AET0003E.PPT2004-03-13 1

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

byby

Dr. Anwar El-TawilDr. Anwar El-Tawil

Director ISO Programme for Developing CountriesDirector ISO Programme for Developing Countries

QUALITY MANAGEMENT SYSTEMQUALITY MANAGEMENT SYSTEMACCORDING TO ISO 9001-2000ACCORDING TO ISO 9001-2000

Product RealizationProduct Realization (II)(II)

AET0003E.PPT2004-03-13 2

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design & Development

Customer-related processesCustomer-related processes

Control of measuring

devices

Control of measuring

devicesDesign &

DevelopmentDesign &

Development

RealizationRealization PurchasingPurchasing

Planning of Product

Realization

Planning of Product

Realization

AET0003E.PPT2004-03-13 3

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design and development (7.3)Design and development (7.3)

User requirements

User requirements

Design input

Design input

Design processDesign process

Design outputDesign output ProductProduct

VerificationVerification

ValidationValidation

Design reviewDesign reviewDesign reviewDesign review

AET0003E.PPT2004-03-13 4

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design and development planning (7.3.1)Design and development planning (7.3.1)

The organization shall determine design and development stages

review, verification and validation activities for each stage

responsibilities and authorities for design and development

The organization shall manage the interfaces between The organization shall manage the interfaces between different groups involved in design and development!different groups involved in design and development!

According to ISO 9004, the life cycle, safety, maintenability, dependability, durability, ergonomics, product disposal and identified risks should be taken into consideration

AET0003E.PPT2004-03-13 5

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design and development inputs (ISO 9004)Design and development inputs (ISO 9004)

Design and development inputs include: external inputs such as

customer needs and expectations needs and expectations of other interested parties statutory requirements supplier’s contribution user input to achieve robust design international or national standards industry codes of practices

AET0003E.PPT2004-03-13 6

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design and development inputs (ISO 9004) Design and development inputs (ISO 9004) (cont.)(cont.)

Internal inputs such as

policies and objectives competence requirements technological developments feedback information from past experience records and data on existing products and

processes outputs from other processes

AET0003E.PPT2004-03-13 7

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design and development inputs (ISO 9004) Design and development inputs (ISO 9004) (cont.)(cont.)

Other inputs, such as

operation, installation and application

storage, handling and delivery

physical parameters and the environment

requirements for the disposal of products

AET0003E.PPT2004-03-13 8

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

The organization shall definedefine and documentdocument:

functional and performance requirements

regulatory requirements

information derived from previous similar designs

other essential requirements

Inputs should be Inputs should be reviewedreviewed; incomplete, ambiguous ; incomplete, ambiguous and conflicting requirements shall be and conflicting requirements shall be resolvedresolved

Design and development inputs (ISO 9001 – 7.3.2)Design and development inputs (ISO 9001 – 7.3.2)

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

E.g.: product specifications, requirements for training, methodology, purchasing and acceptance criteria

Outputs shall: meet input requirements provide appropriate information for purchasing,

production and service provision contain (or reference) product acceptance criteria specify the characteristics of the product essential for its

safe and proper use Design and development documents shall be

approvedapproved before they are made available

Design and development outputs (ISO 9001 – 7.3.3)Design and development outputs (ISO 9001 – 7.3.3)

AET0003E.PPT2004-03-13 10

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Verification shall be performed to ensure that design and development outputs satisfy design and development input requirements

RecordsRecords of the results of the verification and any necessary actions shall be maintained

Verification activities include, for example:

comparative methods, such as alternative design and development calculations

evaluation against similar products tests, simulations or trials to verify conformity to

specific requirements

Design and development verification (7.3.5)Design and development verification (7.3.5)

AET0003E.PPT2004-03-13 11

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design and development validation shall be performed to ensure that the product is capable of fulfilling the requirements for the intended use

Validation shall be completed prior to the delivery or implementation of the product whenever parcticable. Otherwise, partial validation should be performed

Validation activities may include: validation of engineering designs prior to construction

or installation validation of software outputs prior to installation validation of customer services prior to widespread

introduction

Design and development validation (7.3.6)Design and development validation (7.3.6)

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design review shall be conducted:

to evaluate the ability to fulfill requirements to identify problems and propose solutions

Participants in such reviews shall include representatives of design and development funcitons

Results of the reviews shall be recordedrecorded

According to ISO 9004, design and development review should also take into consideration:

potential hazards or failure modes in product use potential impact of the product on the environment

Design and development review (7.3.4)Design and development review (7.3.4)

AET0003E.PPT2004-03-13 13

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Design and development changes shall be identified and recorded

The effect of changes on constituent parts and delivered product shall be evaluated

Changes shall be reviewed, verified, validated and approved before implementation

RecordsRecords of the results of the review of changes shall be maintained

Control of design and development changes (7.3.7)Control of design and development changes (7.3.7)

AET0003E.PPT2004-03-13 14

QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

PurchasingPurchasing

Customer-related processesCustomer-related processes

Control of measuring

devices

Control of measuring

devicesDesign &

DevelopmentDesign &

Development

RealizationRealization PurchasingPurchasing

Planning of Product

Realization

Planning of Product

Realization

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Purchasing processes shall be controlled to ensure conformity of purchased products

Suppliers shall be evaluated and selected based on their ability to supply a product in accordance with requirements

Criteria for selection, evaluation and reevaluation shall be established

Results of evaluation and selection shall be recordedrecorded

Purchasing (7.4)Purchasing (7.4)

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Purchasing processes include

Timely and accurate identification of needs and purchased product specifications

Cost evaluation of purchased product (taking into account performance, price and delivery)

Verification criteria Unique supplier processes Contract administration Warranty replacement for nonconforming purchased

products Logistic requirements

Purchasing Processes (ISO 9004)Purchasing Processes (ISO 9004)

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Product identification and traceability

Preservation of product

Documentation, including records

Control of purchased product deviation form requirements

Access to supplier’s premises

Product delivery, installation or application history

Supplier development Identification and mitigation of risks associated with the

purchased product

Purchasing Processes (ISO 9004) Purchasing Processes (ISO 9004) (cont.)(cont.)

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

The organization should establish processes to

identify potential suppliers

develop existing suppliers

evaluate their ability to supply the required products

Supplier Control Process (ISO 9004)Supplier Control Process (ISO 9004)

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Supplier Control Processes (ISO 9004) Supplier Control Processes (ISO 9004) (cont.)(cont.)

The supplier control processes includes evaluation of relevant experience review of purchased product quality, price, delivery

performance and responses to problems audits of supplier’s QMS checking supplier references and customer satisfaction financial assessment of supplier viability supplier’s response to inquiries, quotations and

tendering supplier service, installation and support capability supplier’s logistic capability including locations and

resources

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

Purchasing information should include

Requirements for apporval of

product procedures processes equipment

Requirements for qualification of personnel

Requirements of supplier QMS

Purchasing Information (7.4.2)Purchasing Information (7.4.2)

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QMS ACC. TO ISO 9001-2000 QMS ACC. TO ISO 9001-2000 –– Product Realization Product Realization (II)(II)

The organization shall establish and implement inspection or other activities for verifying purchased product

The level of verification can vary according to the nature of the product and previous performance of suppliers

Where the organization or its customer intends to perform verification at the suppliers’s premises, verification arrangements shall be stated in purchasing information

Verification of Purchased Product (7.4.3)Verification of Purchased Product (7.4.3)