ISO 9000-2 1993 Guidelines in Plain English

Guidelines for applying the ISO 9001:1994, ISO 9002:1994, 
and ISO 9003:1994 quality management standards

ISO 9000-2

4.1 Management responsibility 

Quality commitment

• Your senior managers must demonstrate their continuous commitment to your quality policy and your quality system. This commitment should be both active and visible.

• Senior managers can show their commitment by:

  • Ensuring that all staff members understand the 
    quality policy and how it is applied.

  • Demanding strict adherence to the quality policy.

  • Ensuring that the quality system is well designed.

  • Ensuring that quality system is fully implemented.

  • Making sure quality system design and 
    development resources are adequate.

• Make sure all management and staff members 
  understand how their jobs affect quality.

• Make sure all management and staff members 
  have the authority they need to do their jobs properly.

• Make sure everyone in your organization feels 
  responsible for the quality of products and services. 

• Make sure people are appointed to monitor your quality system and to report their observations directly to senior management.

• Identify and provide the resources that people need to verify 
  quality system work. Make sure that your staff members:

  • Understand why verification is important and how 
    verification tasks and activities must be performed.

  • Have enough time to carry out inspection, testing, 
    and verification tasks and activities.

  • Have the equipment they need to perform
    verification tasks and activities.

  • Use only approved verification procedures.

  • Have easy access to quality records.

• Senior managers should carry out quality system 
  reviews. These reviews should evaluate:

  • Process performance.

  • The quality of your products. 

  • The structure of your organization.

  • The structure of your quality system.

  • The adequacy of staffing and resources. 

  • How well the quality system is implemented. 

  • Feedback received from customers and staff.

• Make sure that quality review results are documented 
  and discussed with the people who are affected.

• Changes to your quality system must be 
  designed and implemented without delay.

ISO 9000-2

4.2 Quality system

Quality awareness

• Make sure employees understand your 
  quality system and how it functions.

• Make sure employees understand how they fit into 
  the quality system and what their responsibilities are. 

Quality manual

• Your quality manual could be several manuals. You could have one quality system manual that is supported by several more detailed procedure manuals. All of these define your quality system. 

Quality plans 

• Quality plans can also have several levels, from general to specific. Like procedures, quality plans explain how quality requirements will be met. But, unlike procedures, plans are usually tied to a time frame and often involve contractual obligations.

ISO 9000-2

4.3 Contract review

Customer contracts 

• Make sure you understand what customers need. 

• Make sure that everyone who should review customer contracts actually does so. 

• Make sure that all contract review questions 
  are answered before the contract is finalized.

• Make sure that your customer's contractual 
  requirements are completely specified.

• Make sure that all participants have reviewed 
  and understood the contractual requirements.

• Make sure that your organization is capable 
  of supplying the products ordered by customers.

• Make sure that you and your customers agree 
  on what is required before you agree to the contract.

• Make sure you've developed quality plans that 
  show how contractual obligations will be met.

ISO 9000-2

4.4 Design control

Introduction

• Design control is important because many quality requirements can be satisfied through good design. Control all types of design activities. Make sure you control service design, software design, process design, as well as product design activities.

Design planning

• Develop procedures to control your design and development planning process. These planning procedures should ensure that:

  • Work is scheduled.

  • Responsibilities are distributed.

  • Designs are reviewed and verified.

  • Product safety is reviewed and evaluated.

  • Product performance is reviewed and evaluated.

  • Product dependability is reviewed and evaluated.

  • Product measurement and testing is performed.

  • Other related plans and procedures are respected.

Design
teamwork

• Make sure that design and development 
  responsibilities are allocated to qualified people.

• Make sure that design teams have access to the information they need to do their jobs.

• Your design teams should know:

  • What kinds of information should be shared.

  • Who should get this information.

  • How it should be transmitted.

  • What records should be kept. 

• Make sure that design input is documented, organized, and controlled. Make sure that the people who give and receive input clearly understand how this input process should be carried out.

Design description document

• Use a design description document to:

  • Define and record all design input requirements.

  • Quantify design requirements as much as possible.

  • Record how customer requirements will be met.

  • Record how regulatory requirements will be met.

  • Record design agreements, resolutions, and solutions.

  • Identify any materials, processes, technologies, or techniques that need to be developed.

• Develop procedures to update and distribute changes to the design description document.

  • Make sure that you specify when the design description document should be updated, who should do it, and who should get a copy.

• The design process transforms design inputs into design outputs.

  • Design outputs are documents. They include drawings, parts lists, process specifications, servicing procedures, and storage instructions.

  • Design output documents are used for purchasing, production, installation, inspection, testing, repair, maintenance, and servicing.

Design verification

• Use at least two different methods to verify your design outputs.

• The people who did the design work should not verify outputs. 

• Your design reviewers should be competent.

• Your designs should meet all:

  • Product-input requirements.

  • Process-input requirements.

  • Service-input requirements.

  • Safety-input requirements.

  • Environmental-input requirements. 

  • Functional-input requirements.

  • Operational-input requirements. 

• Your designs should respect processing capabilities.

• Make sure that the materials and components, 
  which will make up your product, are compatible.

• Make sure that product components can be serviced.

• Make sure that you've selected the right materials.

• Make sure that you've selected the right facilities.

• Make sure you can actually implement your design.

• Make sure you can achieve the required tolerances. 

• Verify the accuracy of any design calculations 
  and analyses carried out by computer.

• Document all computer inputs and outputs.

• Verify the validity of all your design assumptions. 

• Test your products in realistic settings.

  • Test and verify product performance.

  • Test and verify product safety.

• Use alternative calculations to verify designs, 
  but make sure that these calculations are appropriate.

• Use proven designs to verify new designs, but do 
  so only if it is realistic to compare these two designs.

Design changes 

• When designs must be changed after the design phase is finished, make sure that previous design verification results are still valid.

• When one aspect of a design is changed, make sure 
  that it doesn't damage the integrity of the design.

• When designs have been changed, make sure 
  your design verification procedures are still valid.

• Develop procedures to ensure that design changes are 
  officially authorized before they are implemented.

• Develop procedures to ensure that all authorized 
  design changes are recorded.

• Develop procedures to ensure that all authorized 
  design changes are communicated to the participants.

ISO 9000-2

4.5 Document control

Quality document and data control procedures

• Control your quality documents and data by:

  • Specifying which documents should be controlled.

  • Developing procedures to control what, when, why, 
    where, and how documents should be:

    • Created

    • Approved

    • Issued

    • Stored

    • Modified

    • Removed

    • Destroyed

    • Archived

• Control documents and data in areas such as purchasing, design, and inspection. In general, all documents and data related to the quality system, and the work that is carried out within the system, should be controlled.

Document and data changes 

• Develop procedures to control changes in documents and data. Make sure that these procedures:

  • Guarantee the accuracy of changes. 

  • Control the initiation of changes. 

  • Control the authorization of changes.

  • Control the documentation of changes.

  • Consider the consequences of changes.

  • Get input from people who are affected by changes.

• Make sure that changes in both internal and 
  external documents are controlled.

ISO 9000-2

4.6 Purchasing

 Introduction

• Control the purchasing process by regulating the:

  • Review and selection of subcontractors (suppliers).

  • Development of purchasing requirements.

  • Verification of purchased products and services.

  • Inspection of purchased products and services.

Subcontractors and suppliers

• Make sure that you have a good working relationship with your subcontractors (suppliers).

  • Make sure that the lines of communication are open.

• When you choose your subcontractors (suppliers), consider whether:

  • They have supplied similar products or services.

  • Their previous performance was satisfactory.

  • Their quality system has been evaluated and certified to an appropriate standard by:

    • A reputable independent audit firm.

    • Your own quality auditors.

• Review the performance of your subcontractors, 
  and do so on a regular basis.

Purchasing records and documents

• Maintain records that show how each subcontractor is selected. Make sure that these records also show that each subcontractor meets your quality and contract requirements.

• In order to assure the quality of purchased products and services, make sure that your purchasing documents precisely describe what you want to purchase from subcontractors (suppliers).

• In order to ensure that your purchasing documents precisely describe what you want to buy, make sure that your:

  • Purchase orders are complete and well defined.

  • Contracts define all obligations and expectations.

  • Purchasing documents refer to all the appropriate:

    • Technical specifications.

    • Quality standards.

    • Testing expectations.

    • Inspection requirements.

• Make sure that you specify who is responsible for approving purchasing documents and data, including purchase orders and contracts.

Customer review of your product and service purchases 

• Customers sometimes wish to verify the quality of products and services that you purchase on their behalf. When this is the case, make sure that:

  • Your subcontracts clearly specify that your customers will want to evaluate the quality of the product or service either at the subcontractor's premises or at yours.

  • Your customers are allowed to review any information you have about your subcontractor's products and services.

  • You retain full responsibility for assuring the quality of the products and services that you purchase on their behalf.

ISO 9000-2

4.7 Customer-supplied product

Control of products
supplied by customers 

• Customers sometimes provide supplies, materials, products, services, or equipment that you are expected to use in order to produce products and services for those customers. In such cases, you must:

  • Ensure that these items are suitable.

  • Ask the customers to tell you how to handle, 
    store, and maintain these items.

  • Examine the items when you receive them to confirm that the right items were shipped withoutloss, damage, or deterioration.

  • Inspect customersupplied products periodically in order to detect any damage or deterioration.

  • Monitor the storage environment to ensure that customer supplied products are secure.

  • Clarify who is responsible for telling customers that products supplied to you by them are unsuitable, damaged, or missing.

  • Document the above.

ISO 9000-2

4.8 Product identification and traceability

Identifying and tracing your products 

• Identify products by marking or tagging:

  • Products, or 

  • Product batches, or

  • Product containers

• Trace products by using unique:

  • Serial numbers

  • Date codes

  • Lot numbers

  • Batch identifiers

  • Container markings 

• You may need to use special identifiers to indicate:

  • Who worked on the product. 

  • What raw materials were used. 

  • What tools and equipment were used. 

  • What process methods were applied. 

• Inspection and stock records should use suitable product identifiers.

ISO 9000-2

4.9 Process control

 Introduction

• All products and services are created, produced, 
  and provided by means of processes. 

• Process control is necessary in order to avoid 
  product and service nonconformities.

• Monitor and control the process characteristics that 
  influence the quality of your products and services.

Procedural controls

• Develop procedures to monitor and control the 
  materials and supplies that enter your processes. 

• Develop procedures to monitor and control processed 
  materials, ingredients, and internal components.

• Develop procedures to ensure that process 
  hardware and software works properly.

  • Make sure that process tools, equipment, 
    and instruments are calibrated and maintained.

• Develop procedures to ensure that processed materials are:

  • Securely stored.

  • Properly handled.

Process controls 

• When product quality cannot be easily measured and established at the finished product stage, make sure that you monitor and control:

  • Process parameters.

  • Personnel performance.

  • Environmental conditions.

  • Raw material characteristics.

  • Process data and documents.

  • Process tools and equipment.

  • Measurement tools and instruments.

• Whenever product quality cannot be easily measured and established at the finished product stage, make sure that your production process meets all quality requirements before you start producing products.

ISO 9000-2

4.10 Inspection and testing

• Develop a record keeping system that you can use to document product testing and inspection activities.

Incoming product inspections

• Develop procedures and plans to verify that incomingshipments:

  • Arrive undamaged.

  • Fulfil quality requirements.

  • Meet contractual obligations.

  • Come with the right documents.

• Inspect or test incoming shipments whenever 
  quality cannot be assured by other means.

• Develop procedures that explain how your staff should handle incoming shipments that do not conform. 

• You may release incoming shipments without inspecting them only if you formally designate them as subject to future recall, and if:

  • Future nonconformities can be addressed without 
    compromising the quality of your products.

  • Future corrections and repairs can be performed without compromising the quality of related parts and components.

• Clarify who has the authority to release incoming products subject to recall, and describe the conditions under which release is allowed.

• Develop procedures to control what happens to incoming products that were released without inspection and later found not to conform.

In-process inspections

• In-process inspection should be carried out in order 
  to detect nonconformities as early as possible.

• Use statistical techniques to monitor and control 
  product and in process parameters.

• Make sure that in-process test and measurement 
  results are accurate and objectively reported.

Final product inspections 

• Make sure that final products are inspected 
  before they are made available for sale.

• Make sure that final products are approved 
  before they are made available for sale.

ISO 9000-2

4.11 Inspection, measuring, and test equipment

Measurement equipment control

• Your measurement process should ensure that:

  • Appropriate measurements are done. 

  • Suitable measuring equipment is used. 

  • Effective measuring procedures are applied.

• Your inspection, testing, and measuring equipment must help you to control your production process and the quality of your products. 

• Measurement instruments can be either tangible (e.g.equipment) or intangible (e.g. questionnaires).

ISO 9000-2

4.12 Inspection and test status

Inspection and test status of products 

• The inspection and test status of your products should be clearly indicated by means of tags, marks, numbers, physical location, or other suitable means. 

• Your inspection and test procedures should ensure that products are identified and (if possible) segregated according to their test status.

• Your products can have the following types of status:

  • Products that have not been inspected.

  • Products that have been inspected.

    • Products that have been accepted.

    • Products that have been rejected.

    • Products that have been placed on hold.

ISO 9000-2

4.13 Control of nonconforming products

Nonconforming product control procedures 

• Develop procedures to control nonconforming products. These procedures should make sure that you:

  • Prevent the inappropriate use of your 
    nonconforming products and services.

  • Avoid the inadvertent use of your subcontractors' 
    (suppliers') nonconforming products and services.

  • Determine exactly where each nonconforming product came from, when it was made, who made it, what materials were consumed, what tools and equipment was used, and how it was produced.

  • Mark all nonconforming products so that they 
    can be distinguished from those that conform.

  • Evaluate and analyze each nonconformance 
    in order to determine how and why it happened.

  • Document all product and service nonconformities, including details about where, when, and how they were produced.

  • Decide what should be done with nonconforming
    products, and document your decisions.

  • Control the storage, use, and disposition 
    of your nonconforming products.

  • Notify all relevant parties whenever 
    a product nonconformance is discovered.

  • Record what is done with nonconforming products.

ISO 9000-2

4.14 Corrective action

Nonconformity

• Nonconformities can occur during:

  • Production and storage.

  • Handling and delivery.

  • Installation and servicing.

Causes of nonconformity

• Nonconformities can be caused by:

  • Tool and equipment faults and malfunctions.

  • Material and supply defects and deficiencies.

  • Process control defects and breakdowns.

  • Process variations and deficiencies.

  • Procedural gaps and weaknesses.

  • Documentary defects and deficiencies.

  • Systemic weaknesses and shortcomings.

  • Environmental hardships and constraints.

  • Communication gaps and breakdowns.

  • Staffing vacancies and weaknesses.

  • Training gaps and shortcomings.

  • Human ignorance and negligence.

  • Supervisory pressures and demands.

  • Scheduling failures and deficiencies.

Discovering nonconformity

• Nonconformities can be discovered by:

  • Examining inspection and testing documents.

  • Analyzing nonconformity records and reports.

  • Observing work activities and processes.

  • Examining service suggestions and feedback.

  • Reviewing subcontractor documents and reports. 

  • Doing quality audits and management reviews. 

  • Reviewing customer ideas and complaints. 

  • Analyzing regulatory input and observations. 

  • Studying staff suggestions and feedback.

  • Monitoring process performance and variations.

Correcting nonconformity

• Develop corrective procedures that explain how corrective actions should be performed. These procedures should make sure that:

  • Responsibility for corrective action is clearly and completely defined and distributed.

  • Nonconformities are corrected without delay.

  • Corrective actions are well designed and effective.

  • Nonconformance patterns and problems are 
    routinely detected and promptly corrected.

  • Product defects and deficiencies are detected 
    and corrected even after products have been shipped.

ISO 9000-2

4.15 Handling, storing, packaging, and delivery

Introduction

• Develop and document methods, plans, and procedures to control product handling, storage, packaging, and delivery. These methods, plans, and procedures should control both inprocess materials and finished products. 

Handling

• Your product handling methods and plans should prevent product damage, deterioration, and contamination. These handling methods and plans should ensure that:

  • Vehicles and vessels, used to transport 
    products, are suitable and well maintained.

  • Containers and pallets, used to protect and 
    support products, are appropriate and durable.

  • Tools and equipment, used to handle products, 
    are appropriate and in good working order.

Storage

• Your product storage methods and facilities should prevent product loss, damage, deterioration, and contamination. These storage methods and facilities should ensure that products are:

  • Segregated.

  • Marked or labeled.

  • Checked while in storage.

  • Removed when damaged.

  • Protected from loss or misuse.

  • Protected from damage or deterioration.

  • Protected from negative environmental influences.

Packaging

• Your product packaging methods and procedures must ensure that products are protected from loss, damage, deterioration, and contamination. These packaging methods and procedures should ensure that:

  • Packages are suitably labeled.

  • Packaging materials are appropriate.

  • Products are protected during storage.

  • Products are protected during transportation.

  • Packaging methods are regularly evaluated.

Delivery 

• Your product delivery methods and procedures should ensure that products are protected from loss, damage, deterioration, and contamination.

• Your delivery methods and procedures should ensure that your products are:

  • Delivered on time.

  • Protected from external damage.

  • Shipped in the most appropriate way.

ISO 9000-2

4.16 Quality records

Quality record keeping system 

• Develop a quality record keeping system. 
  Your quality records should:

  • Prove that your products meet requirements.

  • Show that your quality system is implemented.

  • Indicate what was done to correct nonconformities. 

• Make sure that your records are:

  • Prepared properly.

  • Stored safely.

• Your quality record keeping system should be:

  • Protected from unauthorized access or alteration.

  • Accessible to all authorized users including:

    • Authorized management and staff.

    • Authorized customers (when contracts require).

• Your records can be either paperbased or electronic as long as they document the performance of your products and your quality system.

• When you determine how long records should be kept, consider contractual and regulatory requirements as well as the life expectancy of your products.

ISO 9000-2

4.17 Internal quality audits

Periodic audits

• Perform periodic internal audits in order to:

  • Determine whether quality system elements 
    are documented, implemented, and effective.

  • Assess how well quality objectives are being met.

  • Evaluate the effectiveness of your quality system.

  • Improve the performance of your quality system.

  • Meet external regulatory requirements.

  • Prepare for external quality audits.

Special audits 

• Perform special internal audits in order to:

  • Satisfy contractual requirements.

  • Demonstrate that organizational changes have 
    not destroyed the effectiveness of your quality system.

  • Determine whether quality system nonconformities have undermined product safety, performance, or dependability.

  • Verify that your corrective actions were effective and that nonconformities have been eliminated.

  • Determine whether your quality system meets 
    the standards set by an outside agency.

• Make sure that your internal auditors are competent.

• Develop schedules to control the implementation 
  of audit results and recommendations.

ISO 9000-2

4.18 Training

Training

• Carry out training and awareness activities in order to:

  •  Show people how to:

    • Perform specific tasks.

    • Apply quality procedures.

    • Achieve quality objectives.

  • Describe your quality system.

  • Motivate people to support quality.

  • Make people aware of how important quality is.

  • Explain why quality procedures should be followed.

Competence 

• Maintain the competence of your personnel by:

  • Evaluating personnel performance.

  • Pinpointing training and awareness needs.

  • Delivering training and awareness programs.

  • Evaluating training results and achievements.

  • Recording training results and achievements.

ISO 9000-2

4.19 Servicing

Service delivery process 

• If your products require after-sale service or post-installation support, you should clarify how service responsibilities will be shared between you, your distributors, and your customers.

• Make sure that:

  • Customers and distributors are shown 
    how to service and maintain your products.

  • Service delivery people receive the technical 
    support, training, and information they need.

  • Service delivery plans are prepared.

  • Product service instructions are available.

  • Measuring and test equipment is effective.

  • Product handling equipment is effective.

  • Service delivery equipment is effective.

  • Spare parts are available when needed.

  • Information feedback systems are set up.

ISO 9000-2

4.20 Statistical techniques

Why use statistical methods 

• Use statistical methods to:

  • Evaluate risk.

  • Forecast results.

  • Control processes. 

  • Avoid nonconformities.

  • Decide what data to collect.

  • Make the best use of your data.

  • Analyze customer expectations.

  • Design products and services.

  • Measure quality characteristics.

  • Define product and process limits.

  • Identify problems and analyze causes.

Types of statistical techniques 

• Consider making use of the following kinds 
  of statistical methods and techniques:

  • Graphical techniques to diagnose problems.

  • Control charts to monitor process performance.

  • Experiments to study process performance.

  • Mathematical models to evaluate changes.

  • Variance analyses to evaluate process variations.

  • Sampling methods to monitor process performance.

  • Inspection techniques to evaluate quality.

• Develop a statistical record keeping system to help 
  prove that your quality system meets requirements.

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