ISO 9003 1994 Requirements in Plain English

ISO 9003 is for Organizations that Assure Quality through Final Inspection and Testing

PAGE TWO OF TWO

GO TO PAGE ONE

 

ISO 9003 is now obsolete.  It has been replaced by ISO 9001:2000!

Are you looking for the ISO 90003 2004 Software Standard?

ISO 9003 1994

OTHER PLAIN ENGLISH STANDARDS

ISO 22000 2005 Food Safety Management Standard

OHSAS 18001 Occupational Health and Safety Standard

ISO 13485 2003 Medical Device Management Standard

ISO 14001 2004 Environmental Management Standard

ISO 17799 Information Security Management Standard

ISO 27001 Information Security Management Standard

ISO 90003 Software Quality Management Standard

NFPA 1600 Business Continuity Management Standard

ISO 9003

PAGE TWO OF TWO

ISO 9003

4.8 Product identification and tracing

Track your products

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

4.9 is not used by ISO 9003

 

ISO 9003

4.10 Product inspection and testing

4.10.1
General 
Develop procedures to inspect, test, and verify that final products meet all specified requirements. Also ensure that appropriate product testing and inspection records are developed, and that your procedures ensure that these records are properly maintained.
4.10.2
Receiving inspection

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.

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.

 

ISO 9003

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 9003

4.13 Control of nonconforming products

Control 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 

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

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 9003

4.16 Control of quality records

Develop a quality record keeping system 

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 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 9003

4.18 Training requirements

Develop training procedures 

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

4.19 is not used by ISO 9003

 

ISO 9003

4.20 Statistical techniques

Select and use statistical techniques  Select the statistical techniques that you will need in order to control and verify your product characteristics. Use your statistical techniques and control how they are used.
   

ISO 9003:1994 is now obsolete. It has been replaced by ISO 9001:2000.

 

Please visit our Emergency Management Resource.

 
CONTACT INFORMATION
 
Praxiom Research Group Limited
9619 - 100A Street, Edmonton,
Alberta, T5K 0V7, Canada
Phone: (780)461-4514
Fax: (780)463-6034

info@praxiom.com
 
On the Web since May 25, 1997
This web page was updated on May 26, 2007


Disclaimer and Limitation of Liability

The publisher and authors have used their best efforts in designing and developing this electronic publication. We make no representation or warranties with respect to accuracy or completeness of the contents of this publication and specifically disclaim any implied warranties or merchantability or fitness for any particular purpose and shall in no event be liable for any loss of profit or any other commercial damage, including but not limited to special, incidental, consequential, or other damages.

© 2004 by Praxiom Research Group Limited. All Rights Reserved.

Legal Restrictions on the Use of this Page

Thank you for visiting this page. You are, of course, welcome to view our material as often as you wish, free of charge. And as long as you keep intact all copyright notices, you are also welcome to print or make one copy of this page for your own personal, noncommercial, home use.  But, you are not legally authorized to print or produce additional copies.  If you need to make more than one copy, please contact our Order Desk about purchasing a Site License.

 

ISO 9001 2000

ISO 9000 2000 NAVIGATION GUIDE

       
Home Page Table of Contents Alphabetical Index Site Map
       
How to Order Our Products Our Prices Our Guarantee
       
       
       

Praxiom Research Group Limited