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The ISO 9000 family of standards relate to quality management systems and are

designed to help organizations ensure they meet the needs of customers and other

stakeholders (Poksinska et al, 2002 [1] ). The standards are published by ISO,

the International Organization for Standardization and available through

National standards bodies.

ISO 9000 deals with the fundamentals of quality management systems (Tsim et al,

2002 [2] ), including the eight management principles (Beattie and Sohal, 1999

[3] ; Tsim et al, 2002 [4]) on which the family of standards is based. ISO 9001

deals with the requirements that organizations wishing to meet the standard have

to meet.

Independent confirmation that organizations meet the requirements of ISO 9001

may be obtained from third party certification bodies. Over a million

organizations worldwide [5] are independently certified making ISO 9001 one of

the most widely used management tools in the world today.

Contents [hide]
1 Reasons for use

2 Background

3 Global adoption

4 Contents of ISO 9001

4.1 1.0 Scope

4.2 4.0 Quality management system

4.2.1 4.1 General

4.2.2 4.2 Documentation requirements

4.2.2.1 4.2.1 General Specifications

4.2.2.2 4.2.2 Quality manual

4.2.2.3 4.2.3 Control of documents

4.2.2.4 4.2.4 Control of records

4.3 5.0 Management responsibility

4.3.1 5.1 Management commitment

4.3.2 5.2 Customer focus

4.3.3 5.3 Quality policy

4.3.4 5.4 Planning

4.3.4.1 5.4.1 Quality objectives

4.3.4.2 5.4.2 Quality management system planning

4.3.5 5.5 Responsibility, authority and communication

4.3.5.1 5.5.1 Responsibility and authority

4.3.5.2 5.5.2 Management representative

4.3.5.3 5.5.3 Internal communication

4.3.6 5.6 Management Review

4.3.6.1 5.6.1 General


4.3.6.2 5.6.2 Review input

4.3.6.3 5.6.3 Review output

4.4 6.0 Resource management

4.4.1 6.1 Provision of resources

4.4.2 6.2 Human resource Management

4.4.2.1 6.2.1 General

4.4.2.2 6.2.2 Competence, training, and awareness

4.4.3 6.3 Infrastructure

4.4.4 6.4 Work environment

4.5 7.0 Product realization

4.5.1 7.1 Planning of product realization

4.5.2 7.2 Customer- related processes

4.5.2.1 7.2.1 Determination of requirements related to the product

4.5.2.2 7.2.2 Review of requirements related to the product

4.5.2.3 7.2.3 Customer communication

4.5.3 7.3 Design and development

4.5.3.1 7.3.1 design and development planning

4.5.3.2 7.3.2 Design and development inputs

4.5.4 7.4 Purchasing

4.5.4.1 7.4.1 Purchasing process

4.5.4.2 7.4.2 Purchasing Information

4.5.4.3 7.4.3 Verification of purchased product

4.5.5 7.5 Production and service provision

4.5.5.1 7.5.1 Control of production and service provision

4.5.5.2 7.5.2 Validation of processes for production and service


provision

4.5.5.3 7.5.3 Identification and traceability

4.5.5.4 7.5.4 Customer property

4.5.5.5 7.5.5 Preservation of product

4.5.6 7.6 Control of monitoring and measuring equipment

4.6 8.0 Measurement, analysis and improvement

4.6.1 8.1 General

4.6.2 8.2 Monitoring and measurement

4.6.2.1 8.2.1 Customer satisfaction

4.6.2.2 8.2.2 Internal audit

4.6.2.3 8.2.3 Monitoring and measurement of processes

4.6.2.4 8.2.4 Monitoring and measurement of product

4.6.3 8.3 Control of nonconforming product

4.6.4 8.4 Analysis of data

4.6.5 8.5 Improvement

4.6.5.1 8.5.1 Continual improvement

4.6.5.2 8.5.2 Corrective action

4.6.5.3 8.5.3 Preventive action

4.7 1987 version

4.8 1994 version

4.9 2000 version

4.10 Certification

5 Auditing

6 Industry-specific interpretations

7 Effectiveness
7.1 Advantages

7.2 Problems

7.3 Summary

8 See also

9 References

10 Further reading

11 See also

12 External links

Reasons for useThe global adoption of ISO 9001 may be attributable to a number

of factors. A number of major purchasers require their suppliers to hold ISO

9001 certification. In addition to several stakeholders͛ benefits, a number of

studies have identified significant financial benefits for organizations

certified to ISO 9001. Corbett et al (2005) [6] showed that certified

organizations achieved superior return on assets [7] compared to otherwise

similar organizations without certification. Heras et al (2002) [8] found

similarly superior performance [9] and demonstrated that this was statistically

significant and not a function of organization size. Naveh and Marcus (2007)

[10] showed that implementing ISO 9001 led to superior operational performance

[11] . Sharma (2005) [12] identified similar improvements in operating

performance and linked this to superior financial performance. Chow-Chua et al

(2002) [13] showed better overall financial performance was achieved for

companies in Denmark. Rajan and Tamimi (2003) [14] showed that ISO 9001

certification resulted in superior stock market performance [15] and suggested

that shareholders were richly rewarded [16] for the investment in an ISO 9001
system.

While the connection between superior financial performance and ISO 9001 may be

seen from the above, there remains no proof of direct causation, though

longitudinal studies, such as those of Corbett et al (2005) [17] may suggest it.

Other writers such as Heras et al (2002) [18] have suggested that while there is

some evidence of this, the improvement is partly driven by the fact that there

is a tendency for better performing companies to seek ISO 9001 certification.

The mechanism for improving results has also been the subject of much research.

Lo et al (2007) [19] identified operational improvements (cycle time reduction,

inventory reductions, etc.) as following from certification. Buttle (1997) [20]

and Santos (2002) [21] both indicated internal process improvements in

organizations leading to externally observable improvements. Hendricks and

Singhal (2001) [22] results indicate that firms outperform their control group

during the post implementation period and effective implementation of total

quality management principles and philosophies leads to significant wealth

creation. The benefit of increased international trade and domestic market

share, in addition to the internal benefits such as customer satisfaction,

interdepartmental communications, work processes, and customer/supplier

partnerships derived, far exceeds any and all initial investment according to

Alcorn [23].

Background

With permission of BSI GroupISO 9001 was first published in 1987 [24]. It was

largely based on the previous standard BS 5750 that was developed by BSI Group

[25]. BSI has been certifying organizations for their quality management systems

since 1978. Its first certification [26] (FM 00001) is still extant and held by
the Tarmac company, a successor to the original company which held this

certificate. Today BSI claims to certify organizations at nearly 70,000 sites

globally[27]. The development of the ISO 9000 series is shown in the diagram to

the right.

Global adoptionThe growth in ISO 9001 certification is shown in the table below.

The worldwide total of ISO 9001 certificates can be found in the ISO Survey of

9001 in 2003, 2007, 2008 and 2009.

Worldwide total of ISO 9001:2000/2008 certificatesDec 2000Dec 2001Dec

2002Dec 2003Dec 2004Dec 2005Dec 2006Dec 2007Dec 2008Dec 2009

4578345103495617674979196601327738678969299514869828321064785

Source: ISO Survey 2009

In recent years there has been a rapid growth in China which now accounts for

approximately a quarter of the global certifications.

Top 10 countries for ISO 9001 certificates - 2009RankCountryNo. of

certificates

1China257076

2Italy130066

3Japan68484

4Spain59576

5Russian Federation53152

6Germany47156

7United Kingdom41193

8India37493
9USA28935

10Korea, Republic of23400

Source: ISO Survey 2009

Contents of ISO 9001

ISO 9001 certification of a fish wholesaler in TsukijiISO 9001:2008 Quality

management systems Ͷ Requirements is a document of approximately 30 pages which

is available from the national standards organization in each country. Outline

contents are as follows:

Page iv: Foreword

Pages v to vii: Section 0 Introduction

Page 1: Requirements

Section 1: Scope

Section 2: Normative references

Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO

9000)

Pages 2 to 14 132 1

Section 4: Quality management system

Section 5: Management responsibility

Section 6: Resource management

Section 7: Product realization

Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 need

implementing within a QMS.

Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
Page 23: Bibliography

The standard specifies six compulsory documents:

Control of Documents (4.2.3)

Control of Records (4.2.4)

Internal Audits (8.2.2)

Control of Nonconforming Product / Service (8.3)

Corrective Action (8.5.2)

Preventive Action (8.5.3)

In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual

(which may or may not include the above documents).

1.0 Scope[example]

(Company Name) has developed and implemented this quality management system to

demonstrate its ability to consistently provide a product that meets customer

and statutory and regulatory requirements, and to address customer satisfaction

through the effective application of the system.

1.3 Quality Policy

(Company Name) accepts responsibility for the complete satisfaction of its

customers. We exercise this responsibility through adequate training of our

employees, adherence to proven procedures, and total commitment to meeting and

exceeding customer requirements.

4.0 Quality management system4.1 GeneralThe Company establishes, documents,

implements, and maintains a quality management system and continually improves

its effectiveness in accordance with the requirements of the ISO 9001:2008

International Standard, that comprises:

(Company Name):
determines the processes needed for the quality management system and their

application throughout (Company Name),

determines the sequence and interaction of these processes,

determines criteria and methods needed to ensure that both the operation and

control of these processes are effective,

ensures the availability of resources and information necessary to support the

operation and monitoring of these processes,

monitors, measures where applicable and analyzes these processes,

implements actions necessary to achieve planned results and continual

improvement of these processes.

These processes are managed by (Company Name) in accordance with the

requirements of the ISO 9001:2008 International Standard. Where (Company Name)

chooses to outsource any process that affects product conformity with

requirements, (Company Name) ensures control over such processes. The type and

extent of control of such outsourced processes are identified within the quality

management system.

NOTE: Processes needed for the quality management system referred to above

include processes for management activities, provision of resources, product

realization, measurement, analysis, and improvement.

4.2 Documentation requirements4.2.1 General SpecificationsThe quality management

system documentation includes:

documented statements of a quality policy and quality objectives,

a quality manual,

documented procedures and records required by the ISO 9001:2008 International

Standard, and
documents, including records determined by (Company Name) to be necessary to

ensure the effective planning, operation and control of its processes

NOTE 1: Where the term ͞documented procedure͟ appears within the ISO 9001:2008

International Standard, means that a procedure is established, documented,

implemented and maintained.

NOTE 2: Documentation can be in any form or type of medium.

4.2.2 Quality manual(Company Name) establishes and maintains a quality manual

that includes

the scope of the quality management system, including details of and

justification for any exclusions,

the documented procedures established for the quality management system, or

reference to them, and

a description of the interaction between the processes of the quality

management system.

4.2.3 Control of documentsDocuments required by the quality management system

are controlled. Records required by the quality management system are controlled

according to the requirements given in 4.2.4. A documented procedure is

established to define the controls needed:

to approve documents for adequacy prior to issue,

to review and update as necessary and re-approve documents,

to ensure that changes and the current revision status of documents are

identified,

to ensure that relevant versions of applicable documents are available at

points of use,

to ensure that documents remain legible and readily identifiable,


to ensure that documents of external origin determined by the organization to

be necessary for the planning and operation of the quality management system

are identified and their distribution controlled, and

to prevent the unintended use of obsolete documents, and to apply suitable

identification to them if they are retained for any purpose.

Supporting Documentation

QOP-42-01 Control of Documents

4.2.4 Control of recordsRecords established to provide evidence of conformity to

requirements and or the effective operation of the quality management system

shall be controlled. (Company Name) will establish a documented procedure to

define the controls needed for the identification, storage, protection,

retrieval, retention time and disposition of records. Records will remain

legible, readily identifiable, and retrievable.

Supporting Documentation

QOP-42-02 Control of Records.

5.0 Management responsibility5.1 Management commitmentTop management is

committed to the development and implementation of the quality management system

and continually improves its effectiveness by:

communicating to (Company Name) the importance of meeting customer as well as

statutory and regulatory requirements,

establishing a quality policy,

ensuring that quality objectives are established,

conducting management reviews, and

ensuring the availability of resources.

5.2 Customer focusTop management ensures that customer requirements are


determined and are met with the aim of enhancing customer satisfaction. (see

7.2.1 and 8.2.1)

5.3 Quality policy͞(Company Name) is committed to Exceeding Customer

Expectations through Implementation and Continuous Improvement of our Quality

Management System. Absolute Customer Satisfaction is the expectation and, will

be achieved through supplying a Superior Product, On-time, at a Competitive

Price.͟ Top management ensures that the quality policy

is appropriate to the purpose of the quality policy,

includes a commitment to comply with requirements and continually improve the

effectiveness of the quality management system,

provides a framework for establishing and reviewing quality objectives,

is communicated and understood within (Company Name), and

is reviewed for continuing suitability.

5.4 Planning5.4.1 Quality objectivesTop management ensures that quality

objectives, including those needed to meet requirements for product [see 7.1 a],

are established at relevant functions and levels within (Company Name). The

quality objectives are measurable and consistent with the quality policy. 1.

Meet or exceed customer expectations by effective communication and review of

customer requirements. 2. Provide our customers high quality products and

services, on time delivery, and at a reasonable cost. 3. Effectively manage our

products, processes, and services to provide superior customer satisfaction. 4.

Promote the safety, awareness, and well being of employees through training and

education.

5.4.2 Quality management system planningTop management ensures that:

the planning of the quality management system is carried out in order to meet
the requirements given in 4.1, as well as the quality objectives, and

the integrity of the quality management system is maintained when changes to

the quality management system are planned and implemented.

5.5 Responsibility, authority and communication5.5.1 Responsibility and

authorityTop management ensures that responsibilities and authorities are

defined and communicated within (Company Name) to promote effective management

of the quality system. An Organizational Chart illustrates the responsibility

and relative authority of the personnel who manage, perform, and verify the

activities affecting the QMS. Changes to the quality system are planned within

the framework of management reviews. These changes may be in response to

changing circumstances, such as product, process, capacity, or other operational

or organizational changes; or to improve the effectiveness and efficiency of the

quality system.

Supporting Documentation

Organizational Chart

5.5.2 Management representativeTop management has appointed a member of the

organization͛s management who, irrespective of other responsibilities, has the

responsibility and authority that includes

ensuring that processes needed for the quality management system are

established, implemented and maintained,

reporting to top management on the performance of the quality management

system and any need for improvement, and

ensuring the promotion of awareness of customer requirements throughout

(Company Name).

NOTE The responsibility of a management representative can include liaison with


external parties on matters relating to the quality management system.

5.5.3 Internal communicationTop management ensures that appropriate

communication processes are established within (Company Name) and that

communication takes place regarding the effectiveness of the quality management

system.

5.6 Management Review5.6.1 GeneralTop management reviews (Company Name)͛s

quality management system, at planned intervals, to ensure its continuing

suitability, adequacy and effectiveness. The review includes assessing

opportunities for improvement and the need for changes to the quality management

system, including the quality policy and quality objectives. Records from

management reviews are maintained (see 4.2.4).

Supporting Documentation

QOP-56-01 Management Review

5.6.2 Review inputThe input to management review includes information on below:

results of audits,

customer feedback,

process performance and product conformity,

status of preventive and corrective actions,

follow-up actions from previous management reviews,

changes that could affect the quality management system, and

recommendations for improvement.

5.6.3 Review outputThe output from the management review includes any decisions

and actions related to:

improvement of the effectiveness of the quality management system and its

processes,
improvement of product related to customer requirements, and

resource needs.

6.0 Resource management6.1 Provision of resources(Company Name) determines and

provides the resources needed

to implement and maintain the quality management system and continually

improve its effectiveness

to enhance customer satisfaction by meeting customer requirements.

6.2 Human resource Management6.2.1 GeneralPersonnel performing work affecting

conformity to product requirements are competent on the basis of appropriate

education, training, skills and experience.

6.2.2 Competence, training, and awareness(Company Name) :

determines the necessary competence for personnel performing work affecting

conformity to product requirements,

where applicable, provides training or takes other actions to achieve the

necessary competence,

evaluates the effectiveness of the actions taken,

ensures that its personnel are aware of the relevance and importance of their

activities and how they contribute to the achievement of the quality

objectives, and

maintains appropriate records of education, training, skills and experience

(see 4.2.4).

Supporting Documentation

QOP-62-01 Competence, Training, and Awareness

6.3 Infrastructure(Company Name) determines, provides for, and maintains the

infrastructure needed to achieve conformity to product requirements.


Infrastructure includes, as applicable:

buildings, workspace and associated utilities,

Process equipment (both hardware and software), and

Supporting services (such as transport, communication or information systems).

Supporting Documentation

QOP-63-01 Equipment Maintenance.

6.4 Work environment(Company Name) determines and manages the work environment

needed to achieve conformity to product requirements.

7.0 Product realization7.1 Planning of product realization(Company Name) plans

and develops the processes needed for product realization. Planning of product

realization is consistent with the requirements of the other processes of the

quality management system (see 4.1). In planning product realization, (Company

Name) determines the following, as appropriate:

quality objectives and requirements for the product,

the need to establish processes, and documents, and provide resources specific

to the product,

required verification, validation, monitoring, measurement, inspection and

test activities specific to the product and the criteria for product

acceptance, and

records needed to provide evidence that the realization processes and

resulting product meet requirements (see 4.2.4).

The output of the planning is in a form suitable for (Company Name)s method of

operations.

NOTE 1 A document specifying the processes of the quality management system

(including the product realization processes) and the resources to be applied to


a specific product, project or contract, is referred to as the quality plan.

NOTE 2 (Company Name) also applies the requirements given in 7.3 to the

development of product realization processes.

Supporting Documentation

QOP-71-01 Planning of Product Realization

7.2 Customer- related processes7.2.1 Determination of requirements related to

the product(Company Name) determines:

requirements specified by the customer, including the requirements for

delivery and post-delivery activities,

requirements not stated by the customer but necessary for specified or

intended use, where known,

statutory and regulatory requirements applicable to the product, and

any additional requirements considered necessary by (Company Name).

Supporting Documentation

QOP-72-02 Order Processing & Review

7.2.2 Review of requirements related to the product(Company Name) reviews the

requirements related to the product. This review is conducted prior to (Company

Name)s commitment to supply a product to the customer (e.g. submission of

tenders, acceptance of contracts or orders, acceptance of changes to contracts

or orders) and ensures that:

product requirements are defined,

contract or order requirements differing from those previously expressed are

resolved, and

(Company Name) has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review are
maintained (see 4.2.4). Where the customer provides no documented statement of

requirement, the customer requirements are confirmed by (Company Name) before

acceptance. Where product requirements are changed, (Company Name) ensures that

relevant documents are amended and that relevant personnel are made aware of the

changed requirements.

NOTE In some situations, a formal review is impractical for each order. Instead

the review can cover relevant product information such as catalogues or

advertising material.

Supporting Documentation

QOP-72-02 Order Processing & Review

7.2.3 Customer communication(Company Name) determines and implements effective

arrangements for communicating with customers in relation to:

product information,

enquiries, contracts or order handling, including amendments, and

customer feedback, including customer complaints.

Supporting Documentation

QOP-72-02 Order Processing & Review

QOP-85-02 Customer Complaints

7.3 Design and development7.3.1 design and development planning(Company Name)

plans and controls the design and development of product. During the design and

development planning, (Company Name) determines:

the design and development stages.

the review, verification and validation that are appropriate to each design

and development stage, and


the responsibilities and authorities for design and development.

(Company Name) manages the interface between different groups involved in design

and development to ensure effective communication and clear assignment of

responsibility.

Planning output is updated, as appropriate, as the design and development

progresses.

7.3.2 Design and development inputsInputs relating to product requirements are

determined and records maintained. these inputs include:

functional and performance requirements.

applicable statutory and regulatory requirements.

where applicable information derived from previous similar designs, and

other requirements essential for design and development.

The inputs are reviewed for adequacy. Requirements are complete, unambiguous and

not in conflict with each other.

7.4 Purchasing7.4.1 Purchasing process(Company Name) ensures that purchased

product conforms to specified purchase requirements. The type and extent of

control applied to the supplier and the purchased product is dependent upon the

effect of the purchased product on subsequent product realization or the final

product.

Supporting Documentation

QOP-74-01 Purchasing

7.4.2 Purchasing InformationPurchasing information describes the product to be

purchased, including where appropriate

requirements for approval of product, procedures, processes and equipment,


requirements for qualification of personnel, and

quality management system requirements.

(Company Name) ensures the adequacy of specified purchase requirements prior to

their communication to the supplier.

Supporting Documentation

QOP-74-01 Purchasing

7.4.3 Verification of purchased product(Company Name) establishes and implements

the inspection or other activities necessary for ensuring that purchased product

meets specified purchase requirements. Where (Company Name) or its customer

intends to perform verification at the supplier͛s premises, (Company Name)

states the intended verification arrangements and method of product release in

the purchasing information.

Supporting Documentation

QOP-74-02 Verification of Purchase Product

7.5 Production and service provision7.5.1 Control of production and service

provisionAs applicable, (Company Name) plans and carries out production and

service provisions under controlled conditions. Controlled conditions include:

the availability of information that describes the characteristics of the

product,

the availability of work instructions, as necessary,

the use of suitable equipment,

the availability and use of monitoring and measuring equipment,

the implementation of monitoring and measurement activities, and

the implementation of product release, delivery and post-delivery activities.

Supporting Documentation
QOP-75-01 Work Order and Production Records

QOP-63-01 Equipment Maintenance

QOP-76-01 Measuring and Monitoring Equipment

QOP-84-02 Final Inspection

QOP-75-06 Shipping

7.5.2 Validation of processes for production and service provision(Company Name)

validates any processes for production and service provisions where the

resulting output cannot be verified by subsequent monitoring or measurement and,

as a consequence, deficiencies become apparent only after the product is in use

or the service has been delivered. Validation demonstrates the ability of these

processes to achieve planned results. As applicable, (Company Name) establishes

arrangements for these processes including:

defined criteria for review and approval of the processes,

approval of equipment and qualification of personnel,

use of specific methods and procedures,

requirements for records (see 4.2.4), and

revalidation.

Note: (Company Name) has no Special Processes at this time.

7.5.3 Identification and traceabilityWhere appropriate, (Company Name)

identifies the product by suitable means throughout product realization.

(Company Name) identifies the product status with respect to monitoring and

measurement requirements throughout product realization. Where traceability is a

requirement, (Company Name) controls the unique identification of the product an

maintain records (4.2.4).


Supporting Documentation

QOP-75-04 Product Identification and Traceability

7.5.4 Customer property(Company Name) exercises care with customer property

while it is under (Company Name)s control or being used by (Company Name).

(Company Name) identifies, verifies, protects and safeguards customer property

provided for use or incorporation into the product. If any customer property is

lost, damaged or otherwise found to be unsuitable for use, (Company Name) will

report this to the customer and maintain records (see 4.2.4).

Note: Customer property can include intellectual property and personal data.

Note: (Company Name) has no Customer Property at this time.

7.5.5 Preservation of product(Company Name) preserves the product during

internal processing and delivery to the intended destination in order to

maintain conformity to requirements. As applicable, preservation includes

identification, handling, packaging, storage and protection. Preservation also

applies to the constituent parts of a product.

7.6 Control of monitoring and measuring equipment(Company Name) determines the

monitoring and measurement to be undertaken and the monitoring and measuring

equipment needed to provide evidence of conformity of product to determined

requirements. (Company Name) establishes processes to ensure that monitoring and

measurement can be carried out, and is carried out in a manner that is

consistent with the monitoring and measurement requirements. Where necessary to

ensure valid results measuring equipment is:

calibrated, verified or both at specified intervals, or prior to use, against

measurement standards traceable to international or national measurement

standards; where no such standards exist, the basis used for calibration or
verification shall be recorded,

adjusted or re-adjusted as necessary,

have identification in order to determine it͛s calibration status,

safeguarded from adjustments that would invalidate the measurement result, and

protected from damage and deterioration during handling, maintenance and

storage.

In addition, (Company Name) assesses and records the validity of the previous

measuring results when the equipment is found not to conform to requirements.

(Company Name) takes appropriate action on the equipment and any product

affected. Records of the results of calibration and verification are maintained

(see 4.2.4).

When used in the monitoring and measurement of specified requirements, the

ability of computer software to satisfy the intended application is confirmed.

This is undertaken prior to initial use and reconfirmed as necessary.

Note: Confirmation of the ability of computer software to satisfy the intended

application will typically include its verification and configuration management

to maintain its suitability for use.

Supporting Documentation

QOP-76-01 Monitoring and Measuring Equipment

8.0 Measurement, analysis and improvement8.1 General(Company Name) plans and

implements the monitoring, measurement, analysis and improvement processes

needed:

to demonstrate conformity to product requirements,

to ensure conformity of the quality management system, and

to continually improve the effectiveness of the quality management system.


This includes determination of applicable methods, including statistical

techniques, and the extent of their use.

8.2 Monitoring and measurement8.2.1 Customer satisfactionAs one of the

measurements of the performance of the quality management system, (Company Name)

monitors information relating to customer perception as to whether (Company

Name) has met customer requirements. The methods for obtaining and using this

information are determined.

Supporting Documentation

QOP-82-01 Customer Satisfaction

8.2.2 Internal audit(Company Name) conducts internal audits at planned intervals

to determine whether the quality management system:

conforms to the planned arrangements (see 7.1), to the requirements of ISO

9001:2008 and to the quality management system requirements established by

(Company Name), and

is effectively implemented and maintained.

An audit program is planned, taking into consideration the status and importance

of the processes and areas to be audited, as well as the results of previous

audits. The audit criteria, scope, frequency and methods are defined. The

selection of auditors and conduct of audits ensures objectivity and impartiality

of the audit process. Auditors do not audit their own work.

The responsibilities and requirements for planning and conducting audits, and

for reporting results and maintaining records (see 4.2.4) are defined in a

documented procedure.

The management responsible for the area being audited ensures that any necessary

correction and corrective actions are taken without undue delay to eliminate
detected nonconformities and their causes. Follow-up activities include the

verification of the actions taken and the reporting of verification results (see

8.5.2).

Supporting Documentation

QOP-82-02 Internal Quality Audits

8.2.3 Monitoring and measurement of processes(Company Name) applies suitable

methods for monitoring and where applicable, measurement of the quality

management system processes. These methods demonstrate the ability of the

processes to achieve planned results. When planned results are not achieved,

correction and corrective action is taken, as appropriate.

8.2.4 Monitoring and measurement of product(Company Name) monitors and measures

the characteristics of the product to verify that product requirements have been

met. This is carried out at appropriate stages of the product realization

process in accordance with the planned arrangements (see 7.1). Evidence of

conformity with the acceptance criteria is maintained. Records indicate the

person(s) authorizing release of product for delivery to the customer (see

4.2.4). The release of product and delivery of service to the customer does not

proceed until the planned arrangements (see 7.1) have been satisfactorily

completed, unless otherwise approved by a relevant authority and where

applicable, by the customer.

Supporting Documentation

QOP-82-03 In Process Inspections

QOP-82-04 Final Inspection

8.3 Control of nonconforming product(Company Name) ensures that product which

does not conform to product requirements is identified and controlled to prevent


its unintended use or delivery. A documented procedure is established to define

the controls and related responsibilities and authorities for dealing with

nonconforming products. Where applicable (Company Name) deals with nonconforming

product by one or more of the following ways:

by taking action to eliminate the detected nonconformity,

by authorizing its use, release or acceptance under concession by a relevant

authority and, where applicable, by the customer, and

by taking action to preclude its original intended use or application.

by taking action appropriate to the effects, or potential effects, of the

nonconformity when nonconforming product is detected after delivery or use has

started.

When nonconforming product is corrected the product is subjected to

re-verification to demonstrate conformity to the requirements. When

nonconforming product is detected after delivery or use has started, (Company

Name) takes action appropriate to the effects, or potential effects, of the

nonconformity. Records of the nature of nonconformities and any subsequent

actions taken, including concessions obtained, are maintained (see 4.2.4).

Supporting Documentation

QOP-83-01 Control of Nonconforming Product

8.4 Analysis of data(Company Name) determines, collects and analyzes appropriate

data to demonstrate the suitability and effectiveness of the quality management

system and to evaluate where continual improvement of the effectiveness of the

quality management system can be made. This includes data generated as a result

of monitoring and measurement and from other relevant sources. The analysis of

data provides information relating to:


customer satisfaction (see 8.2.1),

conformity to product requirements (see 8.2.4),

characteristics and trends of processes and products including opportunities

for preventive action (see 8.2.3 and 8.2.4),

suppliers (see 7.4),

Supporting Documentation

QOP-56-01 Management Review

8.5 Improvement8.5.1 Continual improvement(Company Name) continually improves

the effectiveness of the quality management system through the use of the

quality policy, quality objectives, audit results, analysis of data, corrective

and preventive actions and management reviews.

Supporting Documentation

QOP-85-01 Continual Improvement

8.5.2 Corrective action(Company Name) takes action to eliminate the causes of

nonconformities in order to prevent recurrence. Corrective actions are

appropriate to the effects of the nonconformities encountered. A documented

procedure is established to define requirements for:

reviewing nonconformities (including customer complaints),

determining the causes of nonconformities,

evaluating the need for action to ensure that nonconformities do not recur,

determining and implementing action needed,

records of the results of action taken (see 4.2.4), and

reviewing the effectiveness of the corrective action taken.

Supporting Documentation

QOP-85-02 Customer Complaints


QOP-85-03 Corrective and Preventive Actions

8.5.3 Preventive action(Company Name) determines actions to eliminate the causes

of potential nonconformities in order to prevent their occurrence. Preventive

actions are appropriate to the effects of the potential problems. A documented

procedure is established to define requirements for:

determining potential nonconformities and their causes,

evaluating the need for action to prevent occurrence of nonconformities,

determining and implementing action needed,

records of results of action taken (see 4.2.4), and

reviewing the effectiveness of the preventive action taken.

Supporting Documentation

QOP-85-03 Corrective and Preventive Actions

1987 versionISO 9000:1987 had the same structure as the UK Standard BS 5750,

with three 'models' for quality management systems, the selection of which was

based on the scope of activities of the organization:

ISO 9001:1987 Model for quality assurance in design, development, production,

installation, and servicing was for companies and organizations whose

activities included the creation of new products.

ISO 9002:1987 Model for quality assurance in production, installation, and

servicing had basically the same material as ISO 9001 but without covering the

creation of new products.

ISO 9003:1987 Model for quality assurance in final inspection and test covered

only the final inspection of finished product, with no concern for how the

product was produced.

ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards
("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to

be placed on conformance with procedures rather than the overall process of

managementͶwhich was likely the actual intent.[citation needed]

1994 versionISO 9000:1994 emphasized quality assurance via preventive actions,

instead of just checking final product, and continued to require evidence of

compliance with documented procedures. As with the first edition, the down-side

was that companies tended to implement its requirements by creating shelf-loads

of procedure manuals, and becoming burdened with an ISO bureaucracy. In some

companies, adapting and improving processes could actually be impeded by the

quality system.[citation needed]

2000 versionISO 9001:2000 combines the three standards 9001, 9002, and 9003 into

one, called 9001. Design and development procedures are required only if a

company does in fact engage in the creation of new products. The 2000 version

sought to make a radical change in thinking by actually placing the concept of

process management front and center ("Process management" was the monitoring and

optimizing of a company's tasks and activities, instead of just inspecting the

final product). The 2000 version also demands involvement by upper executives,

in order to integrate quality into the business system and avoid delegation of

quality functions to junior administrators. Another goal is to improve

effectiveness via process performance metrics Ͷ numerical measurement of the

effectiveness of tasks and activities. Expectations of continual process

improvement and tracking customer satisfaction were made explicit.

The ISO 9000 standard is continually being revised by standing technical

committees and advisory groups, who receive feedback from those professionals

who are implementing the standard.[1]


ISO 9001:2008 only introduces clarifications to the existing requirements of ISO

9001:2000 and some changes intended to improve consistency with ISO 14001:2004.

There are no new requirements. Explanation of changes in ISO 9001:2008. A

quality management system being upgraded just needs to be checked to see if it

is following the clarifications introduced in the amended version.

CertificationISO does not itself certify organizations. Many countries have

formed accreditation bodies to authorize certification bodies, which audit

organizations applying for ISO 9001 compliance certification. Although commonly

referred to as ISO 9000:2000 certification, the actual standard to which an

organization's quality management can be certified is ISO 9001:2008. Both the

accreditation bodies and the certification bodies charge fees for their

services. The various accreditation bodies have mutual agreements with each

other to ensure that certificates issued by one of the Accredited Certification

Bodies (CB) are accepted worldwide.

The applying organization is assessed based on an extensive sample of its sites,

functions, products, services and processes; a list of problems ("action

requests" or "non-compliance") is made known to the management. If there are no

major problems on this list, or after it receives a satisfactory improvement

plan from the management showing how any problems will be resolved, the

certification body will issue an ISO 9001 certificate for each geographical site

it has visited.

An ISO certificate is not a once-and-for-all award, but must be renewed at

regular intervals recommended by the certification body, usually around three

years. There are no grades of competence within ISO 9001: either a company is

certified (meaning that it is committed to the method and model of quality


management described in the standard), or it is not. In this respect, it

contrasts with measurement-based quality systems such as the Capability Maturity

Model.

AuditingTwo types of auditing are required to become registered to the standard:

auditing by an external certification body (external audit) and audits by

internal staff trained for this process (internal audits). The aim is a

continual process of review and assessment, to verify that the system is working

as it's supposed to, find out where it can improve and to correct or prevent

problems identified. It is considered healthier for internal auditors to audit

outside their usual management line, so as to bring a degree of independence to

their judgments.

Under the 1994 standard, the auditing process could be adequately addressed by

performing "compliance auditing":

Tell me what you do (describe the business process)

Show me where it says that (reference the procedure manuals)

Prove that this is what happened (exhibit evidence in documented records)

The 2000 standard uses a different approach. Auditors are expected to go beyond

mere auditing for rote "compliance" by focusing on risk, status and importance.

This means they are expected to make more judgments on what is effective, rather

than merely adhering to what is formally prescribed. The difference from the

previous standard can be explained thus:

Under the 1994 version, the question was broadly "Are you doing what the

manual says you should be doing?", whereas under the 2000 version, the

question is more "Will this process help you achieve your stated objectives?

Is it a good process or is there a way to do it better?"


Industry-specific interpretationsThe ISO 9001 standard is generalized and

abstract. Its parts must be carefully interpreted, to make sense within a

particular organization. Developing software is not like making cheese or

offering counseling services; yet the ISO 9001 guidelines, because they are

business, management guidelines can be applied to each of these. Diverse

organizationsͶpolice departments (US), professional soccer teams (Mexico) and

city councils (UK)Ͷhave successfully implemented ISO 9001:2000 systems.

Over time, various industry sectors have wanted to standardize their

interpretations of the guidelines within their own marketplace. This is partly

to ensure that their versions of ISO 9000 have their specific requirements, but

also to try and ensure that more appropriately trained and experienced auditors

are sent to assess them.

The TickIT guidelines are an interpretation of ISO 9000 produced by the UK

Board of Trade to suit the processes of the information technology industry,

especially software development.

AS9000 is the Aerospace Basic Quality System Standard, an interpretation

developed by major aerospace manufacturers. Those major manufacturers include

AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines,

Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney,

Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is

AS9100.

PS 9000 is an application of the standard for Pharmaceutical Packaging

Materials. The Pharmaceutical Quality Group (PQG) of the Institute of Quality

Assurance (IQA) has developed PS 9000:2001. It aims to provide a widely

accepted baseline GMP framework of best practice within the pharmaceutical


packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical printed

and contact packaging materials.

QS 9000 is an interpretation agreed upon by major automotive manufacturers

(GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is

now replaced by ISO/TS 16949.

ISO/TS 16949:2009 is an interpretation agreed upon by major automotive

manufacturers (American and European manufacturers); the latest version is

based on ISO 9001:2008. The emphasis on a process approach is stronger than in

ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and

automotive industry-specific requirements.

TL 9000 is the Telecom Quality Management and Measurement System Standard, an

interpretation developed by the telecom consortium, QuEST Forum. The current

version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000

includes standardized product measurements that can be benchmarked. In 1998

QuEST Forum developed the TL 9000 Quality Management System to meet the supply

chain quality requirements of the worldwide telecommunications industry.

ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas

the standards it replaces were interpretations of how to apply ISO 9001 and

ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard.

Compliance with ISO 13485 does not necessarily mean compliance with ISO

9001:2000.

ISO/IEC 90003:2004 provides guidelines for the application of ISO 9001:2000 to

computer software.

ISO/TS 29001 is quality management system requirements for the design,

development, production, installation and service of products for the


petroleum, petrochemical and natural gas industries. It is equivalent to API

Spec Q1 without the Monogram annex.

EffectivenessThe debate on the effectiveness of ISO 9000 commonly centers on the

following questions:

Are the quality principles in ISO 9001:2000 of value? (Note that the version

date is important: in the 2000 version ISO attempted to address many concerns

and criticisms of ISO 9000:1994).

Does it help to implement an ISO 9001:2000 compliant quality management

system?

Does it help to obtain ISO 9001:2000 certification?

Effectiveness of the ISO system being implemented depends on a number of

factors, the most significant of which are:

Commitment of Senior Management to monitor, control, and improve quality.

Organizations that implement an ISO system without this desire and commitment,

often take the cheapest road to get a certificate on the wall and ignore

problem areas uncovered in the audits.

How well the ISO system integrates into their business practices. Many

organizations that implement ISO try to make their system fit into a

cookie-cutter quality manual rather than create a manual that documents

existing practices and only adds new processes to meet the ISO standard when

necessary.

How well the ISO system focuses on improving the customer experience. The

broadest definition of quality is "Whatever the customer perceives good

quality to be". This means that you don't necessarily have to make a product

that never fails, some customers will have a higher tolerance for product
failures if they always receive shipments on-time, or some other dimension of

customer service. Your ISO system should take into account all areas of the

customer experience, the industry expectations, and seek to improve them on a

continual basis. This means taking into account all processes that deal with

the three stakeholders (your customers, your suppliers, and your

organization), only then will you be able to sustain improvements in your

customer experience.

How well the auditor finds and communicates areas of improvement. Now, ISO

auditors may not provide consulting to the clients they audit, however, there

is the potential for auditors to point out areas of improvement. Many auditors

simply rely on submitting reports that indicate compliance or non-compliance

with the appropriate section of the standard, however, to most executives,

this is like speaking a foreign language. Auditors that can clearly identify

and communicate areas of improvement in language and terms executive

management understands allows the companies they audit to act on improvement

initiatives. When management doesn't understand why they were non-compliant

and the business implications, they simply ignore the reports and focus on

what they do understand.

AdvantagesIt is widely acknowledged that proper quality management improves

business, often having a positive effect on investment, market share, sales

growth, sales margins, competitive advantage, and avoidance of litigation.The

quality principles in ISO 9000:2000 are also sound, according to Wade and

Barnes, who say that "ISO 9000 guidelines provide a comprehensive model for

quality management systems that can make any company competitive implementing

ISO often gives the following advantages:


Create a more efficient, effective operation

Increase customer satisfaction and retention

Reduce audits

Enhance marketing

Improve employee motivation, awareness, and morale

Promote international trade

Increases profit

Reduce waste and increases productivity.

ProblemsA common criticism of ISO 9001 is the amount of money, time and

paperwork required for registration.[28] According to Barnes, "Opponents claim

that it is only for documentation. Proponents believe that if a company has

documented its quality systems, then most of the paperwork has already been

completed."[29]

ISO 9001 is not in any way an indication that products produced using its

certified systems are any good. A company can intend to produce a poor quality

product and providing it does so consistently and with the proper documentation

can put an ISO 9001 stamp on it. According to Seddon, ISO 9001 promotes

specification, control, and procedures rather than understanding and

improvement.[30][31] Wade argues that ISO 9000 is effective as a guideline, but

that promoting it as a standard "helps to mislead companies into thinking that

certification means better quality, ... [undermining] the need for an

organization to set its own quality standards." [32] Paraphrased, Wade's

argument is that reliance on the specifications of ISO 9001 does not guarantee a

successful quality system.

While internationally recognized, most US consumers are not aware of ISO 9000
and it holds no relevance to them. The added cost to certify and then maintain

certification may not be justified if product end users do not require ISO 9000.

The cost can actually put a company at a competitive disadvantage when competing

against a non ISO 9000 certified company.

The standard is seen as especially prone to failure when a company is interested

in certification before quality.[30] Certifications are in fact often based on

customer contractual requirements rather than a desire to actually improve

quality.[29][33] "If you just want the certificate on the wall, chances are, you

will create a paper system that doesn't have much to do with the way you

actually run your business," said ISO's Roger Frost.[33] Certification by an

independent auditor is often seen as the problem area, and according to Barnes,

"has become a vehicle to increase consulting services." [29] In fact, ISO itself

advises that ISO 9001 can be implemented without certification, simply for the

quality benefits that can be achieved.[34]

Another problem reported is the competition among the numerous certifying

bodies, leading to a softer approach to the defects noticed in the operation of

the Quality System of a firm.

Abrahamson[35] argued that fashionable management discourse such as Quality

Circles tends to follow a lifecycle in the form of a bell curve, possibly

indicating a management fad.

SummaryA good overview for effective use of ISO 9000 is provided by Barnes:

"Good business judgment is needed to determine its proper role for a company. Is

certification itself important to the marketing plans of the company? If not, do

not rush to certification Even without certification, companies should utilize

the ISO 9000 model as a benchmark to assess the adequacy of its quality
programs."

See alsoConformity assessmentͶContaining ISO published standards

ISO 10006ͶQuality managementͶGuidelines to quality management in projects

ISO 14001ͶEnvironmental management standards

ISO 19011ͶGuidelines for quality management systems auditing and environmental

management systems auditing

ISO/TS 16949ͶQuality management system requirements for automotive-related

products suppliers

ISO/IEC 27001ͶInformation security management

AS 9100 - aerospace industry implementation of ISO 9000/1

List of ISO standards

Quality management system

Test management

Verification and Validation

References^ Poksinska, B.; Kahlgaard, J.J.; Antoni, M. (2002), "The state of

ISO 9000 certification: A study of Swedish organisations", The TQM Magazine 14

(5),

http://www.emeraldinsight.com/journals.htm?articleid=842040&show=abstract,

retrieved 2010-11-22

^ Tsim, Y.C.; Yeung, V. W. S.; Leung, E. T. C. (2002), "An adaptation to ISO

9001: 2000 for certified organisations", Managerial Auditing Journal 17 (5),

http://www.emeraldinsight.com/journals.htm?articleid=868561&show=abstract,

retrieved 2010-11-22

^ Beattie, K.R.; Sohal, A.S. (1999), "Implementing ISO 9000: A study of its

benefits among Australian organizations", Total Quality Management 10 (1):


95ʹ106, http://www.informaworld.com/smpp/content~db=all~content=a713600335,

retrieved 2010-11-22

^ Tsim, Y.C.; Yeung, V. W. S.; Leung, E. T. C. (2002), "An adaptation to ISO

9001: 2000 for certified organisations", Managerial Auditing Journal 17 (5),

http://www.emeraldinsight.com/journals.htm?articleid=868561&show=abstract,

retrieved 2010-11-22

^ http://www.iso.org/iso/pressrelease.htm?refid=Ref1363 ISO Press Release, 25

October 2010]

^ Corbett, C.J.; Montes-sancho, M.J.; Kirsch, D.A. (2005), "The financial

impact of ISO 9000 certification in the United States: An empirical analysis",

Management Science 51 (7): 1046ʹ1059,

http://personal.anderson.ucla.edu/charles.corbett/papers/does_iso_9000_pay.pdf,

retrieved 2010-11-22

^ http://www.bsi-emea.com/Quality/CaseStudies/Interstate.pdf Interstate ISO

9000 Case Study]

^ Heras, I.; Dick, G.P. M.; Casadesus, M. (2002), "ISO 9000 registration's

impact on sales and profitability - A longitudinal analysis of performance

before and after accreditation", International Journal of Quality and

Reliability Management 19 (6): 774ʹ791,

http://eps.udg.es/oe/webmarti/p774.pdf, retrieved 2010-11-22

^ http://www.bsi-emea.com/Quality/CaseStudies/Hardies.pdf Hardies ISO 9000

Case Study ]

^ Naveh, E.; Marcus, A. (2007), "Financial performance, ISO 9000 standard and

safe driving practices effects on accident rate in the U.S. motor carrier

industry", Accident Analysis & Prevention 39 (4): 731ʹ742,


http://www.ncbi.nlm.nih.gov/pubmed/17166474, retrieved 2010-11-22

^ http://www.bsi-emea.com/Quality/CaseStudies/DFDSTransport.pdf DFDS Transport

ISO 9000 Case Study ]

^ Sharma, D.S. (2005), "The association between ISO 9000 certification and

financial performance", The international Journal of Accounting 40: 151ʹ172,

http://masp.bus.ku.ac.th/files/ISO%209000%20and%20performamce.pdf, retrieved

2010-11-22

^ Chow-chua, C.; Goh, M.; Wan, T.B. (2002), "Does ISO 9000 certification

improve business performance?", The International Journal of Quality &

Reliability Management 20 (8): 936ʹ953,

http://www.emeraldinsight.com/journals.htm?articleid=840633&show=abstract,

retrieved 2010-11-22

^ Rajan, M.; Tamimi, N. (2003), "Payoff to ISO 9000 registration", Journal of

Investing 12 (1), http://www.iijournals.com/doi/abs/10.3905/joi.2003.319536,

retrieved 2010-11-22

^ http://www.bsi-emea.com/Quality/CaseStudies/Accenture.pdf Accenture ISO 9000

Case Study ]

^ http://www.bsi-emea.com/Quality/CaseStudies/BritishGas.pdf British Gas ISO

9000 Case Study ]

^ Corbett, C.J.; Montes-sancho, M.J.; Kirsch, D.A. (2005), "The financial

impact of ISO 9000 certification in the United States: An empirical analysis",

Management Science 51 (7): 1046ʹ1059,

http://personal.anderson.ucla.edu/charles.corbett/papers/does_iso_9000_pay.pdf,

retrieved 2010-11-22

^ Heras, I.; Dick, G.P. M.; Casadesus, M. (2002), "ISO 9000 registration's
impact on sales and profitability - A longitudinal analysis of performance

before and after accreditation", International Journal of Quality and

Reliability Management 19 (6): 774ʹ791,

http://eps.udg.es/oe/webmarti/p774.pdf, retrieved 2010-11-22

^ Lo, Chris K.Y.; Yeung, Andy C.L.; Cheng, T.C. Edwin (2007), "Impact of ISO

9000 on time-based performance: An event study", World Academy of Science,

Engineering and Technology 30 (7): 35 - 40,

http://www.waset.org/journals/waset/v30/v30-7.pdf, retrieved 2010-11-22

^ Buttle, F. (1997), "ISO 9000: marketing motivations and benefits",

International Journal of Quality & Reliability Management 14 (9): 936 - 947,

http://www.emeraldinsight.com/journals.htm?articleid=1502750&show=abstract,

retrieved 2010-11-22

^ Santos, L. (2002), "Benefits of the ISO 9000:1994 system: Some consideration

to reinforce competitive advantage", International Journal of Quality &

Reliability Management 19 (3): 321 - 344,

http://www.emeraldinsight.com/journals.htm?articleid=840553&show=abstract,

retrieved 2010-11-22

^ Hendreicks, K.B.; Singhal, V.R. (2001), "The long-run stock price

performance of firms with effective TQM programs", Management Science 47 (3):

359 - 368, http://www.jstor.org/pss/2661504, retrieved 2010-11-22

^ Alcorn, J. E. (1995), "Benefits of ISO 9000 Certification", Ceramic

Engineering and Science Proceedings 16 (2): 15ʹ18,

http://md1.csa.com/partners/viewrecord.php?requester=gs&collection=TRD&recid=WCA103967WC&q
=Benefits+of+ISO+9000+Certification&uid=788436682&setcookie=yes,

retrieved 2010-11-18
^ http://www.bsieducation.org/Education/about/brief-history.shtml History of

the BSI Group

^ http://www.bsigroup.com/en/About-BSI/News-Room/BSI-Fast-Facts2/ Fast Facts

About BSI Group

^ Tarmac Certificate of Registration

^ http://www.bsigroup.com/en/About-BSI/About-BSI-Group/ More About BSI Group

^ "So many standards to follow, so little payoff". Stephanie Clifford. Inc

Magazine, May 2005.

^ a b c "Good Business Sense Is the Key to Confronting ISO 9000" Frank Barnes

in Review of Business, Spring 2000.

^ a b "The 'quality' you can't feel", John Seddon, The Observer, Sunday

November 19, 2000

^ "A Brief History of ISO 9000: Where did we go wrong?". John Seddon. Chapter

one of "The Case Against ISO 9000", 2nd ed., Oak Tree Press. November 2000.

ISBN 1-86076-173-9

^ "Is ISO 9000 really a standard?" Jim Wade, ISO Management Systems ʹ MayʹJune

2002

^ a b "ISO a GO-Go." Mark Henricks. Entrepreneur Magazine Dec 2001.

^ The ISO Survey ʹ 2005 (abridged version, PDF, 3 MB), ISO, 2005

^ Abrahamson, E. (1996). "Managerial fashion." Academy of Management Review.

21(1):254-285.

Further readingBamford, Robert; Deibler, William (2003). ISO 9001: 2000 for

Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press.

ISBN 0849320631, ISBN 978-0849320637

Naveh. E., Marcus, A. (2004). "When does ISO 9000 Quality Assurance standard
lead to performance improvement?", IEEE Transactions on Engineering

Management, 51(3), 352ʹ363.

http://www.iso.org/iso/survey2007.pdf - An abstract of the 2007's ISO survey

of certificates

http://www.iso.org/iso/survey2008.pdf - An abstract of the 2008's ISO survey

of certificates

See alsoInternational Organization for Standardization

External linksISO 9000 at the Open Directory Project

Introduction to ISO 9000 and ISO 14000

International Organization for Standardization

ISO's Technical Committee 176 on Quality Management and Quality Assurance

Technical Committee No. 176, Sub-committee No. 2, which is responsible for

developing ISO 9000 standards.

Basic info on ISO 9000 development

ISO 9000 FAQs

[show]v ͻ d ͻ eISO standards

Lists: List of ISO standards · List of ISO romanizations · List of

IEC standards

Categories: Category:ISO standards · Category:OSI protocols

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27729 · 27799 · 29199-2 · 29500 · 31000 · 32000 · 38500 · 42010 ·

80000

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