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Introduction toIntroduction toISO 9001:2008ISO 9001:2008

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Evolution of quality standardsEvolution of quality standards

ISO 90012008

ISO 90011987

ISO 90011994

ISO 90012000

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Quality System StandardQuality System Standard

• generic (ISO 9000)• industry related (AS 9000, TL 9000)

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ISO 9002 and 9003ISO 9002 and 9003

• Prior to ISO 9001:2000, there were ISO 9002 and ISO 9003 too. These were subsets of ISO 9001 with certain exclusions.

• ISO 9002 & ISO 9003 (1987 and 1994) incorporated in ISO 9001:2000 and withdrawn

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Process approachProcess approach

• Process approach to quality management encouraged• An activity using resources, and managed in order to

enable the transformation of inputs into outputs, can be considered as a process.

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Processes:Processes:

Activities or

set of activities

InputInput OutputOutput

ControlsControls ResourcesResources

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Processes - understand interactionsProcesses - understand interactions

Process A

Process DProcess B

Process CInputInput

OutputOutput

ControlsControls ResourcesResources

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Customer satisfactionCustomer satisfaction

CUSTOMERS

CUSTOMERS

Management responsibility

Resourcemanagement

Measurement, Analysis andimprovement

ProductProductrealisation

Continual Improvement of theQuality Management System

Requirements

Satisfaction

InputOutput

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Relationship with ISO 9001 and ISO 9004Relationship with ISO 9001 and ISO 9004

• Designed to complement each other • Can be used independently• Different scope - similar structure• ISO 9001 can apply for certification or contractual

purposes and focuses on effectiveness• ISO 9004 provides wider focus on quality management

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1 Scope (1.1 General)1 Scope (1.1 General)

Standard specifies QMS requirements for use to:• demonstrate organisation’s ability to consistently provide product

meeting customer & applicable statutory & regulatory (legal) requirements

• enhance customer’s satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable statutory & regulatory requirements

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1.2 Application1.2 Application

• Requirements are generic• Requirement may be excluded if cannot be applied due to

the nature of organisation and its product• Exclusions must:

– Not affect ability or responsibility to provide conforming product

– Be limited to Clause 7

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2 Normative reference2 Normative reference

• ISO 9000 : 2005, Quality management systems - Fundamentals and vocabulary.

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3 Terms and definitions3 Terms and definitions

• The term “product” also means “service”

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4.1 General requirements4.1 General requirements

• Establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the standard

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4.1 General Requirements4.1 General Requirements

• Determine the processes necessary for QMS • Determine the sequence and interaction of processes• Determine criteria & methods to ensure effective operation &

control of the processes• Ensure availability of resources and information needed to

support the operation & monitoring of the processes • Monitor, measure where applicable and analyse processes• Implement actions necessary to achieve planned results &

continual improvement

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4.1 General Requirements4.1 General Requirements

• Manage the processes in accordance with the standard• Ensure control of outsourced processes affecting product

conformity• Define control of outsourced processes within the QMS• Control over outsourced processes does not absolve the

organization of its responsibilities

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4.2 Documentation requirements4.2 Documentation requirements

4.2.1 General4.2.1 General• QMS documentation:

– Quality policy, objectives– Quality manual– Documented procedures and records– Documents, including records determined by the organisation

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4.2.1 General4.2.1 General

• Documented procedure means that it must be established, documented, implemented and maintained

• Extend of documentation may differ due to– Size & type of organisation– Complexity & interaction of processes– Competence of personnel

• Documentation may be in any type of media

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4.2.2 Quality manual4.2.2 Quality manual

• Quality manual must include as minimum:– The scope of QMS including details of, and justification for,

any exclusions

– Documented procedures or reference thereto

– Description of the interaction between the processes of the QMS

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4.2.3 Control of documents4.2.3 Control of documents

• Documented procedures to:– approve documents prior to issue– review, update as necessary and re-approve documents– to identify the changes and the current revision status of documents– to ensure documents remain legible, readily identifiable – ensure relevant versions of applicable documents are available at points of use– ensure that documents of external origin necessary for planning and operation

of QMS are identified and distribution controlled– obsolete documents are prevented from unintended use and identified if kept

for any reason

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4.2.4 Control of records4.2.4 Control of records

• Records to provide evidence are controlled• Documented procedure to define the controls needed for

the identification, storage, protection, retrieval, retention and disposition of quality records.

• Records must be legible, readily identifiable and retrievable.

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5 Management responsibility5 Management responsibility

• 5.1 Management commitment

• 5.2 Customer focus

• 5.3 Quality policy

• 5.4 Planning– 5.4.1 Quality objectives

– 5.4.2 QMS planning

• 5.5 Responsibility, authority and communication

– 5.5.1 Responsibility & authority – 5.5.2 Management representative– 5.5.3 Internal communication

• 5.6 Management review– 5.6.1 General– 5.6.2 Review input– 5.6.3 Review output

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5.1 Management commitment5.1 Management commitment

• Provide evidence of commitment to the development implementation and continual improvement of QMS by:– communicating the importance of meeting customer and

statutory and regulatory requirements

– establishing quality policy & objectives

– management reviews

– provision of resources

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5.2 Customer focus5.2 Customer focus

Determine customerrequirements

Meet requirements

Customer satisfaction

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5.3 Quality policy5.3 Quality policy

• appropriate to the purpose of the organisation • commitment to comply with requirements • continually improve the effectiveness of the QMS• framework for establishing & reviewing quality objectives• communicated and understood• reviewed for continuing suitability

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5.4.1 Quality objectives5.4.1 Quality objectives

• Establish quality objectives• Measurable & consistent with the quality policy • Include those needed to meet requirements for product

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5.4.2 Quality management system planning5.4.2 Quality management system planning

• Planning of the QMS is carried out in order to meet requirements given in 4.1, as well as the quality objectives

• Maintain the integrity of the QMS integrity when changes are planned and implemented

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5.5 Responsibility, authority and communication5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority5.5.1 Responsibility and authority

• define and communicate responsibilities and authorities

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5.5.2 Management Representative5.5.2 Management Representative

• Member of the organization’s management• Ensures that processes needed for the QMS are established,

implemented and maintained• Reports on performance of QMS including needs for improvement• Promotes awareness of customer requirements

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5.5.3 Internal communication5.5.3 Internal communication

• Communication processes are established• Communication takes place regarding the effectiveness of

QMS

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5.6 Management Review5.6 Management Review

5.6.1 General5.6.1 General

• Review of the QMS by top management at planned intervals to:– ensure QMS suitability, adequacy & effectiveness– assess opportunities for improvement– evaluate the need for changes to QMS including policy & objectives

• Records maintained.

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5.6.2 Review input5.6.2 Review input

audit results customer feedbackprocess performance product conformity status of PAs and CAsfollow up actions from earlier reviewschanges that could affect the QMSrecommendations for improvement

ManagementReview

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5.6.3 Review output5.6.3 Review output

improved effectiveness of the QMS

improvement of product

resource needs

ManagementReview

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6 Resource Management6 Resource Management

• 6.1 Provision of resources• 6.2 Human resources

– 6.2.1 General

– 6.2.2 Competence, training and awareness

• 6.3 Infrastructure• 6.4 Work environment

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6.1 Provision of resources6.1 Provision of resources

• Determine & provide the resources needed to:– implement, maintain the QMS and continually improve its

effectiveness

– enhance customer satisfaction

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6.2 Human Resources6.2 Human Resources

• 6.2.1 General

Personnel performing work affecting conformity to product requirements must be competent on the basis of :

• appropriate education• training• skills • experience.

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6.2.2 Competence, training and awareness6.2.2 Competence, training and awareness

• Determine the necessary competence• Provide training or take other action to satisfy those needs• Evaluate the effectiveness of actions taken• Ensure staff aware of relevance and importance of their

activities and contribution to achieving objectives• Maintain appropriate records of education, training, skills

and experience

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6.3 Infrastructure6.3 Infrastructure

• Determine, provide & maintain the infrastructure needed to achieve product conformity. Infrastructure includes, as applicable:– buildings, workspace

– equipment

– supporting services

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6.4 Work environment6.4 Work environment

• Determine and manage the work environment needed to achieve product conformity.

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7 Product realization7 Product realization

7.1 Planning of product realization

7.2 Customer related processes

7.3 Design & development

7.4 Purchasing

7.5 Production & service provision

7.6 Control of measuring & monitoring equipment

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7.1 Planning of product realization7.1 Planning of product realization

• Planning must determine as appropriate:– quality objectives and requirements for the product

– the need for processes, documentation, resources specific to the product

– verification and validation activities & acceptance criteria

– Records to provide evidence

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7.2 Customer related processes7.2 Customer related processes

7.2.1 Determination of requirements related to product

7.2.2 Review of requirements related to product

7.2.3 Customer communication

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7.2.1 Determination of requirements related to product7.2.1 Determination of requirements related to product

• Organisation must determine:– requirements specified by the customer

– requirements not specified but necessary

– statutory and regulatory requirements applicable to product,

– any additional requirements

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7.2.2 Review requirements related to the product7.2.2 Review requirements related to the product

• Review requirements before commitment to supply product & ensure that:

– product requirements are defined– difference between contract requirements from those previously expressed

resolved– organisation has ability to meet the requirements

• Record the results of review and actions• Confirm requirements, when customer does not provide documented

requirements• When requirements are changed ensure that documents are

amended and relevant persons are made aware of the changes.

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7.2.3 Customer communication7.2.3 Customer communication

• Effective arrangements for communication with customers relating to :– product information

– enquiry, contract & order handling including amendments

– customer feedback including complaints

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7.3 Design & development (not applicable in L&M)7.3 Design & development (not applicable in L&M)

7.3.1 Design & development planning

7.3.2 Design & development inputs

7.3.3 Design & development outputs

7.3.4 Design & development review

7.3.5 Design & development verification

7.3.6 Design & development validation

7.3.7 Control of design & development changes

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7.3.1 Design & development (D&D) planning7.3.1 Design & development (D&D) planning

• Plan & control D&D of the product.• Planning to include:

– D&D stages– required review, verification and validation activities– responsibilities & authorities for D&D

• Interfaces between groups must be managed• Planning to be updated as the D&D progresses

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7.3.2 Design & development inputs7.3.2 Design & development inputs

• Determine & record product requirements including:– functional & performance requirements– applicable statutory and regulatory requirements– information from previous similar designs– any other essential requirements

• Review input for adequacy• Requirements must be complete, unambiguous and not in

conflict with each other

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7.3.3 Design & development outputs7.3.3 Design & development outputs

• D&D output in a form suitable for verification

• D&D output must– meet the input requirements– provide information for purchasing, production and service provision– contain or reference acceptance criteria– define characteristics essential for proper & safe use

• Approve output prior to release

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7.3.4 Design & development review7.3.4 Design & development review

• At suitable stages systematic reviews of D&D to:– evaluate the ability to meet requirements

– identify problems and propose follow up

• Involve all functions concerned• Record the results and any necessary actions

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7.3.5 Design & development verification7.3.5 Design & development verification

• Verify D&D to ensure that output meets the input requirements

• Record the results of verification and necessary actions

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7.3.6 Design & development validation7.3.6 Design & development validation

• Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or intended use

• Whenever applicable to be completed prior to delivery• Results of validation and necessary actions must be

recorded

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7.3.7 Control of design and development changes7.3.7 Control of design and development changes

• Design & development changes must be identified and records maintained

• Changes must be reviewed, verified and validated as appropriate and approved before implementation

• Record results of review of changes and any necessary actions

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7.4 Purchasing7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchased product

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7.4.1 Purchasing process7.4.1 Purchasing process

• Ensure that purchased product meets requirements• Type & extend of control depends on effect purchased product

may have on the final product• Evaluate and selects suppliers based on their ability to supply

conforming product• Establish criteria for selection, evaluation and re-evaluation of

suppliers• Results of evaluation and any necessary actions must be

recorded

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7.4.2 Purchasing information7.4.2 Purchasing information

• Purchasing information must include where appropriate:– requirements for approval of product, procedures, processes

and equipment

– requirements for qualification of personnel

– quality management system requirements

• Ensure adequacy of specified purchase requirements prior to their communication to supplier

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7.4.3 Verification of purchased product7.4.3 Verification of purchased product

• Establish & implement inspection or other activities needed to ensure purchased product conformity

• Where organisation or its customer propose verification at supplier’s premises, organisation must specify in purchasing information:– verification arrangements

– method of product release

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7.57.5 Production and service provisionProduction and service provision

7.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service provision

7.5.3 Identification & traceability

7.5.4 Customer property

7.5.5 Preservation of product

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7.5.1 Control of production and service provision7.5.1 Control of production and service provision

• Plan and carry out production & service provision under controlled conditions. Controlled conditions include as applicable:

a) availability of information describing product characteristicsb) availability of work instructions, as necessary c) the use of suitable equipment d) availability & use of monitoring and measuring equipment e) implementation of monitoring and measurement f) the implementation of product release, delivery and post delivery

activities

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7.5.2 Validation of processes7.5.2 Validation of processes

• Validate processes where outcome is not verified and as a consequence, deficiencies may become apparent after delivery

• Validation shall demonstrate the ability of processes to achieve results• For these processes establish:

– criteria for review and approval of the process– approval of equipment and qualification of personnel– use of defined methods & procedures– requirements for records– revalidation

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7.5.3 Identification and traceability7.5.3 Identification and traceability

• Where appropriate identify product by suitable means throughout product realization

• Identify status with respect to measurement & monitoring requirements throughout product realization

• Where traceability is required control the unique identification of product

• Maintain records

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7.5.4 Customer property7.5.4 Customer property

• Care for customer’s property while it is under organisation’s control or being used by organisation

• Identification, verification, protection & safeguarding customer property provided for use or incorporation

• Any customer property that is lost, damaged or found unsuitable must recorded & reported to customer

Customer property includes intellectual property & personal data

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7.5.57.5.5 Preservation of productPreservation of product

• Preserve the product during internal processing and final delivery to intended destination

• Include identification, handling, packaging, storage and protection

• This applies to constituent parts of a product

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7.6 Control of monitoring & measuring equipment7.6 Control of monitoring & measuring equipment

• Determine monitoring and measurements to be made & measurement & monitoring equipment needed to provide evidence of conformity of product

• Ensure measuring and monitoring is carried out consistently with monitoring and measurement requirements

• Suitability of measuring/monitoring software must be confirmed prior to use and re-confirm as necessary

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7.6 Control of monitoring & measuring equipment7.6 Control of monitoring & measuring equipment

• Calibrate or verify or both at specified intervals or prior to use against international or national standards. Where no such standard exist record the basis

• Adjust or re-adjust as necessary• Have identification to determine calibration status• Safeguard from adjustments invalidating calibration• Protect from damage or deterioration during handling, maintenance& storage• record results of calibration• assess and record validity of previous results when device found to be out of

calibration

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8 Measurement, analysis and improvement8 Measurement, analysis and improvement

• 8.1 General• 8.2 Monitoring/measurement

– 8.2.1 Customer satisfaction– 8.2.2 Internal Audit– 8.2.3 Monitoring &

measurement of processes– 8.2.4 Monitoring &

measurement of product

• 8.3 Control of nonconforming product

• 8.4 Analysis of data• 8.5 Improvement

– 8.5.1 Continual improvement– 8.5.2 Corrective action– 8.5.3 Preventive action

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8.1 General8.1 General

• Plan & implement measurement, monitoring analysis and improvement processes needed to:– demonstrate conformity to product requirements

– ensure conformity of the QMS

– continually improve the effectiveness of the QMS

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8.2.1 Customer satisfaction8.2.1 Customer satisfaction

• Organisation shall monitor information related to customer perception as to whether the organisation has met customer requirements.

• The methods for obtaining and using this information must be determined

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8.2.2 Internal audit8.2.2 Internal audit

• Conduct internal audits at planned intervals to determine if :– QMS conforms to the planned arrangements, requirements of the

standard and organisation’s requirements– QMS is effectively implemented & maintained

• Plan the audit programme considering:– status and importance of the processes and the areas– results of previous audits

• Define audit criteria, scope, frequency & methodologies

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8.2.2 Internal audit8.2.2 Internal audit

• Select auditors to ensure objectivity and impartiality.

• Auditor must not audit own work.

• The documented procedure must cover:– responsibilities & requirements for planning and conducting audits– reporting results and maintaining records

• Corrective actions without undue delay

• Follow up to verify actions taken & report verification results

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8.2.3 Monitoring and measurement of processes8.2.3 Monitoring and measurement of processes

• Apply suitable methods for monitoring and, where applicable, measurement of QMS processes– These methods shall demonstrate the ability of the processes

to achieve planned results

– Where planned results are not achieved corrections and corrective actions must be taken

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8.2.4 Monitoring and measurement of product8.2.4 Monitoring and measurement of product

• Monitor & measure product characteristics to verify conformity at appropriate stages

• Evidence of conformity with the acceptance criteria must be maintained. • Records must indicate the person(s) authorising release of the product

for delivery to the customer• Release or delivery must not proceed until all 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 nonconforming product8.3 Control of nonconforming product

• Nonconforming product must be identified and controlled to prevent unintended use or delivery

• Documented procedure to define controls, responsibility and authority

• When the nonconforming product is corrected it must be re-verified to demonstrate conformity

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8.3 Control of nonconforming product8.3 Control of nonconforming product

• Organisation must deal with nonconforming product by one or more of the following ways:– action to eliminate detected nonconformity– concession– preclude original intended use or application– Taking actions appropriate to the effects, when

nonconformity is detected after delivery• Records of the nature of nonconformity and any subsequent

action including concessions must be maintained

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8.4 Analysis of data8.4 Analysis of data

• Determine, collect & analyse appropriate data to demonstrate the suitability and effectiveness of QMS and to evaluate where continual improvement of the QMS can be made

• Data from measurement & monitoring & other relevant sources• Analyze data to provide information on:

– customer satisfaction– conformity to product requirements– process, product characteristics and their trends including opportunities for

preventive action– suppliers

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8.5 Improvement8.5 Improvement

8.5.1 Continual improvement• Organisation shall continually improve the effectiveness of the QMS

through use of:– quality policy– quality objectives– audit results– analysis of data– corrective actions – preventive actions– management review

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8.5.2 Corrective action8.5.2 Corrective action

• Take actions to eliminate the causes of nonconformities to prevent recurrence.

• Corrective actions appropriate to the impact of the problem• Documented procedure shall define requirements for:

– reviewing nonconformities (including customer complaints)– determining the causes of nonconformities– Evaluating the need for corrective action– determining & implementing action needed– recording results of action taken– reviewing the effectiveness of the corrective action taken

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8.5.3 Preventive action8.5.3 Preventive action

• Determine action to eliminate the causes of potential nonconformances to prevent occurrence.

• Actions appropriate to the impact of the potential problem• Documented procedure must define the requirements for

– determining potential nonconformances & their causes– evaluating the need for preventive action– determining and implementing action needed– recording the results of action taken– reviewing the effectiveness of the preventive action taken