ISO 9002 1994 in Plain English

 

ISO 9002 1994 is now obsolete. Please see ISO 9001 2015.

Praxiom Research

4.1.3
Management review

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 9002

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.

4.2.2
Quality system procedures

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.

4.2.3
Quality planning

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 9002

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.

4.3.2
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.

4.3.3
Amendments
Develop procedures which specify how customer contracts 
are amended, and which ensure that changes in contracts 
are communicated throughout the organization.
4.3.4
Records 
Develop a record keeping system that you can use to 
document the review of customer orders and contracts.

ISO 9002

4.4 is not used by ISO 9002

ISO 9002

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.

4.5.2
Document and data approval and distribution

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.

4.5.3
Document and data changes

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 9002

4.6 Purchasing requirements

4.6.1
General 

Develop procedures to ensure that purchased products (including
services) meet all requirements. These procedures should control
the selection of subcontractors, the use of purchasing data, and
the verification of purchased products.
4.6.2
Evaluation of subcontractors

Develop procedures to select, evaluate, monitor, and control
your subcontractors (your suppliers). These procedures should
define how:

  • Subcontractors are selected.

  • Subcontractor performance is monitored.

  • Subcontractor performance is evaluated.

  • Subcontractor performance is controlled.

These procedures should ensure that subcontractors 
are chosen only if they are able to meet your:

  • Contractual expectations.

  • Quality assurance requirements.

Make sure that quality records are kept which chronicle the
performance of your subcontractors. Your records should identify the
acceptable subcontractors and the products and services they provide.

4.6.3
Purchasing data

Develop procedures to ensure that your purchase order documents
precisely describe what you want to buy. When appropriate, these
procedures should ensure that your purchasing documents:

  • Use technical specifications and drawings 
    to describe exactly what you want to order.

  • State the type or grade of product being purchased.

  • Define product inspection and approval requirements.

  • Specify process requirements that must be met.

  • Identify process equipment that should be used.

  • Describe procedures that should be followed.

  • Specify technical support service requirements.

  • Reference the applicable quality system standards.

  • Are carefully reviewed to ensure that they meet all 
    requirements before they are approved and issued.

4.6.4
Verification of purchased product
Develop procedures that allow you or your customers 
to verify the acceptability of products you have purchased.

4.6.4.1 Supplier verification at subcontractor's place

When you must verify the acceptability of purchased products
at the subcontractor's premises, ensure that your purchase order
documents and contracts specify your verification and acceptance
requirements and methods.

4.6.4.2 Customer verification of subcontracted product

When your customers wish to verify the acceptability of the
products you purchase on their behalf, ensure that they are given
this opportunity at both the subcontractors' premises and yours.

ISO 9002

4.7 Customer-supplied products

Protect 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 9002

4.8 Product identification and tracing

Track your products

Develop and document procedures to identify and track products
from start to finish. When appropriate, these procedures should
make sure that you:

  • Identify and document products every step of the way from the
    purchase of supplies and materials through all stages of handling,
    storage, production, delivery, installation, and servicing.

  • Trace products or product batches by means of 
    unique identifiers and suitable record keeping.

ISO 9002

4.9 Process control requirements

Control production, installation,
and servicing

Develop procedures to plan, monitor, and control your production,
installation, and servicing processes. Your procedures must be
documented, and should ensure that each process is:

  • Approved and performed by qualified personnel.

  • Monitored and controlled by qualified personnel.

  • Performed using approved tools and equipment.

  • Documented using proper record keeping systems.

  • Carried out within a supportive work environment.

Your procedures should ensure that each process:

  • Maintains a high standard of workmanship.

  • Follows your quality plans, policies, and procedures.

  • Complies with the appropriate standards and codes.

  • Is monitored by tracking process and product qualities.

  • Is carried out with well-maintained tools and equipment.

Design a record keeping system that monitors and controls process
personnel and equipment. Make sure that all important process
qualities are monitored and recorded.

ISO 9002

4.10 Product inspection and testing

4.10.1
General 
  • Develop procedures to inspect, test, and verify 
    that your products meet all specified requirements.

    • Develop procedures to inspect, test, and verify 
      that incoming products meet all requirements.

    • Develop procedures to inspect, test, and verify 
      that in-process products meet all requirements.

    • Develop procedures to inspect, test, and verify 
      that final products meet all requirements.

  • Ensure that appropriate product inspection and testing records
    are developed and that these records are properly maintained.

4.10.2
Receiving inspection
Develop procedures that ensure that incoming products are not used
until you have verified that they meet all specified requirements.

4.10.2.1 Inspection of incoming products

Your procedures should ensure that incoming products are inspected
and approved before they are used or processed. All incoming products
must conform to specified requirements.

4.10.2.2 Inspections done by subcontractors

If your subcontractors (your suppliers) carry out some of the
required inspections and if they provide you with recorded evidence
which demonstrates that their products are, in fact, acceptable, then
your procedures should not ask you to repeat these inspections.

4.10.2.3 Use of products prior to inspection

If products must be used prior to inspection, your procedures should
tell you to identify and record them so that they can be quickly recalled
and replaced if they subsequently do not meet all requirements.

4.10.3
In-process inspection
and testing

Develop procedures that ensure that work in process meets
all requirements before work is allowed to continue.

  • Your procedures should ensure that work in process is held
    up until the required inspections and tests have been completed
    and until the required inspection reports have been received
    and approved (see exception explained below).

  • Work in process need not be held up if the product must be
    used right away and if it has been identified and recorded as a
    product that can be recalled and replaced by a subcontractor
    if it doesn't meet your requirements.

4.10.4
Final inspection and testing 

Develop procedures to ensure that final products meet 
all requirements before they are made available for sale. 
Your procedures should ensure that:

  • Final products are inspected and approved 
    before they are made available for sale.

  • Incoming and in process inspections and tests are
    completed, and that all requirements are met, before
    the product is made available for sale.

  • Final products are not released until all relevant quality
    procedures have been carried out, all documents have
    been completed, and all approvals have been granted.

4.10.5
Inspection and test records 

Develop a record keeping system that your staff can use 
to document product testing and inspection activities. 
Your record keeping system should:

  • Prove that your products have been formally 
    inspected and tested using authorized procedures.

  • Show whether your products passed or failed 
    your inspections and tests.

  • Demonstrate that authorized acceptance criteria were 
    used to decide whether products passed or failed.

  • Indicate what was done with products that failed 
    your inspections and tests.

Specify who inspected or tested your products, 
and who authorized their release.

ISO 9002

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.

4.11.2
Control procedures

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.

Develop procedures to calibrate hardware and tools 
used to test and validate your software products.

ISO 9002

4.12 Inspection and test status of products

Control the inspection status of your 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 9002

4.13 Control of nonconforming products

4.13.1
General 

Develop procedures to prevent the inappropriate use of 
nonconforming products. Make sure these products are:

  • Identified, evaluated, and documented.

  • Segregated from products that conform.

Also make sure that everyone is notified when your 
products do not conform to specified requirements.

4.13.2
Review and disposition of nonconforming products 

Develop procedures to control how your nonconforming products 
are reviewed, reworked, regraded, retested, recorded, and discussed
with your customers.

  • Specify who is responsible for and has the authority 
    to review and dispose of nonconforming products.

  • Specify how review of nonconforming products
    must be carried out.

  • Specify the conditions under which nonconforming
    products may be reworked, accepted without modification,
    used for other purposes, or scrapped.

  • Ensure that your customers are notified when nonconforming
    products are going to be used with or without modification
    (when required by contract).

  • Be sure you record the actual condition of any nonconforming
    product that is, nevertheless, accepted and used.

  • Be sure you record a description of the repairs that 
    were made to nonconforming products.

  • Ensure that repaired or reworked products 
    are re-tested and re-inspected prior to use.

ISO 9002

4.14 Corrective and preventive action

4.14.1
General 

Develop procedures to correct or prevent nonconformities.

  • Corrective or preventive actions should eliminate 
    the causes of nonconformity.

  • Corrective or preventive actions should consider how 
    big the problem is and how much risk is involved.

  • When corrective or preventive actions indicate that systemic
    or procedural changes should be made, make sure that these
    changes are implemented.

  • Make sure that corrective and preventive actions 
    and changes are properly documented.

  • Corrective actions may affect:

    • Software items and products.

    • Software life cycle processes.

  • Use configuration management procedures to control 
    corrective actions that affect software items and products.

  • Use document and data control procedures to control 
    corrective actions that affect software life cycle processes.

4.14.2
Corrective action 

Develop procedures to ensure that nonconformities are 
identified and corrected without delay. Ensure that:

  • Nonconformity reports are handled properly.

  • Customer complaints are handled effectively.

  • Causes of nonconformity are investigated and recorded.

  • Corrective actions are promptly implemented.

  • Corrective actions eliminate causes.

  • Corrective actions are effective.

4.14.3
Preventive action 

Develop procedures to ensure that potential nonconformities
are routinely detected and prevented. Your procedures must:

  • Use every appropriate source of information to detect 
    potential nonconformities. Use sources such as:

    • Work activities and processes.

    • Audit results and quality records.

    • Service reports and customer complaints.

  • List the steps that make up your preventive measures.

  • Ensure that effective preventive measures are taken.

  • Ensure that preventive measures are reported
    to senior managers.

  • Ensure that appropriate information about
    preventive measures is fed
    back into the management review process
    (please see section 4.1.3).

  • Develop preventive actions by identifying and
    analyzing the root causes of nonconformities.

  • Develop preventive actions by identifying and
    analyzing unfavorable metric levels and trends.

ISO 9002

4.15 Handling, storage, and delivery

4.15.1
General 
Develop and document procedures to handle, store, 
package, preserve, and deliver your products.
4.15.2
Handling 

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

4.15.3
Storage 
  • 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.

4.15.4
Packaging 
Develop packing, packaging, and marking methods and procedures
to protect and control the quality of products and packaging materials.
4.15.5
Preservation 

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.

4.15.6
Delivery 

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

ISO 9002

4.16 Control of quality records

Develop a quality record keeping system 

Develop a quality record keeping system, 
and develop procedures to control it.

  • Identify the information that should be collected.

  • Develop procedures to:

    • Collect and record this information (create records).

    • File, index, store, and maintain quality records.

    • Remove, archive, and destroy old quality records.

    • Protect quality records from unauthorized access.

    • Prevent records from being altered without approval.

    • Safeguard records from damage or deterioration.

Your quality record keeping system should:

  • Show that your quality system is implemented.

  • Prove that your quality system works properly.

  • Specify how long old records should be retained.

  • Allow information to be retrieved without difficulty.

  • Produce documents that are dated and easy to read.

  • Permit customers to access records (when required).

  • Include quality records provided by subcontractors.

ISO 9002

4.17 Internal quality audit requirements

Develop internal audit procedures 

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 9002

4.18 Training requirements

Develop training procedures 

Develop quality-training procedures. These procedures 
should be properly documented, and must ensure that:

  • Quality system training needs are identified.

  • Quality training is provided to those who need it.

  • People are able to perform quality system jobs.

  • People have the qualifications they need to do the work.

  • Accurate and appropriate training records are kept.

  • Everyone understands how your quality system works.

ISO 9002

4.19 Servicing requirements

Develop service procedures 

Develop and document quality service procedures. 
Your procedures should specify how:

  • Products should be serviced.

  • Product service activities are reported.

  • The quality of product service is verified.

ISO 9002

4.20 Statistical techniques

4.20.1
Identification
of need 

Select the statistical techniques that you will need 
in order to establish, control, and verify your:

  • Process capabilities.

  • Product characteristics.

4.20.2
Procedures 

Develop procedures to:

  • Explain how your techniques should be applied.

  • Monitor and control how these techniques are used.

Make sure that:

  • All statistical procedures are documented.

  • Statistical records are kept.

ISO 9002:1994 is now obsolete. It has been replaced by ISO 9001:2015.

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