ISO 9001 1994 in Plain English

 

ISO 9001 1994 is now OBSOLETE. Please see ISO 9001 2015.

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This web page is based on the ISO 9001:1994 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.
If you're looking for a
complete interpretation of this quality 
management standard, you've come to the right place.

 

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.

4.1.2
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.

4.1.3
Management review

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:

 

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.

4.2.2
Quality system procedures

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.

4.2.3
Quality planning

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?

 

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.

4.3.2
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.                        

4.3.3
Amendments

Develop procedures which specify how customer contracts 
are amended, and which ensure that changes in contracts 
are communicated throughout the organization.

4.3.4
Records 

Develop a record keeping system that you can use to 
document the review of customer orders and contracts.

 

4.4 Product development and design

4.4.1
General 

Develop and document procedures to control the product
design and development process. These procedures must
ensure that all requirements are being met.

4.4.2
Design and development planning 

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.                 

4.4.3
Organizational and technical interfaces

Identify the groups who should be routinely involved
in the product design and development process, and 
ensure that their design input is properly documented, 
circulated, and reviewed.

4.4.4
Design input 

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.

4.4.5
Design output

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.                  

4.4.6
Design review

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.

4.4.7
Design verification

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.

4.4.8
Design
validation

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.

4.4.9
Design changes

Develop procedures to ensure that all product design modifications are
documented, reviewed, and formally authorized before the resulting
documents are circulated and the changes are implemented.

 

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.

4.5.2
Document and data approval and distribution

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.

4.5.3
Document and data changes

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.

 

4.6 Purchasing requirements

4.6.1
General 

Develop procedures to ensure that purchased products (including
services) meet all requirements. These procedures should control
the selection of subcontractors, the use of purchasing data, and
the verification of purchased products.

4.6.2
Evaluation of subcontractors

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.

4.6.3
Purchasing data

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
Verification of purchased product

Develop procedures that allow you or your customers 
to verify the acceptability of products you have purchased.

 

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.

 

4.7 Customer-supplied products

Protect 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.

TO SEE SECTIONS 4.8 TO 4.20, PLEASE GO TO PAGE TWO


OTHER ISO 9001 RESOURCES

ISO 9001 2015 Introduction

Quality Management Principles

Outline of ISO 9001 2015 Standard

Overview of ISO 9001 2015 Standard

ISO 9001 2015 versus ISO 9001 2008

Plain English ISO 9001 2015 Definitions

ISO's Process Approach in Plain English

ISO 9001 2015 Translated into Plain English

Plain English Quality Management Checklist

OTHER STANDARDS

ISO 9004 Quality Standard

ISO 19011 2011 Auditing Standard

ISO 13485 Medical Device Quality Standard

ISO 14971 Medical Device Risk Management Standard

AS9100 Rev C Aerospace Quality Management Standard

ISO 90003 Software Quality Management Standard

ISO 28000 Supply Chain Security Management Standard

OHSAS 18001 Occupational Health and Safety Standard

ISO 27001 Information Security Management Standard

ISO 27002 Information Security Management Standard

ISO 14001 Environmental Management Standard

ISO 22000 Food Safety Management Standard

ISO 31000 2009 Risk Management Standard

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Updated on January 12, 2015. First published on June 6, 1997.

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