processes in the business. 6 Clearly lay out a well-communicated plan of activities and timescales. Make sure everybody understands them and their role in achieving them Look at what systems, policies, procedures and processes you have in place at the moment. Then compare those with what ISO 9001 asks for. You may be surprised at how much you already do. ISO 9001 will allow you to keep the things that work for you while refining those that don t. 3 Make sure you have good internal communication channels and processes within the organization. Staff need to be involved and kept informed of what s going on. 4 Give some thought to how departments work together. It s important that the people within your organization don t work in isolation but work as a team for the benefit of the customers and the organization. 5 Don t ignore the impact that introducing these systems will have on your customers and suppliers. Speak to them to gain insight as to how they view your service and how they feel improvements could be made The nature and complexity of your documentation will depend on the nature and complexity of your organization. ISO 9001 only defines the need for six procedures. What you have in addition to this is up to you. Consider using your IT systems or software such as BSI s Entropy Software to manage your system and documentation more efficiently. 8 Make the achievement of ISO 9001 engaging and fun. Use competitions, such as for the first completed process. These will increase motivation. 9 Train your staff to carry out audits of the system. Auditing can help with an individual s development and understanding as well as providing valuable feedback on potential problems and opportunities for improvement. 10 And finally, if you feel that you are doing something just for the sake of ISO 9001 and it doesn t add any value to you as a business, question whether it s necessary. Nine times out of ten it won t be needed. 9

10 The key steps in getting certified to ISO Make contact Get in touch and tell us what you need, so that we can sort out the best services for you. We ll then give you a proposal detailing the cost and time involved. 2. Complete BSI s application form We ll assign you a Client Manager, who will be your point of contact through the process and beyond. They ll have an excellent understanding of your business area and will support you as you move forward to the assessment and certification of your quality management system. 3. Consider training Whether you re seeking to implement a quality management system or would like to increase your general awareness of ISO 9001, there are a range of workshops, seminars and training courses available. 4. Gap analysis We can carry out an optional gap analysis, also called a Pre-Assessment, of your existing management system against the requirements of the standard and identify any omissions or weaknesses that need resolving before formal assessment. 5. Formal assessment We ll do a two-stage assessment. First a desktop review of your management system against ISO 9001 identifying any omissions or weaknesses that need resolving before Stage 2 when we ll conduct a full on-site assessment. 6. Certification and beyond Once the assessment has been successfully completed, we ll issue a certificate of registration, clearly explaining the scope of your management system. The certificate is valid for three years, and your assessor will visit you regularly to help you make sure that you remain compliant, and support you in the continual improvement of your systems. 10

11 BSI supporting you every step of the way BSI keeps you informed BSI s publications draw on a wealth of expert knowledge from across industry. They are particularly useful when you are getting started. Standards and publications can be purchased individually, as a kit, or as part of an annual subscription. Key ISO 9000 standards and publications are: ISO 9000 describes the fundamentals of quality management and defines terms used in the ISO 9000 quality management family of standards. ISO 9001 is the core document. It specifies the requirements for a quality management system. ISO 9004 provides guidance to organizations to support achieving sustained success with a quality management approach. BIP 2013 understanding ISO 9001 and process-based management systems. BIP 2014 creating a process-based management system for ISO 9001 These standards and publications are available from our online shop at Fast forward with BSI training BSI has a comprehensive range of ISO 9001 training courses. Our introductory courses broaden general awareness of customer-focused business practice, and our implementation and auditing courses take that knowledge further to drive change within your organization. Our training comes in a number of formats including open schedule courses, in-company training, elearning modules and distance learning qualifications. Visit or call for details. Manage information with Entropy Software BSI s Entropy Software system is used by leading companies at over 14,000 sites around the world to improve their business performance and manage their risks. For further information please visit call or info.entropy@bsigroup.com. Show you meet the standard with certification Independent assessment by BSI will assure you and your key stakeholders that your quality management system meets the requirements of ISO Before the formal certification assessments, BSI can perform a gap-analysis (a review of what you do compared with the standard s requirements) to help identify the areas that need to be tackled to achieve certification smoothly. You can also use our online Self-Assessment Tool. When your certification has been awarded by BSI you have a market differentiator that is recognized worldwide. BSI also works with you to promote your achievement. For more information visit or call now to start your journey to be a more successful business. From beginners through to advanced users, BSI has a broad range of Quality solutions - ROI Calculator - Assessment - Certification QUALITY MANAGEMENT BEST PRACTICE 11

12 Start your journey to a more successful business BSI/GM/52/0611/E/BG BSI PO Box 6221 Kitemark Court Davy Avenue Milton Keynes MK1 9EP T: +44 (0) F: +44 (0) E: certification.sales@bsigroup.com Copyright 2011 The British Standards Institution *BSI customers who reported cost savings from using ISO 9001 (Source: BSI Client Survey 2010) Financial benefits of ISO 9001 have been shown by BSI customer research and independent research papers published by Management Science; V. 51;Journal of Business & Economics Research; V. 6; International Journal of Quality and Reliability Management; V. 19; managent Science; V. 47; Accident Analysis & Prevention; V. 39 Journal of Operations Management; V. 24; Total Quality Management/University of Houston, Texas. The BSI certification mark can be used on your stationery, literature and vehicles when you have successfully achieved certification. raising standards worldwide BSI Group: Standards Information Software Training Inspection Testing Assessment Certification