Professional Documents
Culture Documents
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0 Introduction
Comments
0.1 General Y
Has the system been developed around N
ISO 9001:2008?
Y
0.2 Process model
Has a process approach been adopted? N
1 Scope
Have exclusions been claimed and if so Y
what are they? N
(see 4.2.2 below)
Y
Are these processes managed in N
accordance with the ISO 9001?
Y
Does the organisation ensure control
over processes that affects product N
conformity that are outsourced?
Y
Is the type and extent of these control
defined in the QMS? N
Y Y Y
Y Y Y
c) ensure changes and current
revision status of documents are N N N
identified?
Y Y
e) ensure documents remain legible N N
and readily identifiable?
Y
Do records provide evidence of N
effective operation of the QMS?
Y
Do records remain legible, readily N
identifiable and retrievable?
5 Management Responsibility
5.1 Management commitment
Is top management committed to Y Y Y
the development and
implementation of the QMS? N N N
b) includes a commitment to Y Y
comply with requirements and
N N
continually improve the
effectiveness of the QMS?
Y Y Y
e) is reviewed for continuing N N N
suitability?
5.4 Planning
5.4.1 Quality Objectives
c) promoting awareness of Y Y Y
customer requirements N N N
throughout organisation?
Note - The responsibility of a management representative can include liaison with external parties on matters relating to the quality management systems.
Y Y Y
Are records of management
reviews maintained (see 4.2.4 N N N
above)?
6 Resource Management
6.1 Provision of resources
6.3 Infrastructure
Y Y Y
b) process equipment (both
N N N
hardware and software)?
Y Y Y
c) supporting services (such as
transport & communication or N N N
information systems)?
7 Product Realisation
7.1 Planning of realisation process
Note 1 A document specifying the processes of the QMS (including the product realisation processes) and the resources to be applied to a specific product, project or contract,
can be referred to as a quality plan.
Note 2 The organisation may also apply the requirements given in 7.3 to the development of product realisation processes
a) product information?
b) enquiries, contracts or order Y Y Y
handling, including amendments?
c) customer feedback, including N N N
customer complaints?
Y Y Y
b) review, verification & validation
that are appropriate to each N N N
design/development stage?
Y Y Y
c) responsibilities and authorities N N N
for design/development?
Y Y Y
d) other requirements essential for N N N
design and development?
Y Y Y
Are these inputs reviewed for N N N
adequacy?
Y Y Y
Y Y Y
Are the result of the reviews and
any necessary actions maintained? N N N
(see 4.2.4 above)
Is verification performed in
accordance with planned
arrangements to ensure the design Y Y Y
and development outputs meet the
design and development inputs N N N
requirements?
Y Y Y
Wherever practicable, is validation
completed prior to the delivery or N N N
implementation of the product?
Y Y Y
Are design and development
changes identified and records N N N
maintained?
Y Y Y
Are the changes reviewed, verified
and validated, as appropriate, and N N N
approved before implementation?
7.4 Purchasing
7.4.1 Purchase process
Y Y
Does the organisation ensure that
purchased product conforms to N N
specified purchase requirements?
Y Y Y
b) the availability of work
instructions, as necessary? N N N
Y Y Y
c) the use of suitable equipment ? N N N
Y Y Y
d) the availability and use of
monitoring and measuring N N N
equipment?
Y Y Y
e) the implementation of N N N
monitoring and measuring?
Y Y Y
f) the implementation of product
release, delivery and post- N N N
delivery activities?
7.5.2 Validation of processes for production and service provision (processes that cannot be verified by subsequent monitoring or measurement)
Y Y Y
Does validation demonstrate the
ability of these processes to N N N
achieve planned results?
Where traceability is a
requirement, does the organisation Y Y Y
control the unique identification of
the product and maintain records? N N N
(see 4.2.4 above)
Note In some industry sectors, configuration management is a means by which identification and traceability are maintained.
Note - Customer property may include intellectual property and personal data
Y Y Y
Does preservation also apply to the N N N
constituent parts of a product?
Y Y Y
where no such standards exist, is
the basis used for calibration or N N N
verification recorded?
b) adjusted or re-adjusted as
necessary?
Y Y Y
Note - Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its
suitability for use.
Y Y Y
N N N
b) ensure conformity of the QMS?
Y Y Y
c) continually improve the N N N
effectiveness of the QMS?
Y Y Y
Are the methods for obtaining and N N N
using this information determined?
Note - Monitoring customer perception can include obtaining input for sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion
surveys, lost business analysis, compliments, warranty claims and dealer reports.
Y Y Y
Y Y Y
Are the audit criteria, scope, N N N
frequency and methods defined?
Y Y Y
Do these methods demonstrate the
ability of the processes to achieve N N N
planned results?
Note - When determining suitable methods, it is advisable that the organisation consider the type and extent of monitoring or measurement appropriate to each of its processes
in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
Y Y Y
Is the evidence of conformity with
the acceptance criteria N N N
maintained?
Y Y Y
c) by taking action to preclude its
N N N
original intended use or
application?
b) conformance to customer Y Y Y
requirements? N N N
(see 7.2.1 above)
Y Y Y
N N N
d) suppliers? (see 7.4 above)
8.5 Improvement
8.5.1 Continual improvement
Y Y Y
b) determining the causes of N N N
nonconformities?
Y Y Y
d) determining and implementing N N N
the action needed?
Y Y Y
e) recording results of action taken? N N N
(see 4.2.4 above)
Y Y Y
f) reviewing the effectiveness of N N N
corrective action taken?
Y Y Y
Are the preventive actions taken
appropriate to the effects of the N N N
potential problems?
a) determining potential Y Y Y
nonconformities and their N N N
causes?
Y Y Y
b) evaluating the need for action to
prevent occurrence of N N N
nonconformities?
Y Y Y
Y Y Y
d) recording results of action taken? N N N
(see 4.2.4 above)
Y Y Y
e) reviewing the effectiveness of N N N
preventive action taken?