This
section summarizes ISO 9000-2. It highlights the main points.
It does not present
detail. If you need a detailed and complete interpretation
of the ISO 9000-2 standard, please consider purchasing our hardcopy version.
ISO
prepared 9000-2 to help you implement ISO 9001, ISO 9002, and
ISO 9003. Because of the close link between this section and
ISO 9001, ISO 9002, and ISO 9003, we suggest you study
these three sections before you examine ISO 9000-2. But you
do not need to do so in order to understand ISO 9000-2.
Also,
please note that ISO 9000-2, ISO 9001, ISO 9002, and
ISO 9003 use the same numbering system. This is designed to
make cross-referencing easier. However, this similarity breaks
down at the more detailed level.
- ISO
9000-2 4.1 Management responsibility
- Your senior
managers must demonstrate their continuous
commitment to your quality policy and your
quality system.
This commitment must be both active and visible.
- Make sure all
management and staff members understand
how their jobs affect quality.
- Encourage
everyone in your organization to feel responsible
for the quality of your products and services.
- Appoint
people to monitor your quality system and to
report their observations directly to senior
management.
- Provide the
resources that people need to verify quality
work.
- Quality
system reviews should be carried out by senior
managers.
- Changes to
the quality system must be implemented without
delay.
- ISO
9000-2 4.2 Quality system
- Your quality
manual could be several manuals. You could have
one quality system manual that is supported by
several more detailed procedure manuals. All of
these define your quality system.
- Quality plans
can also have several levels, from general to
specific. Like procedures, quality plans explain
how quality requirements will be met. But, unlike
procedures, plans are usually tied to a time
frame and often involve contractual obligations.
- ISO
9000-2 4.3 Contract review
- Make sure you
understand what customers need.
- Make sure
that everyone who must review contracts in fact
does so.
- Make sure
that all contract review concerns and questions
are answered before the contract is finalized.
- ISO
9000-2 4.4. Design control
- Design
control is very important because many quality
requirements can be satisfied through good
design.
- Make sure you
develop plans to evaluate, test, and measure the
safety, dependability, and performance of your
products.
- Your design
teams should know what kinds of information
should be shared, who should get this
information, how it should be transmitted, and
what records should be kept.
- Use a
"design description document" to record
design agreements and solutions. And develop
procedures to update and distribute this design
description document.
- Use at least
two different methods to verify your design
outputs.
- Your design
reviewers should be competent.
- Your designs
should deal with safety and environmental issues.
- Your designs
should meet functional and operational
requirements.
- Make sure you
can actually implement your design.
- Verify the
accuracy of design calculations done by computer.
- Verify the
validity of all your design assumptions.
- Test your
products in realistic settings.
- When designs
must be changed, after the design phase is
finished, make sure that previous design
verification results are still valid.
- When designs
have been changed, make sure your design
verification procedures are still valid.
- ISO
9000-2 4.5 Document control
- Control
documents by maintaining a central registry that
specifies exactly which documents should be
controlled, their revision status, what kinds of
approvals they need, and how they should be
distributed and stored.
- Control
documents and data in areas such as purchasing,
design, and inspection. In general, all documents
and data related to the quality system, and the
work that is carried out within the system,
should be controlled.
- Develop
procedures that specify exactly which documents
should be controlled, who should control them, as
well as how, when, and where this control should
occur.
- Develop
procedures to control changes in documents and
data.
- ISO
9000-2 4.6 Purchasing
- Make sure
that you have a good working relationship with
your subcontractors (suppliers), and make sure
that the lines of communication and feedback are
always open.
- Maintain
records that show how each subcontractor is
selected. Make sure that these records show that
each subcontractor meets your quality and
contract requirements.
- Review the
performance of your subcontractors on a regular
basis.
- Make sure
that you specify who is responsible for reviewing
and approving purchasing documents and data,
including purchase orders and contracts.
- ISO
9000-2 4.7 Customer-supplied product
- Clarify who
is responsible for telling the customer that
products supplied to you by him are unsuitable.
- You (the
supplier) should ensure that all products and
services provided by your customers are suitable.
- ISO
9000-2 4.8 Product identification and traceability
- Mark or tag
products, product batches, or product containers.
- You may need
to use special identifiers to indicate:
- Who
worked on the product.
- What
raw materials were used.
- What
tools and equipment were used.
- What
process methods were applied.
- Inspection
and stock records should use product identifiers.
- ISO
9000-2 4.9 Process control
- All products
(and services) are created by means of processes.
- Process
control is necessary to avoid product
nonconformities.
- Control the
process characteristics that influence product
quality.
- Monitor and
control the materials that enter your processes.
- Monitor and
control the materials that are inside your
processes.
- Develop
procedures to ensure that process:
- Software
and hardware works properly.
- Materials
are suitable and properly stored.
- ISO
9000-2 4.10 Inspection and testing
- Develop
procedures that explain how your staff should
verify that incoming shipments meet all
contractual requirements.
- Develop
procedures that explain how your staff should
handle incoming shipments that do not conform to
requirements.
- When incoming
shipments are subject to future recall, try not
to release them for use until you have inspected
them.
- Develop
procedures to control what happens to incoming
products that are released without inspection and
later found not to conform.
- Clarify who
has authority to release incoming products
subject to recall and describe the conditions
under which release is allowed.
- In-process
inspection should be carried out in order to
detect nonconformities as early as possible.
- ISO
9000-2 4.11 Inspection, measuring, and test equipment
- Your
measurement process should ensure that:
- Appropriate
measurements are done.
- Suitable
measuring equipment is used.
- Effective
measuring procedures are applied.
- Measurement
instruments can be either tangible (e.g.
equipment)
or intangible (e.g. questionnaires).
- ISO
9000-2 4.12 Inspection and test status
- The
inspection and test status of your products
should be clearly indicated by means of tags,
marks, numbers, physical location, or any other
suitable means.
- Your
inspection and test procedure should identify and
segregate products that:
- Have
not been inspected.
- Have
been inspected and
- Have
either been accepted, or
- Have
been rejected, or
- Have
been placed on hold.
- ISO
9000-2 4.13 Control of nonconforming products
- Develop
procedures to prevent the inappropriate use of
nonconforming products. These procedures should
cover both your own products and the products
supplied to you by your subcontractors
(suppliers).
- Make sure
that you identify exactly where each
nonconforming product came from, when and how it
was produced, and what caused the problem.
- ISO
9000-2 4.14 Corrective action
- Product
nonconformities can be caused by:
- Tool
and equipment faults and malfunctions.
- Material
and supply defects and deficiencies.
- Systemic
weaknesses and shortcomings.
- Process
failures and deficiencies.
- Process
control defects and breakdowns.
- Procedural
gaps and weaknesses.
- Human
ignorance and negligence.
- Product
nonconformities can be discovered by:
- Examining
inspection, testing, and nonconformity
documents.
- Observing
work activities and processes.
- Conducting
quality audits and reviews.
- Reviewing
customer ideas and complaints.
- Analyzing
regulatory input and observations.
- Studying
staff suggestions and feedback.
- ISO
9000-2 4.15 Handling, storing, packaging, and delivery
- Procedures
for handling, storing, packaging, and delivery
should cover both in-process materials and
finished products.
- Tools and
equipment, used to handle products, should be
appropriate and well maintained.
- Storage
methods should ensure that products are secure
and protected from damaging environmental
conditions.
- Packaging
methods must ensure that products are identified
and protected against damage, deterioration, or
contamination.
- Delivery
methods must ensure that that products are
protected from loss, damage, deterioration, or
contamination.
- ISO
9000-2 4.16 Quality records
- Develop a
record keeping system that can prove that your
products meet requirements and your quality
system is implemented.
- Your records
can be either paper based or electronic as long
as they document the performance of your quality
system.
- When you
determine how long old quality system records
should be kept, consider contractual and
regulatory requirements as well as the life
expectancy of your products.
- ISO
9000-2 4.17 Internal quality audits
- Periodic
internal quality audits should be done to:
- Determine
whether you have documented all quality
elements.
- Determine
whether you have implemented all quality
elements.
- Evaluate
how effective your quality system is.
- Improve
your quality system.
- Prepare
for external quality audits.
- Special
internal audits may also be done after major
systemic or procedural changes have been made or
after significant problems have been solved. This
type of audit is done to verify that the changes
were effective and that the problems really were
solved.
- ISO
9000-2 4.18 Training
- Make sure
that your training records keep track of the
training provided and the results that were
achieved.
- Training and
awareness activities should be carried out in
order to:
- Show
people how to carry out tasks.
- Show
people how to apply procedures.
- Motivate
people to support quality.
- ISO
9000-2 4.19 Servicing
- If your
products require after-sale service or
post-installation support, you should clarify how
service responsibilities will be shared between
you, your distributors, and your customers.
- Make sure
that:
- Customers
and distributors know how to service
products.
- Service
delivery people receive technical
support.
- Service
delivery people receive training.
- You
develop product service delivery plans.
- Your
service and test equipment is effective.
- You
have an adequate supply of spare parts.
- You
set up an information feedback system.
- ISO
9000-2 4.20 Statistical techniques
- Use
statistical methods to help you:
- Decide
what data to collect.
- Make
the best use of your data.
- Control
processes.
- Avoid
nonconformities.
- Measure
quality characteristics.
- Design
products and services.
- Define
product and process limits.
- Identify
problems and analyze causes.
Related Publications |
If you
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and detailed
version of
ISO 9000-2 Guidelines Translated
into Plain English, please consider
the following options. Notice that ISO 9000-2 is part of
Titles 5, 7, and 8. |
Title 7: ISO 9000
Translated into Plain English |
Title 7
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ISO 10013 |
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