ISO 9001 version 2008 The Origins of ISO 9001:2008 BS EN ISO 9001:2008, to give it its full title, is an internationally recognised standard for quality management systems requirements, formerly know as BS 5750. During the First World War it was noted that some munitions were particularly unreliable. This meant that not only were they ineffective, but also in some cases, they caused loss of life to those attempting to deploy them. This lead to the development of a defence standard for the management of quality in the production of munitions. Over the following 60 years this standard evolved into BS 5750, which was widely adopted by industry (both commercial and military). In a move towards the globalisation of standards, BS 5750 was combined with international standards and evolved into BS EN ISO 9000 in 1987. Recognition for the need of quality management systems in all areas of business (i.e. service industries as well as the traditional manufacturing sector) throughout the 1990's lead to the demands on the standard (ISO 9000 series) changing. Because it had its roots in the manufacturing industry, it was difficult for other industries (the service sector in particular) to adopt the standard. In the year 2000 this was addressed in the most significant ame ndment to ISO 9001 since its inception. It re-evaluated the principles of quality management and the result was a restructuring of the standard. The most recent review of the standard was published in 2008, but this revision was not a major change. The principles of ISO 9001:2008 There are eight management principles that underpin the standard. These are all recognised principles of good management and ISO 9001 brings them together to form the model for a robust and effective management system. The principles are: Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships When developing any element of a management system each of these principles needs to be considered. What is require d The 2008 version of the standard adopts a business process management approach. Only four core elements now exist in the standard and these apply equally to any business process whether engaged in the manufacturing or service industries.. These elements are: Management responsibilities Resource management Product realisation Measurement, analysis and improvement In summary, this means that the standard requires that your management systems cover the following issues: 1. Management responsibilities The roles and responsibilities of management and staff need to be clearly defined and understood. This includes an understanding of the structure of the organisation and how the groups within it interrelate. This enables adequate planning, objective setting and effective management of the organisation. 2. Resource manage ment Adequate resources (including human resources) need to be made available and managed to ensure the implementation of a quality management system. These include: Providing methods for identifying the level of resource required for key tasks and functions. Understanding the knowledge and skills required to effectively manage the business, both now and in the future. 3. Product realisation These are the controls employed to ensure that any product or service delivered to the customer meets their requirements. These include the traditional controls for manufacturing and the definition of customer requirements for services. This will usually form the largest part of a management system and will identify how the organisation controls its business from identifying customer requirements, through contract review, planning and execution of the tasks that deliver the product or service to the customer. These controls will contain a definition of the checks and balances that are in place to ensure that each stage of the process achieves what is required to deliver satisfaction to the customer. 4. Measure ment, analysis and improve ment For the effectiveness of any management system to be monitored it is necessary to measure its performance. The need to continually improve is now integral to ISO 9001. Gaining third party ce rtification ISO 9001:2008 provides an internationally recognised model for quality management systems. There are many tangible benefits to adopting the ISO 9001 model. These include improvements to organisation effectiveness, efficiency and the continual improvement of the business. Gaining third party certification can also bring benefits. It allows you to demonstrate to your customers and potential customers that you are a well organised, capable supplier who provides consistently high levels of custo mer satisfaction and operates best practice in business management. Certification means using an accredited independent third party to objectively assess your management system to certify that it complies with the standard. It is achieved by having an independent third party assessor audit your management system. There are a number of certification companies in the UK and worldwide who provide this service. In the UK these assessment bodies are regulated by the United Kingdom Accreditation Service (UKAS http://www.ukas.com ). This organisation provides the assessment bodies with an accreditation service that regulates the process and provides the industry with assurance that consistent standards are applied. Any organisation can issue a certificate that claims compliance with the standard but this only has independent credibility in the UK if the issuing authority is a UKAS accredited body. The process of certification typically takes the form of a pre-assessment followed by an initial assessment that is maintained by ongoing periodic surveillance audits. Pre-assessment - takes place 3 to 6 months after the management system has been established. This allows time for records to be generated as evidence of the operation of the system. The pre-assessment allows the assessment body assessor to familiarise themselves with the system and identify any major omissions in the system before the assessment. Time Period - usually 6-12 weeks between the pre-assessment and initial assessment to allow amendments to the system to be completed and implemented. Initial assessment - formal assessment of the management system against the standard. This involves an examination of the documentation that forms the management system plus an assessment of the evidence gathered. This demonstrates that the documented system is working in practice. Initial assessment process - involves interviewing a number of managers and staff. An assessment is carried out on a sample basis, so not all records will be examined and not all staff will be interviewed. When issued, a certificate is only valid for a limited period of time and can be removed or cancelled by the certification company at any time. A certificate is normally valid for three years. Maintenance of certificate - the certification body re-visits and carries out surveillance audits to ensure standards are maintained. These are typically conducted every 6-9 months, dependent upon the size and complexity of the business under assessment. Where an initial assessment will need to evaluate the entire system, a surveillance audit is likely to be of more limited scope and will sample areas of the system in rotation. Over the 3- year period it is necessary for the certification body to have re-visited all areas of the system. Renewal of certificate - a full reassessment of the system is required after three years. A copy of the standard can be obtained from the International Organisation for Standardisation (ISO) or British Standards Institute (BSI). Certification services are offered by a large number of companies worldwide. A full list is available from UKAS. What to do next If you are considering implementing ISO 9001:2008 or are simply looking to develop a quality management system and think you may need help and advice, please contact The Quality Team today for an informal no obligation chat.