ISO 9001 1994 Requirements in Plain English

ISO 9001 is for Organizations that Design, Develop, Produce, Install, and Service Products

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 It has been replaced by ISO 9001:2000.

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

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ISO 9001

4.8 Product identification and tracing

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 9001

4.9 Process control requirements

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 9001

4.10 Product inspection and testing

• 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.

4.10.2.1 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.

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.

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.

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 9001

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.

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

ISO 9001

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 9001

4.13 Control of nonconforming products

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.

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 9001

4.14 Corrective and preventive action

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.

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.

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 your nonconformities.

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

ISO 9001

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 9001

4.16 Control of quality records

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 9001

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 9001

4.18 Training requirements

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 9001

4.19 Servicing requirements

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 9001

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 It has been replaced by ISO 9001:2000.

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