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ISO 9001 1994 in Plain English

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

PAGE ONE OF TWO GO TO PAGE TWO

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 Define a policy that describes your organization's attitude

Quality policy 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 Define the organizational structure that you will

Organization 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.
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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 Define a procedure that your senior managers can use

Management to review the effectiveness of your quality system.
review
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.

4.2 Quality system

4.2.1 Develop a quality system and a manual that describes it.

General
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.

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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 Develop and implement quality system procedures

Quality system that are consistent with your quality policy.
procedures
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 Develop quality plans that show how you intend to fulfill quality
Quality system requirements. You are expected to develop quality plans
planning 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

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4.3.1 Develop and document procedures to coordinate the review of

General sales orders and customer contracts. Make sure you include the
customer in the process of review.

4.3.2 Your contract review procedures should ensure that all contractual
Review 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 Develop procedures which specify how customer contracts

Amendments are amended, and which ensure that changes in contracts
are communicated throughout the organization.

4.3.4 Develop a record keeping system that you can use to

Records document the review of customer orders and contracts.

4.4 Product development and design

4.4.1 Develop and document procedures to control the product

General design and development process. These procedures must
ensure that all requirements are being met.

4.4.2 Create design and development planning procedures.

Design and Your product planning procedures should ensure that:
development
planning 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 Identify the groups who should be routinely involved

Organizational in the product design and development process, and
and technical ensure that their design input is properly documented,
interfaces circulated, and reviewed.

4.4.4 Develop procedures to ensure that all design-input requirements

Design input 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.

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Safety considerations.
Performance standards.
Functional specifications.
Descriptive prescriptions.
Aesthetic preferences.

4.4.5 Develop procedures to control design outputs.

Design output
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 Develop procedures that specify how design reviews should be

Design review 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 Develop procedures that specify how design outputs, at every stage
Design of the product design and development process, should be verified.
verification 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 Develop procedures that validate the assumption that your newly
Design designed products will meet customer needs. Develop design
validation validation procedures that:

Confirm that your new product performs properly

under all real world operating conditions.

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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 Develop procedures to ensure that all product design modifications are
Design changes 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 Develop procedures to control all the documents and data related
General to your quality system. These procedures should control:

Internal and external documents and data.

Electronic or hardcopy documents and data.

4.5.2 Develop procedures to review, approve, and manage all of

Document your quality system documents and data. These procedures
and data should ensure that:
approval and
distribution 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 Develop procedures to control changes to documents and data.

Document and These procedures should ensure that changes are:
data changes
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 Develop procedures to ensure that purchased products (including

General 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 Develop procedures to select, evaluate, monitor, and control your

Evaluation of subcontractors (your suppliers). These procedures should define how:
subcontractors
Subcontractors are selected.

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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 Develop procedures to ensure that your purchase order documents

Purchasing precisely describe what you want to buy. When appropriate, these
data 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 Develop procedures that allow you or your customers

Verification to verify the acceptability of products you have purchased.
of purchased
product 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 Develop procedures to control products supplied to you

customer by customers. These procedures should ensure that you:
supplied
products 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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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

Home Page Our Libraries A to Z Index Customers

How to Order Our Products Our Prices Guarantee

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

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ISO 9001 1994 in Plain English

PAGE TWO OF TWO GO TO PAGE ONE

ISO 9001 1994 is OBSOLETE. The most current standard is ISO 9001 2015.

4.8 Product identification and tracing

Track your Develop and document procedures to identify and track products
products from start to finish. When appropriate, these procedures should
make sure that you:

Identify and document products every step of the way from the
purchase of supplies and materials through all stages of handling,
storage, production, delivery, installation, and servicing.
Trace products or product batches by means of
unique identifiers and suitable record keeping.

4.9 Process control requirements

Control Develop procedures to plan, monitor, and control your production,

production, installation, and servicing processes. Your procedures must be
installation, documented, and should ensure that each process is:
and servicing
Approved and performed by qualified personnel.
Monitored and controlled by qualified personnel.
Performed using approved tools and equipment.
Documented using proper record keeping systems.
Carried out within a supportive work environment.

Your procedures should ensure that each process:

Maintains a high standard of workmanship.

Follows your quality plans, policies, and procedures.
Complies with the appropriate standards and codes.
Is monitored by tracking process and product qualities.
Is carried out with well-maintained tools and equipment.
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Design a record keeping system that monitors and controls process

personnel and equipment. Make sure that all important process
qualities are monitored and recorded.

4.10 Product inspection and testing

4.10.1 Develop procedures to inspect, test, and verify

General that your products meet all specified requirements.
Develop procedures to inspect, test, and verify
that incoming products meet all requirements.
Develop procedures to inspect, test, and verify
that in process products meet all requirements.
Develop procedures to inspect, test, and verify
that final products meet all requirements.
Ensure that appropriate product inspection and testing records
are developed and that these records are properly maintained.

4.10.2 Develop procedures that ensure that incoming products are not used
Receiving until you have verified that they meet all specified requirements.
inspection
4.10.2.1 Inspection of incoming products
Your procedures should ensure that incoming products are
inspected and approved before they are used or processed. All
incoming products must conform to specified requirements.

4.10.2.2 Inspections done by subcontractors

If your subcontractors (your suppliers) carry out some of the
required inspections and if they provide you with recorded evidence
which demonstrates that their products are, in fact, acceptable, then
your procedures should not ask you to repeat these inspections.

4.10.2.3 Use of products prior to inspection

If products must be used prior to inspection, your procedures should
tell you to identify and record them so that they can be quickly recalled
and replaced if they subsequently do not meet all requirements.

4.10.3 Develop procedures that ensure that work in process meets

In-process all requirements before work is allowed to continue.
inspection
and testing Your procedures should ensure that work in process
is held up until the required inspections and tests have
been completed and until the required inspection reports
have been received and approved. See exception below.
Work in process need not be held up if the product must
be used right away and if it has been identified and recorded
as a product that can be recalled and replaced by a
subcontractor if it doesn't meet your requirements.

4.10.4 Develop procedures to ensure that final products meet

Final inspection all requirements before they are made available for sale.
and testing Your procedures should ensure that:

Final products are inspected and approved

before they are made available for sale.
Incoming and in process inspections and tests are
completed, and that all requirements are met, before
the product is made available for sale.

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Final products are not released until all relevant quality

procedures have been carried out, all documents have
been completed, and all approvals have been granted.

4.10.5 Develop a record keeping system that your staff can use
Inspection and to document product testing and inspection activities.
test records Your record keeping system should:

Prove that your products have been formally

inspected and tested using authorized procedures.
Show whether your products passed or failed
your inspections and tests.
Demonstrate that authorized acceptance criteria were
used to decide whether products passed or failed.
Indicate what was done with products that failed
your inspections and tests.

Specify who inspected or tested your products,

and who authorized their release.

4.11 Control of inspection equipment

4.11.1 Develop procedures to control, calibrate, and maintain inspection,

General measuring, and test equipment used to demonstrate that products
conform to requirements.

The amount of measurement uncertainty should be known

and should be reasonable given the degree of precision
required to establish that the product meets requirements.
In order to prove that your equipment is capable of verifying
the acceptability of your products, it should be checked and
rechecked on a regular basis.
Every time equipment is checked to ensure that it is capable
of verifying that products are acceptable, the results should
be properly recorded.
Whenever your customers must confirm that your inspection,
measuring, and test equipment is reliable and appropriate,
make sure you allow them to do so.

4.11.2 Develop procedures to ensure that your measurement equipment is

Control appropriate, effective, and secure. Your procedures should specify:
procedures
What kinds of measurements must be made.
What kinds of measurement methods must be used.
How accurate these measurements should be.
Which quality measurement equipment should be used.
What kinds of environmental conditions are suitable.
How and where your equipment should be stored.
How equipment will be protected from harm.

Develop procedures to calibrate all of your quality oriented inspection,

measuring, and test equipment. Your procedures should ensure that:

Calibration methods are clearly defined.

Equipment is calibrated on a regular basis.
Equipment calibration status is clearly shown.
Calibration acceptance criteria are clearly specified.
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Equipment is calibrated against official standards.

Calibrations are carried out in a suitable environment.
Calibration documents and records are maintained.
Calibration records are accurate and up-to-date.
Appropriate remedial actions are taken whenever
calibration results are found to be unacceptable.
Valid calibration settings are protected from
unauthorized adjustment.
Previous calibration results are rechecked whenever
equipment is found to be out-of-calibration.

Develop procedures to calibrate hardware and tools

used to test and validate your software products.

4.12 Inspection and test status of products

Control the Develop procedures to control the inspection status

inspection of your products. These procedures should ensure that:
status of your
products Each and every product is identified as having passed
or failed the required tests and inspections.
The test status of each product is documented and respected
throughout the production, installation, and servicing process.
Only products that have passed all tests and inspections are
subsequently used or sold to customers (unless an exception
is made under section 4.13.2 below).

4.13 Control of nonconforming products

4.13.1 Develop procedures to prevent the inappropriate use of

General nonconforming products. Make sure these products are:

Identified, evaluated, and documented.

Segregated from products that conform.

Also make sure that everyone is notified when your

products do not conform to specified requirements.

4.13.2 Develop procedures to control how your nonconforming products

Review and are reviewed, reworked, regraded, retested, recorded, and discussed
disposition of with your customers.
nonconforming
products Specify who is responsible for and has the authority
to review and dispose of nonconforming products.
Specify how review of nonconforming products
must be carried out.
Specify the conditions under which nonconforming
products may be reworked, accepted without modification,
used for other purposes, or scrapped.
Ensure that your customers are notified when nonconforming
products are going to be used with or without modification.
Be sure you record the actual condition of any nonconforming
product that is, nevertheless, accepted and used.
Be sure you record a description of the repairs that
were made to nonconforming products.
Ensure that repaired or reworked products
are retested and reinspected prior to use.

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4.14 Corrective and preventive action

4.14.1 Develop procedures to correct or prevent nonconformities.

General
Corrective or preventive actions should eliminate
the causes of nonconformity.
Corrective or preventive actions should consider how
big the problem is and how much risk is involved.
When corrective or preventive actions indicate that systemic
or procedural changes should be made, make sure that these
changes are implemented.
Make sure that corrective and preventive actions
and changes are properly documented.

4.14.2 Develop procedures to ensure that nonconformities are

Corrective identified and corrected without delay. Ensure that:
action
Nonconformity reports are handled properly.
Customer complaints are handled effectively.
Causes of nonconformity are investigated and recorded.
Corrective actions are promptly implemented.
Corrective actions eliminate causes.
Corrective actions are effective.

4.14.3 Develop procedures to ensure that potential nonconformities

Preventive are routinely detected and prevented. Your procedures must:
action
Use every appropriate source of information to detect
potential nonconformities. Use sources such as:
Work activities and processes.
Audit results and quality records.
Service reports and customer complaints.
List the steps that make up your preventive measures.
Ensure that effective preventive measures are taken.
Ensure that preventive measures are reported.
Ensure that appropriate information about preventive
measures is fed back into the management review process.

4.15 Handling, storage, and delivery

4.15.1 Develop and document procedures to handle, store,

General package, preserve, and deliver your products.

4.15.2 Develop product handling methods and procedures

Handling that prevent product damage or deterioration.

4.15.3 Designate secure areas to store and protect products.

Storage
Develop procedures which specify how products will be:

Placed into storage.

Removed from storage.
Protected from damage, deterioration, or destruction.

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Monitored and evaluated to detect damage or deterioration.

4.15.4 Develop packing, packaging, and marking methods and procedures

Packaging to protect and control the quality of products and packaging materials.

4.15.5 Develop methods and procedures to protect and preserve product

Preservation quality prior to delivery while the product is still under your
organization's supervision and control.

Ensure that products are segregated from one another.

4.15.6 Develop procedures to protect your products after final testing

Delivery and inspection, and during product delivery (when the latter
is contractually required).

4.16 Control of quality records

Develop a Develop a quality record keeping system,

quality record and develop procedures to control it.
keeping
system Identify the information that should be collected.
Develop procedures to:
Collect and record this information (create records).
File, index, store, and maintain quality records.
Remove, archive, and destroy old quality records.
Protect quality records from unauthorized access.
Prevent records from being altered without approval.
Safeguard records from damage or deterioration.

Your quality record keeping system should:

Show that your quality system is implemented.

Prove that your quality system works properly.
Specify how long old records should be retained.
Allow information to be retrieved without difficulty.
Produce documents that are dated and easy to read.
Permit customers to access records (when required).
Include quality records provided by subcontractors.

4.17 Internal quality audit requirements

Develop Develop internal quality audit procedures which:

internal audit
procedures Determine whether quality activities and results comply
with written quality plans, procedures, and programs.
Evaluate the performance of your quality system.
Verify the effectiveness of your corrective actions.

These procedures should also ensure that:

Audit activities are properly planned.

Auditors are independent of the people being audited.
Audit results and remedial actions are properly recorded.
Audit conclusions are discussed with auditee representatives.
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Deficiencies are corrected by the managers of the audited areas.

Audit reports are fed back into quality system review process.

4.18 Training requirements

Develop Develop quality-training procedures. These procedures

training should be properly documented, and must ensure that:
procedures
Quality system training needs are identified.
Quality training is provided to those who need it.
People are able to perform quality system jobs.
People have the qualifications they need to do the work.
Accurate and appropriate training records are kept.
Everyone understands how your quality system works.

4.19 Servicing requirements

Develop service Develop and document quality service procedures.

procedures Your procedures should specify how:

Products should be serviced.

Product service activities are reported.
The quality of product service is verified.

4.20 Statistical techniques

4.20.1 Select the statistical techniques that you will need

Identification in order to establish, control, and verify your:
of need
Process capabilities.
Product characteristics.

4.20.2 Develop procedures to:

Procedures
Explain how your techniques should be applied.
Monitor and control how these techniques are used.

Make sure that:

All statistical procedures are documented.

Statistical records are kept.

ISO 9001:1994 is obsolete. It has been replaced by ISO 9001:2015.

OTHER ISO 9001 PAGES

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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 2009 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

Home Page Our Libraries A to Z Index Customers

How to Order Our Products Our Prices Guarantee

Praxiom Research Group Limited help@praxiom.com 780-461-4514

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

Legal Restrictions on the Use of this Page

Thank you for visiting this webpage. You are welcome to view our material as often as

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