ISO 9001 1994 Requirements in Plain English

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ISO 9001 1994 is now obsolete. Please see ISO 9001 2000.

ISO 22000 2005 Food Safety Management Standard

OHSAS 18001 Occupational Health and Safety Standard

ISO 13485 2003 Medical Device Management Standard

ISO 14001 2004 Environmental Management Standard

ISO 17799 Information Security Management Standard

ISO 27001 Information Security Management Standard

ISO 90003 Software Quality Management Standard

NFPA 1600 Business Continuity Management Standard

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ISO 9001

4.1 Management responsibility

4.1.1
Quality policy 

Define a policy that describes your organization's attitude 
towards quality. Your quality policy should:

• State a clear commitment to quality.

• Recognize customer needs and expectations.

• Be actively supported by senior management.

• List the quality objectives you want to achieve.

• Be understood by everyone in the organization.

• Be consistent with your organization's goals.

• Be applied throughout your organization.

Define the organizational structure that you will 
need in order to manage a quality system.

4.1.2.1 Responsibility and authority

Define quality system responsibilities, give quality system personnel the authority to carry out these responsibilities, and ensure that the interactions between these personnel are clearly specified. And make sure all of this is well documented. This requirement must be met for those who:

• Manage quality system work.

• Perform quality system work. 

• Verify quality system work.

More specifically, this quality system requirement 
must be met for those who:

• Control nonconforming products.

• Prevent product nonconformities.

• Prevent process nonconformities.

• Prevent quality system nonconformities.

• Identify problems related to the quality system.

• Report problems related to the quality system.

• Record problems related to the quality system.

• Recommend solutions to quality system problems.

• Design solutions to quality system problems.

• Verify that solutions were implemented.

• Evaluate whether solutions were effective.

4.1.2.2 Resources

Identify and provide the resources that people will need to manage,
perform, and verify quality system work. Make sure that:

• Only trained personnel are assigned.

• Managers have the resources they need to verify work.

• Internal auditors have the resources they need.

4.1.2.3 Management representative

Appoint a senior executive to manage your quality system and give him or her the necessary authority. This senior executive must ensure that your quality system is developed and implemented. This executive must:

• Monitor the performance of your quality system.

• Control the performance of your quality system.

• Report on the performance of your quality system.

• Help improve the performance of your quality system.

• Act as your organization's spokesperson on quality.

Define a procedure that your senior managers can use 
to review the effectiveness of your quality system.

• Quality system reviews should be:

  • Carried out on a regular basis.

  • Documented and records should be maintained.

• Quality system reviews should ensure that your:

  • Quality system requirements are being met.

  • Quality objectives are being achieved.

  • Quality policy is being applied.

ISO 9001

4.2 Quality system

4.2.1
General 

Develop a quality system and a manual that describes it.

• Your quality system should ensure that your products 
  conform to all specified requirements.

•  Your quality manual should:

  • State your quality policy.

  • List your quality objectives.

  • Provide an overview of your quality system.

  • Describe the structure of your organization.

  • Discuss your quality system procedures.

  • Introduce your quality documents and records.

  • Teach people about your quality system.

  • Control quality system work practices.

  • Guide the implementation of your quality system.

  • Explain how your quality system will be audited.

Develop and implement quality system procedures 
that are consistent with your quality policy.

• Develop your procedures for all areas of your quality system.

• Document your procedures, and keep them up to date.

• Each procedure should:

  • Specify its purpose and scope.

  • Describe how an activity should be carried out.

  • Describe who should carry out the activity.

  • Explain why the activity is important to quality.

  • Describe when and where it should be carried out.

  • Explain what tools and equipment should be used.

  • Explain what supplies and materials should be used.

  • Explain what documents and records should be kept.

• Procedures may also refer to detailed work instructions 
  that explain exactly how the work should be done.

Develop quality plans that show how you intend to fulfill quality system requirements. You are expected to develop quality plans for products, processes, projects, and customer contracts.

• Your quality plans should list the quality objectives you intend to achieve, and the steps you intend to take to achieve these objectives.

• When you construct your quality plan, consider 
  the following questions:

  • Do you need to purchase any new equipment or 
    instruments, or any new inspection and test tools?

  • Do you need to carry out any special training in 
    order to fulfill all quality system requirements?

  • Do you need to improve design, production, testing, 
    inspection, installation, or servicing procedures?

  • Do you need to improve your quality 
    measurement and verification procedures?

  • Do you need to develop any new 
    measurement methods or instruments?

  • Do you need to clarify your organization's 
    standards of acceptability?

  • Do you need to develop any new documents, 
    forms, reports, records, or manuals?

  • Do you need to allocate more resources in 
    order to achieve the required levels of quality?

ISO 9001

4.3 Contract review

4.3.1
General 

Develop and document procedures to coordinate the review of sales orders and customer contracts. Make sure you include the customer in the process of review.

Your contract review procedures should ensure that all contractual requirements are acceptable before you agree to provide products to your customers. Specifically, your procedures should make sure that:

• Your customer's order is clearly and completely defined. 
  When verbal orders are received, make sure that you 
  and your customer agree on what is required.

• You have resolved all differences between the original
  tender or proposal and the final contract or sales order.

• Your organization is capable of supplying the 
  products ordered by the customer.

ISO 9001

4.4 Product development and design

4.4.1
General 

Create design and development planning procedures. 
Your product planning procedures should ensure that:

• Plans are prepared for each design activity or phase.

• Responsibility for implementing each plan, 
  activity, or phase is properly defined.

• Qualified personnel are assigned to the 
  product design and development process.

• Adequate resources are allocated to the 
  product design and development process.

• Plans are updated, and circulated to the 
  appropriate participants, as designs change.

Develop procedures to ensure that all design-input requirements are identified, documented, and reviewed; and that all design flaws, ambiguities, contradictions, and deficiencies are resolved. Design input requirements can be classified as follows:

• Customer expectations.

• Contractual conditions.

• Statutory imperatives.

• Regulatory requirements.

• Environmental constraints.

• Safety considerations.

• Performance standards.

• Functional specifications.

• Descriptive prescriptions.

• Aesthetic preferences.

Develop procedures to control design outputs.

• Design outputs are usually documents. They include drawings, parts lists, process specifications, servicing procedures, and storage instructions. These types of documents are used for purchasing, production, installation, inspection, testing, and servicing.

• Design outputs must be expressed in terms that allow 
  them to be compared with design input requirements.

• Design output documents must identify those aspects of the product that are crucial to its safe and effective operation. These aspects can include operating, storage, handling, maintenance, and disposal requirements.

• Design output documents must be reviewed 
  and approved before they are distributed.

• Design outputs must be accepted only if 
  they meet official acceptance criteria.

Develop procedures that specify how design reviews should be 
planned and performed. Design review procedures should:

• Be formally documented.

• Ensure that reviews are recorded.

• Ensure that representatives from all relevant 
  areas are involved in the process of review.

Develop procedures that specify how design outputs, at every stage
of the product design and development process, should be verified.
These procedures should:

• Verify that outputs satisfy design-input requirements.

• Ensure that objective evidence is used to verify outputs.

• Ensure that all design verifications are recorded.

• Ensure that all design documents are verified.

These design verification procedures may also:

• Use alternative calculations to verify design outputs.

• Use tests and demonstrations to verify outputs.

• Compare design outputs with proven designs.

Develop procedures that validate the assumption that your newly
designed products will meet customer needs. Develop design
validation procedures that:

• Confirm that your new product performs properly 
  under all real-world operating conditions.

• Confirm that your new product will meet every
  legitimate customer need and expectation.

• Ensure that validations are carried out early in the design process whenever this will help guarantee that customer needs will be met.

ISO 9001

4.5 Document and data control

4.5.1
General 

Develop procedures to control all the documents and data related
to your quality system. These procedures should control:

• Internal and external documents and data.

• Electronic or hardcopy documents and data.

Develop procedures to review, approve, and manage all of your quality system documents and data. These procedures should ensure that:

• Only authorized people are allowed to formally 
  approve documents and data prior to distribution.

• All documents and data are formally approved before 
  they are distributed throughout the organization.

• The accidental use of obsolete documents and data is prevented.

• Only current versions of documents and data are available for use.

• Documents and data, that are used to maintain your quality system, are available wherever and whenever they are needed.

• Documents that are retained for legal or historical purposes should be officially marked as such and segregated from current versions.

Develop procedures to control changes to documents and data. 
These procedures should ensure that changes are:

• Justified.

• Marked as changes.

• Reviewed and approved by the original review and approval groups.

The procedures should also ensure that these review and approval groups have all the information they need to justify their approval.

ISO 9001

4.6 Purchasing requirements

4.6.1
General 

Develop procedures to select, evaluate, monitor, and control your subcontractors (your suppliers). These procedures should define how:

• Subcontractors are selected.

• Subcontractor performance is monitored.

• Subcontractor performance is evaluated.

• Subcontractor performance is controlled.

These procedures should ensure that subcontractors 
are chosen only if they are able to meet your:

• Contractual expectations.

• Quality assurance requirements.

Make sure that quality records are kept which chronicle the performance of your subcontractors. Your records should identify the acceptable subcontractors and the products and services they provide.

Develop procedures to ensure that your purchase order documents precisely describe what you want to buy. When appropriate, these procedures should ensure that your purchasing documents:

• Use technical specifications and drawings 
  to describe exactly what you want to order.

• State the type or grade of product being purchased.

• Define product inspection and approval requirements.

• Specify process requirements that must be met.

• Identify process equipment that should be used.

• Describe procedures that should be followed.

• Specify technical support service requirements.

• Reference the applicable quality system standards.

• Are carefully reviewed to ensure that they meet all 
  requirements before they are approved and issued.

4.6.4.1 Supplier verification at subcontractor's place

When you must verify the acceptability of purchased products at the subcontractor's premises, ensure that your purchase order documents and contracts specify your verification and acceptance requirements and methods.

4.6.4.2 Customer verification of subcontracted product

When your customers wish to verify the acceptability of the products you purchase on their behalf, ensure that they are given this opportunity at both the subcontractors' premises and yours.

ISO 9001

4.7 Customer-supplied products

Develop procedures to control products supplied to you 
by customers. These procedures should ensure that you:

• Examine the product when you receive it to confirm 
  that the right items were shipped without loss or damage.

• Prevent product loss, misuse, damage, or deterioration 
  through proper storage and security.

• Record product loss, misuse, damage, or deterioration, 
  and report it to the customer.

• Clarify who is responsible for the maintenance and 
  control of the product while it is in your possession.

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