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ISO 9001 Quality Management

This FactFile information sheet contains information on the requirements of the
International Standard ISO 9001:2008 which sets out the criteria for a quality management
system (QMS) and can be used by any organisation, large or small, regardless of its field of
activity.
Overview
The standard is based on a number of quality management principles which any business must
address to perform well, including a strong customer focus, the motivation and involvement of
top management, and continual improvement.
This International Standard can be used by internal and external parties, including
certification bodies, to assess the organisation's ability to meet customer, statutory and
regulatory requirements applicable to the product, and the organisation's own
requirements.
Implementing ISO 9001 ensures that customers get consistent, good quality products and
services, which is why main contractors and local authorities use it as a pre-qualification tool,
and which in turn brings many business benefits. AIS members, who secure independent UKAS
accredited certification to ISO 9001 can provide that customer assurance. Any business serious
about enhancing customer satisfaction can achieve 9001 rapidly and cost-effectively.
The ISO conducted 42 scientific studies showing that implementing 9001 enhances financial
performance (mainly through increased sales). Importantly however, organisations aiming at
real internal quality improvements gain more than those using ISO 9001 as a ‘quick fix’ in
response to quality problems or customer pressure.
Those aiming at real quality improvement could expect to achieve higher overall benefits.
Internalisation of ISO 9001 principles is considered necessary in achieving the most significant
performance benefits from the QMS standard.
The adoption of a quality management system should therefore be a strategic decision of an
organisation – aimed at real quality improvements that demonstrate consistent service aimed
at meeting customer requirements, and enhancing customer satisfaction.
It is not the intent of ISO 9001 imply uniformity in the structure of quality management
systems or uniformity of documentation. It is of utmost importance that 9001 is
implemented in a manner appropriate to the organisation in hand.
The Requirements of ISO 9001 in relation to a company’s Quality Management System
(QMS)
General
First and foremost there needs to be a demonstrable QMS and the desire and capacity to
continually improve its effectiveness. This involves determining and implementing processes for
the QMS, ensuring they are effective, providing resources and information for monitoring and
analysing them and acting to achieve planned results and continual improvement (outsourcing
or sub-contracting processes is allowed as long as control is maintained).
Documentation requirements
Whilst it is not the intent of 9001 to generate a complex documented system there are of
course some required documents, namely:
a documented statement of a quality policy (see below),

they represent a major and powerful improvement process. Quality management system planning – ensuring that planning of quality management is carried out to meet customer requirements and achieve quality objectives and that the integrity of the QMS is maintained. communicating and reviewing a quality policy that commits to complying with the QMS requirements and continually improving performance. this centres mainly around ensuring the correct use of the right docs. Responsibility and authority . Done correctly. Quality objectives . to implement. The second mandatory procedure similarly relates to controlling records so that they are protected and readily identifiable and retrievable (for example O&M Manuals) Management responsibility and commitment A fundamental ISO principle is that top management shall provide evidence of its commitment to the development and implementation of the quality management system and to continually improving its effectiveness. to ensure its continuing suitability. Other expectations of top management are as follows: Quality policy – establishing. Communication .ensuring that quality objectives are established at relevant functions and levels within the organisation. Resource management The organisation shall determine and provide the resources needed and improve the QMS and enhance customer satisfaction. The first of these is control of those documents that are generated. Control of documents Contrary to popular belief there are only six mandatory documented procedures in ISO 9001 and these could be written on two sides of A4. maintain Human resources Determining and demonstrating the competence of all personnel is another fundamental ISO principle.appointing a member of the organisation’s management as the ‘custodian’ of the QMS. at planned intervals.ensuring that appropriate internal and external communication processes are established within the organisation Management Review – comprehensively reviewing the organisation's quality management system.a quality manual of some sort. in any form or medium. operation and control of its processes. This will involve communicating the importance of determining and meeting customer requirements with the aim of enhancing customer satisfaction. adequacy and effectiveness. but one that ensures effective planning. The policy also provides a framework for establishing and reviewing quality objectives.ensuring that responsibilities and authorities are defined and communicated within the organisation Management representative . Product/service realisation and provision The organisation shall plan and develop the processes needed for product/service . Infrastructure The organisation shall maintain the infrastructure and environment needed to achieve conformity to product requirements. quality objectives (see below).

Continual improvement is arguably the most important ISO principle of all and one of course that is impossible to argue with and leads to long-term business value. determining. The fourth mandatory documented procedure relates to what is called ‘dealing with nonconformity’ ie what arrangements the organisation has in place for when things go wrong. Internal audit ISO 9001 expects the organisation to conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements and to the requirements of 9001. internal audit then the fifth and sixth mandatory documented procedures come into play which are corrective action (action to put things right) and preventive action (action to stop them going wrong in the first place) respectively. customer communications. shall be established to define the responsibilities and requirements for planning and conducting audits. and b) is effectively implemented and maintained. The adequacy of specified purchase requirements needs to be established and demonstrated so that purchased items conforms to specified purchase requirements. record keeping. This represents a major improvement opportunity. reviewing and meeting customer requirements. verification and validation that are appropriate to each design and development stage. establishing records and reporting results. quality objectives. or things that have gone wrong are discovered at. and to continually improve the effectiveness of the quality management system. internal audits and management review. provision. approval and handover. for example. resources required. When non-conformances. Purchasing Procurement is clearly fundamental to construction operations so it is not surprising that 9001 has a lot to say about the need for effective purchasing.realisation. maintenance and calibration of appropriate equipment. A documented procedure. support activities. b) the review. control of core business activities. monitoring. ensure conformity of the quality management system. Design and development For those organisations that undertake design and development 9001 is prescriptive about controlling and managing design: a) the design and development stages advising on inputs and outputs and the control of changes. 9001 expects an organisation to continually improve the effectiveness of the quality management system through its policy.foycertification. Acknowledgement: This information has been provided by Andrew Foy. One of the measurements shall monitor information relating to customer perception as to whether the organisation has met customer requirements (customer satisfaction and feedback). for example: quality requirements. is the need to evaluate and select suppliers and subcontractors based on their ability to supply what the organisation requires. Foy Certification Ltd www. inspection and test activities. the third mandatory procedure. Alongside these requirements. Monitoring and improvement The organisation shall plan and implement the monitoring and improvement processes to demonstrate the performance of the quality management system.com . and c) the responsibilities and authorities for design and development.