ISO 9000 is a family of standards for quality management systems.

ISO 9000 is maintained by

ISO, the International Organization for Standardization and is administered by accreditation and
certification bodies. The rules are updated, as the requirements motivate changes over time.
Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000
family) include

 a set of procedures that cover all key processes in the business;

 monitoring processes to ensure they are effective;
 keeping adequate records;
 checking output for defects, with appropriate and corrective action where necessary;
 regularly reviewing individual processes and the quality system itself for effectiveness;
and
 facilitating continual improvement

A company or organization that has been independently audited and certified to be in

conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001
registered". Certification to an ISO 9001 standard does not guarantee any quality of end products
and services; rather, it certifies that formalized business processes are being applied.

Although the standards originated in manufacturing, they are now employed across several types
of organizations. A "product", in ISO vocabulary, can mean a physical object, services, or
software.

Contents
[hide]

 1 Contents of ISO 9001

o 1.1 Summary of ISO 9001:2008
o 1.2 1.0 Scope
o 1.3 2.0 Normative reference
o 1.4 3.0 Terms and definitions
o 1.5 4.0 Quality management system
o 1.6 5.0 Management responsibility
 1.6.1 5.1 Management commitment
o 1.7 6.0 Resource management
o 1.8 7.0 Product realization
o 1.9 8.0 Measurement, analysis and improvement
 1.9.1 8.5 Improvement
 1.9.1.1 8.5.1 Continual improvement
o 1.10 1987 version
o 1.11 1994 version
o 1.12 2000 version
o 1.13 Certification
  2 Auditing
 3 Industry-specific interpretations
 4 Effectiveness
o 4.1 Advantages
o 4.2 Problems
o 4.3 Summary
 5 See also
 6 References
 7 Further reading
 8 External links

[edit] Contents of ISO 9001

ISO 9001 certification of a fish wholesaler in Tsukiji

ISO 9001:2008 Quality management systems — 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 Intro
 Pages 1 to 14: Requirements
o Section 1: Scope
o Section 2: Normative Reference
o Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
 Pages 2 to 14 132 1
o Section 4: Quality Management System
o Section 5: Management Responsibility
o Section 6: Resource Management
o Section 7: Product Realization
o 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).

[edit] Summary of ISO 9001:2008

 A quality policy is a formal statement from an organization's management, closely linked

to the business and marketing plan and to customer needs. A quality policy is understood
and followed at all levels and by all employees. Each employee needs measurable
objectives to work towards.
 Decisions about the quality system are made based on recorded data. The system is
regularly audited and evaluated for conformance and effectiveness.
 Records maintained should show how and where raw materials and products were
processed, to allow products and problems to be traced to the source.
 Customer requirements are determined and systems created for communication with
customers about product information, inquiries, contracts, orders, feedback and
complaints.
 When developing new products, organizations need to plan the stages of development,
with appropriate testing at each stage. Testing is carried out and documentation produced
as to whether a product meets design requirements, regulatory requirements and user
needs.
 Regular performance reviews through internal audits and meetings are a prerequisite of
ISO 9001:2008. These determine whether the quality system is working and what
improvements can be made whilst dealing with past problems and potential problems.
Records of audit and meeting activities and the resultant decisions are kept and their
effectiveness monitored. Note that a documented procedure for internal audits is required
 Documented procedures for dealing with actual and potential nonconformances
(problems involving suppliers or customers, or internal problems) are required by the
standard. Systems and processes should ensure that no inferior product is used whilst
determining what to do with bad product. The root cause of the problem should be dealt
with and records kept as tools used to improve the system.
[edit] 1.0 Scope

(Company Name) has developed and implemented this quality management system to
demonstrate its ability to consistently provide product that meets customer and statutory and
regulatory requirements, and to address customer satisfaction through the effective application of
the system, including continual improvement and the prevention of nonconformity. This is
basically for quality check.

[edit] 2.0 Normative reference

The normative document contains provisions which, through reference in this text, constitute
provisions of ISO 9001:2008. For dated references, subsequent amendments to, or revisions of,
any of these publications do not apply. However, parties to agreements based on ISO 9001:2008
are encouraged to investigate the possibility of applying the most recent edition of the normative
document indicated below. For undated references, the latest edition of the normative document
referred to applies. ISO 9000: 2005 Quality Management System –Fundamentals and
Vocabulary.

[edit] 3.0 Terms and definitions

“Supplier” and “Vendor” are synonymous and refer to the external source used to acquire
purchased products by (Company Name).

[edit] 4.0 Quality management system

4.1 General requirements: The Company 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 of:
(Company Name):
a) determines the processes needed for the quality management system and their application
throughout (Company Name),
b) determines the sequence and interaction of these processes,
c) determines criteria and methods needed to ensure that both the operation and control of these
processes are effective,
d) ensures the availability of resources and information necessary to support the operation and
monitoring of these processes,
e) monitors, measures where applicable and analyzes these processes,
f) 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 requirements

4.2.1 General

The quality management system documentation includes:

a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by the ISO 9001:2008 International Standard,
and
d) 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 procedure” 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

a) the scope of the quality management system, including details of and justification for any
exclusions,
b) the documented procedures established for the quality management system, or reference to
them, and
c) a description of the interaction between the processes of the quality management system.

4.2.3 Control of documents

Documents 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:
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use, e) to
ensure that documents remain legible and readily identifiable,
f) 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
g) 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 records

Records 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

[edit] 5.0 Management responsibility

[edit] 5.1 Management commitment

Top management is committed to the development and implementation of the quality

management system and continually improves its effectiveness by: a) communicating to
(Company Name) the importance of meeting customer as well as statutory and regulatory
requirements, b) establishing a quality policy, c) establishing quality objectives, d) conducting
management reviews, and e) ensuring the availability of resources.

5.2 Customer focus. Top 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 policy “(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 a) is
appropriate to the purpose of the quality policy, b) includes a commitment to comply with
requirements and continually improve the effectiveness of the quality management system, c)
provides a framework for establishing and reviewing quality objectives, d) is communicated and
understood within (Company Name), and e) is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality objectives Top 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 planning Top management ensures that: a) 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 b) 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 communication

5.5.1 Responsibility and authority Top 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 representative Top management has appointed a member of the

organization’s management who, irrespective of other responsibilities, has the responsibility and
authority that includes a) ensuring that processes needed for the quality management system are
established, implemented and maintained, b) reporting to top management on the performance of
the quality management system and any need for improvement, and c) 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 communication Top 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 Review

5.6.1 General Top 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 input The input to management review includes information on: a) results of
audits, b) customer feedback, c) process performance and product conformity, d) status of
preventive and corrective actions, e) follow-up actions from previous management reviews, f)
changes that could affect the quality management system, and g) recommendations for
improvement.

5.6.3 Review output The output from the management review includes any decisions and actions
related to: a) improvement of the effectiveness of the quality management system and its
processes, b) improvement of product related to customer requirements, and c) resource needs.

[edit] 6.0 Resource management

6.1 Provision of resources (Company Name) determines and provides the resources needed a) to
implement and maintain the quality management system and continually improve its
effectiveness, and b) to enhance customer satisfaction by meeting customer requirements.

6.2 Human resources

6.2.1 General Personnel 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) : a) determines the necessary
competence for personnel performing work affecting conformity to product requirements, b)
where applicable, provides training or takes other actions to achieve the necessary competence,
c) evaluates the effectiveness of the actions taken, d) 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 e) 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: a)
buildings, workspace and associated utilities, b) Process equipment (both hardware and
software), and c) 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.

[edit] 7.0 Product realization

7.1 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:

a) quality objectives and requirements for the product,

b) the need to establish processes, and documents, and provide resources specific to the product,
c) required verification, validation, monitoring, measurement, inspection and test activities
specific to the product and the criteria for product acceptance, and
d) 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 processes

7.2.1 Determination of requirements related to the product

(Company Name) determines:

a) requirements specified by the customer, including the requirements for delivery and post-
delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where
known,
c) statutory and regulatory requirements applicable to the product, and
d) 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:
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) (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:

a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.

Supporting Documentation
QOP-72-02 Order Processing & Review
QOP-85-02 Customer Complaints

7.3 Design and development 7.3.1 design and development planing (Company Name) plans and
controls the design and development of product. During the design and development planning,
(Company Name) determines: a) the design and development stages. b) the review, verification
and validation that are appropriate to each design and development stage, and c) the
responsibilities and authorities for design and development.

7.3.2 Design and development inputs. Inputs relating to product requirements shall be
determined and records maintained. these inputs shall include a) functional and performance
requirements. b) applicable statutory and regulatory requirements. c) where applicable
information derived from previous similar designs, and d) other requirements essential for design
and development.

the inputs shall be reviewed for adequacy, requirements shall be complete, unambiguous and not
in conflict with each other.

7.4 Purchasing

7.4.1 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 Information

Purchasing information describes the product to be purchased, including where appropriate a)

requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) 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 supplier’s 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 provision

7.5.1 Control of production and service provision

As applicable, (Company Name) plans and carries out production and service provisions under
controlled conditions. Controlled conditions include:

a) the availability of information that describes the characteristics of the product,

b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring equipment,
e) the implementation of monitoring and measurement activities, and
f) 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:
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

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

7.5.3 Identification and traceability Where 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 date.

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:

a)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,
b)adjusted or re-adjusted as necessary,
c)have identification in order to determine it’s calibration status,
d)safeguarded from adjustments that would invalidate the measurement result, and
e)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).

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

[edit] 8.0 Measurement, analysis and improvement

8.1 General (Company Name) plans and implements the monitoring, measurement, analysis and
improvement processes needed: a)to demonstrate conformity to product requirements, b)to
ensure conformity of the quality management system, and c)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 measurement

8.2.1 Customer satisfaction As 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 Audits (Company Name) conducts internal audits at planned intervals to determine
whether the quality management system: a)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 b)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 ensure 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: a)by
taking action to eliminate the detected nonconformity, b)by authorizing its use, release or
acceptance under concession by a relevant authority and, where applicable, by the customer, and
c)by taking action to preclude its original intended use or application. d)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 subject 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: a)customer satisfaction
(see 8.2.1), b)conformity to product requirements (see 8.2.4), c)characteristics and trends of
processes and products including opportunities for preventive action (see 8.2.3 and 8.2.4),
d)suppliers (see 7.4), Supporting Documentation QOP-56-01 Management Review

[edit] 8.5 Improvement

[edit] 8.5.1 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:
a) reviewing nonconformities (including customer complaints), b) determining the causes of
nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d)
determining and implementing action needed, e) records of the results of action taken (see 4.2.4),
and f) 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: a) determining potential nonconformities and their causes, b) evaluating the need for action
to prevent occurrence of nonconformities, c) determining and implementing action needed, d)
records of results of action taken (see 4.2.4), and e) reviewing the effectiveness of the preventive
action taken. Supporting Documentation QOP-85-03 Corrective and Preventive Actions