ISO 9004-1 1994 in Plain English

Guidelines for Managing Quality System Elements

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ISO 9004-1 1994 is technically obsolete but still very useful.
It was replaced by the new ISO 9004 2009 quality standard.

We've also translated the ISO 9001 2015 standard into plain English.

 

Control environmental influences 

  • Identify, monitor, verify, and control all the environmental factors that can influence process and product quality.  Control environmental factors such as:                

    • Air

    • Water

    • Power

    • Humidity

    • Temperature

    • Contaminants

    • Chemicals

 

Control
handling
process 

  • Develop and document product-handling methods  that will protect and preserve product quality.

    • Develop product-handling methods that will  protect the quality of all incoming products.

    • Develop product-handling methods that will  protect the quality of all in-process products.

    • Develop product-handling methods that will  protect the quality of all final products.

 

Control
process
materials 

  • Control all materials, parts, components,  and products throughout their life cycle.           

    • Inspect incoming materials, parts, components,  and products before they enter a process.

    • Assign unique identifiers to all incoming products and maintain a record of these identities throughout  the products' life cycle. This record should allow you  to trace products back to their origins.

    • Protect in-process products through proper  monitoring, handling, and storage.                     

 

Control
process
equipment 

  • Control the use, maintenance, and storage of all kinds of process equipment. Control your process tools, machines, templates, patterns, jigs, gauges, and instruments.

    • Verify the accuracy and suitability of your  process equipment before you use it.                   

    • Recalibrate your process equipment  whenever accuracy is no longer assured.

    • Establish preventive maintenance programs  to control those process equipment characteristics  that influence product quality.                                

    • Protect your equipment when it's not being  used; make sure that it's stored properly.

 

Control
process
variables

  • Monitor, control, and verity those process variables  and conditions which influence product quality.  Monitor, control, and verify the:                    

    • Accuracy of process data.

    • Reliability of process equipment.

    • Effectiveness of process operators.

    • Suitability of environmental conditions.

    • Acceptability of process records and documents.

 

Control
process
changes 

  • Develop and document procedures to control process changes.  Your procedures should ensure that process changes are:

    • Authorized

    • Documented

    • Approved

      • By management

      • By customers

  • Document any change in the relationship between  process characteristics and product qualities.

    • Make sure that process changes do not  undermine product quality.                         

    • Make sure that all participants are made aware of changes  in the relationship between process and product quality.

 

Control
process
outputs 

  • Develop and document procedures to identify and control  process outputs. These output control procedures  should ensure that you:                                   

    • Distinguish between outputs that have been  verified and those that have not yet been verified.

    • Distinguish between outputs that conform  to requirements and those that do not conform.

 

Verify
incoming
products 

  • Develop methods to verify the quality of purchased products.  Verify the quality of purchased materials, parts, components,  and assemblies. Your verification methods should consider:

    • How much influence the purchased product has  on the quality of your final products.

    • How much control your subcontractor (supplier)  has over the quality of his own products.

 

Verify
in-process products 

  • Develop methods to verify the quality of in-process products.  Your verification methods will include inspections and tests,  and should consider:                                         

    • Where in-process verifications should be performed.

    • When in-process verifications should be performed.

    • How in-process verifications should be performed.

    • What in-process characteristics should be verified.

    • What in-process verifications should be done.  Your options include:                                  

      • Setup inspection and testing.

      • First-piece inspection and testing.

      • Operator inspection and testing.

      • Automatic inspection and testing.

      • Stationary inspection and testing.

      • Mobile inspection and testing.

  • Make sure that your in-process products are verified  before they are released for further processing.

    • But, if an in-process product has been identified as one  that can be recalled and replaced if it doesn't meet your requirements, then you may release it for further  processing without verification.                          

 

Verify
final
products 

  • Develop methods to verify the quality of your final products.  These methods should include product acceptance inspections  and product quality audits. In either case, you will:

    • Verify all or some products.

    • Sample continuously or periodically.

  • Make sure that you control nonconforming products. Make sure that nonconforming products are:

    • Identified and documented.

    • Segregated or removed.

    • Reworked or repaired.

    • Re-graded or scrapped.

    • Re-tested or re-inspected.

  • Make sure that final products are not released until  all relevant quality plans and procedures have been  performed, all documents have been completed,  and all approvals have been granted.

 

Control
measuring equipment

  • Control all equipment, systems, and methods used to  measure, test, and inspect the quality of your products.

    • Control equipment, systems, and methods used  during product development, production, installation,  and servicing.                                           

    • Control all kinds of hardware and software  including gauges, instruments, and sensors.

    • Control the amount of measurement uncertainty.  Make sure that this uncertainty is known and is  reasonable, given the degree of precision needed  to verify the quality of your products.

    • Control all personnel used to measure, test,  and inspect the quality of your products.

    • Control how your subcontractors measure, test,  and inspect the quality of their products.

    • Control how outside agencies measure, test,  and inspect the quality of your products.

 

Develop measurement procedures 

  • Develop procedures to control all equipment, systems, and  methods used to measure, test, and inspect the quality of  your products. Your measurement procedures should:

    • Control the use of all equipment, systems, and  methods used to measure, test, and inspect.

    • Control the selection of all equipment, systems,  and methods used to measure, test, and inspect.

      • Equipment, systems, and methods must  be suitable, accurate, and robust.

    • Control the testing of all equipment, systems, and methods used to measure, test, and inspect.

      • Automatic measurement equipment and systems  should be tested before they are used.

    • Control the calibration of all equipment, systems,  and methods used to measure, test, and inspect.

      • Equipment and systems should be calibrated  before they are used for the first time.

      • Equipment and systems should be calibrated  according to nationally or internationally  recognized standards.                           

      • Equipment and systems should be recalibrated  in order to maintain measurement accuracy.

    • Control the documentation of equipment, systems,  and methods used to measure, test, and inspect.

      • Develop a system of documents and records in order to track the following data:                

        • Identity numbers

        • Usage patterns

        • Recall status

        • Calibration data

        • Calibration status

        • Repair information

        • Adjustment instructions

        • Handling guidelines

        • Storage rules

 

Correct measurement problems 

  • Take corrective actions whenever your equipment, systems,  and methods fail to accurately measure, test, and inspect  the quality of your products.                                     

    • Investigate what happened and pinpoint causes.

    • Evaluate the impact that measurement problems  have had on the quality of completed work.

    • Decide whether recalibration, retesting, rework,  or rejection will be necessary.                           

    • Develop corrective actions. Your corrective actions  should address causes and consequences, and  should prevent recurrence.                          

      • Recheck previous calibration results whenever  your equipment is found to be out-of-calibration.

 

Control nonconforming products

  • Develop and document procedures to control  nonconforming products. Your procedures should:

    • Prevent nonconforming products from being  shipped to customers without their approval.

    • Avoid the cost of having to repair, rework,  regrade, and retest nonconforming products.

Identification

  • Develop and document procedures to identify nonconforming products. These procedures should ensure that nonconforming products are:                                                             

    • Immediately discovered.

    • Properly recorded.

Segregation

  • Develop and document procedures to segregate nonconforming products. These procedures should ensure that nonconforming products are:                                             

    • Marked or identified as such.

    • Segregated from those that conform.

Review

  • Develop and document procedures to review and dispose of nonconforming products. These procedures should help you to:

    • Decide whether nonconforming products should be:

      • Accepted without modification.

      • Reworked or repaired.

      • Re-tested or re-inspected.

      • Re-graded or scrapped.

    • Ensure that your nonconformance decisions are  documented with cautionary notes and waivers.

Action 

  • Develop and document procedures to ensure that corrective  actions are taken to deal with nonconforming products.  Your procedures should ensure that you:

    • Prevent the unintentional or inadvertent use of nonconforming products.                          

    • Review other related products or product batches that could also be noncompliant.

    • Limit the cost of having to modify, repair, rework, or scrap nonconforming products.

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

    • Recall nonconforming products whenever you or your customers could be at risk.

    • Prevent a repeat of the same type  of nonconformity.                                       

 

Control corrective
actions

  • Control how nonconformities are detected are corrected. Detect nonconformities by studying:            

    • Market feedback

    • Customer complaints

    • Nonconformity reports

    • Management reviews

    • Audit reports

Assign responsibility

  • Define who is responsible for and has the authority to:

    • Initiate and coordinate corrective actions.

    • Implement and monitor corrective actions.

    • Document and record corrective actions.

Evaluate importance

  • Evaluate the importance of each nonconformity. Nonconformities increase in importance when  they cause:                                                         

    • Costs to increase.

    • Safety to decrease.

    • Performance to decrease.

    • Dependability to decrease.

    • Customer satisfaction to decrease.

Analyze
causes

  • Determine exactly why nonconformities occur. Identify  and analyze the root causes of each nonconformity and  record your findings.                                        

    • In order to thoroughly understand what happened, you might need to study processes, operations, specifications, records, reports, and complaints.               

    • In order to ensure that you learn from previous experience, consider setting up a permanent nonconformity record keeping system.                                                  

Eliminate
causes

  • Eliminate the causes of each nonconformity. In order  to eliminate causes, you may need to modify:

    • Product specifications

    • Production processes

    • Packaging techniques

    • Servicing procedures

    • Delivery methods

    • Storage systems

Prevent
recurrence 

  • Prevent the recurrence of each nonconformity by:

    • Monitoring results

    • Controlling processes

    • Institutionalizing change

      • Institutionalize quality solutions by making permanent changes in procedures, process documents, work instructions, specifications, and quality system documents.                      

 

Control
storage
conditions

  • Develop and document methods to control product  storage. Your methods should ensure that you:

    • Protect products from loss, misuse,  damage, or deterioration.                           

    • Monitor products to detect loss, misuse, damage, or deterioration.                            

 

Control
product
delivery

  • Develop and document procedures to control product  delivery. Your procedures should ensure that you:

    • Protect products from loss, misuse, damage, or deterioration.                            

    • Prevent the shipment and use of products that are damaged or have deteriorated.

 

Control
product
installation 

  • Develop and document procedures to control product installation  and field assembly. Your procedures should ensure that:

    • Products are properly installed.

    • Product quality is protected.

    • Product safety is assured.

 

Control
service
delivery 

  • Develop and document procedures to control service  delivery. Your procedures should ensure that you:

    • Manage the availability of spare parts.

    • Control the provision of technical advice.

    • Assure the competence of service personnel.

    • Control the distribution of service responsibility.

    • Govern the use of service tools and equipment.

    • Control the use of testing tools and equipment.

    • Validate the effectiveness of service equipment.

    • Control the use of measuring tools and instruments.

 

Control
market
feedback 

  • Develop and document an early warning system to control market feedback. Your early warning system should allow you to:

    • Monitor the quality of your products.

    • Identify product faults and failures.

    • Detect and report customer complaints.

    • Track customer needs and expectations.

    • Ensure that information about problems is fed back  to design, production, and service departments.

    • Take rapid corrective and preventive actions.

 

Develop
quality
records

  • Develop a quality record keeping system. This system  should control quality records, documents, and data.  It should allow you to:                                           

    • Collect and record quality information.

    • Retrieve information without difficulty.

    • Prove that your quality system works properly.

    • Prove that all quality requirements are being met.

    • Prove that your quality system is implemented.

    • Monitor the effectiveness of corrective actions.

    • Identify quality problems and nonconformities.

    • Discover quality system patterns and trends.

 

Control
quality
records 

  • Develop and document policies and procedures to control  quality records, documents, and data. Your policies and  procedures should ensure that you:

    • Control the creation of quality records.

    • Include quality records provided by contractors.

    • Protect quality records from unauthorized access.

    • Control customer and contractor access to records.

    • Produce documents that are dated and easy to read.

    • Prevent records from being altered without approval.

    • Protect quality records from loss, misuse, or abuse.

    • Safeguard records from damage or deterioration.

    • Specify how long old records should be retained.

    • Remove, archive, or destroy old quality records.

 

Control
quality
documents 

  • Control quality documents such as:

    • Plans

    • Reports

    • Policies

    • Manuals

    • Drawings

    • Procedures

    • Instructions

    • Specifications

 

Control
quality
data 

  • Control quality data:

    • Collection

    • Creation

    • Indexing

    • Access

    • Filing

    • Security

    • Storage

    • Retrieval

    • Disposal

    • Availability

 

Control
personnel qualifications 

  • Control the qualifications of anyone directly  or indirectly responsible for quality.                               

    • Define the required qualifications of personnel  directly or indirectly responsible for quality.

    • Document the actual qualifications of personnel  directly or indirectly responsible for quality.

 

Identify
training
needs 

  • Identify the training needs of anyone directly  or indirectly responsible for quality.

    • Identify executive training needs.

    • Identify staff training needs.

    • Identify new employee training needs.

 

Control
executive
training 

  • Develop and document procedures to control the training  of all executives. Your procedures should ensure that  executives and managers understand:

    • How the quality system functions.

    • How to manage the quality system.

    • How to review the quality system.

 

Control
staff
training

  • Develop and document procedures to control the training  of all non-management personnel. Your procedures should  make sure that anyone directly or indirectly responsible for  quality receives the appropriate training.

    • Make sure that the following kinds of people  understand how they influence quality:

      • Technical staff

      • Operational staff

      • Marketing staff

      • Purchasing staff

      • Engineering staff

    • Make sure that all process operators  and supervisors understand:                 

      • How to assure quality.

      • How to promote safety.

      • How to operate their equipment.

      • How to interpret their documentation.

    • Make sure that all new employees understand  how their performance will influence quality.

    • Make sure that suitable training records are kept.

 

Motivate
quality
personnel 

  • Develop a quality awareness program to motivate  anyone directly or indirectly responsible for quality.

    • Motivate your personnel by ensuring that they:

      • Understand how to do their jobs.

      • Understand how they can influence quality.

      • Understand how they fit into the big picture.

    • Encourage all managerial, clerical, operational, production, inspection, design, purchasing, marketing, shipping, and servicing personnel to make a genuine commitment to quality.                                       

 

Evaluate
quality
performance

  • Evaluate the skills and performance of anyone  directly or indirectly responsible for quality.

    • Measure their quality performance.

    • Recognize their quality achievements.

 

Control
product
safety 

  • Control the safety of your products.

    • Identify and apply relevant product safety standards.

    • Test the safety of product designs and prototypes.

    • Write product manuals and instructions that warn  users about potential safety hazards.

    • Establish product-tracking systems that allow  you to trace and recall hazardous products.

    • Develop an emergency recall plan in case it becomes  necessary to pull a hazardous product off the market.

 

Control
statistical
methods

  • Develop and document procedures to control the  selection of statistical methods and techniques.

  • Develop and document procedures to control the  application of statistical methods and techniques.

  • Use statistical methods and techniques to:

    • Study product performance.

    • Study process performance.

    • Analyze nonconformities.

    • Review product designs.

    • Explore market trends.

    • Evaluate safety.

    • Analyze risk.

  • Consider using:

    • Factorial analysis.

    • Regression analysis.

    • Variance analysis.

    • Control charts.

    • Correlation analysis.

    • Sampling techniques.

 

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 Updated on November 29, 2014. First published on June 6, 1997.

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