Download - Chapter 2 - Overview of ISO 9001 2000

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Chapter 2 Overview of ISO 9001:2000

Chapter 2Overview of

ISO 9001:2000

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� 0.1 General

� Strategic decision - adoption of QMS

� QMS design & implementation is organisation specific

� Standard can be used by internal & external parties to assess the ability to meet customer, regulatory and organisation’s own requirements

� QMS requirements are complementary to technical requirements forproduct

� NOTES are for guidance or clarification only

0 Introduction

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0.2 Process approach

• Process approach to quality management encouraged

• Introduces & explains the process model as conceptual presentation of QMS requirements specified

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Plan

Do

Verify

Correct

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Processes

ProcessActivities

+Resources

InputInput OutputOutput

ControlsControls(e.g.procedure(e.g.procedure) )

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Processes - understand interactions

ProcessA

ProcessD

ProcessB

ProcessC

InputOutputControls

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Management responsibility

Resourcemanagement

Measurement, analysis,improvement

ProductProductrealisation

Continual Improvement of theQuality Management System

Requirements

Satisfaction

InputOutput

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0.3 Relationship with ISO 9004

� ISO 9001 & ISO 9004 - consistent pair

� Designed to complement each other

� Can be used as stand alone

� Different scope - similar structure

� ISO 9001 can apply for certification or contractual purposes andfocuses on effectiveness

� ISO 9004 aims on improving performance and efficiency

� ISO 9004 not an implementation guidance


0.4 Compatibility with other management systems

• Standard is intended to be compatible with other systems

• It is aligned with ISO 14000 to enhance compatibility

• Standard does not include requirements for other management systems such as EMS, OHSM, or financial management

• Integration of management systems is possible

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1 Scope (1.1 General)

� Standard specifies QMS requirements for use to:

• demonstrate organisation’s ability to consistently provide product meeting customer & applicable regulatory 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 regulatory requirements

NOTE:

Product = product intended for or required by customer

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1.2 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

(Cl. 4.2.2: “details of & justification for any exclusion” to be included in the quality manual”)

� Conformity to ISO 9001 may not be stated if exclusions go beyondabove

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2 Normative reference

�Amendments or revisions of cited standard do not apply

�Users encouraged to use most recent revision

�ISO 9000 : 2000 Quality Management Systems -Fundamentals and Vocabulary.

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• ISO 9000 : 2000 applies

• New supply chain terminology

Supplier

Organisation

Customer

3 Terms and definitions

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3 Terms and definitions

Product = Result of processProduct = Result of process

Note: four generic product categories:� hardware� software� services� processed materials

ISO 9000:2000

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4.1 General requirements4.1 General requirements

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

4 Quality management system

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� Identify 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

�Measure, monitor and analyse processes

� Implement actions necessary to achieve planned results & continual improvement

4.1 General Requirements

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� Manage the processes in accordance with the standard

� Ensure control of outsourced processes affecting product conformity

� Identify control of outsourced processes within the QMS

Note: Processes needed for QMS include processes for management activity, provision of resources, product realisation and measurement.

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4.2 Documentation requirements

4.2.1 General

QMS documentation must include:

� Quality Policy

� Quality Objectives

� Documented procedures required by standard

� Documents required by organisation to ensure effective planning, operation & control processes

� Records required by the standard

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Note 1 Term documented procedure means that it must be established, documented, implemented and maintained

Note 2 Extend of documentation may differ due to

• Size & type of organisation

• Complexity & interaction of processes

• Competence of personnel

Note 3 Documentation may be in any type of media (now note 15)

4.2.1 General

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4.2.2 Quality manual

Quality manual must include as minimum:

� The scope of QMS including details of, and justification for, and exclusions (See 1.2)

� Documented procedures or reference thereto

� Description of the interaction between the processes of the QMS

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4.2.3 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 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 records

�Records must be established and maintained

�Records must be legible, readily identifiable and retrievable.

�Documented procedure for control of identification, storage, retrieval, retention time and disposition of quality records.

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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 Management responsibility

5.5 Responsibility, authority and communication

5.5.1 Responsibility & authority

5.5.2 Management representative

5.5.3 Internal communication

5.6 Management review5.6.1 General

5.6.2 Review input

5.6.3 Review output

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5.1 Management commitment

Provide evidence of commitment to the development implementation and 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 focus Determine customerrequirements

Meet requirements

Customer satisfaction

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5.3 Quality policy

a) appropriate to the purpose of the organisation

b) commitment to comply with requirements & continually improve the effectiveness of the QMS

c) framework for establishing & reviewing quality objectives

d) communicated and understood within the organisation

e) is reviewed for continuing suitability

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5.4.1 Quality objectives

�establish quality objectives at relevant functions and levels

�objectives must be measurable & consistent with the quality policy

� include those needed to meet requirements for product {see 7.1 (a)}

�documented {see 4.2.1 (a)}

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5.4.2 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

�the integrity of the QMS integrity must be maintained when changes are planned and implemented

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5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Responsibilities and authorities shall be

defined and communicated within the organisation.

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5.5.2 Management Representative

Member of the management who has responsibility and authority that includes

• ensuring that processes needed for the QMS are established, implemented and maintained

• reporting on performance of QMS including needs for improvement

• ensuring the promotion of awareness of customer needs & requirements

Note: Responsibility may include liaison with external parties in relation to QMS

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5.5.3 Internal communication

Ensure appropriate communication within the organisation regarding the processes of the QMS and their effectiveness.

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5.6 Management Review

5.6.1 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

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5.6.2 Review input

Review performance and improvement opportunities related to:

» audit results

» customer feedback

» process performance & product conformity

» status of preventive and corrective actions

» follow up actions from earlier reviews

» changes that could affect the QMS

» recommendations for improvement

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5.6.3 Review output

Output to include actions related to:

� improvement of the effectiveness of the QMS and its processes

� improvement of product

� resource needs

Results of management review must be recorded

Note changes to 4.1.3Role of management review significantly enhancedImpact: significant

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InputOutput

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6 Resource Management

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

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6.1 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 Resources

6.2.1 General

Personnel performing work affecting product quality must be competent on the basis of appropriate education, training, skills and experience.

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Competence considerations:

� Future demands

� Anticipated management and workforce succession needs

� Changes in the processes and equipment

� Individual competencies needed

� Statutory and regulatory requirements, standards, directives, etc.

(ISO 9004 :2000)

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6.2.2 Competence, awareness and training

�Determine the necessary competence

�Provide training or take other action to satisfy those needs

�Evaluate the effectiveness of actions taken

�Ensure staff are 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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Awareness

�The vision for future

�Policy & objectives

�Organisational change & development

� Improvement activities

�Creativity

� Innovation

� Impact on society

� Introductory programmes

�Refreshers

(ISO 9004 :2000)

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6.3 Infrastructure

Identify, provide & maintain the infrastructure needed to achieve product conformity. Infrastructure includes, as applicable:

• buildings, workspace & associated facilities

• equipment (hardware & software)

• supporting services

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Determine and manage the work environment needed to achieve product conformity

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6.4 Work environmentHuman Factors

�creative work methods�opportunities for greater involvement of people

�safety rules and guidance

�ergonomics

�special facilities for people

�social interaction

(ISO 9004 :2000)

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Physical factors

�Heat

�Noise

�Light

�Hygiene

�Humidity

�Cleanliness

�Vibration

�Pollution

�Air flow

(ISO 9004 :2000)

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7 Product realisation

7.1 Planning of product realisation

7.2 Customer related processes

7.3 Design & development

7.4 Purchasing

7.5 Production & service provision

7.6 Control of measuring & monitoring devices

Note: exclusionswithin this clauseare allowed

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7.1 Planning of product realisation

Planning must determine as appropriate:

�quality objectives and requirements for the product

� the need for processes, documentation, resources specific to theproduct

� verification and validation activities & acceptance criteria

� records

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7.2 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 product

Organisation must determine:

� requirements specified by the customer including delivery & post delivery activities

� requirements not specified but necessary for specified or intended use, where known

� statutory and regulatory requirements related to product,

� any additional requirements

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7.2.2 Review requirements related to the product

Review identified requirements before commitment to supply product and ensure that:

• product requirements are defined

• differences between tender & contract are resolved

• organisation has ability to meet the requirements

Record the results

Documentation to be amended in case of changes & personnel made aware

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7.2.3 Customer communication

Determine and implement 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

7.3.1 Design & development planning (4.4.1, 4.4.2 & 4.4.3)

7.3.2 Design & development inputs (4.4.4)

7.3.3 Design & development outputs (4.4.5)

7.3.4 Design & development review (4.4.6)

7.3.5 Design & development verification (4.4.7)

7.3.6 Design & development validation (4.4.8)

7.3.7 Control of design & development changes (4.4.9)

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7.3.1 Design & development 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 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 outputs

�D&D output in a form allowing verification

�D&D output must

• meet the input requirements

• provide information for purchasing, production or 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 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 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 validation

� Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or intended use, where known

� 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 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 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 process

�Ensure that purchased product meets requirements

�Type & extend of control depends on effect purchased product may have on product realisation or 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 information

Purchasing information must describe the product to be purchasedincluding 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 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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7.5 Production 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 provisionPlan and carry out production & service provision under controlled conditions. Controlled conditions include as applicable:

a) availability of information describing product characteristics

b) availability of work instructions, as necessary

c) the use of suitable equipment

d) availability & use of measuring & monitoring devices

e) implementation of monitoring and measurement

f) the implementation of release, delivery and post delivery activities

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7.5.2 Validation of processes

Processes where outcome is not verified and/or where deficiencies may become apparent after delivery must be validated to demonstrate ability to achieve planned results

Arrangements must be established for these processes including, as applicable:�criteria for review and approval of the process�approval of equipment�qualification of personnel�use of defined methods & procedures�requirements for records�re-validation

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Considerations:

�High value products

�Where deficiency will only be apparent when product is in use

�Where process can not be repeated

�Where product verification is not possible

(ISO 9004:2000)

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Examples of risk assessment:

» FMEA

» Fault tree analysis

» Relationship diagrams

» Reliability prediction

» Simulation techniques

(ISO 9004:2000)

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7.5.3 Identification and traceability

�Where appropriate identify product by suitable means throughout realisation

� Identify status with respect to measurement & monitoring requirements

�Where traceability is required control & record unique identification of product

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7.5.4 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

Note: Customer property includes intellectual property

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7.5.5 Preservation of product

�Preserve conformity of 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 devices

� Determine monitoring and measurements to be made & measurement & monitoring devices 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

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7.6 Control of monitoring & measuring devices� Calibrate or verify measuring and monitoring devices (MMD) 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

� Identify to enable the determination of calibration status

� Safeguard MMD from adjustments invalidating calibration

� Protect MMD 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

Note: See ISO 10012 for guidance

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8 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 General

Plan & implement measurement, monitoring analysis and improvement processes needed to:

�demonstrate conformity of the product

�ensure conformity of QMS

�continually improve the effectiveness of the QMS

This includes determination of applicable methods, including statistical techniques, and the extent of their use

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8.2.1 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 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

Select auditors to ensure objectivity and impartiality.

Auditor must not audit own work.

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8.2.2 Internal audit�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

Note:See ISO 10011 for guidance

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8.2.3 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 to ensure conformity of the product

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8.2.4 Monitoring and measurement of product

�Monitor & measure product characteristics to verify conformity at appropriate stages of realisation processes in accordance with planned arrangements

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

�Release or delivery must not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicableby the customer

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

� Documented procedure to define controls, responsibility and authority

� When non conformance detected after delivery take appropriate action

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� 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

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

� Records of the nature of nonconformity and any subsequent actionincluding concessions must be maintained

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8.4 Analysis of data

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

�Data from measurement & monitoring & other relevant sources

�Analyse data to provide info 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 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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Continual Improvement

SPCBenchmarkingQuality Circles

Risk AssessmentTeamwork for Quality

Quality Function Deployment


Continual Improvement

Problem Solving TechniquesProblem Solving Techniques

� Cause & effect diagram

� Pareto analysis

� Flowcharting

� Brain storming

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8.5.2 Corrective action

Organisation shall 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 corrective action taken

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8.5.3 Preventive action

Organisation shall 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 preventive action taken

Download - Chapter 2 - Overview of ISO 9001 2000

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