04/13/23 ISO 9001:2008 1

ABACUSABACUS

ISO 9001:2008 Quality Management Systems-

Requirements

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ISO 9000: SERIES OF ISO 9000: SERIES OF STANDARDSSTANDARDS

ISO 9000:2005 Fundamentals

ISO 9001:2008 The requirements

ISO 9004:2000 Guidance

ISO 19011:2002 Auditing Quality & Environmental systems

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SCOPE OF THE STANDARDSCOPE OF THE STANDARD

The standard specifies requirements for a quality management system where an organization

(a) Needs to Demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and

(b) Aims to Enhance customer satisfaction through effective application of the system including processes for continual improvement of the system and the assurance of conformity to customer & applicable statutory and regulatory requirements

Note : “Product” only applies to product intended for the customer /any intended out put resulting from product realization. Statutory & regulatory requirements can be expressed as legal requirements.

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ELEMENTS OF ISO ELEMENTS OF ISO 9000:20089000:2008

CLAUSE NO. 4 QUALITY MANAGEMENT SYSTEM

CLAUSE NO. 5 MANAGEMENT RESPONSIBILITY

CLAUSE NO. 6 RESOURCE MANAGEMENT

CLAUSE NO. 7 PRODUCT REALIZATION

CLAUSE NO. 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

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1.2 Permissible exclusions1.2 Permissible exclusions

Limited to clause 7 Product Realisation

Exclusions do not affect the organization’s ability or responsibility to provide product that meets customer / statutory & regulatory requirements

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Process-Based QMS ModelProcess-Based QMS Model 4 quality management system

8 Continual improvement

4 quality management system

8 Continual improvement

5 Management responsibility

5 Management responsibility

7 Product realization

7 Product realization

8 Measurement, analysis and improvement

8 Measurement, analysis and improvement

CUSTOMERS

Requirements

CUSTOMERS

Requirements

CUSTOMERS

Satisfaction

CUSTOMERS

Satisfaction

ProductProduct

6 Resource management6 Resource

management

OUTPUTINPUT

Value-adding activities

Information flow

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4 4 Quality management Quality management systemsystem

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4.1 General requirements4.1 General requirements

The organisation shall – establish, – document, – implement, – maintain and – continually improve effectiveness in accordance

with the International Standard. To enhance Customer Satisfaction To ensure that the product meets statutory &

regulatory requirements

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4.1 General requirements4.1 General requirements

To implement the organisation shall: identify the processes needed; determine the sequence and interaction of these processes; determine criteria and methods required to

ensure the effective operation and control of these processes;

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4.1 General requirements4.1 General requirements

availability of information to support the operation and monitoring of these processes;

measure, monitor and analyse these processes, and implement action necessary to achieve planned results and continual improvement.

The organisation shall manage these processes in accordance with the requirements of this International Standard.

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4.2 Documentation Requirements4.2 Documentation RequirementsGeneralGeneral

The quality management system documentation shall include: documented statements of a quality policy and quality

objectives a quality manual documented procedures required by this International

Standard. documents required by the organisation to ensure the

effective planning operation and control of its processes.

Records required by this International Standard

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4.2 Documentation Requirements4.2 Documentation RequirementsGeneralGeneral

The extent of the quality management system

documentation shall be dependent on the following:

size and type of the organisation; complexity and interaction of the processes; competence of personnel.

The documentation can be in any form or type of medium

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4.2.2 Quality Manual4.2.2 Quality Manual

The organization shall establish and maintain a quality manual that includes the scope of the quality management system,

including details of, and justification for, any exclusions

documented procedures or reference to them; a description of the interaction between the

processes of the quality management system.

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4.2.3 Control of documents4.2.3 Control of documents Documents required for the quality management system

shall be controlled. Records are a special type of document and shall be controlled according to the requirements for control of records

A documented procedure shall be established to define controls needed to approve documents for adequacy prior to issue; to review, 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;

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4.2.3 Control of documents 4.2.3 Control of documents

to ensure that documents remain legible and readily identifiable ;

to ensure that documents of external origin 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.

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4.2.4 Control of records4.2.4 Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled .

The organization shall establish a documented procedure to define controls needed for the identification, storage, retrieval, retention and disposition of records.

Records shall remain legible, readily identifiable and retrievable

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5 Management responsibility5 Management responsibility

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5.1 Management commitment5.1 Management commitment Top management shall provide evidence of its

commitment to the development and implementation of the quality management system and continually improving its effectiveness by: communicating to the organisation the

importance of meeting customer as well as statutory and regulatory l requirements,

establishing the quality policy and ensuring that quality objectives are established,

conducting management reviews & ensuring the availability of resources.

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5.2 5.2 Customer focusCustomer focus

Top management shall ensure that customer requirements are determined and are met with the aim of achieving customer satisfaction.

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5.3 5.3 Quality policyQuality policy Top management shall ensure that the quality

policy: is appropriate to the purpose of the

organisation; includes a commitment to comply with

requirements and to continually improve the effectiveness of the quality management system;

provides a framework for establishing and reviewing quality objectives;

is communicated and understood within the organisation; and

is reviewed for continuing suitability.

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5.4 Planning5.4 Planning

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5.4.1 5.4.1 Quality objectivesQuality objectives

Top management shall ensure that quality objectives,including those needed to meet requirements for product are established at relevant functions and levels within the organization.

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5.4.1 Quality objectives5.4.1 Quality objectives

The quality objectives shall be measurable

and consistent with the quality policy.

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5.4.2 Quality Planning5.4.2 Quality Planning

Top management shall ensure that the resources needed to achieve the quality

objectives are identified and planned.

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5.4.2 Quality planning5.4.2 Quality planning Top management shall ensure that

the planning of the management system is carried out to meet the requirements in clause 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.

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5.5 5.5 Responsibility, authority, Responsibility, authority, and communicationand communication

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5.5.1 5.5.1 Responsibility and Responsibility and Authority Authority

Top management shall ensure that responsibilities and authorities are defined and communicated within the organisation.

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5.5.2 5.5.2 Management representativeManagement representative Top management shall appoint a member of the

management team who, irrespective of other responsibilities, shall have responsibility and authority that includes: ensuring that processes of the quality

management system are established and maintained;

reporting to top management on the performance of the quality management system, including needs for improvement;

ensuring the promotion of customer requirements

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5.5.3 Internal communication5.5.3 Internal communication

The organisation shall ensure that appropriate communication processes are established within the organization regarding the effectiveness of quality management system.

Department A Department B

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5.6 Management review5.6 Management review 5.6.1 General Top management shall review the organization’s

quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.

The review shall include assessing opportunities for improvement and the need for changes to the organisation's quality management system, including quality policy and quality objectives.

Records from management reviews shall be maintained

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5.6.2 Review input5.6.2 Review input The Input to management review shall include

information on: results of audits; customer feedback; process performance and product conformity; status of preventive and corrective actions; follow-up actions from earlier management

reviews; changes that could affect the quality

management system, and Recommendations for improvement

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5.6.3 Review output5.6.3 Review output

The output from the management review shall include any decisions and actions related to improvement of the management system

and its processes; improvement of product related to

customer requirements; resource needs.

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6 6 Resource managementResource management

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6.1 Provision of resources6.1 Provision of resources

The organisation shall determine and provide the resources needed: to implement and maintain the quality

management system and continually improve its effectiveness, and

to enhance customer satisfaction by meeting customer requirements.

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6.2 Human resources6.2 Human resources

6.2.1 General Personnel performing work affecting product

quality shall be competent on the basis of applicable education, training, skills and experience.

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6.2.2 Competence ,Training, 6.2.2 Competence ,Training, and awarenessand awareness

The organisation shall: Determine the necessary competence for personnel

performing work affecting product quality; Where applicable provide training or take other

actions to achieve the necessary competence; evaluate the effectiveness of the actions taken; ensure that its personnel are aware of the relevance

and importance of their activities and how they contribute to the achievement of the quality objectives;

maintain appropriate records of education,training ,skills and experience.

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6.3 Infrastructure6.3 Infrastructure

The organisation shall identify, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes as applicable:

buildings, workspace and associated utilities; process equipment (hardware and software); supporting services (such as transport,

communication or information systems ).

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6.4 Work environment6.4 Work environment

The organisation shall determine and manage the work environment needed to achieve conformity to product requirements.

Note: “Work environment” relates to those conditions under which work is performed including physical environment and other factors ( such as noise , temperature, humidity , lighting or weather .)

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7 Product realization7 Product realization

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7.1 Planning of Product 7.1 Planning of Product RealizationRealization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of other processes of the quality management system (see 4.1)

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7.1 Planning of realization 7.1 Planning of realization processesprocesses

In planning product realization the organisation shall determine the following as appropriate:– quality objectives and requirements for the product – need to establish processes, documents, and provide

resources specific to the product– Required Verification, validation, monitoring, inspection

and testing activities specific to the product and criteria for product acceptance

– records to provide evidence that the realisation processes and the resulting product meet requirements

– output of this planning shall be in a form suitable for the organisation’s methods of operation

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7.2 Customer - related 7.2 Customer - related processesprocesses

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7.2.1 Determination of requirements 7.2.1 Determination of requirements related to the product related to the product

The organisation shall determine– customer requirements including requirements for

delivery and post-delivery activities– requirements not stated by the customer but

necessary for intended or specified use, where known,

– statutory and regulatory requirements applicable to the product, and

– any additional requirements considered necessary & determined by the organisation

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7.2.2 Review of product requirements7.2.2 Review of product requirements

The organisation shall review the requirements related to the product

The review shall be conducted prior to the commitment to supply a product to the customer (e.g. submission of a tender, acceptance of a contract or order, acceptance of changes to contracts or orders) to ensure that:– product requirements are defined– contract or order requirements differing from

those previously expressed are resolved – the organisation has the ability to meet the

defined requirements

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7.2.2 Review of product requirements7.2.2 Review of product requirements

Records of the review shall be maintained Where the customer provides no documented

statement of requirement, the customer requirements shall be confirmed by the organization before acceptance

Where product requirements are changed, the organization shall ensure that– the relevant documents are amended – relevant personnel are made aware of the

changed requirements

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7.2.3 Customer communication7.2.3 Customer communication

The organisation shall determine and implement effective arrangements for communicating with customers in relation to product information; enquiries, contracts or order handling,

including amendments; and customer feedback, including customer

complaints.

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7.3 Design and development

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7.3.1 Design and 7.3.1 Design and development planningdevelopment planning

The organization shall plan and control the design and development of product.

During the design and development planning, the organization shall determine: 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 the design and development.

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7.3.1 Design and development 7.3.1 Design and development planningplanning

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clarity of responsibilities.

Planning output shall be updated, as appropriate, as the design and development progresses.

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7.3.2 Design and development 7.3.2 Design and development inputsinputs

Inputs relating to product requirements shall be determined and records maintained ( See 4.2.4 ). These shall 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. Inputs shall be reviewed for adequacy. Requirements

shall be complete, unambiguous and not in conflict with each other

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7.3.3 Design and development 7.3.3 Design and development outputsoutputs

The output of design and development shall be provided in a form that enables verification against the design and development inputs and shall be approved prior to release.

Design and development output shall: meet the input requirements for design &

development provide appropriate information for purchasing,

production, and service provision contain or reference product acceptance criteria specify the characteristics that are essential for

safe and proper use. ( can include details of preservation of the product )

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7.3.4 Design and development 7.3.4 Design and development reviewreview

At suitable stages, systematic reviews of design and development shall be conducted in accordance with the planned arrangements to evaluate the ability of the results of the design

process to meet requirements; and to identify problems and propose necessary

actions. Participants in such reviews shall include

representatives of functions concerned with the design and development stage(s) being reviewed.

Records of the results of the reviews and any necessary actions shall be maintained.

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7.3.5 Design and development 7.3.5 Design and development verificationverification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements.

Records of the results of the verification and any necessary actions shall be maintained. (see 4.2.4)

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7.3.6 Design and / or development 7.3.6 Design and / or development validationvalidation

Design and development validation shall be performed in accordance with planned arrangements to ensure that resulting product is capable of meeting the requirements for the specified application or intended use, where known.

Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.

Records of the results of validation and any necessary actions shall be maintained.

(see 4.2.4)

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7.3.7 Control of design and 7.3.7 Control of design and development changesdevelopment changes

Design and development changes shall be identified and records maintained.

The changes shall be reviewed, verified and validated,as appropriate and approved before implementation.

The review of design and development changes shall include evaluation of the effect of the changes on – Constituent parts and Products already delivered

Records of the results of the review of changes and any necessary actions shall be maintained

( see 4.2.4 )

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7.4 Purchasing7.4 Purchasing

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7.4.1 Purchasing process7.4.1 Purchasing process

The organization shall ensure that purchased product conforms to specified purchase requirements.

The type and extent of control shall be dependent upon the effect of the purchased product on

- subsequent product realisation or the final product.

The organisation shall evaluate and select suppliers based on their ability to supply product as per the

requirements.

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7.4.1 Purchasing process7.4.1 Purchasing process

Criteria for supplier selection, evaluation and re-evaluation shall be established.

Records of the results of evaluations and any necessary actions arising shall be maintained.

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7.4.2 Purchasing information7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate: requirements for approval of product, procedures,

processes, equipment requirements for qualification of personnel & quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

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7.4.3 Verification of purchased 7.4.3 Verification of purchased productsproducts

The organization shall establish and implement the inspection or other activities necessary for ensuring that the purchased product meets specified purchase requirements.

Where the organisation or its customer intends to perform verification at the supplier's premises, the organisation shall state the intended verification arrangements and method of product release in the

purchasing information.

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7.5 Production 7.5 Production andand service service provisionprovision

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7.5.1 Control of production and 7.5.1 Control of production and service provisionservice provision

The organisation shall plan & carry out production and service provision under controlled conditions. Controlled conditions shall include as applicable

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 measuring and monitoring

equipments , the implementation of monitoring and measurement, the implementation of release, delivery and post-

delivery activities.

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7.5.2 Validation of processes7.5.2 Validation of processes

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent measurement or monitoring & as a consequence , deficiencies become apparent only after the product is in use or the service has been delivered.

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7.5.2 Validation of processes7.5.2 Validation of processes

Validation shall demonstrate the ability of the processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable– 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– revalidation

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7.5.3 Identification and traceability7.5.3 Identification and traceability

Where appropriate, the organization shall identify, where appropriate, the product by suitable means throughout product realization.

The organization shall identify the product status with respect to measurement and monitoring requirements throughout product realization .

Where traceability is a requirement, the organization shall control and record the unique identification of the product and maintain records .

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7.5.4 Customer property7.5.4 Customer property

The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization

The organization shall identify, verify, protect and safeguard 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, the organization shall be report this to the customer and maintain records.NOTE: Customer property can include intellectual

property & personal data.

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7.5.5 Preservation of product7.5.5 Preservation of product

The organization shall preserve conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to the requirements .

As applicable this preservation shall include identification, handling, packaging, storage and protection.

Preservation shall also apply to the constituent parts of a product.

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7.6 Control of monitoring and 7.6 Control of monitoring and measuring devicesmeasuring devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.

The organization shall establish processes to ensure that d monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and

measuring requirements.

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7.6 Control of monitoring and 7.6 Control of monitoring and measuring devicesmeasuring devices

Where necessary to ensure valid results, measuring equipment shall: be calibrated or verified 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;

Be adjusted or readjusted as necessary; Have identification to enable the calibration status to be

determined be safeguarded from adjustments that would invalidate the

measurement results Be protected from damage and deterioration during handling,

maintenance, & storage

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7.6 Control of measuring and 7.6 Control of measuring and monitoring devicesmonitoring devices

The organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements

The organization shall take appropriate action on the equipment and any product affected

Records of the results of calibration and verification shall be maintained

When used in monitoring and measurement, the ability of computer software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed as necessary.

( Confirmation of the ability of the computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use .)

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8 Measurement, analysis 8 Measurement, analysis and improvementand improvement

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8.1 General8.1 General

The organization shall plan and implement the measurement, monitoring, analysis and improvement processes needed :

- to demonstrate conformity to the product requirements – to ensure conformity of the management system – to continually improve the effectiveness of the

management system This shall include the determination of applicable methods,

including statistical techniques & the extent of their use.

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8.2 Measurement and 8.2 Measurement and monitoringmonitoring

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8.2.1 Customer satisfaction8.2.1 Customer satisfaction

As on of the measurements of the performance of the Quality management System , the organization shall monitor information to customer perception as to weather the organization has met the customer requirements.

( Monitoring customer perception can include obtaining input from source such as customer satisfaction surveys, customer data, and delivered product quality ,user surveys, lost business analysis, compliments, warranty claims & dealer reports )

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8.2.2 Internal audit8.2.2 Internal audit The organization shall conduct internal audits at planned

intervals to determine whether the quality management system

Conforms to the planned arrangements to the requirements of this international standard & to the Quality management system requirements established by the organization

Is effectively implemented & maintained. An audit programme shall be 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 shall be

defined.

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8.2.2 Internal audit8.2.2 Internal audit

The selection of auditors & conduct of audits shall ensure objectivity and impartiality of the audit process . Auditors shall not audit their own work.

Documented procedure shall be established to define the responsibilities and requirements for planning & conducting audits, establishing records and reporting results.

Records of the audits and their results shall be maintained

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8.2.2 Internal audit8.2.2 Internal audit

The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without any delay to eliminate detected non conformities and their causes.

Follow-up actions shall include the verification of the actions taken & reporting of verification results.

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8.2.3 Monitoring and 8.2.3 Monitoring and measurement of processesmeasurement of processes

The organization shall apply suitable methods for monitoring & where applicable, measurement of the Quality management system processes.

These methods shall demonstrate the ability of the processes to achieve the planned results. When results are not achieved, correction & corrective actions shall be taken, as appropriate . ( It is advisable that the type and extent of monitoring or measurement appropriate to each process in relation to their impact of the conformity with the product requirements & on effectiveness of the Quality management System.)

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8.2.4 Monitoring and 8.2.4 Monitoring and measurement of productmeasurement of product

The organization shall monitor & Measure the characteristics of the product to verify that product requirements have been met.

This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements..

Evidence of conformity with the acceptance criteria shall be maintained.

Records shall indicate the person/s authorizing release of the product for delivery to the customer.

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8.2.4 Measurement and 8.2.4 Measurement and monitoringmonitoring

The release of the Product & to the customer shall not proceed until the planned arrangements have been satisfactorily completed , unless otherwise approved by a relevant authority and, where applicable, by the customer.

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8.3 Control of Non-conformances8.3 Control of Non-conformances

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8.3 Control of nonconforming 8.3 Control of nonconforming productproduct

The organization shall ensure that product which does not conform to product requirements is identified & controlled to prevent its unintended use or delivery.

A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.

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8.3 Control of nonconformity8.3 Control of nonconformity Where applicable the organization shall deal 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 By taking action to preclude its original intended use or

application By taking action appropriate to the effects or potential effects, of

the nonconformity product is detected after delivery or use has started.

When nonconforming product is corrected it shall be subjected to revivification to demonstrate conformity to requirements.

Record of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained.

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8.4 Analysis of data8.4 Analysis of data

The organization shall determine, collect & analyse appropriate data to demonstrate the suitability and effectiveness of the Quality Management System and to evaluate where continual improvements of the effectiveness of the Quality management System can be made .

This shall include data generated as a result of monitoring and measuring activities from other relevant sources.

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8.4 Analysis of data8.4 Analysis of data

The analysis of data shall provide information relating to : customer satisfaction Conformity to product requirements characteristics of processes, products and

opportunities for preventive action suppliers.

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8.5 Improvement8.5 Improvement

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8.5.1 Continual improvement8.5.1 Continual improvement

The organisation shall continually improve the effectiveness of the management system through the use of:– the quality policy– quality objectives– audit results– analysis of data– corrective and preventive actions– management review.

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8.5.2 Corrective action8.5.2 Corrective action The organisation shall take action to eliminate the cause of

nonconformities in order to prevent recurrence. Corrective action shall be appropriate to the effect of the non-conformities encountered.

A documented procedure shall be established to define requirements for:

Reviewing nonconformities (including customer complains) Determining the causes of the nonconformities Evaluating the need for action to ensure that nonconformities do not

reoccur. Determining and implementing actions needed.

Record the actions taken Reviewing the effectiveness of the corrective action taken .

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8.5.3 8.5.3 PreventivePreventive action action

The organization shall determine action to eliminate the causes of potential nonconformities to prevent occurrence Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for : Determining potential nonconformities and their

causes evaluating the need for action to prevent occurrence of

non-conformities determining and implementing the actions needed recording results of action taken reviewing preventive action taken

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Thank you

ANY QUESTIONS