Senin, 12 Juli 2010

ISO 9001:2008

(Company Name)
Quality System Manual
Rev 11/15/08




ISO 9001:2008











Table of Contents
Contents Page
1.0 Scope 3
2.0 Normative reference 3
3.0 Terms and definitions 3
4.0 Quality management system 3
4.1 General 3
4.2 Documentation 3
5.0 Management responsibility 4
5.1 Management commitment 4
5.2 Customer focus 5
5.3 Quality policy 5
5.4 Planning –Quality Objectives 5
5.5 Responsibility, authority and communication 5
5.6 Management review 6
6.0 Resource management 6
6.1 Provision of resources 6
6.2 Human resources 6
6.3 Infrastructure 7
6.4 Work environment 7
7.0 Product realization 7
7.1 Planning of product realization 7
7.2 Customer-related processes 7
7.3 Design and development 8
7.4 Purchasing 8
7.5 Production and service provision 9
7.6 Control of monitoring and measuring equipment 10
8.0 Measurement, analysis and improvement 10
8.1 General 10
8.2 Monitoring and measurement 10
8.3 Control of nonconforming product 11
8.4 Analysis of data 11
8.5 Improvement 12







1.0 Scope
(Insert Scope Here)
(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.
(Company Name) has excluded section 7.3 Design and Development from the applicable requirements of ISO 9001:2008, due to the nature of (Company Name) and its products. All principal product characteristics are specified by the customers or their consultants. This exclusion does not affect (Company Name)’s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
2.0 Normative reference
The following 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.
3.0 Terms and definitions
“Supplier” and “Vendor” are synonymous and refer to the external source used to acquire purchased products by (Company Name).
4.0 Quality management system
4.1 General requirements
(Company Name) 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.
(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, and
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,
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
5.0 Management responsibility
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.
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.
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 Excluded (See 1.0 Scope)
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 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
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

8.5 Improvement
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

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