ISO 9003 1994 in Plain English

ISO 9003 1994 is now obsolete. Please see ISO 9001 2008.

Are you looking for the ISO 90003 2004 Software Standard?

ISO 9003

4.1 Management responsibility

4.1.1
Quality policy 

Define a policy that describes your organization's attitude 
towards quality. Your quality policy should:

• State a clear commitment to quality.

• Recognize customer needs and expectations.

• Be actively supported by senior management.

• List the quality objectives you want to achieve.

• Be understood by everyone in the organization.

• Be consistent with your organization's goals.

• Be maintained throughout your organization.

• Be applied throughout your organization.

Define the organizational structure that you will 
need in order to manage a quality system.

4.1.2.1 Responsibility and authority

Define quality system responsibilities, give quality system
personnel the authority to carry out these responsibilities, and
ensure that the interactions between these personnel are clearly
specified. And make sure all of this is well documented. This
requirement must be met for those who:

• Manage quality system work.

• Perform quality system work. 

• Verify quality system work.

More specifically, this quality system requirement 
must be met for those who:

• Control nonconforming products.

• Prevent product nonconformities.

• Prevent process nonconformities.

• Prevent quality system nonconformities.

• Identify problems related to the quality system.

• Report problems related to the quality system.

• Record problems related to the quality system.

• Recommend solutions to quality system problems.

• Design solutions to quality system problems.

• Verify that solutions were implemented.

• Evaluate whether solutions were effective.

4.1.2.2 Resources

Identify and provide the resources that people will need to manage,
perform, and verify quality system work. Make sure that:

• Only trained personnel are assigned.

• Managers have the resources they need to verify work.

• Internal auditors have the resources they need.

4.1.2.3 Management representative

Appoint a senior executive to manage your quality system and
give him or her the necessary authority. This senior executive must
ensure that your quality system is developed and implemented.
This executive must:

• Monitor the performance of your quality system.

• Control the performance of your quality system.

• Report on the performance of your quality system.

• Help improve the performance of your quality system.

• Act as your organization's spokesperson on quality.

Define a procedure that your senior managers can use 
to review the effectiveness of your quality system.

• Quality system reviews should be:

  • Carried out on a regular basis.

  • Documented and records should be maintained.

• Quality system reviews should ensure that your:

  • Quality system requirements are being met.

  • Quality objectives are being achieved.

  • Quality policy is being applied.

ISO 9003

4.2 Quality system

4.2.1
General 

Develop a quality system and a manual that describes it.

• Your quality system should ensure that your products 
  conform to all specified requirements.

•  Your quality manual should:

  • State your quality policy.

  • List your quality objectives.

  • Provide an overview of your quality system.

  • Describe the structure of your organization.

  • Discuss your quality system procedures.

  • Introduce your quality documents and records.

  • Teach people about your quality system.

  • Control quality system work practices.

  • Guide the implementation of your quality system.

  • Explain how your quality system will be audited.

Develop and implement quality system procedures 
that are consistent with your quality policy.

• Develop your procedures for all areas of your quality system.

• Document your procedures, and keep them up to date.

• Each procedure should:

  • Specify its purpose and scope.

  • Describe how an activity should be carried out.

  • Describe who should carry out the activity.

  • Explain why the activity is important to quality.

  • Describe when and where it should be carried out.

  • Explain what tools and equipment should be used.

  • Explain what supplies and materials should be used.

  • Explain what documents and records should be kept.

• Procedures may also refer to detailed work instructions 
  that explain exactly how the work should be done.

Develop quality plans that show how you intend to fulfill quality
system requirements. You are expected to develop quality plans
for products, processes, projects, and customer contracts.

• Your quality plans should list the quality objectives you
  intend to achieve, and the steps you intend to take to
  achieve these objectives.

• When you construct your quality plan, consider 
  the following questions:

  • Do you need to purchase any new equipment or 
    instruments, or any new inspection and test tools?

  • Do you need to carry out any special training in 
    order to fulfill all quality system requirements?

  • Do you need to improve design, production, testing, 
    inspection, installation, or servicing procedures?

  • Do you need to improve your quality 
    measurement and verification procedures?

  • Do you need to develop any new 
    measurement methods or instruments?

  • Do you need to clarify your organization's 
    standards of acceptability?

  • Do you need to develop any new documents, 
    forms, reports, records, or manuals?

  • Do you need to allocate more resources in 
    order to achieve the required levels of quality?

ISO 9003

4.3 Contract review

4.3.1
General 

Develop and document procedures to coordinate the review
of sales orders and customer contracts. Make sure you include
the customer in the process of review.

Your contract review procedures should ensure that all contractual
requirements are acceptable before you agree to provide products to
your customers. Specifically, your procedures should make sure that:

• Your customer's order is clearly and completely defined. 
  When verbal orders are received, make sure that you 
  and your customer agree on what is required.

• You have resolved all differences between the original
  tender or proposal and the final contract or sales order.

• Your organization is capable of supplying the 
  products ordered by the customer.

ISO 9003

4.5 Document and data control

4.5.1
General 

Develop procedures to control all the documents and data related
to your quality system. These procedures should control:

• Internal and external documents and data.

• Electronic or hardcopy documents and data.

Develop procedures to review, approve, and manage all
of your quality system documents and data. These procedures
should ensure that:

• Only authorized people are allowed to formally 
  approve documents and data prior to distribution.

• All documents and data are formally approved before 
  they are distributed throughout the organization.

• The accidental use of obsolete documents
  and data is prevented.

• Only current versions of documents and
  data are available for use.

• Documents and data, that are used to maintain
  your quality system, are available wherever and
  whenever they are needed.

• Documents that are retained for legal or historical
  purposes should be officially marked as such and
  segregated from current versions.

Develop procedures to control changes to documents and
data. These procedures should ensure that changes are:

• Justified.

• Marked as changes.

• Reviewed and approved by the
  original review and approval groups.

The procedures should also ensure that these review and approval
groups have all the information they need to justify their approval.

ISO 9003

4.7 Customer-supplied products

Develop procedures to control products supplied to you 
by customers. These procedures should ensure that you:

• Examine the product when you receive it to confirm 
  that the right items were shipped without loss or damage.

• Prevent product loss, misuse, damage, or deterioration 
  through proper storage and security.

• Record product loss, misuse, damage, or deterioration, 
  and report it to the customer.

• Clarify who is responsible for the maintenance and 
  control of the product while it is in your possession.

ISO 9003

4.8 Product identification and tracing

Develop and document procedures to identify and track all of
your products. Track your products or product batches by means
of unique identifiers and suitable record keeping.

ISO 9003

4.10 Product inspection and testing

Your organization's final inspection and 
testing procedures should ensure that:

• Final products are inspected, tested, and 
  approved before they are sold to customers.

• Prior tests and inspections are used when conformity 
  cannot be fully verified on the finished product.

Make sure that your organization's final 
inspection and testing records show:

• That your products were inspected and tested.

• That your products conform to specified requirements.

• Who inspected or tested your final products.

•  Who authorized the release of inspected products.

ISO 9003

4.11 Control of inspection equipment

4.11.1
General 

Develop procedures to control, calibrate, and maintain inspection,
measuring, and test equipment used to demonstrate that products
conform to requirements.

• The amount of measurement uncertainty should be known
  and should be reasonable given the degree of precision
  required to establish that the product meets requirements.

• In order to prove that your equipment is capable of verifying
  the acceptability of your products, it should be checked and
  rechecked on a regular basis.

• Every time equipment is checked to ensure that it is capable
  of verifying that products are acceptable, the results should
  be properly recorded. 

• Whenever your customers must confirm that your inspection,
  measuring, and test equipment is reliable and appropriate,
  make sure you allow them to do so.

Develop procedures to ensure that your measurement equipment is
appropriate, effective, and secure. Your procedures should specify:

• What kinds of measurements must be made.

• What kinds of measurement methods must be used.

• How accurate these measurements should be.

• Which quality measurement equipment should be used.

• What kinds of environmental conditions are suitable.

• How and where your equipment should be stored.

• How equipment will be protected from harm.

Develop procedures to calibrate all of your quality oriented
inspection, measuring, and test equipment. Your procedures
should ensure that:

• Calibration methods are clearly defined.

• Equipment is calibrated on a regular basis.

• Equipment calibration status is clearly shown.

• Calibration acceptance criteria are clearly specified.

• Equipment is calibrated against official standards.

• Calibrations are carried out in a suitable environment.

• Calibration documents and records are maintained.

• Calibration records are accurate and up-to-date.

• Appropriate remedial actions are taken whenever 
  calibration results are found to be unacceptable.

• Valid calibration settings are protected from 
  unauthorized adjustment.

• Previous calibration results are rechecked whenever 
  equipment is found to be out-of-calibration.

ISO 9003

4.12 Inspection and test status of products

Develop procedures to control the inspection status 
of your products. These procedures should ensure that:

• Each and every product is identified as having passed 
  or failed the required tests and inspections.

• The test status of each product is documented and respected throughout the production, installation, and servicing process.

• Only products that have passed all tests and inspections are subsequently used or sold to customers (unless an exception
  is made under section 4.13.2 below).

ISO 9003

4.13 Control of nonconforming products

Control nonconforming products in order 
to prevent inappropriate use or delivery.

• Make sure that nonconforming products are:

  • Identified, evaluated, and documented.

  • Segregated from products that conform.

• Also make sure that you:

  • Notify all relevant persons when your products 
    do not conform to specified requirements.

  • Record the actual condition of any nonconforming 
    product that is, nevertheless, accepted and used.

  • Record a description of the repairs that 
    were made to nonconforming products.

  • Re-test and re-inspect products that 
    have been repaired or reworked.

ISO 9003

4.14 Corrective action requirements

Take corrective actions to handle product 
nonconformities. Make sure that:

• Product nonconformities are identified by analyzing
  final inspection and test reports and by reviewing
  customer complaints & feedback.

• Product nonconformities are thoroughly investigated.

• Actions to correct nonconformities are implemented.

• Corrective measures are fed back into the 
  quality system review process (see 4.1.3).

ISO 9003

4.15 Handling, storage, and delivery

Develop product handling methods and procedures 
that prevent product damage or deterioration.

Designate secure areas to store and protect products.

Develop procedures which specify how products will be:

• Placed into storage.

• Removed from storage.

• Protected from damage, deterioration, 
  or destruction during storage.

• Monitored and evaluated to detect damage 
  or deterioration while in storage.

Develop methods and procedures to protect and preserve product
quality prior to delivery while the product is still under your
organization's supervision and control.

• Ensure that products are segregated from one another.

Develop procedures to protect your products after final testing 
and inspection, and during product delivery (when the latter 
is contractually required).

ISO 9003

4.16 Control of quality records

Develop a quality record keeping system, and control its use.
Your quality record keeping system should:

• Show that your quality system is implemented.

• Prove that your quality system works properly.

• Prove that finished products meet requirements.

• Specify how long old records should be retained.

• Produce documents that are dated and easy to read.

ISO 9003

4.17 Internal quality audit requirements

Develop internal quality audit procedures which:

• Determine whether quality activities and results comply 
  with written quality plans, procedures, and programs.

• Evaluate the performance of your quality system.

• Verify the effectiveness of your corrective actions.

These procedures should also ensure that:

• Audit activities are properly planned.

• Auditors are independent of the people 
  whose activities are being audited.

• Audit results, corrective actions, and corrective 
  action results and consequences are properly recorded.

• Audit conclusions are discussed with the people whose activities 
  and results are being audited, and deficiencies are corrected 
  by the managers of the audited areas.

• Audit reports are fed back into the quality system
  review process (see section 4.1.3).

ISO 9003

4.18 Training requirements

Make sure that the people who perform final inspection and testing
activities are competent, and make sure that a record of their
competence is kept. Make sure that:

• Training is provided to anyone who performs
  final inspections and testing activities.

• Anyone who performs final inspections and testing
  activities is suitably experienced and qualified. 

• Accurate and appropriate training records are kept.

ISO 9003

4.20 Statistical techniques

ISO 9003:1994 is now obsolete. It has been replaced by ISO 9001:2008.