印刷企业管理相关标准
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GLOBAL ACCEPTED MANAGEMENT STANDARD
--ISO9001：1994
ENGLISH VERSION
ISO9001：1994 Standard
Quality systeems-Model for quality assurance in design,development,production,installation
and servicing
1 Scope
This International Standard specifies quality system requirements for
use where a supplier’s capability to design and supply conforming product
needs to be demonstrated.
The requirements specified are aimed primarily at achieving customer satisfaction
by prevent nonconformity at all stages from design through to servicing.
This International Standard is applicable in situations when design is
required and the product requirements are stated principally in performance
terms, or they need to be established, and confidence in product conformance
can be attained by adequate demonstration of a supplier’s capabilities
in design, development, production, installation and servicing.
NOTE 1 For informative references, see annex A.
2 Normative reference
The following standard contains provisions which, through reference in
this text, constitute provisions of this International Standard. At the
time of publication, the edition indicated was valid. All standards are
subject to revision, and parties to agreements based on this International
Standard are encouraged to investigate the possibility of applying the
most recent edition of the standard indicated below. Members of IEC and
ISO maintain registers of currently valid International Standards.
ISO 8402:1994, Quality management and quality assurance-Vocabulary.
3 Definitions
For the purposes of this International Standard, the definitions given
in ISO 8402 and the following definitions apply.
3.1 product:
Result of activities or processes.
NOTES
1. A product may include service, hardware, processed materials, software
or a combination thereof.
2. A product can be tangible (e.g. assemblies or processed materials)
or intangible (e.g. knowledge or concepts), or a combination thereof.
3. For the purposes of this International Standard, the term “product”
applies to the intended product offering only and not to unintended “by-products”
affecting the environment. This differs from the definition given in ISO
8402.
3.2 tender:
Offer made by a supplier in response to an invitation to satisfy a contract
award to provide product.
3.3 contract:
Agreed requirements between a supplier and customer transmitted by anymeans.
4 Quality system requirements
4.1 Management responsibility
4.1.1 Quality policy
The supplier’s management with executive responsibility shall define and
document its policy for quality including objectives for and commitment
to quality. The quality policy shall be relevant to the supplier’s organizational
goals and the expectations and needs of its customers.
The supplier shall ensure that the policy is understood, implemented and
maintained at all levels of the organization.
4.1.2 Organization
4.1.2.1 Responsibility and authority
The responsibility, authority and the interrelation of personnel who manage,
perform and verify work affecting quality shall be defined and documented,
particularly for personnel who need the organizational freedom and authority
to:
a) initiate action to prevent the occurrence of any nonconformities relating
to the product, process and quality system;
b) identify and record any problems relating to the product, process and
quality system;
c) initiate, recommend or provide solutions through designated channels;
d) verify the implementation of solutions;
e) control further processing, delivery or installation of nonconforming
product until the deficiency or unsatisfactory condition has been corrected.
4.1.2.2 Resources
The supplier shall identify resource requirements and provided adequate
resources, including the assignment of trained personnel for management,
performance of work and verification activities including internal quality
audits.
4.1.2.3 Management representative
The supplier’s management with executive responsibility shall appoint
a member of the supplier’s own management who irrespective of other responsibilities,
shall have defined authority for:
a) ensuring the quality system is established, implemented and maintained
in accordance with the appropriate standard, and
b) reporting on the performance of the quality system to the supplier’s
management for review and as a basis for improvement of the quality system.
NOTE 5 The responsibility of a management representative may also include
liaison with external parties on matters relating to the supplier’s quality
system.
4.1.3 Management review
The supplier’s management with executive responsibility reviews the quality
system at defined intervals sufficient to ensure its continuing suitability
and effectiveness in satisfying the requirements of the appropriate standard
and the supplier’s stated quality policy and objectives.
Records of such reviews shall be maintained.
4.2 Quality system
4.2.1 General
The supplier shall establish, document and maintain a quality system as
a means of ensuring that product conforms to specified requirements.
The supplier shall prepare a quality manual covering the requirements
of the appropriate standard.
The quality manual includes or makes reference to the quality system procedures
and outlines the structure of the documentation used.
4.2.2 Quality system procedures
The supplier shall:
a) prepare documented procedures consistent with the requirements of the
appropriate standard and the suppliers stated quality policy, and
b) effectively implemente the quality system and its documented procedures.
4.2.3 Quality planning
The supplier shall define and document how the requirements for quality
will be met. Quality planning is consistent with all other requirements
of the supplier’s quality system and is documented in a format to suit
the suppliers method of operation.
The supplier shall give consideration to the following activities, as
appropriate, in meeting the specified requirements for products, projects
or contracts:
a) the preparation of quality plans;
b) the identification and acquisition of any controls, processes, equipment
(including inspection and test equipment), fixtures, resources and skills
that may be needed to achieve the required quality;
c) ensuring the compatibility of the design, the production process, installation,
servicing, inspection and test procedures and the applicable documentation;
d) the updating, as necessary, of quality control, inspection and testing
techniques, including the development of new instrumentation;
e) the identification of any measurement requirement involving capability
that exceeds the known state of the art, in sufficient time for the needed
capability to be developed;
f) the identification of suitable verification at appropriate stages in
the realization of product;
g) the clarification of standards of acceptability for all features and
requirements, including those which contain a subjective element;
h) the identification and preparation of quality records.
4.3 Contract review
4.3.1 General
The supplier shall establish and maintain documented procedures for contract
review and for the coordination of these activities.
4.3.2 Review
Before submission of a tender, or the acceptance of a contract or order
(statement of requirement), the tender, contract or order is reviewed
by the supplier to ensure that:
a) the requirements are adequately defined and documented;
where no written statement of requirement is available for an order received
by verbal means, the supplier shall ensure that the order requirements
are agreed before their acceptance;
b) any differences between the contract or order requirements and those
in the tender are resolved;
c) the supplier has the capability to meet the contract or order requirements.
4.3.3 Amendment to a contract
The supplier shall identify how an amendment to a contract is made and
correctly transferred to the functions concerned within the organization.
4.3.3 Records
Records of contract reviews are maintained.
4.4 Design control
4.4.1 General
The supplier shall establish and maintain documented procedures to control
and verify the design of the product in order to ensure that the specified
requirements are met.
4.4.2 Design and development planning
The supplier shall prepare plans for each design and development activity.
The plans describe or reference design activities, and define responsibility
for their implementation.
The design and development activities are assigned to qualified personnel
equipped with adequate resources.
The plans are be updated as the design evolves.
4.4.3 Organizational and technical interfaces
Organizational and technical interfaces between different groups which
input into the design process are defined and the necessary information
documented, transmitted and regularly reviewed.
4.4.4 Design input
Design input requirements relating to the product, including applicable
statutory and regulatory requirements, are identified, documented and
their selection reviewed by the supplier for adequacy.
Incomplete, ambiguous or conflicting requirements are resolved with those
responsible for imposing the requirements.
Design input take into consideration the results of any contract review
activities.
4.4.5 Design output
Design output is documented and expressed in terms that can be verified
and validated against design input requirements.
Design output:
a) meets the design input requirements;
b) contains or makes reference to acceptance criteria;
c) identifies those characteristics of the design that are crucial to
the safe and proper functioning of the product.
Design output documents are reviewed before release.
4.4.6 Design review
At appropriate stages of design, formal documented reviews of the design
results are planned and conducted.
Participants at each design review include representatives of all functions
concerned with the design stage being reviewed, as well as other specialist
personnel, as required.
Records of such reviews are maintained.
4.4.7 Design verification
At appropriate stages of design, design verification is performed to ensure
that the design stage output meets the design stage input requirements.
The design verification measures are recorded.
4.4.8 Design validation
Design validation is performed to ensure that product conforms to defined
used needs and/or requirements.
4.4.9 Design changes
All design changes and modifications are identified, documented, reviewed
and approved by authorized personnel before their implementation.
4.5 Document and data control
4.5.1 General
The supplier shall establish and maintain documented procedures to control
all documents and data that relate to the requirements of the appropriate
standard including, to the extent applicable, documents of external origin
such as standards and customer drawings.
4.5.2 Document and data approval and issue
The documents and data are reviewed and approved for adequacy by authorized
personnel prior to issue.
A master list or equivalent document control procedure identifying the
current revision status of documents shall be established and is readily
available to preclude the use of invalid and/or obsolete documents.
The control ensures that:
a) the pertinent issues of appropriate documents are available at all
locations where operations essential to the effective functioning of the
quality system are performed;
b) invalid and/or obsolete documents are promptly removed from all points
of issue or use, or otherwise assured against unintended use;
c) any obsolete documents retained for legal and/or knowledge-preservation
purposes are suitably identified.
4.5.3 Document and data changes
Changes to documents and data are reviewed and approved by the same functions/organizations
that performed the original review and approval, unless specifically designated
otherwise.
The designated functions/organizations have access to pertinent background
information upon which to base their review and approval.
The nature of changes is identified in the document or on appropriate
attachments, whichever is practical.
4.6 Purchasing
4.6.1 General
The supplier shall establish and maintain documented procedures to ensure
that purchased product conforms to specified requirements.
4.6.2 Evaluation of subcontractors
The supplier shall:
a) evaluated and selected subcontractors on the basis of their ability
to meet subcontract requirements including the quality system and any
specific quality assurance requirements;
b) defined the type and extent of control exercised over subcontractors.
the control is dependent upon the type of product, the impact of subcontracted
product on the quality of final product and, where applicable, on the
quality audit reports and/or quality records of the previously demonstrated
capability and performance of the subcontractor;
c) established and maintained quality records of acceptable subcontractors.
4.6.3 Purchasing data
Purchasing documents contain data clearly describing the product ordered,
including where applicable:
a) the type, class, grade or other precise identification;
b) the title or other positive identification, and applicable issues of
specifications, drawings, process requirements, inspection instructions
and other relevant technical data, including requirements for approval
or qualification of product, procedures, process equipment and personnel;
c) the title, number and issue of the quality system standard to be applied.
The supplier reviews and approves purchasing documents for adequacy of
the specified requirements prior to release.
4.6.4 Verification of purchased product
4.6.4.1 Supplier verification at subcontractor’s premises
When the supplier verifies purchased product at the subcontractors premises,
verification arrangements and the method of product release are specified
in the purchasing documents.
4.6.4.2 Customer verification of subcontracted product
Where specified in the contract, the supplier’s customer of the customer’s
representative is afforded the right to verify at the subcontractor’s
premises and the supplier’s premises that subcontracted
product conforms to specified requirements.
Such verification is not used by the supplier as evidence of effective
control of quality by the subcontractor.
Verification by the customer does not absolve the supplier of the responsibility
to provide acceptable product, nor does it preclude subsequent rejection
by the customer.
4.7 Control of customer-supplied product
The supplier shall establish and maintain documented procedures for the
control of verification, storage and maintenance of customer-supplied
product provided for incorporation into the supplies or for related activities.
Any such product that is lost, damaged or is otherwise unsuitable for
use is recorded and reported to the customer.
Verification by the supplier does not absolve the customer of the responsibility
to provide acceptable product.
Customer supplied product is controlled in accordance with the procedure.
4.8 Product identification and traceability
Where appropriate, the supplier shall establish and maintain documented
procedures for identifying the product by suitable means from receipt
and during all stages of production, delivery and installation.
Product is identified in accordance with the procedures.
Where and to the extent that traceability is a specified requirement,
the supplier shall establish and maintain documented procedures for unique
identification of individual product or batches.
This identification shall be recorded.
Product traceability is maintained in accordance with the procedures.
4.9 Process control
The supplier shall identify and plan the production, installation and
servicing processes which directly affect quality and has ensured that
these processes are carried out under controlled conditions.
Controlled conditions include the following:
a) documented procedures defining the manner of production, installation
and servicing, where the absence of such procedures could adversely affect
quality;
b) use of suitable production, installation and servicing equipment, and
a suitable working environment;
c) compliance with reference standards/codes, quality plans and/or documented
procedures;
d) monitoring and control of suitable process parameters and product characteristics;
e) the approval of processes and equipment, as appropriate;
f) criteria for workmanship, which shall be stipulated in the clearest
practical manner (e.g. written standards, representative samples or illustrations);
and
g) suitable maintenance of equipment to ensure continuing process capability.
Where the results of processes cannot be fully verified by subsequent
inspection and testing of the product and where, for example, processing
deficiencies may become apparent only after the product is in use, the
processes are carried out by qualified operators and/or require continuous
monitoring and control of process parameters to ensure that the specified
requirements are met.
The requirements for any qualification of process operations, including
associated equipment and personnel, are specified.
Records are maintained for qualified processes, equipment and personnel,
as appropriate.
4.10 Inspection and testing
4.10.1 General
The supplier shall establish and maintained documented procedures for
inspection and testing activities in order to verify that specified requirements
for the product are met.
The required inspection and testing, and the records to be established,
are be detailed in the quality plan or documented procedures.
4.10.2 Receiving inspection and testing
4.10.2.1
The supplier ensures that incoming product is not used or processed (except
in 4.10.2.3) until it has been inspected or otherwise verified as conforming
to specified requirements.
Verification of conformance to the specified requirements is in accordance
with the quality plan and/or documented procedures.
4.10.2.2
In determining the amount and nature of receiving inspection, consideration
shall be given to the amount of control exercised at the subcontractor’s
premises and the recorded evidence of conformance provided.
4.10.2.3
Where incoming product is released for urgent production purposes prior
to verification, it is positively identified and recorded (see 4.16) in
order to permit immediate recall and replacement in the event of nonconformity
to specified requirements.
4.10.3 In-process inspection and testing
The supplier:
a) inspects and tests the product as required by the quality plan and/or
documented procedures;
b) holds product until the required inspection and tests have been completed
or necessary reports have been received and verified, except when product
is released under positive-recall procedures (see 4.10.2.3)
Release under positive-recall procedures does not preclude the activities
outlined in 4.10.3a).
4.10.4 Final inspection and testing
The supplier carries out all final inspection and testing in accordance
with the quality plan and/or documented procedures to complete the evidence
of conformance of the finished product to the specified requirements.
The quality plan and/or documented procedures for final inspection and
testing require that all specified inspection and tests, including those
specified either on receipt of product or in-process, have been carried
out and that the results meet specified requirements.
No product is dispatched until all the activities specified in the quality
plan and/or documented procedures have been satisfactorily completed and
the associated data and documentation are available and authorized.
4.10.5 Inspection and test records
The supplier shall establish and maintains records which provide evidence
that the product has been inspected and/or tested.
These records show clearly whether the product has passed or failed the
inspections and/or tests according to defined acceptance criteria.
Where product fails to pass any inspection and/or test, the procedures
for control of nonconforming product are applied(see 4.13).
Records identify the inspection authority responsible for the release
of product.
4.11 Control of inspection, measuring and test equipment
4.11.1 General
The supplier shall establish and maintained documented procedures to control,
calibrate and maintain inspection, measuring and test equipment (including
test software) used by the supplier to demonstrate the conformance of
product to the specified requirements.
Inspection, measuring and test equipment is used in a manner which ensures
that the measurement uncertainty is known and is consistent with the required
measurement capability.
Where test software or comparative references such as test hardware are
used as suitable forms of inspection, they are checked to prove that they
are capable of verifying the acceptability of product, prior to release
for use during production, installation or servicing, and are rechecked
at prescribed intervals.
The suppliers shall establish the extent and frequency of such checks
and maintains records as evidence of control.
Where the availability of technical data pertaining to the inspection,
measuring and test equipment is a specified requirement, such data is
be made available, when required by the customer or customer’s representative,
for verification that the inspection, measuring and test equipment is
functionally adequate.
4.11.2 Control procedure
The supplier shall:
a) determine the measurements to be made and the accuracy required, and
selected the appropriate inspection, measuring and test equipment that
is capable of the necessary accuracy and precision;
b) identify all inspection, measuring and test equipment that can affect
product quality, and calibrated/adjusted them at prescribed intervals,
or prior to use, against certified equipment having a known valid relationship
to internationally or nationally recognized standards.
Where no such standards exist, the basis used for calibration is documented;
c) define the process employed for the calibration of inspection, measuring
and test equipment, including details of equipment type, unique identification,
location, frequency of checks, check method, acceptance criteria and the
action to be taken when results are unsatisfactory;
d) identify inspection, measuring and test equipment with a suitable indicator
or approved identification record to show the calibration status;
e) maintain calibration records;
f) assesse and document the validity of previous inspection and test results
when inspection, measuring or test equipment is found to be out of calibration;
g) ensure that the environmental conditions are suitable for the calibrations,
inspections, measurements and tests being carried out;
h) ensure that the handling, preservation and storage of inspection, measuring
and test equipment is such that the accuracy and fitness for use are maintained;
I) safeguard inspection, measuring and test facilities, including both
test hardware and test software, from adjustments which would invalidate
the calibration setting.
4.12 Inspection and test status
The inspection and test status of product is identified by suitable means,
which indicate the conformance or nonconformance of product with regard
to inspection and tests performed.
The identification of inspection and test status is maintained, as defined
in the quality plan and/or documented procedures, throughout production,
installation and servicing of the product to ensure that only product
that has passed the required inspections and tests [or released under
an authorized concession (see 4.13.2)] is dispatched, used or installed.
The inspection and test status of product is in accordance with the procedure.
4.13 Control of nonconforming product
4.13.1 General
The supplier shall establish and maintained documented procedures to ensure
that product that does not conform to specified requirements is prevented
from unintended use or installation.
This control provides for identification, documentation, evaluation, segregation
(when practical), disposition, and for notification to the functions concerned.
4.13.2 Review and disposition of nonconforming product
The responsibility for review and authority for the disposition of nonconforming
product is defined.
Nonconforming product is reviewed in accordance with documented procedures.
It may be:
a) reworked to meet the specified requirements;
b) accepted with or without repair by concession;
c) regraded for alternative applications, or
d) rejected or scrapped.
Where required by contract, the proposed use or repair of product [see
4.13.2b)] which does not conform to specified requirements is reported
for concession to the customer or customer’s representative.
The description of the nonconformity that has been accepted, and of repairs,
is recorded to denote the actual condition (see 4.16).
Repaired and/or reworked product is re-inspected in accordance with the
quality plan and/or documented procedures.
4.14 Corrective and preventive action
4.14.1 General
The supplier shall establish and maintained documented procedures for
implementing corrective and preventive action.
Any corrective or preventive action taken to eliminate the causes of actual
or potential nonconformities is to a degree appropriate to the magnitude
of problems and commensurate with the risks encountered.
The supplier shall implement and record any changes to the documented
procedures resulting from corrective and preventive action.
4.14.2 Corrective action
The procedures for corrective action include:
a) the effective handling of customer complaints and reports of product
nonconformities;
b) investigation of the cause of nonconformities relating to product,
process and quality system, and recording the results of the investigation;
c) determination of the corrective action needed to eliminate the cause
of nonconformities; and
d) application of controls to ensure that corrective action is taken and
that it is effective.
Corrective actions have been completed in accordance with the procedures.
4.14.3 Preventive action
The procedures for preventive action include:
a) the use of appropriate sources of information such as processes and
work operations which affect product quality, concessions, audit results,
quality records, service reports and customer complaints to detect, analyze
and eliminate potential causes on nonconformities;
b) determination of the steps needed to deal with any problems requiring
preventive action;
c) initiation of preventive action and application of controls to ensure
that it is effective;
d) ensuring that relevant information on actions taken is submitted for
management review (see 4.1.3).
Preventive actions have been completed in accordance with the procedures.
4.15 Handling, storage, packaging, preservation and
delivery
4.15.1 General
The supplier shall establish and maintained documented procedures for
handling, storage, packaging, preservation and delivery of product.
4.15.2 Handling
The supplier shall provide methods of handling product that prevent damage
or deterioration.
4.15.3 Storage
The supplier uses designated storage areas or stock rooms to prevent damage
or deterioration of product, pending use or delivery.
Appropriate methods for authorizing receipt to and dispatch from such
areas are stipulated.
In order to detect deterioration, the condition of product in stock is
assessed at appropriate intervals.
4.15.4 Packaging
The supplier controls packing, packaging and marking processes (including
materials used) to the extent necessary to ensure conformance to specified
requirements.
4.15.5 Preservation
The supplier applies appropriate methods for preservation and segregation
of product when the product is under the supplier’s control.
4.15.6 Delivery
The supplier arranges for the protection of the quality of product after
final inspection and test.
Where contractually specified, this protection is extended to include
delivery to destination.
4.16 Control of quality records
The supplier shall establish and maintained documented procedures for
identification, collection, indexing, access, filing, storage, maintenance
and disposition of quality records.
Quality records are maintained to demonstrate conformance to specified
requirements and the effective operation of the quality system.
Pertinent quality records from the subcontractor are an element of the
data.
All quality records are legible and stored/retained in such a way that
they are readily retrievable in facilities that provide a suitable environment
to prevent damage or deterioration and to prevent loss.
Retention times of quality records are established and recorded.
Where agreed contractually, quality records are made available for evaluation
by the customer or the customer’s representative for an agreed period.
Records are stored in accordance with the procedures.
4.17 Internal quality audits
The supplier shall establish and maintained documented procedures for
planning and implementing internal quality audits to verify whether quality
activities and related results comply with planned arrangements and to
determine the effectiveness of the quality system.
Internal quality audits are scheduled on the basis of the status and importance
of the activity to be audited.
Internal audits are carried out by personnel independent of those having
direct responsibility for the activity being audited.
The results of the audits are recorded and brought to the attention of
the personnel having responsibility in the area audited.
The management personnel responsible for the area take timely corrective
action on deficiencies found during the audit.
Follow-up activities verify and record the implementation and effectiveness
of the corrective action taken.
4.18 Training
The supplier shall establish and maintained documented procedures for
identifying training needs and provide for the training of all personnel
performing activities affecting quality.
Personnel performing specific assigned tasks are qualified on the basis
of appropriate education, training and/or experience, as required.
Appropriate records of training are maintained.
4.19 Servicing
Where servicing is a specified requirement, the supplier shall establish
and maintained documented procedures for performing, verifying and reporting
that the servicing meets the specified requirements.
Servicing is performed in accordance with the procedures.
4.20 Statistical techniques
4.20.1 Identification of need
The supplier shall identify the need for statistical techniques required
for establishing, controlling and verifying process capability and product
characteristics.
4.20.2 Procedures
The supplier shall establish and maintained documented procedures to implement
and control the application of the statistical techniques identified in
4.20.1.
Statistical techniques are utilized in accordance with the procedures.
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