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CLAUSE |
REQUIREMENTS |
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1.1 |
GENERAL |
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The standard is designed to apply to an organisation that
needs to consistently provide product that meets customer
and Regulatory requirements. It aims to "enhance" customer
satisfaction through the organisation's QMS and processes
for continual improvement. This emphasis differs with the
ISO 9001: 1994 standard which emphasises prevention and
aims to achieve customer satisfaction by preventing
non-conforming product. |
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1.2 |
Application |
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Exclusions are permitted within clause 7 provided such
exclusions do not affect the organisation's ability to
provide product that fulfils both customer and regulatory
requirements. |
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2 |
Normative references |
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Undated references to standards in ISO 9001: 2000 imply
the latest versions should be applied. |
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3 |
Terms and definitions |
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ISO 9000 is an applicable reference for terms and
definitions, the terms "Organisation" and "supplier" are
defined. |
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4 |
QUALITY MANAGEMENT SYSTEM |
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4.1 |
General requirements |
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The Quality Management System must focus on processes;
their interaction, control, resourcing, monitoring and
continual improvement. |
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4.2.1 |
Documentation, General |
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The Quality Management System documentation includes;
Quality Policy, Quality Objectives, Quality Manual,
Procedures, Documents for effective planning, operation
and control of processes and Quality Records. |
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4.2.2 |
Quality Manual |
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The Quality Manual must include a description of the
proposed scope and details of "exclusions" (exclusions are
limited to product realisation, i.e. Clause 7 only,
provided the exclusion does not affect the ability to meet
customer and regulatory requirements). The Quality Manual
must either include or reference documentation and must
provide a description of the processes and their
interaction, for example a business process overview. |
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4.2.3 |
Control of documents |
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Documents required by the Quality Management System must
be controlled as specified in the standard, these are
typically documents that describe products/services and
describe how to undertake the processes e.g. procedures
and support documentation. A documented procedure is
required for controlling such documents. |
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4.2.4 |
Control of quality records |
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Quality records are also documents used to record
information, these must be controlled as specified in the
standard and there must be a documented procedure as an
addition to the 4.2.3 requirements. |
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5 |
MANAGEMENT RESPONSIBILITY |
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5.1 |
Management commitment |
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Top management commitment to the development,
implementation and continual improvement of the Quality
Management System is required. Top management has specific
responsibilities to communicate customer and Regulatory
requirements within the organisation and for establishing
the Quality Policy, Quality Objectives, Management Reviews
and Resourcing requirements. |
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5.2 |
Customer focus |
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Determining customer requirements is a top management
responsibility with an aim at enhancing customer
satisfaction (Note: Clause 1.1 emphasis is not as final as
to "satisfy" customers because of the enhancement of the
"continual improvement" concept within the standard).
Customer focus is also intended as a proactive process
rather than just reacting to a sale or contract.
Understanding customer needs will involve marketing
activities. |
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5.3 |
Quality policy |
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The Quality Policy set by top management must include the
specific requirements that provide a framework to allow
appropriate quality objectives to be set. It is not to be
a "vision" statement. |
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5.4.1 |
Quality objectives |
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Quality objectives must be set by top management at all
functions and levels (including for individuals if
applicable). A link with the Quality Policy should be
clear and objectives must be measurable. |
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5.4.2 |
Quality management system planning |
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Top management planning activities for the QMS must be
consistent with 4.1, i.e. must focus on processes, and
ensure that integrity of the QMS is retained when changes
occur. |
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5.5.1 |
Responsibility and authority |
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Top management must define and communicate
responsibilities, authorities and their inter-relation for
the whole organisation. |
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5.5.2 |
Management representative |
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The management representative must have responsibility and
authority for the establishment, implementation and
maintenance of processes needed for the QMS, reporting to
top management on QMS performance and promotion of
awareness of customer requirements. |
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5.5.3 |
Internal communication |
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Appropriate internal communication processes must be
established including those related to the effectiveness
of the QMS. |
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5.6.1 |
Management review, general |
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Management review by top management will include assessing
opportunities for improvement and need for change of the
QMS, Quality Policy and Quality Objectives. |
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5.6.2 |
Review input |
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Management review input requirements are specified and
listed as regular requirements for consideration. Input
may be in the form of a report or a presentation.
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5.6.3 |
Review output |
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Management review decisions and actions are required on
improvements for the QMS and processes, improvement of
product, on resource needs and suitability of the QMS. |
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6 |
RESOURCE MANAGEMENT |
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6.1 |
Provision of resources |
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Resources must be determined and provided to implement,
maintain and continually improve the QMS and to enhance
customer satisfaction. |
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6.2.1 |
Human resources |
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Personnel performing work affecting product quality must
be competent. This means that only competent personnel
must be assigned. |
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6.2.2 |
Competence |
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The competence required must be determined and training
provided (or other action taken). This means that
competence of personnel must be determined and compared
with competence requirements. The effectiveness of
training in achieving the competence required must be
evaluated. |
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6.3 |
Infrastructure |
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The facilities provided must be appropriate for the
achievement of product quality requirements. |
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6.4 |
Work environment |
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The work environment must be appropriate for the
achievement of product quality requirements. |
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7 |
PRODUCT REALIZATION |
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7.1 |
Planning of product realization |
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Note that the whole of Clause 7 is subject to permitted
exclusion but in practice Clause 7.3, design and
development will normally be the main consideration for
exclusion if the organisation does not have a design and
development capability.
Planning for product realisation requires consideration of
the processes involved. Product realisation planning must
determine the product quality requirements, including
inspection and testing needed, control documentation
needed, resources required and records to be retained.
Where design is involved, design controls must be included
in the planning activity. |
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7.2.1 |
Determination of requirements related to products |
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Determining product requirements must include not only
customer specified requirements, but also the
unspecified/implied requirements expected from the known
state of the art. The organization is responsible for
including Regulatory requirements in determining product
requirements. |
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7.2.2 |
Review of requirements related to products |
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The capability to supply a product must be reviewed before
submission of a tender or accepting an order. In limited
cases where a review is not practical, such as internet
sales, the organization can assume that the publication of
a catalogue or advertising material will cover the review
requirement before acceptance of an order. |
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7.2.3 |
Customer communication |
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Communication arrangements with customers must be
established to ensure understanding of product and
contract requirements and facilitate feedback, including
complaints. |
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7.3 |
Design and development |
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The organization must ensure that it has defined,
implemented and maintained the necessary design and
development processes to respond to customer needs and
expectations. The design process must consider
expectations of "other interested parties" e.g. customers,
suppliers, employees, society in general. All factors that
contribute to meeting the expected product and process
performance must be considered. These factors include life
cycle, safety and health, usability and user friendliness,
durability, the environment including disposability. These
factors will contribute to the identification of
interested parties and their expectations. |
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7.4.1 |
Purchasing process |
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The type and extent of control applied to suppliers must
be dependent upon the effect of purchased product on the
product realization. Organizations must determine this
significance. Criteria for selection, evaluation and
re-evaluation of suppliers must be established and
implemented. The evaluation and what product(s) have been
approved for supply must be recorded. |
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7.4.2 |
Purchasing information |
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The adequacy of purchasing information to describe the
product to be purchased must be reviewed before
communication to the supplier. The approval process and
technical competence of "approver" should be considered.
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7.4.3 |
Verification of purchased product |
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The inspection required for incoming purchased product
must be established and implemented. The extent of this
should be considered together with 7.4.1, 7.4.2 and any
intended inspection at the supplier's premises. |
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7.5.1 |
Control of production and service provision |
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The planning and provision of production should include
7.5.1 a) - f). Although "where applicable" is added to
this requirement and the exclusion limitation applies to
clause 7 as a whole, if the exclusion of a sub-clause
requirement a) - f) would adversely affect the product it
may not be excluded. |
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7.5.2 |
Validation of processes for production and service
provision |
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Validation of processes is now a more clearly specified
requirement where the resulting output cannot be monitored
or measured. Typical examples include welding, soldering,
sterilisation. The requirements for validation and
re-validation are now clearly specified in a) - e). |
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7.5.3 |
Identification and traceability |
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The requirement for appropriate identification and
traceability allows an understanding of the status of
product and processes through monitoring, measurement and
unique identification. The identification and traceability
requirement for product and process activities may also
arise due to the need to meet a number of additional
criteria including Regulatory requirements, control of
hazardous materials, mitigation of risks and product
recall capability. |
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7.5.4 |
Customer property |
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The organization must identify responsibilities to protect
the value of the customer's property including items
supplied by the customer to be subsequently included in
product, product supplied for repair, packaging materials
and documents such as customer specifications and
drawings. Intellectual property provided by the customer
is also included in this requirement. |
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7.5.5 |
Preservation of product |
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Processes must be defined to prevent damage, deterioration
or misuse during internal processing and final delivery of
the product. Suppliers must be involved with the
organization in determining effective processes to protect
purchased materials.
The organization should communicate to customers and other
interested parties, the information needed to preserve the
intended use of the product throughout its life cycle
against damage or misuse. The information must consider
any precautionary aspects arising from the nature of the
product. |
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7.6 |
Control of monitoring and measuring devices |
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There are two main objectives for measuring and
monitoring. The first is to collect data to ensure
compliance, i.e. for products and for testing device
calibration. The second is to collect data on processes as
a means to enhance customer satisfaction. Measuring and
monitoring processes must be defined and implemented to
'ensure satisfaction' of customers and interested parties.
Devices used for measurement and monitoring must be fit
for the intended use, including measurement accuracy, and
have calibration traceable to national measurement
standards. Measurement and monitoring devices must be
protected against invalid adjustment and demage.If
measurement and monitoring devices are not found to meet
performance requirements, the organisation must take
appropriate action on the product affected and preclude
the use of the device. Where used in monitoring and
measurement, validation of computer software is a
requirement. |
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8 |
MEASUREMENT, ANALYSIS AND IMPROVEMENT |
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8.1 |
General |
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Measurement, monitoring, analysis and improvement
processes are required to demonstrate conformity of
product, ensure conformity of the Quality Management
System and continually improve the effectiveness of the
Quality Management System. Applicable statistical methods
and the extent of their use must be determined.
Data must be collected as the basis for factual decision
making on the performance of products, capability of
processes, achievement of objectives and level of customer
satisfaction and of other interested parties. The analysis
of relevant data must be used at management review.
A list of considerations for measurement, analysis and
improvement are indicated in ISO 9004: 2000 with the
objective of benefiting the organisation, establishing
priorities, improving product/process performance and
effectiveness and for measuring customer satisfaction.
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8.2.1 |
Customer satisfaction |
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Monitoring and measurement must include a measure of
customer perception of the fulfilled customer requirements
and a method for obtaining and using this information must
be determined. |
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8.2.2 |
Internal audit |
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Planned internal audits must be carried out to demonstrate
conformity to planned arrangements (clause 7.1), ISO 9001:
2000 and the Quality Management System. The audit scope,
frequency and method must be defined. An audit procedure
is required. Action to eliminate the cause of
non-conformity must be taken without undue delay and
verification action recorded.
ISO 10011/1 and 10011/2 apply for audit/auditor guidance.
The audit procedure must therefore include a requirement
for the collection of objective evidence and auditors must
be competent to determine the strengths and weaknesses of
the quality management system.
Improvement action must be taken in response to internal
audit results. Internal audit planning should consider a
wide range of subjects, ref. ISO 9004: 2000. |
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8.2.3 |
Monitoring and measurement of processes |
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Monitoring and measurement of processes must be carried
out to demonstrate the ability of processes to achieve
planned results. This should provide information for
continual improvement and for achieving strategic
objectives and the needs of customers and interested
parties. |
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8.2.4 |
Monitoring and measurement of product |
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Monitoring and measurement of product characteristics must
be carried out in accordance with clause 7.1.
Evidence of conformity to acceptance criteria is required
before release of the product by authorised personnel.
When selecting measurement methods for products, the
organisation must consider customer needs and
expectations, needs of interested parties and also
opportunities for performance improvement, including from
inspection and test reports.
Interested parties may include the people in the
organisation, investors, suppliers and partners,
regulators and the public. |
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8.3 |
Control of non-conforming product |
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Non-conforming product must be identified, segregated, and
controlled to prevent misuse. The organisation must deal
with non-conforming product by taking action to eliminate
the non-conformity and either obtain authorisation for its
use from the customer, or remove it from the possibility
of use.
Review of the extent of non-conforming product should be
part of management review to consider reduction goals and
resource needs.
People carrying out the product non-conformity review and
making the decision on disposition must have the
competence to evaluate the total effects and the authority
to agree the outcome and corrective action.
When non-conforming product is corrected for subsequent
use it must be subjected to re-verification to demonstrate
conformity.
When non-conforming product is detected after delivery,
appropriate action must be taken dependent on the effects,
e.g. recall. A procedure is required to describe the
process for controlling non-conforming product.
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8.4 |
Analysis of data |
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The organisation must determine, collect and analyse
appropriate data to demonstrate the suitability and
effectiveness of the quality management system. This must
give information relating to customer satisfaction,
product conformity, trends in processes and suppliers.
Other data may be collected, such as success of
performance improvement objectives, economics of quality,
market related performance, benchmarking and
competitiveness. |
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8.5.1 |
Continual improvement |
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Continual improvement of the Quality Management System
must be demonstrated through the use of the Quality
Policy, Quality Objectives, audit results, analysis of
data, corrective and preventive action and management
review. |
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8.5.2 |
Corrective action |
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A procedure is required to define requirements for
reviewing non-conformities, determining their cause,
evaluating the need for action to eliminate recurrence,
determining and implementing action needed, recording the
results of action taken and reviewing corrective action
taken. Sources of potential information for corrective
action are listed in ISO 9004: 2000. Note that prevention
of recurrence of non-conformity may involve competence
assessment and training. |
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8.5.3 |
Preventive action |
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A procedure is required to define requirements for
determining potential non-conformities and their causes,
evaluating the need for action, determining and
implementing action, record results of action taken and
review of its effectiveness. |
