Senior managers must make a commitment to quality 

• Your senior managers must demonstrate 
  a continuous commitment to quality.

• Your senior managers must define and document:

  • Quality policy.

  • Quality objectives.

  • Quality responsibilities.

• Your senior managers must ensure that your quality policy
  is understood and applied throughout your organization.

• Your senior managers must ensure that your quality objectives
  are understood and achieved throughout your organization.

• Your senior managers must ensure that your quality
  responsibilities are understood and implemented
  throughout your organization.

Senior managers must develop a quality system 

• Your senior managers must develop and 
  implement a quality system in order to:

  • Apply your quality policy.

  • Achieve your quality objectives.

  • Implement your quality responsibilities.

• Your quality system should be able to prove that:

  • Customer needs are being met.

  • Societal obligations are being satisfied.

  • Environmental concerns are being addressed.

• You should be able to prove that your quality 
  system is understood and implemented.

• You should be able to prove that your quality 
  system is effective and well maintained.

• Your quality system must monitor and control every aspect 
  of quality. Any activity, function, or process that influences 
  quality must be monitored and controlled.

  • Your quality system should prevent quality problems. 

  • Your quality system should ensure that quality 
    problems are routinely solved when they do occur.

Your quality system should control product quality 

• Your quality system should control the quality of your product
  during every phase of its lifecycle. These phases can include:

  • Market research and product development. 

  • Process research, planning, and development. 

  • Purchasing, production, packaging, and storage. 

  • Marketing, sales, distribution, and delivery. 

  • Product installation, service, and support. 

  • Product disposal or recycling.

Develop an organizational structure to control your quality system 

• Define the organizational structure that you will need 
  in order to manage and control your quality system.

  • Define and document all quality system activities.

  • Define and document quality system responsibilities.

  • Specify who is responsible for each quality activity.

  • Grant the authority to carry out each responsibility.

  • Clarify the patterns of interaction and communication 
    that affect quality.

Senior managers must provide all quality system resources 

• Identify and provide the resources that people need in order
  to implement and maintain your quality system. Make sure
  that they can:

  • Apply your quality policy.

  • Achieve your quality objectives.

  • Perform quality responsibilities.

• Make sure that people have the following 
  kinds of quality system resources:

  • Skills and knowledge.

  • Tools and equipment.

  • Software and hardware.

  • Facilities and supplies.

  • Data and information.

Develop procedures to control your quality system 

• Develop, document, and implement procedures to:

  • Apply your quality policy.

  • Achieve your quality objectives.

  • Perform your quality responsibilities.

• Quality system procedures should:

  • Define the quality activities that must be performed.

  • Explain how quality activities should be performed.

Document your quality system 

• Document every aspect of your quality system.
  Your quality system documentation should include:

  • Policies

  • Procedures

  • Manuals

• Document your quality system using a quality manual.

  • Your quality manual should be used to guide 
    the implementation of your quality system. 

  • Your quality manual should be used to control 
    the maintenance of your quality system.

  • Your quality manual must also include a procedure 
    that controls how the manual will be revised. 

  • Your quality procedures should support, 
    and be tied into, your quality manual.

Develop
quality 
plans

• A quality plan should be developed for every product, 
  process, project, or contract. It should define the:

  • Quality objectives that must be achieved. 

  • Practices, processes, procedures, programs, methods,
    resources, and equipment that will be used to achieve
    these objectives.

• Specifically, quality plans should define the:

  • Practices and processes you intend to use. 

  • Responsibilities that will be allocated. 

  • Procedures that you intend to follow. 

  • Resources that you will need. 

  • Internal audit programs that you will use.

  • Inspections and tests that you will carry out.

  • Methods that you will use to measure success. 

  • Steps that will be taken to modify your plan.

Perform
internal 
quality
audits 

• Regular internal audits should be carried out to ensure that your
  quality system is implemented and to evaluate its effectiveness. 
  Your internal quality audit program should clarify:

  • What should be audited.

  • Who should carry out the audits. 

  • What audit procedures should be used.

  • What audit reports should be prepared.

  • How corrective actions should be taken.

  • How corrective measures will be evaluated.

  • How audits should be documented.

  • What audit records should be kept. 

• Your audits should examine:

  • Quality system elements.

  • Procedures and processes. 

  • Tools and equipment.

  • Policies and programs.

  • Products and services. 

  • Documents, reports, and records.

  • Personnel activities and practices.

  • Organizational structure and resources.

Perform management reviews 

• Your senior managers should perform quality system reviews. 
  These reviews should be planned and performed on a regular 
  basis. They should:

  • Study the results of your internal audits.

  • Evaluate your quality policy and objectives.

    • Evaluate how well your policy is being applied.

    • Evaluate how well objectives are being achieved.

  • Review and evaluate the activities that support 
    your quality policy and objectives. 

  • Determine whether your quality system should be updated
    response to changes in technologies, quality concepts, 
    corporate strategies, or the business environment.

Encourage continuous
improvement

• Your quality system should create an environment 
  that supports continuous quality improvement.

  • An environment of continuous quality improvement is one
    that encourages everyone to improve the efficiency and
    effectiveness of all activities and processes for the benefit
    of both the organization and its customers. 

  • An environment of continuous improvement:

    • Encourages a supportive management style. 

    • Promotes values that support improvement. 

    • Expects people to set quality improvement goals.

    • Shows people how to make quality improvements.

    • Supports teamwork and good communication. 

    • Recognizes achievements and contributions. 

Measure the financial effectiveness of your quality system

• Measure the financial effectiveness of your quality system. 
  Consider using one of the following methods:

  • The quality-cost approach.

  • The process-cost approach. 

  • The quality-loss approach. 

Quality-cost approach

• The quality-cost approach divides costs as follows:

  • Investments, which are divided into:

    • Prevention costs. This is money spent trying
      to prevent and avoid quality system problems,
      faults, failures, and nonconformities. 

    • Appraisal costs. This is money spent on testing
      and inspection, as well as quality system reviews,
      evaluations, and audits.

  • Losses, which are divided into:

    • Internal failures. This is money spent dealing with
      products, which fail to meet quality requirements,
      before they are sold.

    • External failures. This is money spent dealing with 
      problematic products after they've been sold.

Process-cost approach

• The process-cost approach selects a process, and then 
  figures out what it costs to serve the needs of its customers. 
  It divides costs as follows:

  • The cost of conformity. This adds up all the money spent
    ensuring that the process continues to work properly. 

  • The cost of nonconformity. This adds up all the money that
    must be spent because the process fails to work properly. 

Quality-loss approach 

• The quality-loss approach focuses on losses that are 
  caused by poor quality. It divides losses as follows:

  • Tangible losses. These are losses that result 
    from re-work, repair, warranty work, and so on.

  • Intangible losses. These are losses due to lost 
    opportunities, systemic inefficiencies, and so on. 

Prepare
financial
quality
reports 

• Financial quality reports should be prepared and 
  submitted to senior management. They should:

  • Discuss the effectiveness of your quality system. 

  • Identify quality system weaknesses and problems. 

  • Formulate quality and cost objectives.

Set up
a market research
system 

• Before you develop a product, do market research. 

  • Ask your marketing people to find out:

    • How many customers need the product. 

    • What grade of product customers want. 

    • What price customers are prepared to pay.

    • What customer needs and expectations are.

  • Ask your marketing people to ensure that everyone:

    • Understands what customers need. 

    • Agrees that you can meet customer needs. 

  • Ask your marketing people to specify customer 
    requirements. Ask them to specify:

    • Performance or functional requirements. 

    • Aesthetic or sensory requirements. 

    • Installation or layout requirements. 

    • Packaging and storage requirements. 

    • Quality assurance and verification requirements.

• Ask your marketing people to set up a customer feedback
  system in order to monitor the experience customers have 
  with your products. This will help you to make market 
  oriented improvements.

Prepare
product
design
plans 

• Prepare design plans. Make sure that your design 
  manager prepares a design plan for each product. 
  Make sure that this plan:

  • Describes what tasks and activities must be
    performed and who will be responsible for
    performing each task and activity. 

  • Defines the product development process that will be
    followed including the hold-points that dictate when
    prototypes will be evaluated before the development
    process is allowed to continue.

Control your design process 

• Control your product design process. Make sure that your 
  design team identifies those special product characteristics
  (qualities) that constitute the quality of the product. These
  may include characteristics or qualities such as:

  • Dependability

  • Serviceability

  • Disposability

  • Suitability

  • Longevity

• Control your design team. Make sure that they:

  • Translate customer needs into specifications.

  • Prove that the specified product can be made 
    at a cost that ensures a reasonable profit. 

  • Provide the technical data that other staff members 
    will need to purchase materials, to produce the product, 
    and to verify its quality. 

  • Verify design outputs by means of calculations 
    and the testing of models and prototypes.

  • Validate your designs by evaluating product performance,
    durability, and dependability, and by determining whether 
    your design features will meet customer needs.

  • Confirm that your designs conform to all safety, 
    environmental, and other regulations.

Control your testing and measurement process 

• Explain how products and processes will be evaluated.

  • Explain how your products and processes will be 
    evaluated and accepted during the design phase.

    • Specify product testing and measurement 
      methods, techniques, tools, and equipment.

    • Specify process testing and measurement 
      methods, techniques, tools, and equipment.

  • Explain how your products and processes will be 
    evaluated and accepted during the production phase.

    • Specify product testing and measurement 
      methods, techniques, tools, and equipment.

    • Specify process testing and measurement 
      methods, techniques, tools, and equipment.

Prove that your designs meet requirements 

• Review and verify your product designs in order to identify 
  and prevent problems. Carry out design reviews in order to:

  • Prove that your product will meet all customer 
    needs, expectations, and requirements.

  • Prove that your product will perform properly 
    under all real-world operating conditions.

  • Prove that your product will be durable and 
    dependable in all operational situations.

  • Prove that your product will meet all 
    aesthetic and sensory requirements.

  • Prove that your product will comply with 
    all relevant health and safety regulations.

  • Prove that your product will comply with 
    all relevant environmental regulations.

  • Prove that your product will comply with all 
    relevant national and international standards.

  • Prove that your product will be properly 
    identified, labeled, and tracked.

  • Prove that your product will be properly 
    packaged, handled, and stored.

  • Prove that standard parts can be used to 
    manufacture your product (when required).

  • Prove that your product can be safely handled 
    during storage and under all operating conditions.

  • Prove that you can, in fact, manufacture 
    the product you have designed.

  • Prove that you can test, measure, and 
    inspect the product you have designed.

  • Prove that all materials, supplies, components, 
    and subassemblies have been specified.

  • Prove that all materials, supplies, components, 
    and subassemblies will be available.

  • Prove that all subcontractors and suppliers have 
    been identified and will be available when needed.

  • Prove that all design changes have been reviewed, 
    authorized, implemented, and well documented.

  • Prove that all design reviews and evaluations 
    have been approved and well documented.

  • Prove that final design documents have 
    been created, reviewed, and approved.

Use appropriate design review methods 

• Review your designs in the following way:

  • Compare your designs with other similar designs.

  • Compare your designs with technical specifications.

  • Compare your designs with product specifications.

  • Test, inspect, or demonstrate models.

  • Test, inspect, or demonstrate prototypes.

  • Test, inspect, or demonstrate production samples.

  • Perform risk analyses.

  • Perform fault tree analyses.

  • Perform failure mode and effect analyses.

  • Perform calculations to verify original calculations.

  • Perform independent reviews, tests, and calculations.

Review and verify product qualities 

• Review and verify the following types of 
  product design characteristics (qualities):

  • Dependability

  • Reliability

  • Durability

  • Usability

  • Misusability

  • Availability

  • Buildability

  • Serviceability

  • Maintainability

  • Upgradability

  • Transportability

  • Installability

  • Storability

  • Securability

  • Preservability

  • Identifiability

  • Traceability

  • Disposability

Carry out market readiness review 

• Carry out a market readiness review before you begin 
  full scale production. This review should confirm that:

  • Distribution, service, and field people are ready.

  • Installation, operation, and repair manuals are ready.

  • Product tests and production runs were successful.

  • Spare parts inventory levels are adequate.

Control design changes 

• Develop procedures to control changes in product design. 
  These procedures should make sure that you:

  • Authorize changes in product design. 

  • Verify that authorized changes were implemented.

  • Control the release of documents that define changes. 

  • Manage the use of documents that define changes.

  • Make emergency design changes, when necessary.

  • Authorize the removal of obsolete documents.

  • Remove obsolete drawings and specifications.

  • Verify that obsolete documents are removed. 

Re-evaluate your designs 

• Perform regular design re-evaluations to ensure that 
  designs are still valid. Re-evaluations should study:

  • Customer feedback

  • Field experiences

  • New technologies

  • New trends

  • Specifications

  • Process modifications

  • Production experiences

Develop a purchasing system 

• Develop and document a quality purchasing system. 
  Your purchasing system should control:

  • Purchasing documents

  • Subcontractor selection

  • Purchase quality

  • Verification methods

  • Dispute settlement

  • Product receiving

  • Purchasing records.

Control your purchasing documents 

• Develop procedures to control the preparation and use
  of purchasing documents (specifications, drawings,
  purchase orders, etc.).

  • Make sure that your purchasing requirements 
    are clearly and completely defined.

  • Make sure that the product you wish to 
    purchase is clearly and completely defined.

  • Make sure that your subcontractors understand 
    exactly what you want to purchase.

  • Make sure that your purchasing documents 
    refer to all relevant quality system standards.

  • Make sure that inspection and testing instructions 
    are clearly and completely defined.

  • Make sure that your purchasing documents 
    are approved before they are released.

Control your subcontractors 

• Monitor and control your subcontractors and suppliers.

  • Develop procedures to ensure that subcontractors 
    are competent. Ensure their competence by:

    • Evaluating subcontractor products and facilities. 

    • Checking subcontractors' historical performance. 

  • Develop a subcontractor feedback system. Such a system 
    should allow you to maintain a close working relationship 
    with the people who supply you with products and services.

  • Develop a procedure to manage disputes
    between you and your subcontractors.

  • Develop quality assurance agreements
    with your subcontractors.

  • Develop quality verification agreements
    with your subcontractors.

Develop quality
agreements with your subcontractors 

• Develop quality assurance agreements with your subcontractors.
  These agreements should help ensure that all subcontractor 
  products and services will meet your quality requirements. 
  Such agreements could specify that you will:

  • Rely on the subcontractor's own quality system.

  • Ask subcontractors to send inspection or test 
    data and documents with each shipment.

  • Ask subcontractors to send process control 
    records with every shipment.

  • Expect subcontractors to develop and implement 
    an ISO 9001, ISO 9002, or ISO 9003 quality system.

  • Expect the subcontractor to perform regular 
    independent quality audits.

  • Expect subcontractors to test or inspect 
    every shipment before it leaves.

  • Test or inspect every incoming shipment yourself.

• Develop quality verification agreements with your
  subcontractors. These agreements should explain how
  conformance to requirements would be verified.

Control
incoming
products 

• Develop plans and procedures to control product receiving. 
  These plans and procedures must:

  • Prevent the unintentional use or misuse 
    of nonconforming products.

  • Ensure that all inspection tools and equipment 
    are available, calibrated, and ready for use.

  • Make sure that all receiving and inspection 
    personnel are suitably trained.

• Develop a product receiving and inspection 
  record keeping system in order to:

  • Monitor subcontractor performance.

  • Facilitate product traceability.

  • Analyze historical trends.

Control
process
quality 

• Develop and document plans, procedures, and work instructions 
  to control process conditions. These plans, procedures, and
  instructions should be used to control your:

  • Production

  • Products

  • Services

  • Materials

  • Supplies

  • Personnel

  • Practices

  • Workmanship

  • Standards

  • Packaging

  • Handling

  • Delivery

  • Software

  • Equipment

  • Environment

  • Utilities

• Define and document concrete standards of good workmanship 
  by using photographs, diagrams, and work samples.

  • Make sure that these workmanship standards are built 
    into all relevant procedures and instructions.

Verify
process
quality 

• Verify the quality of your process. At key points 
  in your process, verify the condition and status of:

  • Products

  • Materials

  • Hardware

  • Software

  • Services

  • Supplies

  • Production

  • Environment

• Develop and document plans and procedures to 
  verify the quality of both in-process and final products.

• Develop and document procedures to test and 
  inspect every product quality (characteristic).

Monitor
process
quality 

• Monitor and control the relationship between process 
  variables and final product characteristics.

  • Document the relationship between process 
    variables and product characteristics.

  • Make sure that process personnel understand the
    relationship between process variables and product
    characteristics.

• Verify final product quality whenever process 
  quality cannot be reliably established.

Verify
process
capability 

• Make sure that your production process is capable 
  of producing the products you intend to produce.

  • Identify all of the processes that affect product
    quality and verify that these processes can,
    in fact, produce a quality product.

  • Develop methods to encourage personnel
    to improve the quality of all processes

>>> TO SEE THE REST OF ISO 9004-1, PLEASE GO TO PAGE TWO <<<

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