ISO 9004-3 Standard for Managing the Quality of Processed Materials

This web page is based on the ISO 9004-3:1993 Quality Standard
published by the International Organization for Standardization.
It presents a detailed interpretation of this standard using
language that is clear and easy to understand.

ISO prepared the ISO 9004-3 guidelines to explain how quality assurance
concepts can be applied to organizations that process materials. This web
page will summarize these guidelines by listing the main points. Much of the
material in ISO 9004-3 repeats what we have already discussed elsewhere
(see ISO 9000-2 and ISO 9004-1, for example). To avoid wasting your time,
we have tried to minimize this repetition.

Develop a quality system

Develop a quality system. Develop and implement a quality
system in order to apply your quality policy and achieve your
quality objectives. Your system should:
- Meet customer needs and prevent quality problems.
- Control every phase of your product life cycle including:
  - Market and technical research.
  - Design engineering and product development.
  - Material purchasing, receiving, and storage.
  - Process planning and development.
  - Production, process control, and maintenance.
  - Product inspection, testing, and analysis.
  - Product packaging, handling, and transport.
  - Product sales, use, and disposal.

Develop a quality organizational structure

Develop a quality organizational structure.
- Define and document all quality-oriented activities.
- Define, document, delegate, and distribute the
  responsibility for performing quality-oriented activities.
- Give your people the authority they need to carry out
  all quality system responsibilities.
- Define the patterns of interaction and communication
  that will integrate and regulate your quality system.
- Define the patterns of reporting and accountability
  that will integrate and regulate your quality system.
- Provide the resources that are needed to implement,
  maintain, and improve your quality system.

Document your quality system

Document every aspect of your quality system. Document your
quality policies, procedures, programs, and plans. Documents
will include manuals, records, and reports.
Develop written quality system procedures. Develop procedures
to govern and control all quality-oriented activities. Your
procedures should:
- Implement your quality policy and
  achieve your quality objectives.
- Describe how all quality-oriented
  activities should be carried out.
Develop a quality manual. Develop a manual that describes your
quality system and serves as your main coordinating document.
- Make sure you specify a method for updating your
  manual and controlling document revisions.
- Your quality manual may consist of many manuals
  (one for each department or function, for example).

Develop a quality plan

Develop a quality plan. Develop and document a quality plan
whenever you intend to launch a project to develop a new
product, service, or process. Your quality plan should:
- Define the quality objectives you want to achieve.
- Allocate responsibility and authority for each project phase.
- Develop steps that should be taken to implement the plan.
- Specify tests, inspections, and audits that should be done.
- Explain how your quality plan can be modified.

Perform
internal
audits

Perform internal audits. Your audits should evaluate:
- Organizational and interactional structures.
- Policies, procedures, plans, and programs.
- Work patterns and personnel behavior.
- Tools, technologies, and equipment.
- Processes, products, and services.
- Documents, reports, and records.
Prepare internal audit reports. These reports should:
- Itemize nonconformities, deficiencies, and causes.
- Recommend corrective and preventive actions.
- Evaluate corrective actions that were taken
  in response to previous quality audits.

Develop a management review procedure

Develop a management review procedure. It should explain
how senior managers would evaluate your quality system.
These reviews should:
- Examine internal and external audit results.
- Review how well the quality policy is being applied.
- Evaluate how well quality objectives are being met.
- Recommend how your system can be improved.
- Study the impact that innovation and changes
  in technology are having on your quality system.

Measure quality costs

Measure quality costs. Measure the cost of your quality system
and routinely report this to senior management. Track and
distinguish between:
- Internal quality operating costs. There are two kinds:
  - Investments, which are divided into:
    - Prevention costs. This is money spent trying
      to prevent failures and nonconformities.
    - Appraisal costs. This is money spent on
      testing, inspections, reviews, audits, etc.
  - Losses, which are divided into:
    - Internal failures. This is money spent handling
      nonconforming products before they're sold.
    - External failures. This is money spent dealing
      with nonconforming products after they're sold.
- External quality assurance costs. These are costs incurred
  trying to prove to customers that your quality system meets
  all requirements.

Prepare a product brief

Prepare a product brief. Ask your marketing personnel to
prepare a product brief. This document is a preliminary
specification. It should describe the product and list
customer needs and requirements. Your brief should:
- Define all product performance requirements.
- Specify all sensory and aesthetic requirements.
- Clarify all safety and environmental requirements.
- Discuss all packaging and storage requirements.
- Identify all handling and transportation requirements.
- Highlight all relevant regulatory requirements.

Design your product

Select a design team, develop a design
plan, and then design your product.
- Select a design team. Select a product design team,
  define their responsibility and authority, and give
  them the resources they need.
- Define a product development plan. Ask your design team
  to define your product development project. Ask them to
  define a project plan that lists the steps that should be
  taken and the resources that will be needed.
- Design your product. Ask your design team to:
  - Ensure that customers help translate qualitative
    expectations into quantitative specifications.
  - Translate the product brief into a set of technical
    specifications. Define specifications for:
    - Materials
    - Products
    - Processes
  - Provide definitive technical data that
    can be used to:
    - Purchase raw materials.
    - Verify that products conform to requirements.
    - Confirm that processes meet requirements.
  - Ensure that your product will
    meet regulatory requirements.
  - Describe all of the characteristics that will
    define the quality of the product. They should
    identify characteristics (qualities) such as purity,
    durability, reliability, safety, suitability,
    disposability, longevity and so on.
  - Define all of the characteristics that will be used
    to control the quality of the process and to plan
    process maintenance tasks.
  - Specify product and process testing and
    measurement methods, and define the technical
    criteria that should be used to accept or reject
    product and process results. Specify:
    - Accuracy requirements.
    - Target values and tolerances.
    - Sampling, measurement,
      and analysis methods.

Develop a design review procedure

Develop a design review procedure. This review
procedure should be carried out at the end of each
phase of the design process.
- Your review procedure should:
  - Compare product briefs and specifications.
  - Evaluate both product and process designs.
  - Determine if customers' needs will be satisfied.
  - Inspect and test product samples and prototypes.
  - Verify designs using alternative tests and methods.
  - Verify designs using alternative calculations.
  - Ensure that product misuse will be prevented.
  - Confirm that you can manufacture the product.
  - Prove that your product will meet requirements.
  - Make sure that safety requirements will be met.
  - Make sure that environmental needs will be met.
  - Verify that only approved design features are used.
  - Prove that production process meets requirements.
- Your review procedure should ensure that:
  - Regulatory requirements will be met.
  - Potential product failures will be benign.
  - Product manufacturing needs will be met.
  - Manufacturing costs have been evaluated.
  - Training programs will be ready when needed.
  - Independent design evaluations are performed.
  - Product maintenance requirements will be met.
  - Purity and tolerance requirements will be met.
  - Product performance requirements will be met.
  - Aesthetic and sensory requirements will be met.
  - Product testing and inspections will be possible.
  - Product labeling and tracking needs will be met.
  - Product packaging and handling needs will be met.
  - Raw materials, tools, and supplies will be available.
  - Products can be mass-produced at specified costs.
  - Product delivery and storage needs will be met.
  - Process parameters are known and are controlled.

Perform a market readiness review

Perform a market readiness review. Before you begin full-scale
production, make sure everyone is ready to bring the product to
market. Your review should confirm that:
- Initial products were tested and approved.
- Field personnel are trained and ready to go.
- Field trials and qualitative tests were successful.
- Procedures for handling and storage are ready.
- Product packaging was inspected and approved.
- Distribution and customer service people are ready.
- Procedures for transportation and delivery are ready.
- Production process is capable of making the product.

Control design changes

Develop and document procedures to control changes
in product and process design. These procedures should:
- Regulate the release and use
  of all design documents.
- Control the removal of obsolete
  designs and specifications.
- Authorize and control changes
  in product and process designs.
- Verify that authorized design
  changes were implemented.
- Allow you to make emergency
  changes to avoid nonconformities.
- Ensure that design reviews and
  tests are repeated when needed.

Authorize commercial production

Authorize commercial production of your product.
- Ask your senior management to review and approve all
  documents that define the quality of the product before
  you go ahead with full-scale commercial production.
- Ask your senior management to review and approve
  all documents that specify how the product will be
  manufactured before you go ahead with full-scale
  commercial production.
- Ask your senior management to authorize
  commercial production of your product.

Control purchasing

Develop a quality purchasing program to plan and
control your procurement activities. Your program
should ensure that:
- Purchase orders are used to
  procure materials and supplies.
- Technical documents are used
  to tell suppliers what you want.
- Qualified and competent suppliers
  and subcontractors are chosen.
- Dispute settlement methods have
  been developed and are used.
- Purchased materials and supplies
  are inspected and controlled.
- Records are kept to track purchased
  supplies and services.
- You and your suppliers and
  subcontractors agree:
  - On your approach to quality assurance.
  - On the methods you will use to verify purchases.

Control your purchasing documents

Control purchasing documents. Develop procedures
which will ensure that your purchasing documents:
- Refer to the relevant quality system standards.
- Specify packaging, labeling, and transportation
  expectations and requirements.
- State any laboratory tests and analyses
  that must be conducted and documented.
- Define the grade, composition, and properties of
  the products, supplies, and materials being purchased.
- Request evidence that proves that your suppliers'
  process controls are adequate and functioning properly.
- Ask suppliers to notify you when they plan to make
  changes that may affect the quality of their product
  or process as well as yours.

Control your suppliers

Control the selection and supervision of suppliers.
- Control the selection of suppliers. Develop procedures
  to evaluate and select your suppliers. These procedures
  should ensure that you:
  - Review suppliers' quality systems.
  - Examine suppliers' product test results.
  - Check suppliers' historical performance.
  - Evaluate suppliers' products and facilities.
  - Evaluate suppliers' manufacturing process.
- Control communication with suppliers.
  Develop a feedback system to help you to:
  - Make quality improvements.
  - Solve problems and avoid disputes.
  - Maintain a close working relationship.

Develop quality assurance and verification agreements

Develop quality assurance agreements with your suppliers.
These agreements should help ensure that all supplier products
and services will meet your quality requirements. Such
agreements could specify that you will:
- Rely on the supplier's own quality system.
- Ask suppliers to send inspection or test data
  and documents with each shipment.
- Ask suppliers to send process control
  records with every shipment.
- Expect suppliers to develop and implement an
  ISO 9001, ISO 9002, or ISO 9003 quality system.
- Expect the supplier to perform
  regular independent quality audits.
- Expect suppliers to test or inspect
  every shipment before it leaves.
- Test or inspect every incoming shipment yourself.
Develop quality verification agreements with your suppliers.
These agreements should explain how conformance to quality
requirements would be verified.

Control incoming materials
and supplies

Develop procedures to receive, inspect, and control incoming
products, materials, and supplies. These procedures should:
- Ensure that unqualified or uninspected materials,
  supplies, and products are not accidentally used
  in the production process.
- Make sure that inspections of all incoming materials
  and supplies are planned and executed.
- Specify the characteristics (qualities) that will be
  routinely tested and inspected to assure compliance.
- Ensure that sampling tools, instruments, and containers,
  will be ready for use when materials and supplies arrive.
- Ask suppliers to submit samples for analysis
  before large or costly shipments are initiated.

Control production process

Control your production process. Your production process
must operate under controlled conditions. You must control
your raw materials, supplies, tools, equipment, and instruments.
And you must control your process and environmental variables.
You must:
- Carry out process capability studies to ensure
  that your production process will work properly.
- Define production standards of workmanship.
  These standards should define, in concrete terms,
  what "good" workmanship means. Use work samples,
  pictures, and so on.
- Define causal relationships between production
  process characteristics (qualities) and product
  characteristics (qualities).
- Verify that your production process is consistently
  capable of producing products that conform to all
  quality requirements.
- Confirm that all environmental influences and
  conditions are carefully monitored and controlled.
  Make sure they support and preserve the quality
  of your production process and your products.

Develop process control procedures

Develop process control procedures. Develop procedures
to control every aspect of your production process. Develop
procedures to:
- Make sure raw materials meet
  requirements before they are used.
- Sample, evaluate, and verify the
  quality of processed materials.
- Monitor, evaluate, and verify
  production process characteristics.
- Track and trace materials that are
  used in the production process.
- Control the storage, use, testing, maintenance,
  and repair of all production tools and equipment.
- Verify the performance of special process stages-those
  that have an extremely important impact on process or
  product quality. Evaluate people, equipment, records,
  and measurements.
- Control changes in the production process.
  - Authorize, monitor, and document
    production process changes.
  - Document how particular changes in
    process characteristics create particular
    changes in product characteristics.
  - Define what, when, why, and how production
    process adjustments should be made.

Control incoming products

Develop methods and procedures to monitor and control
the quality of all incoming materials. These methods and
procedures should ensure that:
- Bulk materials are segregated, marked, inspected,
  tested, and accepted before they are used.
- Packaged materials are segregated, marked,
  inspected, and accepted before they are used.
When incoming shipments cannot be inspected or tested
prior to use, make sure you have taken other steps to assure
the quality of these shipments.

Control in-process materials

Develop methods and procedures to monitor and control
the quality of in-process materials. These methods and
procedures should:
- Ensure that all production process parameters stay
  at target values or within a target range of values.
- Use process sensors and equipment to monitor
  and control process performance.
- Use automatic on-line methods and techniques
  to inspect and analyze process materials.
- Use manual off-line methods to analyze the physical
  and chemical composition of process materials.
- Expect process operators to monitor
  instruments and do visual checks.


Control measurement process	Develop procedures to control the measurement process. Your procedures should ensure that: Appropriate measurement equipment is used. Measurement equipment is regularly recalibrated. Unreliable measurement equipment is not used. Measurement methods are tested before use. Reference is made to published standards. Measurement records are maintained.

Control nonconforming products

Develop procedures to control nonconforming products. Your
procedures should ensure that nonconforming products are:
- Identified, segregated, and recorded.
- Reviewed to determine what should be done.
- Used only if customers agree to accept the defect.
- Reworked, reclassified, or scrapped when
  customers have not agreed to accept defects.
- Controlled and contained when they have
  inadvertently been delivered to customers.
  - Develop emergency response plans to deal with
    cases where the sale and delivery of nonconforming
    products is automatic or unavoidable.

Correct or prevent product nonconformities

Develop procedures to correct or prevent product
nonconformities. Procedures should ensure that:
- Responsibility for taking corrective or preventive actions
  and for implementing emergency response plans to deal
  with nonconformities is allocated, and authority is granted.
- The importance of a quality problem, its root causes, and
  its precise impact on quality is analyzed and evaluated.
- Preventive and corrective actions to deal with product
  nonconformities have, in fact, been taken.
- Permanent changes, designed to correct or prevent
  product nonconformities, are suitably documented.
- Product and quality system characteristics are
  monitored to see whether solutions actually work.
- Nonconforming products are recalled when safety,
  environmental, or legal standards have been violated.

Develop
product
handling, storage,
transportation,
and servicing procedures

Develop and document procedures to handle, store,
identify, package, and deliver processed materials.
Develop procedures to:
- Prevent damage, deterioration, or contamination
  during product handling, storage, and transport.
- Identify and track processed materials so that
  product recalls, tests, inspections, and customer
  complaints can be handled.
- Specify how processed materials should be
  packaged in order to prevent product damage,
  deterioration, and contamination.
- Ensure that customers do not accidentally use
  products that have deteriorated during transport.
Develop customer service and support programs.
- Develop an after-sales service program to advise
  customers on how to handle and use your products.
- Develop a customer feedback system to:
  - Collect customer complaints.
  - Track product failures.
  - Initiate corrective actions.
  - Encourage design re-evaluations.

Control quality documents and records

Control quality documents and data.
Develop procedures to control the:
- Creation of quality system documents.
- Use of quality system documents.
- Revision of quality system documents.
- Removal and disposition of old documents and data.
Develop a quality record keeping system and control its use.
This system should identify, collect, index, file, store, and
maintain quality system information.
- Develop a materials record keeping system
  to document the verification status of materials
  used in the production process.
- Develop a production process record
  keeping system to document:
  - Changes in production process parameters.
  - Abnormal production events and activities.
- Develop a measurement equipment record keeping
  system to document the use, maintenance, repair,
  calibration, status, and storage of all measurement
  and test equipment.

Develop quality training, awareness, & recognition programs

Develop training, awareness, and recognition programs.
- Develop an executive training and awareness program
  to teach all senior executives about the quality system,
  including how it should be managed, monitored,
  reviewed, and evaluated.
- Develop a personnel training program that covers all
  aspects of your quality system. Make sure that all workers
  know how to do their jobs, and make sure that all workers
  understand how they contribute to quality.
- Develop a quality awareness program to motivate
  everyone to do their best and to make them aware
  of why quality is important.
- Develop a quality recognition program. Develop a
  quality job recognition program to identify, recognize,
  and reward individual and collective quality
  achievements and improvements.

Develop a product safety program

Develop a safety program that will minimize your risk by
maximizing product safety and minimizing product liability.
Your product safety program should:
- Develop a policy that describes your
  company's attitude towards safety.
- Identify all relevant safety standards and ensure
  that your specifications respect these standards.
- Test all designs and prototypes to ensure that
  they meet all safety requirements.
- Warn customers and users that your product could
  be hazardous if specified precautions are not taken.
- Track your products so that you can trace, recall,
  and investigate safety problems and incidents.
- Identify all relevant safety laws and regulations
  and make sure that your products respect them.


Control the use of statistical methods and techniques	Control the selection and use of statistical methods. Consider using statistical methods and techniques in order to help you to: Study market trends. Define quality levels. Review product designs. Study process capability. Control process performance. Predict product performance. Control measuring equipment. Analyze performance data. Develop inspection plans. Assess product defects. Consider using the following kinds of statistical methods and techniques: Factorial analysis. Regression analysis. Variance analysis. Safety analysis. Risk 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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Processed materials	Processed materials are tangible products that result from transformations. Processed materials can be solids, liquids, or gases, or a combination of these materials. They are usually transported in bulk using pipelines, drums, bags, tanks, cans, or rolls.


Develop a quality policy and quality objectives	Develop a quality policy. Design a policy that describes your attitude towards quality and ensure that it is understood and applied by everyone in your company. Develop quality objectives. Develop objectives that support your quality policy.


Develop an internal quality audit plan	Develop an internal quality audit plan. Develop an audit plan that describes how every element and aspect of your quality system will be routinely evaluated. Your internal audit plan should: List the activities and areas that will be audited. Define the qualifications that auditors should have. Describe how audit results will be reported.


Perform market research	Ask your marketing personnel to: See if there is a demand for the product you wish to develop. Define the market demand and clarify who needs the product. Specify exactly what customers expect from your product. Explain customer needs and expectations to your personnel.


Appoint design review team	Appoint a product and process design review team. Define their responsibility and authority. Ask them to develop a design review procedure.


Re-evaluate products and processes	Develop procedures to periodically re-evaluate your products and processes. Do so in order to: Ensure that all existing requirements are still being met. Determine if changes should be made to meet new requirements.


Verify final products	Develop methods and procedures to prove that your final products meet all quality requirements. Perform acceptance tests and inspections. Take continuous or periodic samples.