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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)
AET0003E.PPT2004-03-13 9
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)
AET0003E.PPT2004-03-13 12
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
AET0003E.PPT2004-03-13 15
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)
AET0003E.PPT2004-03-13 16
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)
AET0003E.PPT2004-03-13 17
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.)
AET0003E.PPT2004-03-13 18
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)
AET0003E.PPT2004-03-13 19
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
AET0003E.PPT2004-03-13 20
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)
AET0003E.PPT2004-03-13 21
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)
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