Standard Requirements ISO 9001-2000 (Feb. 05)

8/4/2019 Standard Requirements ISO 9001-2000 (Feb. 05)

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Clause 4 - Quality Management System

4.1General Requirements 4.2Documentation

Requirements4.2.1 General Requirement

QP, QO, QM

Procedure, records4.2.2 Quality Manual

Scope- exclusion

Procedures/ references

Business flow chart

4.2.3 Control of documents

Approval/ reapproval Changes & revision status

Availibility, legibility of docs

External/ obsolete doc4.2.4 Control of records

Identification, storage, protection,

retrieval, retention, disposition

Process & its Linkages

Criteria and methods for control

Resources & information Monitor, measure, analyse

Implementation


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Organization shall establish, document, implement

& maintain QMS & continually improveits

effectiveness in accordance with the requirements

of the StandardISO 9001:2000

4.1 General requirements (1)


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Identify process needed

determine the sequence and interaction of processes

determine criteria and methodsfor effectiveness of

operations and control of processes

ensure the availability of information, resources

monitor, measure and analyse process

implement action necessary to achieve planned results

and continual improvement



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Determineoffering

Designproduct

Acquireorder

Produceproduct

Distributeproduct

Serviceproduct

Marketing Design Production Sales Distribution Servicing

Verb Focus

Noun Focus

Process A Process B Process CNeeds Satisfaction

Verification process

- doc control process- material handling process- data storage process- resource mgt process


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OUTSOURCING (SUBCONTRACTING)

CONTROL


QMS

People, Process


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4.2 Documentation requirements

4.2.1 General

Documented statements of

- Quality Policy- Quality Objectives

- Quality Manual

- Procedures, records

ISO 9001 STANDARD

ORGANIZATION


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Documented Procedure required by ISO9001

(1) Document Control

(2) Record Control

(3) Internal Audit

(4) Nonconformity Control

(5) Corrective Action(6) Preventive Action


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Documented Procedure required by Organization

DerivedDoc

PoliciesPractices

ExternalRef

Standard

Guideline

SOP

Records

Reports

Plans

Test Specs

Procurement

Datas;Customer

Supplier

Industry


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A Quality manual shall be established that includes

scope ( any exclusions ) - Under Clause 7

documented procedure or reference

description of the interaction of the process in the qualitysystem

4.2.2 Quality manual

( Document specifying QMS of an organization )


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QM Framework - Specimen

Introduction(Purpose, Scope, Definition)

Business Overview(Profile, Vision, Mission)

Organization chart

Process Flow

Standard requirement

Procedure/ Approval


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4.2.3 Control of documents

Documented procedure for

approval prior to issue review, update and re-approve documents

changes and status of are identified available at points of use

legible and readily identifiable

external origin are identified and controlled

prevent the unintended use of obsolete

documents, and identification to them


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DOCUMENTS

CONTROLLED UNCONTROLLED

Policies & Practices Specification

Plans/ Schedule/Procedure/W I

Reference Documents

(standards, guides, contracts)

Intentions (proposals, brochures)

Records (results, certificates,reports, meeting minutes)

Memos / Letters

Diaries

Note books


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4.2.4 Control of quality records

Documented Procedure- Legible- Readily Identifiable

- Retrievable

Control : IdentificationStorge

ProtectionRetrievalRetention timeDisposition


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Clause 5

-Management

Responsibility

5.1Mgt Commitment

5.2Customer focus

5.3Quality Policy

5.5Res, Authority, communication

5.4Planning

5.6Management Review

At planned interval

Audit result, customer, product, process, CA,

PA,

follow up, changes, recommendation

Improvement

- QO, QP, Mgt review, resource, communication

- Customer satisfaction

- Align with purpose, framework of objectives,

- commitment, communicate, review

- measurable QO, consistent with QP

- to meet QMS, QO,- to maintain integrity for changes

- Clearly define

- Fully aware


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Top Management

(person/group - direct/control organisation)

show commitment communicate the importance of meeting

customer requirements

statutory and regulatory requirements

establishing a quality policy and quality objectives

conducting management reviews

availability of resources

5.1 Management commitment


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Statutory & Regulatory requirement

Directly / Indirectly related to product

- Environmental, OHSAS, financial laws

-Relationship building- Availability of key personnel

- Information sharing

Customer satisfaction

By - Making employees understand priorities of organization.

Pay attention, understanding, acceptance, correct action of workforce


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Top management must ensure thatcustomer needs and expectations

determined and fulfilled

enhancing customer satisfaction

5.2 Customer focus


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appropriate to the purpose of the organisation

include a commitment to meeting requirements

and continually improve effectiveness of system

provide a framework for establishing andreviewing quality objectives

Communication & Understanding

Review for continuing suitability

5.3 Quality policy(set of guiding principles)


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ORG Purpose : To create customer

Who are customer?

Where they are?

What they buy?

What they need?

What they regard as value?

ORG Goal : To achieve ISO9001-2000

To give customer satisfaction in everything we do

HOW ?

QP states


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Quality Objectives

at relevant functions and levels within organisation

be measurable and consistent with

quality policy

include those needed to meet product requirements

5.4.1 Quality objectives

5.4 Planning


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QUALITY OBJECTIVE

Corporate

Process

Product Departmental/ Functional Personal


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5.4.2 Quality management system planning

Top management shall ensure that

the planning of the system is carried out in orderto meet the requirements(Corporate Plan, Dept Plan, Product Plan)

the integrity of the system is maintained when

changes to system are planned and implemented( Tech, plant, machinery, process, culture, competencylevel of staff )


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5.5.1 Responsibility and authority

5.5 Responsibility, authority and communication

Defineresponsibilities , and authorities

Communicate within organization


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Responsibility and authority for

ensuring the processes are established,implementedand maintained

promoting awareness of customer requirements

through out the organisation

reporting on performance of the system and theneeds for improvement

5.5.2 Management representative


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appropriate communication process are

established within organisation

&

communication takes place regarding the

effectiveness of QMS

5.5.3 Internal communication


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5.6 Management review

5.6.1 General

review QMS at planned intervals for its continuing

- suitability- adequacy- effectiveness

( include assessing opportunities for improvement and the need for changes)

Records maintained


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audit results

customer feedback

process performance and product performance

status of preventive and corrective actions

follow-up actions from earlier reviews

changes that could affect the QMS recommendations for improvement

5.6.2 Review input

Current Performance + improvement opportunities


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The outputs from the review shall include

Improvements of

quality management system and its processes product related to customerrequirements resource needs

5.6.3 Review output


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Clause 6 - Resource Management

6.1 Provision of resources6.2 Human Resources 6.3

Infrastructure

6.4 Work environment

6.2.1 General

6.2.2 Competence, awareness and training


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implement, maintain and improve effectiveness of thesystem

enhance customer satisfaction

The organisation shall determine and provide theresources needed to

6.1 Provision of resources


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applicable education training skills experience

Personnel performing work affecting productquality shall be competent on the basis of

6.2.1 General

6.2 Human resources


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The organisation shall

determine the necessary competence

provide training or other actions

evaluate effectiveness

employees awareness of the relevance andimportance of their activities and how they contributeto the achievement of quality

maintain records

6.2.2 Competence, awarenessand training


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building, workspace and associated facilities process equipment

supporting services

Infrastructure needed to achieve productconformity shall be identified, provided and

maintained, including

6.3 Infrastructure( basic facilities, equipment, service, installation needed for

growth and functioning of org)


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The organisation shall identify and manage thework environment needed to achieve

conformity of product

6.4 Work environment

( set of conditions under which people operate)

Physical, Social, Psychological factors --> Behavior


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Clause 7

-Product

Realization

7.1 Planning of product realization

7.3 Design and Development

7.4 Purchasing

7.2 Customer-related process Know, review Customer Requirement related to

product

Design and Development planning

Design and Development inputs

Design and Development outputs

Design and Development review

Design and Development verification

Design and Development validation

Control of design & development changes

Purchasing process

Purchasing information

Verification of purchased product

QO

Product, Process, Resource requirement

Monitoring & Control

Records for evidence

Customer communication


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Clause 7

-Product

Realization

7.6 Control of monitoring and measuring devices

7.5 Production & service provision

Control of production and service provision

Validation of processes for production and service

provision

Identification and traceability

Preservation of product

Control of monitoring & measuring devices

Customer property


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Sales process Contract process Design process

Procurement process

Production process

Installation process

Supporting process

After sale process


7. Product realization


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Determine quality objectives

Determine products requirements Establish processes,documentation

Provide resources specific to the product

Establish verification, validation, monitoring,

inspection and test, and its criteria

Maintain necessary records


7. Product realization

7 2 C t l t d


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Customer

Necessary for use

Statutory and regulatory requirements(eg. Health & Safety issue, Environmental, Discharge of wastage,

Safe working condition)

Additional requirements(eg. Style, appearance, maintainability, reliability)

7.2.1 Determination of requirementsrelated to product

7.2 Customer-related process


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product requirements resolve differences

ability to meet defined requirements

the results of the review shall be recorded

CHANGES Document - Amend/ Update/ Approval Persons - Notify

Prior committing to supply product, the organisation shall review

7.2.2 Review of requirements related to the product


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Arrangement to be identified and implemented

product information

enquiries, contracts or order handling, amendments

customer feedback, including complaints

7.2.3 Customer communication


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7.3.1 Design and development planning

Organization shall determine

the design and development stages the review, verification and validation that are appropriate

to each design and development stage

responsibilities & authorities for Design & development

manage interfaces between different groups involved in

D&D.

update planning output

7.3 Design and development

Feasibility study (time cost) -


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Feasibility stage

Conceptual stage

Design definition stage

Detail design stage

Development stage

Feasibility study (time, cost) proposed obj Vs practical solution

design detail characteristic method - production/delivery establish

ideas - conceived

theories - tested

design layout risk assessment uncertainty resolved

design development

7 3 2 Design and development inputs


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Inputs shall include

functional and performance requirementsFunctional - speed, power, capacity

Performance - reliability, durability, safety, portability

statutory and regulatory requirementsStatutory - power supply rating, marking, security

Regulatory - health, safety, environmental emission,

certification of compliance required by some country.

information derived from similar previous designs

other requirements

7.3.2 Design and development inputs

7 3 3 Design and development outputs


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7.3.3 Design and development outputs(info, model, specimen)

Provide in a form that enables verification and approve priorrelease

meet the input requirements for design and development

provide appropriate information for purchasing, productionand for service provision

contain or reference product acceptance criteria

specify the characteristics of the product that are essentialfor its safe and proper use


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evaluate the ability to meet requirements

identify problems and propose actions

participants shall include representatives of functions

concerned

records

7.3.4 Design and development reviews


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7.3.5 Design and development verification

ensure that the outputs have satisfied theinput requirements

records maintain

Productrequirement

DesignInput

DesignOutput

DesignVerification

DesignValidation


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To ensure resulting product is capable of fulfilling therequirements for the specified application or

intended use

where practical validation to be completed prior tothe delivery or implementation of the product

Record shall be maintained

7.3.6 Design and development validation


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changes shall be identical and records maintained

verify and validate changes as appropriate

evaluation of changes to include the effect of changes

on constituent parts and delivered products

records and actions maintain

7.3.7 Control of design and developmentchanges

7 4 P h i


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7.4 Purchasing

7.4.1 Purchasing process

ensure purchased product conforms to specifiedpurchase requirements

evaluate and select suppliers based on their ability tosupply product that meet requirements

criteria for selection, evaluation and re - evaluationshall be established


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7.4.2 Purchasing information

Purchasing information shall describe

requirements for approval of product, procedures,

processes and equipment

requirements for qualification of personnel

quality management system requirements


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7.4.3 Verification of purchased product

To ensure purchased product meets requirements

the inspection or other activities

verification at the suppliers premises(Arrangement, Method --- Purchasing Info)

7 5 Production and Service provision


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Plan and carry out production and service provision

under controlled conditions

availability of information that describes the characteristicsof the product

availability of work instruction as necessary

7.5 Production and Service provision

7.5.1 Control of production andservice provision(1)


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7.5.1 Control of production andservice provision(2)

use of suitable equipment

availability and use of monitoring and measuring devices

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

activities


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Where the resulting output cannot be verified bysubsequent monitoring or measurement

Validationshall demonstrate the ability of theseprocessed to achieve planned results

7.5.2 Validation of processes forproduction and service provision (1)

7 5 2 Validation of processes for


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7.5.2 Validation of processes forproduction and service provision (2)

defined criteria for review and approval

approval of equipment and qualification of personnel

use of specific methods and procedures

records

revalidation


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7.5.3 Identification and traceability

identify the product by suitable means throughout

product realization

identify the product status with respect to monitoringand measurement requirement

control and record the unique identification of the

product for traceability purpose


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7.5.4 Customer property

identify, verify, protect and safeguard customer property

if any customer property found to be unsuitable for use,

this shall be reported to the customer

include intellectual property

P i f d


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7.5.5 Preservation of product

preserve the conformity of product and constituent of aproduct

include identification, handling, packaging, storage andprotection

7 6 Control of measuring and monitoring devices (1)


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The organisation shall identify

measurements that need to be made and monitoring devices required to assure conformity of product to specified requirements

Monitoring devices to be used and controlled to ensure

that measurement capability is consistent withmeasurement requirements

7.6 Control of measuring and monitoring devices (1)

7 6 C t l f i d it i d i


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Monitoring devices, where applicable shall be

calibrated and adjusted periodically or prior to use

traceable to international or national standards identify the calibrations status

safeguarded from invalid adjustments

7.6 Control of measuring and monitoring devices(2)

7 6 C t l f i d it i d i


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protected from damage and deterioration

take action when the equipment is found not to conform

to requirements

results recorded

7.6 Control of measuring and monitoring devices(3)


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Clause 8

-Measurement,

analysis and

improvement

8.1 General

8.3 Control of non-conforming product

8.2 Monitoring & measurement Customer satisfaction Internal Audit

Monitoring & measurement of processes

Monitoring & measurement of product

8.4 Analysis of data

8.5 Improvement Continual Improvement

Corrective action

Preventive action

8 M t l i d i t


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8. Measurement, analysis and improvement

8.1 General (1)

Plan and implement the monitoring, measurement,

analysis and improvement processes needed include

demonstrate conformity of the product


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8.1 General (2)

ensure conformity of the quality management system

continually improve the effectiveness of system determination of applicable methods, including

statistical techniques

8 2 Monitoring and measurement


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8.2 Monitoring and measurement

8.2.1 Customer satisfaction

monitor information relating to customer perception

methods for obtaining and using this information


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Conduct internal audits at planned intervals to determine that

conforms to the planned arrangements and to the qualitymanagement system requirements

effectively implemented and maintained

8.2.2 Internal audit(1)


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program shall be planned, taking into consideration thestatus and importance of the processes and the results ofprevious audits

the responsibilities and requirements for planning andconducting audits, and for reporting results andmaintaining records shall be defined in a documented

procedure

8.2.2 Internal audit(2)

8 2 3 Monitoring and measurement


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8.2.3 Monitoring and measurementof process

apply suitable methods for monitoring and measurement

of the processes

demonstrate the ability of the processes to achieveplanned results

when results are not achieved, correction and preventiveaction shall be taken

8 2 4 Monitoring and measurement


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8.2.4 Monitoring and measurementof product

monitor and measure the characteristics of the product to

verify that product requirements are fulfilled

evidence shall be maintained


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8.3 Control of nonconforming product

ensure that non conforming product is identified and

controlled to prevent its unintended use or delivery responsibilities and authorities for dealing with

nonconforming product shall be defined in a

documented procedure

8 3 Control of nonconforming prod ct


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Deal with nonconforming product by the following

taking action to eliminate the detected nonconformity

authorizing its use, release or acceptance underconcession

taking action to preclude its original intended use or

application

records of the nature of non conformities and any

subsequent actions taken

8.3 Control of nonconforming product

8 4 Analysis of data


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the suitability and effectiveness of the QMS to identify improvements that can be made to provide information on

- customer satisfaction and/or dissatisfaction- conformance to customer requirements

- characteristics of processes, product and trends- suppliers

Appropriate data shall be collected and analysed to determine:

8.4 Analysis of data

8 5 I t


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Continual improvement to be planned and managed by

use of:

the quality policy objectives

audit results

analysis of data

corrective and preventive action management review

8.5.1 Continual improvement

8.5 Improvement

8 5 2 Corrective action


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8.5.2 Corrective action

take action to eliminate the cause of non conformities in

order to prevent recurrence

documented procedure shall be established

reviewing non conformities determining the causes of non conformities

evaluating the need for action

determining and implementing action needed

records of the results of action taken reviewing corrective action taken


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8.5.3 Preventive action

determine action to eliminate the causes of potential non-

conformities in order to prevent their occurrence

documented procedure shall be established

determining potential non conformities and their causes

evaluating the need for action

determining and implementing action needed

records of the results of action taken reviewing corrective action taken