Session 16 Iso Product Realization Clause 7 Changed2

8/7/2019 Session 16 Iso Product Realization Clause 7 Changed2

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TOTALTOTAL

QUALITY QUALITY

MANAGEMENTMANAGEMENT

By:By:

Zahid HussainZahid HussainMS-Total Quality ManagementMS-Total Quality Management

IRCA Lead Auditor ISO 9001-2000IRCA Lead Auditor ISO 9001-2000

IRCA Lead Auditor ISO 14001-2004IRCA Lead Auditor ISO 14001-2004

B.Sc Engineering (Chemical)B.Sc Engineering (Chemical)

PCBA–UCPPCBA–UCP

SESSION – 17

(ISO-clause 7)



C U S TO MERS C

U S T

O M E R S

Quality Management

System

5.Management

Responsibility

7. Product

Realization

6. Resource

Management

8. Measurement

Analysis and

Improvement

Requirements

S a t i s f a c t i o n

Continual Improvement of

the Quality Management System

ConsumptionProduct

verv ew oISO9001:2000

ISO 9001 Model

KEY Value AddedActivities

Model of a Process BasedQuality Management System



Provision of

resources

Human

resources

Infrastructures

Workenvironment

6 ResourceManagement

General

requirements

Documentation

Requirements

Planning

Customer

related

processes

Design &

development

Purchasing

Production &

service

provision

Management

Commitment

Customer focus

Quality policy

Planning

Responsibility,

authority &

communication

Management

Reviews

5 ManagementResponsibility 8Measurement

Analysis &

improvement

System Requirements / Structure of theSystem Requirements / Structure of the

StandardStandard

4 QualityManagement

System

7 ProductRealization

General

Monitoring &

measurement

Control of NCP

Analysis of data

Improvements



7. Product Realization7.1 Planning of product realizationThe organization shall plan and develop the

processes needed for product realization.Planning of product realization shall be consistentwith the requirements of the other processes of the quality management system

In planning product realization, the organizationshall determine the following, as appropriate:a) quality objectives and requirements for the product;b) the need to establish processes, documents, and provideresources specific to the product;

c) required verification, validation, monitoring, inspectionand test activities specific to the product and the criteriafor product acceptance;d) records needed to provide evidence that the realizationprocesses and resulting product meet requirements

e). The output of this planning shall be in a form suitablefor the organization's method of operations.



7. Product Realization

7.2 Customer-related processes7.2 Customer-related processes 7.2.1 Determination of 7.2.1 Determination of requirements related toreq

uirements related to

product

product

7.2.27.2.2 Review of requirementsReview of req

uirements related to productrelated to product 7.2.3 Customer7.2.3 Customer communicationcommunication




7.2 Customer-related processes7.2.1 Determination of requirementsrelated to the productThe organization shall determine

a) requirements specified by the customer,including the requirements for delivery and post-delivery activities,b) requirements not stated by the customer butnecessary for specified or intended use, whereknown,c) statutory and regulatory requirements relatedto the product, andd) any additional requirements determined by the

organization.




7.2.2 Review of requirements related tothe productThe organization shall review the requirementsrelated to the product. This review shall be

conducted prior to the organization's commitmentto supply a product to the customer (e.g.submission of tenders, acceptance of contracts ororders, acceptance of changes to contracts ororders) and shall ensure that

a) product requirements are defined,b) contract or order requirements differing fromthose previously expressed are resolved, andc) the organization has the ability to meet the

defined requirements.




Records of the results of the review and actionsarising from the review shall be maintained (see4.2.4).

Where the customer provides no documentedstatement of requirement, the customerrequirements shall beconfirmed by the organization before acceptance.

Where product requirements are changed, theorganization shall ensure that relevantdocuments are amended and that relevantpersonnel are made aware of the changed

requirements.




7.2.3 Customer communicationThe organization shall determine and implementeffective arrangements for communicating withcustomers in relation to

a) product information,b) enquiries, contracts or order handling,including amendments, andc) customer feedback, including customercomplaints.



7.3 Design and Development7.3 Design and Development

7.3.1 D & D

Planning

7.3.2 D & D

Input

Plan & Control the D.D of product.

Planning of D D Stages, Review, verification &

validation appropriate to D D , Stages

Responsibilities & Authorities for D.D, Interface

between different groups involved in D D

to ensure the effective communication and clear assignment of responsibility. Update planning

output

Determination & Recording of Input related to

product requirement.Functional and performance requirement,

Applicable statutory and regulatory requirement,

Info derived from previous similar design, Other

requirements essential for D.& D.Input shall be reviewed, complete , unambiguous




7.3.3 D & D

Output

7.3.4 D & D

Review

In a form to Verify the D D input and approve.Shall meet the input requirement for D & D.

Provide appropriate information for purchasing

production & for service provision. Contain or

reference product acceptance criteria, Specifythe characteristics of product essential for safe

and proper use.

To evaluate the ability of the results of D & D tomeet requirements , To identify any problem

and propose necessary actions., Concerned

Functions participate, Record of review along

with necessary action is maintain.




7.3.5 D & D

Verification

7.3.6 D & D

Validation

To ensure that D & D outputs have met the D & D

inputs requirement. Perform verification in

accordance with planned arrangements. Records

of verification results and action taken

maintained.

To ensure that under planned arrangements,

product is capable of meeting the requirementsfor specified application and intended use.

Where applicable the validation shall be

completed prior to delivery. Record of validation

and necessary actions maintained.




7.3.7. Control

of D & D

Changes

Identify the D & D changes and maintain therecord. Changes are reviewed, verified, and

Validated and approved before implementation.

Review of D & D changes includes evaluation of

effect of changes on parts and products already

delivered. Results of review of changes & action

taken are maintained

7.5.1 Control

of production

and Service

provision.

Plan and carry out production & service

provision under controlled condition ( Productinfo, W I, Suitable equipment, use of monitoring ,

measuring devices, Implementation of monitoring

and measurement, implementation of all activities

related with release, delivery and post delivery

actives.



7.5 Production and Service Provision7.5 Production and Service Provision

7.5.2 Validationof processes

for production

and Service

provision.

To demonstrate the ability of these processesto achieve planned results. Define criteria for

review and approval of these processes.

Approval of Equipment and qualification of

personnel, Use QSP, records. Revalidation

If required.

7.5.3

Identification

and traceability

Identify the product by suitable means

throughout the product realization. Identify

the product status w.r.t. monitoring and

measurement requirements Where traceability

is requirement , the organization shall control

and record the unique identification of the

product.



7.5 Production and Service Provision7.5 Production and Service Provision

The organization shall preserve the conformity of product

during internal processing and delivery to the intendeddestination.The preservation shall include , identification, handling,packing, storage and protection. Preservation is alsoapplied to constituent parts of a product.

7.5.4

Customer Property

The organization shall exercise care with customer propertywhile it is under the organization control or being used byorganization.The organization shall Identify, verify, protect and safeguardcustomer property provided for use or incorporate into the proIf any customer property is lost, damaged or otherwise found tbe unsuitable for use, this shall be reported to the customerand record maintained.Customer property can be intellectual property.

7.5.5

Preservation of Product



QUESTIONQUESTIONSS

Session 16 Iso Product Realization Clause 7 Changed2

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