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 companys 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),
a quality manual of some sort, in any form or medium, but one that ensures effective
planning, operation and control of its processes.
quality objectives (see below),
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.
The first of these is control of those documents that are generated; this centres mainly around
ensuring the correct use of the right docs. 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. This will involve communicating the importance of
determining and meeting customer requirements with the aim of enhancing customer
satisfaction. Other expectations of top management are as follows:
Quality policy establishing, communicating and reviewing a quality policy that commits to
complying with the QMS requirements and continually improving performance. The policy
also provides a framework for establishing and reviewing quality objectives.
Quality objectives - ensuring that quality objectives are established at relevant functions
and levels within the organisation.
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.
Responsibility and authority - ensuring that responsibilities and authorities are defined
and communicated within the organisation
Management representative - appointing a member of the organisations management as
the custodian of the QMS.
Communication - ensuring that appropriate internal and external communication
processes are established within the organisation
Management Review comprehensively reviewing the organisation's quality management
system, at planned intervals, to ensure its continuing suitability, adequacy and
effectiveness. Done correctly, they represent a major and powerful improvement process.
Resource management
The organisation shall determine and provide the resources needed
and improve the QMS and enhance customer satisfaction.
to implement, maintain
Human resources
Determining and demonstrating the competence of all personnel is another fundamental ISO
principle.
Infrastructure
The organisation shall maintain the infrastructure and environment needed to achieve
conformity to product requirements.
Product/service realisation and provision
The organisation shall plan and develop the processes needed for product/service
realisation, for example: quality requirements; determining, reviewing and meeting
customer requirements; resources required; control of core business activities; support
activities; provision, maintenance and calibration of appropriate equipment; customer
communications; inspection and test activities; approval and handover; record keeping.
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, b) the review, verification and validation that are
appropriate to each design and development stage, and c) the responsibilities and authorities
for design and development.
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. The adequacy of specified purchase
requirements needs to be established and demonstrated so that purchased items conforms to
specified purchase requirements. Alongside these requirements, is the need to evaluate and
select suppliers and subcontractors based on their ability to supply what the organisation
requires.
Monitoring and improvement
The organisation shall plan and implement the monitoring and improvement processes to
demonstrate the performance of the quality management system, ensure conformity of the
quality management system, and to continually improve the effectiveness of the quality
management system. One of the measurements shall monitor information relating to
customer perception as to whether the organisation has met customer requirements
(customer satisfaction and feedback).
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; and b) is effectively implemented and
maintained.
This represents a major improvement opportunity. A documented procedure, the third
mandatory procedure, shall be established to define the responsibilities and requirements for
planning and conducting audits, establishing records and reporting results.
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. When non-conformances, or things that have gone wrong are discovered at, for
example, 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.
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. 9001 expects an
organisation to continually improve the effectiveness of the quality management system
through its policy, quality objectives, monitoring, internal audits and management review.
Acknowledgement: This information has been provided by Andrew Foy, Foy Certification Ltd
www.foycertification.com
