ISO 9001 1994 in Plain English

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ISO 9001 1994 is OBSOLETE. The most current standard is ISO 9001 2015.

 

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.

 

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.

 

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 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.

 

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.

 

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).

 

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.

  • 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 retested and reinspected prior to use.

 

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.                       

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.

  • Ensure that appropriate information about preventive  measures is fed back into the management review process.

 

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.

  • Monitored and evaluated to detect damage or deterioration.

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).

 

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.

 

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 being audited.

  • Audit results and remedial actions are properly recorded.

  • Audit conclusions are discussed with auditee representatives.

  • Deficiencies are corrected by the managers of the audited areas.

  • Audit reports are fed back into quality system review process.

 

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.

 

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.

 

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 obsolete. It has been replaced by ISO 9001:2015.


OTHER ISO 9001 PAGES

ISO 9001 2015 Introduction

Quality Management Principles

Outline of ISO 9001 2015 Standard

Overview of ISO 9001 2015 Standard

ISO 9001 2015 versus ISO 9001 2008

Plain English ISO 9001 2015 Definitions

ISO's Process Approach in Plain English

ISO 9001 2015 Translated into Plain English

Plain English Quality Management Checklist


OTHER STANDARDS

ISO 9004 Quality Standard

ISO 19011 2011 Auditing Standard

ISO 13485 Medical Device Quality Standard

ISO 14971 Medical Device Risk Management Standard

AS9100 2009 Aerospace Quality Management Standard

ISO 90003 Software Quality Management Standard

ISO 28000 Supply Chain Security Management Standard

OHSAS 18001 Occupational Health and Safety Standard

ISO 27001 Information Security Management Standard

ISO 27002 Information Security Management Standard

ISO 14001 Environmental Management Standard

ISO 22000 Food Safety Management Standard

ISO 31000 2009 Risk Management Standard

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Updated on January 12, 2015. First published on June 6, 1997.

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