ISO 9004-1 Standard in Plain English

This web page is based on the ISO 9004-1:1994 Quality Standard
published by the International Organization for Standardization.
It presents a detailed and comprehensive interpretation of this
standard using language that is clear and easy to understand.


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
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
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.

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 (whenever possible).
  - 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 types of 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 (quality problems) are detected and 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
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 data	Control quality data: Collection Creation Indexing Access Filing Security Storage Retrieval Disposal Availability

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.

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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First published on June 6, 1997. Updated on December 10, 2011.

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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 variables	Monitor, control, and verity those process variables and conditions which influence product quality. Monitor, control, and verity 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 outputs	Develop and document procedures to identify and control process outputs (products). 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.


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 damage 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 quality documents	Control quality documents such as: Plans Reports Policies Manuals Drawings Procedures Instructions Specifications


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.


Evaluate quality performance	Evaluate the skills and performance of anyone directly or indirectly responsible for quality. Measure their quality performance. Recognize their quality achievements.