This
section summarizes ISO 9004-1. It highlights the main
points. It does not present
detail. If you need a detailed and complete interpretation of the
ISO 9004-1 standard, please consider purchasing our hardcopy version.
ISO
prepared ISO 9004-1 to help you to understand quality system
elements.
- Quality
systems must manage conflicting needs.
- Your quality
system
must balance your:
- Customers'
need to have quality products.
- Company's
need to make quality products at a modest
cost.
- When you sell
products to customers, consider that:
- Both your customers
and your organization wish to benefit.
- Your
customers must buy products that
meet their needs.
- Your
organization must sell products
at a price that allows it to
achieve its financial objectives.
- Both your customers
and your organization must control cost.
- Your
customers wish to minimize their
purchase, operating, maintenance,
repair, and disposal costs.
- Your
organization wishes to minimize
its redesign, repair,
replacement, reprocessing,
production, storage, handling,
servicing, and marketing costs.
- Both your customers
and your organization must control risk.
- Your
customers wish to minimize the
health, safety, environmental,
operational, and financial risks
associated with using your
products.
- Your
organization wishes to minimize
the legal, ethical, and financial
risks that faulty products can
generate.
- Support
quality. Your senior managers must:
- demonstrate
a continuous commitment to quality.
- Develop
and implement a quality system.
- Control
your products.
Your quality system should control every phase
of your product's life cycle.
- Provide
resources.
Provide the resources that your people will need
to implement and maintain your quality system.
- Control
quality.
Your quality system must monitor and control
every aspect of quality. Any activity, function, or
process that influences quality must be monitored and
controlled.
- Develop
a quality manual. It should
describe your quality system.
- Your quality
manual should be used to guide the implementation
and maintenance of your quality system.
- Your quality
manual
must also include a procedure that controls how
the manual's contents will be revised and
updated.
- Your quality
system
procedures and instructions should support, and
be tied into, your quality manual.
- Develop
quality plans.
A plan should be developed for every product, process,
project, or contract. It should define the:
- Quality
objectives that must be achieved.
- Practices,
processes, procedures, programs, methods,
resources, and equipment that will be used to
achieve these objectives.
- Perform
internal audits. Regular audits should be carried out to
ensure that your quality system is implemented and to
evaluate its effectiveness. Your internal quality audit
program should determine:
- Who should
carry out the audits.
- What audit
procedures should be used.
- What audit
records should be kept.
- What audit
reports should be prepared.
- What
corrective actions should be taken.
- What should
be audited.
- Conduct
management reviews. These reviews should:
- Be carried
out by senior management personnel.
- Be planned
and executed at regular intervals.
- Review and evaluate your
quality policy and objectives.
- Review the
activities that support the quality policy and
objectives.
- Examine the
results of your internal audits.
- Evaluate how
well your quality policy is being applied and how
well your quality objectives are being achieved.
- Determine
whether your quality system should be updated in
response to changes in technologies, quality
concepts, corporate strategies, or the business
environment.
- Encourage
continuous quality improvement. Your quality system should
create an environment that supports continuous
quality improvement. An environment of continuous
improvement is one that encourages everyone to improve
the efficiency and effectiveness of all activities and
processes for the benefit of both the organization and
its customers.
- Measure
the financial effectiveness of your quality system.
Consider using one of the following methods:
- The
quality-cost approach.
- The
process-cost approach.
- The
quality-loss approach.
- The quality-cost
approach divides
costs as follows:
- Investments, which are divided
into:
- Prevention
costs. This is money spent trying to
prevent quality system failures and
nonconformities.
- Appraisal
costs. This is money spent on testing,
inspection, and quality system reviews,
evaluations, and audits.
- Losses, which are divided
into:
- Internal
failures. This is money spent dealing
with products, that failed to meet
quality requirements, before they are
sold.
- External
failures. This is money spent dealing
with problematic products after they have
been sold to customers.
- The process-cost
approach
selects a process, and then figures out what it costs to
serve the needs of its customers. It divides costs as
follows:
- The
cost of conformity. This adds up all the money
spent ensuring that the process continues to work
properly.
- The
cost of nonconformity. This adds up all
the money that must be spent because the process
fails to work properly.
- The quality-loss
approach
focuses on losses that are caused by poor quality. It
divides losses as follows:
- Tangible
losses.
These are losses that result from re-work,
repair, warranty work, and so on.
- Intangible
losses. These are losses due to
lost opportunities, systemic inefficiencies, and
so on.
- Prepare
financial quality reports. These
reports should
be prepared and submitted to senior management, and
should:
- Discuss the
effectiveness of your quality system.
- Identify
quality system weaknesses and problems.
- Formulate
quality and cost objectives.
- Conduct
market research. Before you
develop a product,
ask
your market research people to find out:
- How many
customers need the product.
- What grade of
product customers want.
- What price
customers are prepared to pay.
- What customer
needs and expectations are.
- Set
up a customer feedback system. Ask your marketing people to set up a
feedback system to monitor the experience customers have
with your products. This will help you to make market
oriented improvements.
- Prepare
design plans.
Make sure that your design manager prepares a design plan
for each product. Make sure that this plan:
- Describes
what tasks and activities must be performed and
who will be responsible for each task and
activity.
- Defines the
product development process that will be followed
including the "holdpoints" that dictate
when prototypes will be evaluated before the
development process is allowed to continue.
- Control
your design process. Make sure that your design staff:
- Translates
customer needs into technical specifications.
- Ensures that
the specified product can, in fact, be produced
at a cost that ensures a reasonable profit.
- Provides the
technical data that other staff will need to
purchase materials, to produce the product, and
to verify its quality.
- Specifies
product testing methods and target performance
values.
- Verifies
design outputs by means of calculations and the
testing of models and prototypes.
- Validates
your designs by evaluating product performance,
durability, dependability, and safety, and by
determining whether your design features will
meet customer needs.
- Conduct
regular design review meetings in order to identify
problems and to agree upon solutions. Your design reviews
should make sure that:
- Customers
will be satisfied with the product.
- Product
specifications are clearly defined and
implemented.
- Production,
testing, inspection, packaging, handling, and
storage requirements will be met.
- Final design
documents (design baselines) are formally
approved before production begins.
- Carry
out a market-readiness review before you begin
full-scale production. This review should confirm that
your:
- Installation,
operation, and repair manuals are ready.
- Distribution,
service, and field people are ready.
- Spare parts
inventory levels are adequate.
- Product tests
and production runs were successful.
- Control
design changes. Develop procedures to control changes in
product design.
These design control procedures should:
- Authorize
changes in product design.
- Authorize
changes in service and support arrangements.
- Verify that
authorized changes were actually made.
- Control the
release of documents that define design changes.
- Manage the
use of documents that define design changes.
- Allow you to
make emergency changes to prevent
nonconformities.
- Permit you to
carry out additional design reviews when
necessary.
- Allow you to
perform supplementary design reviews and testing.
- Develop
design re-evaluation procedures. Regular design
re-evaluations should be done to ensure that your designs
are still valid.
- Design
re-evaluations should examine customer feedback,
field data, technical specifications, and new
trends and technologies.
- Develop
purchasing procedures. These procedures should plan and
control both product and service purchases. These
procedures should:
- Ensure that
subcontractors understand what you want to buy.
- Verify the
quality of all purchased materials, parts, and
assemblies.
- Monitor
and control your subcontractors.
- Develop
procedures to ensure that subcontractors are
competent.
- Develop a
subcontractor feedback system. Such a system
should allow you to maintain a close working
relationship with the people who supply you with
products and services.
- Develop a
procedure to manage quality disputes between you
and your subcontractors and suppliers.
- Develop
quality assurance agreements with your subcontractors
and suppliers. These agreements should help ensure that
all subcontractor products and services will meet your
quality requirements. Such agreements may specify that
you will:
- Depend on the
subcontractor's own quality assurance program.
- Ask
subcontractor to send inspection or test data
with shipments.
- Expect the
subcontractor to inspect every shipment before it
leaves.
- Inspect every
incoming shipment yourself.
- Expect the
subcontractor to implement ISO 9001, 9002, or
9003.
- Expect the
subcontractor to perform independent quality
audits.
- Control
product receiving.
- Develop a
product receiving record keeping system to
monitor subcontractor performance and to analyze
historical trends.
- Develop
inspection plans and procedures to control
product receiving. These plans and procedures
must prevent the unintentional use of
nonconforming products.
- Control
process quality.
- Identify all
of the processes that affect product quality and
verify that these processes are capable of
producing products that conform to quality
requirements.
- Develop
procedures to ensure that all materials and parts
conform to your requirements before they are used
in a process.
- Identify all
the environmental factors that can influence
process quality and make sure that you monitor
and control these factors.
- Monitor
process variables and make sure that process
measurements are related to final product
characteristics.
- Develop
procedures to test and verify both in-process and
final product characteristics.
- Encourage
staff members always to try to improve process
quality.
- Define
concrete standards of good workmanship using
photographs, diagrams, work samples, and
instructions.
- Develop
procedures to identify and track in-process
products.
- Develop
procedures to handle and preserve in-process
products.
- Protect
product quality. Develop procedures to protect
product quality at every stage in the
product life cycle from receiving to installation.
- Verify
product quality. Develop procedures to verify
product quality at every stage from initial receipt
to just before shipment to the customer.
- Control
materials.
Develop and document procedures to identify,
mark, label, and track the receipt and use of materials.
- Control
tools and equipment.
- Develop
procedures to ensure that all tools and equipment
work properly before they are used in a process
that affects quality.
- Develop
procedures to ensure that tools and equipment are
properly maintained and suitably stored when not
in use.
- Prevent
process deficiencies. You can do so if you verify the:
- Accuracy of
process data.
- Reliability
of process equipment.
- Effectiveness
of process operators.
- Suitability
of environmental conditions.
- Acceptability
of process documents and data.
- Control
process changes. Develop procedures to ensure that:
- Process
changes are authorized and documented.
- Product
changes, caused by process changes, are
documented.
- Control
process outputs. Develop procedures to control
process outputs (products). Distinguish between
outputs that have not yet been verified and those that
have. The latter should be classified as either
conforming or nonconforming outputs.
- Control
measurement systems. Develop procedures to control the
measurement systems used in the
development, production, installation, and servicing of
products.
- Control
nonconforming products.
- Develop and
document procedures to ensure that customers do
not receive nonconforming products.
- Identify and
promptly record any nonconforming products or
lots. Describe the nonconformity and explain why
it happened.
- Segregate and
label all nonconforming products in order to
prevent inadvertent or inappropriate use.
- Document all
decisions to accept nonconforming products and
record the reasons for doing so.
- Correct
and prevent quality problems (nonconformities).
- Define who is
responsible for and has the authority
to analyze and evaluate quality problems.
- Define who is
responsible for and has the authority
to initiate and implement corrective actions.
- Define who is
responsible for and has the authority
to monitor and coordinate corrective actions.
- Define who is
responsible for and has the authority
to document and record corrective actions.
- Eliminate the
root causes of all quality problems.
- Institutionalize
quality solutions by making permanent changes in
procedures, process documents, work instructions,
product specifications and quality system
documents.
- Monitor the
effectiveness of your corrective actions and
solutions.
- Control
service delivery. Develop procedures to monitor and
control the delivery of service to your customers.
- Develop
a market feedback system. Your feedback system should:
- Detect and
report customer complaints and product problems.
- Monitor the
performance of products throughout their life
cycle.
- Ensure that
information about product problems is fed back to
design, production, and service departments.
- Develop
a quality record keeping system. Your quality record keeping
system should control documents such as drawings,
specifications, reports, procedures, policies,
instructions, manuals, and plans.
- Provide
quality training. Develop and document procedures to
provide quality system training to those who need it.
Make sure that:
- New workers
are trained before they do tasks that affect
quality.
- Technical
workers receive the quality system training they
need.
- Process
supervisors and operators are given quality
system training.
- Workers who
do not carry out tasks that directly influence
quality are, nevertheless, given quality system
training.
- Executives
understand how your quality system functions, how
it is evaluated, and how they can participate in
it.
- Control
the quality of your personnel.
- Document the
qualifications of those who affect quality and
those who supervise quality system work.
- Evaluate and
document the skill and competence of anyone who
influences quality, and do so regularly.
- Make sure
that all personnel clearly understand the
influence that poor job performance has on other
workers, customers, and the success of the
organization as a whole.
- Develop a job
performance evaluation program that evaluates how
well employees are achieving their quality
objectives and recognizes their quality
achievements.
- Raise
quality awareness. Delivery quality awareness programs.
Encourage marketing, design, production, purchasing,
inspection, shipping, receiving, servicing, and all other
support staff to make a genuine commitment to quality.
- Develop
product safety programs. Develop programs to evaluate the
safety of your products and set up an emergency plan to
deal with potential product safety hazards.
- Control
statistical methods.
- Develop and
document procedures to control the selection of
statistical methods and techniques.
- Develop and
document procedures to control the application of
statistical methods and techniques.
- Use
statistical techniques to study product and
process performance, nonconformities, designs,
trends, safety, and risk.
Related Publications |
If you would like to purchase a complete
and detailed
version of
ISO 9004-1 Guidelines Translated
into Plain English, please consider
the following options. Notice that ISO 9004-1 is part of
Titles 5, 7, and 9. |
Title 7: ISO 9000
Translated into Plain English |
Title 7
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ISO 9003,
ISO 9004(1-2-3-4), ISO 10011(1-2-3), and
ISO 10013 |
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