Iso 9001.2008 Requirements of Management

378 ISO 9001:2008 for Small Businesses
APPENDIX 7B ISO 9001:2008 REQUIREMENTS OF

MANAGEMENT
Systemic Requirements
Section ISO 9001:2008

no. title Requirement Explanation
4 QMS Establish your So that it meets the

Requirement quality system requirements of
ISO 9001:2008.
4.1 General Develop your Identify the processes

requirements that make up your
Note: Outsourced quality system;
controls shall be Describe your quality
dened in the QMS. management processes;
Implement your QMS;
Use quality system
processes;
Manage process
performance;
Improve your QMS;
Monitor process
performance;
Improve process
performance;
Outsourced controls
shall be dened in the
QMS
4.2 Documentation Document your

requirements quality system
4.2.1 General Develop quality system Develop documents to

documents implement your quality
system (QMS documen-
Note: A single tation also includes
document may records);
address the requirements for Develop documents that
one or more procedures and reect what your orga-
that a requirement for nisation does; and
a documented procedure Ensure that QMS docu-
may be covered by more mentation also includes
than one document. records.
4.2.2 QM Prepare quality system Document your
manual procedures;
Continued
Self-Assessment 379

Describe how your

processes interact; and
Dene the scope of your
quality system.
4.2.3 Control of Control quality system Approve documents

documents documents before you distribute
them;
Note: Only external Provide the correct
documents that the version of documents at
organisation believes are points of use;
necessary for the planning Review and reapprove
and operation of the QMS, documents whenever
need to be identied and for you update them;
their distribution to be Specify the current revi-
controlled. sion status of your
documents;
Monitor documents that
come from external
sources;
Prevent the accidental
use of obsolete docu-
ments; and
Preserve the usability of
your quality documents.
Note: Only external

documents that the
organisation believes are
necessary for the planning
and operation of the QMS,
need to be identied and for
their distribution to be
controlled.
4.2.4 Control of Maintain quality Use your records to

records system records prove that requirements
have been met;
Develop a procedure to
control your records;
and
Ensure that your records
are established and
maintained to provide
evidence of conformity.
Management Requirements

5 Management
responsibility
5.1 Management Support quality Promote the importance

commitment of quality;
Promote the need to
meet customer
requirements;
Promote the need to
meet regulatory
requirements;
Promote the need to
meet statutory
requirements;
Develop a QMS;
Support the develop-
ment of a quality system;
Formulate your organi-
sations quality policy;
Set your organisations
quality objectives;
Provide quality
resources;
Implement your QMS;
Provide resources to
implement your quality
system;
Encourage personnel to
meet quality system
requirements;
Improve your QMS
Perform quality
management reviews;
and
Provide resources to
improve the quality
system.
5.2 Customer focus Satisfy your customers Identify customer

requirements;
Expect your organisation
to identify customer
requirements;
Meet your customers
requirements;
Continued
Self-Assessment 381


to meet customer
requirements;
Enhance customer satis-
faction; and
to enhance customer
satisfaction.
5.3 Quality policy Establish a quality policy Dene your organisa-
tions quality policy;
Ensure that it serves your
organisations purpose;
Ensure that it emphasises
the need to meet
requirements;
Ensure that it facilitates
the development of
quality objectives;
Ensure that it makes
a commitment to
continuous
improvement;
Manage your organisa-
tions quality policy;
Communicate your
policy to your organisa-
tion; and
Review your policy to
ensure that it is still
suitable.
5.4 Planning Carry out quality planning
5.4.1 Quality Formulate your quality Ensure that objectives

objectives objectives are set for functional
areas;
Ensure that objectives
are set at organisational
levels;
facilitate product
realisation;
support the quality
policy; and
are measurable.
Continued

5.4.2 QMS planning Plan your QMS Plan the development of

your QMS;
Plan the implementation
of your QMS;
Plan the improvement of
your QMS; and
Plan the modication of
your QMS.
5.5 Responsibility, Control your quality system

authority and
communication
5.5.1 Responsibility Dene responsibilities and Clarify responsibilities

and authority authorities and authorities; and
Communicate
responsibilities and
authorities.
5.5.2 Management Appoint management Oversee your QMS;

representative representative Report on the status of
your QMS; and
Note: The Support the improve-
management ment of your QMS.
representative must be
a member of the organisa-
tions own management and
outsiders may no longer
perform this important
function.
5.5.3 Internal Support Ensure that internal
communication internal communication
communications processes are
established; and
Ensure that
communication
occurs throughout
the organisation.
5.6 Management Perform management

review reviews
5.6.1 General Review QMS Evaluate the

performance of
your quality
system; and
Continued
Self-Assessment 383

Evaluate whether
your quality system
should be improved.
5.6.2 Review input Examine management Examine audit results;

review inputs Examine product
conformity data;
Examine opportunities
to improve;
Examine feedback from
customers;
Examine process perfor-
mance information;
Examine corrective and
preventive actions;
Examine changes
that might affect
your system; and
Examine previous
quality management
reviews.
5.6.3 Review output Generate management Generate actions to

review outputs improve your quality
system;
Generate actions to
improve your products;
and
Generate actions to
address resource.
Resource Requirements
Section
no. ISO 9001:2008 title Requirement Explanation
6 Resource
management
6.1 Provision of Provide quality Identify quality

resources resources resource
requirements;
Identify resources
needed to support the
quality system;
Identify resources
needed to improve
customer satisfaction;
Provide quality system
resources;
Provide resources
needed to support the
quality system; and
Provide resources
needed to improve
customer satisfaction.
6.2 Human resources Provide quality

personnel
6.2.1 General Use competent As any QMS task

personnel could directly or indi-
rectly inuence
Note: Where product quality, ensure
training needs to that all QMS personnel
be provided, it should be are competent;
in order to achieve the Ensure that your
necessary competence. personnel have the
right experience;
Ensure that your
personnel have the
right education;
Ensure that your
personnel have the
right training; and
Ensure that your
personnel have the
right skills.
6.2.2 Competence, Support competence Dene acceptable

training and levels of competence;
awareness Identify training and
awareness needs;
Continued
Self-Assessment 385
Section
Deliver training and

awareness programs;
Evaluate effectiveness
of training and aware-
ness; and
Maintain a record of
competence.
6.3 Infrastructure Provide quality Identify infrastructure
infrastructure needs;
Identify building
Note: The new needs;
standard expects Identify workspace
an organisation to needs;
provide the infrastructure Identify hardware
(including information needs;
systems) that is needed to Identify software
ensure that product needs;
requirements Identify utility needs;
are being met. Identify equipment
needs;
Identify support
service needs;
Provide needed
infrastructure;
Provide needed
buildings;
Provide needed
workspaces;
Provide needed
hardware;
Provide needed
software;
Provide needed
utilities;
Provide needed
equipment;
Provide needed
support services;
Maintain your
infrastructure;
Maintain your
buildings;
Maintain your
workspaces;
Continued
Section
Maintain your
hardware;
Maintain your
software;
Maintain your utilities;
Maintain your equip-
ment; and
Maintain your support
services.
6.4 Work environment Provide Identify
quality needed work
Note: environment environment;
Work Identify factors needed
environment to ensure products
includes conditions meet requirements;
(i.e. environmental Manage needed work
conditions such as environment; and
noise, temperature; Manage factors
humidity, lighting needed to ensure that
and weather) under products meet
which work is requirements.
performed.
Realisation requirements

7 Product realisation
7.1 Planning and Control realisation Plan product realisation

realisation planning processes;
Dene product quality
objectives and
requirements;
Identify product realisa-
tion needs and
requirements;
Develop product realisa-
tion processes;
Continued
Self-Assessment 387


tion documents;
tion record keeping
systems;
Develop product measure-
ment processes; and
Develop methods to
control quality during
product realisation.
7.2 Customer-related Control customer
processes processes.
7.2.1 Determination of Identify customers Identify the requirements

requirements product requirements that customers want you
related to product to meet;
Note: Post Identify the requirements
delivery that are dictated by the
activities also include products use;
things like warranty provi- Identify the requirements
sions, contractual obliga- that are imposed by
tions (e.g. maintenance), external agencies; and
and supplementary Identify the requirements
services (e.g. recycling that your organisation
and nal disposal). wishes to meet.
7.2.2 Review of Review customers Review requirements
requirements product requirements before you accept orders
related to product from customers;
Maintain a record of your
product requirement
reviews; and
Control changes in
product requirements.
7.2.3 Customer Communicate with your Develop a process to

communication customers control communications
with customers; and
Implement your customer
communications process.
7.3 Design and Control product

development development
7.3.1 Design and Plan design and Dene your product

development development design and development
planning stages;
Note: Whilst
organisations
Continued

are expected to plan and Clarify design and devel-

perform product design opment responsibilities
and development and authorities;
review, verication, and Manage interactions
validation activities, between design and
these three activities can development groups; and
be carried out and Update your design and
recorded separately. development plans as
changes occur.
7.3.2 Design and Dene design and Specify product design
development development inputs and development inputs;
inputs Record product design
and development input
denitions; and
Review product design
and development input
denitions.
7.3.3 Design and devel- Generate design and Create product design
opment outputs development outputs and development
outputs;
Note: Approve design and
Design development outputs
and development prior to release; and
outputs should Use design and develop-
also include infor- ment outputs to control
mation that product quality.
explains how
products can be
preserved during
production and
service provision.
7.3.4 Design and Carry out design and Perform product design
development development reviews and development
review reviews; and
Record product design and
development reviews.
7.3.5 Design and Perform design and Carry out product design
development development and development veri-
verication verications cations; and
Record product design and
development verications.
7.3.6 Design and Conduct design and Perform product design

development development validations and development valida-
validation tions; and;
Continued
Self-Assessment 389

Record product design

and development
validations.
7.3.7 Control of design Manage design and Identify changes in
and development development changes product design and
changes development;
Record changes in
product design and
development;
Review changes in
product design and
development;
Verify changes in
product design and
development;
Validate changes in
product design and
development; and
Approve changes before
they are implemented.
7.4 Purchasing Control purchasing

function
7.4.1 Purchasing Control purchasing Ensure that purchased

process process products meet require-
ments; and
Ensure that suppliers meet
requirements.
7.4.2 Purchasing Document product Describe the products

information purchases being purchased; and
Specify the requirements
that must be met.
7.4.3 Verication of Verify purchased Verify purchased prod-

purchased product products ucts at your own prem-
ises; and
Verify purchased prod-
ucts at suppliers premises
(when required).
7.5 Production and Control operational

service operations activities
7.5.1 Control of Control production and Control production and

production and service provision service processes;
service provision Control production and
service information;
Continued

Control production and

service instructions;
service equipment;
service measurements;
and
service activities.
7.5.2 Validation of Validate production and Prove that special
processes for service provision processes can produce
production and planned outputs;
service provision Prove that process
personnel can produce
planned results; and
Prove that process equip-
ment can produce
planned results.
7.5.3 Identication and Identify and track your Establish the identity of
traceability products your products (when
appropriate);
Maintain the identity
of your products
(when appropriate);
Identify the status of your
products (when
appropriate);
Record the identity of
your products (when
required); and
Identify inspection and
test status must
throughout product
realisation.
7.5.4 Customer property Protect property supplied Identify property supplied

by customers to you by your customers;
Verify property supplied
Note: Personal to you by your customers;
data can also and
Continued
Self-Assessment 391

include property and Safeguard property

personal data. supplied to you by your
customers.
7.5.5 Preservation of Preserve your products Preserve products and

product and components components during
internal processing; and
Preserve products and
components during nal
delivery.
7.6 Control of Control monitoring Identify monitoring and

measuring and devices measuring needs;
monitoring Identify the monitoring
equipment and measuring that
should be done;
Select monitoring and
measuring equipment;
Select equipment that
meet your monitoring and
measuring needs;
Calibrate monitoring and
Perform calibrations;
Record calibrations;
Protect monitoring and
Protect your equipment
from unauthorised
adjustment;
Protect your equipment
from damage or
deterioration;
Validate monitoring and
measuring software;
Validate monitoring and
measuring software
before you use it;
Revalidate monitoring
and measuring software
when necessary;
Use equipments to ensure
that your products meet
requirements; and
Ensure that verication
and conguration
management of computer
software has not been
overlooked.
Remedial Requirements

8 Measurement,
analysis and
improvement
8.1 General Perform remedial Plan remedial processes;

processes Plan how remedial
processes will be used to
assure conformity;
Plan how remedial
processes will be used to
improve the system;
Implement remedial
processes;
Use remedial processes to
demonstrate conformance;
and
Use remedial processes to
improve QMS.
8.2 Monitoring and Monitor and measure

measurement quality
8.2.1 Customer Monitor and measure Identify ways to monitor

satisfaction customer satisfaction and measure customer
satisfaction;
Note: Customer Monitor and measure
satisfaction and customer satisfaction; and
opinion surveys may be Use customer satisfaction
used for this purpose. information.
Auditing has to include
necessary corrections
and corrective actions
and records of audits
must include audit
results.
8.2.2 Internal audit Plan and perform regular Set up an internal audit
internal audits program;
Note: a Develop an internal audit
docu- procedure;
mented proce- Plan your internal audit
dure for Internal projects;
Auditing must Perform regular internal
dene the audits;
responsibilities Solve problems discovered
and require- during audits; and
ments for
Continued
Self-Assessment 393

conducting Verify that problems have

audits; establish- been solved.
ing records and;
reporting and
maintaining
output results.
8.2.3 Monitoring and Monitor and measure Use suitable methods to

measurement of quality processes monitor and measure your
processes processes; and
Take action when your
processes fail to achieve
planned results.
Note: When products

are released for
delivery to customers, records
must indicate who releases the
products for delivery to
customers.
8.2.4 Monitoring and Monitor and measure Verify that product char-
measurement of product characteristics acteristics are being met;
product and
Keep a record of product
monitoring and measuring
activities.
8.3 Control of non- Control non-conforming Develop a procedure to

conforming products control non-conforming
product products;
Dene how non-
conforming products
should be identied;
Dene how non-
conforming products
should be handled;
Identify and control your
non-conforming products;
Eliminate or correct
product non-conformities;
Prevent the delivery or use
of non-conforming
products;
Avoid the inappropriate
use of non-conforming
products;
Continued

Reverify non-conforming
products that were
corrected;
Prove that corrected prod-
ucts now meet
requirements;
Control non-conforming
products after delivery or
use;
Control events when you
deliver or use non-con-
forming products;
Maintain records of non-
conforming products;
Describe your product
non-conformities; and
Describe the actions taken
to deal with non-
conformities;
8.4 Analysis of data Analyse quality Dene quality manage-
information ment information needs;
Dene the information you
need to evaluate your
quality system;
Dene the information you
need to improve your
quality system;
Collect QMS data;
Monitor and measure the
suitability of your quality
system;
Monitor and measure the
effectiveness of your
quality system;
Provide quality manage-
ment information;
Provide information about
your customers;
your suppliers;
your products; and
your processes.
Continued
Self-Assessment 395

8.5 Improvement Make quality

improvements
8.5.1 Continual Improve QMS Use your audits to

improvement generate improvements;
Use your quality data to
generate improvements;
Use your quality policy to
generate improvements;
Use your quality objec-
tives to generate
improvements;
Use your management
reviews to generate
improvements;
Use your corrective
actions to generate
improvements; and
Use your preventive
actions to generate
improvements.
8.5.2 Corrective action Correct actual Review your non-

non-conformities conformities;
Figure out what causes
your non-conformities;
Evaluate whether you need
to take corrective action;
Develop corrective actions
to prevent recurrence;
Take corrective actions
when they are necessary;
Record the results that
your corrective actions
achieve; and
Continued

Examine the effectiveness

of your corrective actions.
8.5.3 Preventive action Prevent potential Review the effectiveness of

non-conformities the preventative action
taken;
Detect potential non-
conformities;
Identify the causes of
potential non-
conformities;
Study the effects of poten-
tial non-conformities;
Evaluate whether you need
to take preventive action;
Develop preventive
actions to eliminate
causes;
Take preventive actions
when they are necessary;
Record the results that
your preventive actions
achieve; and
Examine the effectiveness
of your preventive actions.

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378 ISO 9001:2008 for Small Businesses

APPENDIX 7B ISO 9001:2008 REQUIREMENTS OF

Section ISO 9001:2008

4 QMS Establish your So that it meets the

4.1 General Develop your  Identify the processes

4.2 Documentation Document your

4.2.1 General Develop quality system  Develop documents to

Section ISO 9001:2008

 Describe how your

4.2.3 Control of Control quality system  Approve documents

Note: Only external

4.2.4 Control of Maintain quality  Use your records to

Section ISO 9001:2008

5.1 Management Support quality  Promote the importance

5.2 Customer focus Satisfy your customers  Identify customer

Section ISO 9001:2008

 Expect your organisation

5.4 Planning Carry out quality planning

5.4.1 Quality Formulate your quality  Ensure that objectives

Section ISO 9001:2008

5.4.2 QMS planning Plan your QMS  Plan the development of

5.5 Responsibility, Control your quality system

5.5.1 Responsibility Dene responsibilities and  Clarify responsibilities

5.5.2 Management Appoint management  Oversee your QMS;

5.6 Management Perform management

5.6.1 General Review QMS  Evaluate the

Section ISO 9001:2008

5.6.2 Review input Examine management  Examine audit results;

5.6.3 Review output Generate management  Generate actions to

6.1 Provision of Provide quality  Identify quality

6.2 Human resources Provide quality

6.2.1 General Use competent  As any QMS task

6.2.2 Competence, Support competence  Dene acceptable

 Deliver training and

Section ISO 9001:2008

7.1 Planning and Control realisation  Plan product realisation

Section ISO 9001:2008

 Develop product realisa-

7.2.1 Determination of Identify customers  Identify the requirements

7.2.3 Customer Communicate with your  Develop a process to

7.3 Design and Control product

7.3.1 Design and Plan design and  Dene your product

Section ISO 9001:2008

are expected to plan and  Clarify design and devel-

7.3.6 Design and Conduct design and  Perform product design

Section ISO 9001:2008

 Record product design

7.4 Purchasing Control purchasing

7.4.1 Purchasing Control purchasing  Ensure that purchased

7.4.2 Purchasing Document product  Describe the products

7.4.3 Verication of Verify purchased  Verify purchased prod-

7.5 Production and Control operational

7.5.1 Control of Control production and  Control production and

Section ISO 9001:2008

 Control production and

7.5.4 Customer property Protect property supplied  Identify property supplied

Section ISO 9001:2008

include property and  Safeguard property

7.5.5 Preservation of Preserve your products  Preserve products and

7.6 Control of Control monitoring  Identify monitoring and

Section ISO 9001:2008

8.1 General Perform remedial  Plan remedial processes;

8.2 Monitoring and Monitor and measure

8.2.1 Customer Monitor and measure  Identify ways to monitor

4.1 General Develop your Identify the processes

4.2.1 General Develop quality system Develop documents to

Describe how your

4.2.3 Control of Control quality system Approve documents

4.2.4 Control of Maintain quality Use your records to

5.1 Management Support quality Promote the importance

5.2 Customer focus Satisfy your customers Identify customer

Expect your organisation

5.4.1 Quality Formulate your quality Ensure that objectives

5.4.2 QMS planning Plan your QMS Plan the development of

5.5.1 Responsibility Dene responsibilities and Clarify responsibilities

5.5.2 Management Appoint management Oversee your QMS;

5.6.1 General Review QMS Evaluate the

5.6.2 Review input Examine management Examine audit results;

5.6.3 Review output Generate management Generate actions to

6.1 Provision of Provide quality Identify quality

6.2.1 General Use competent As any QMS task

6.2.2 Competence, Support competence Dene acceptable

Deliver training and

7.1 Planning and Control realisation Plan product realisation

Develop product realisa-

7.2.1 Determination of Identify customers Identify the requirements

7.2.3 Customer Communicate with your Develop a process to

7.3.1 Design and Plan design and Dene your product

are expected to plan and Clarify design and devel-

7.3.6 Design and Conduct design and Perform product design

Record product design

7.4.1 Purchasing Control purchasing Ensure that purchased

7.4.2 Purchasing Document product Describe the products

7.4.3 Verication of Verify purchased Verify purchased prod-

7.5.1 Control of Control production and Control production and

Control production and

7.5.4 Customer property Protect property supplied Identify property supplied

include property and Safeguard property

7.5.5 Preservation of Preserve your products Preserve products and

7.6 Control of Control monitoring Identify monitoring and

8.1 General Perform remedial Plan remedial processes;

8.2.1 Customer Monitor and measure Identify ways to monitor

conducting Verify that problems have

8.2.3 Monitoring and Monitor and measure Use suitable methods to

8.3 Control of non- Control non-conforming Develop a procedure to

8.5.1 Continual Improve QMS Use your audits to

8.5.2 Corrective action Correct actual Review your non-

Examine the effectiveness

8.5.3 Preventive action Prevent potential Review the effectiveness of