1. QUALITY MANAGEMENT SYSTEM ACCORDING TO ISO 9001-2000
Product Realization (II) by
Dr. Anwar El-Tawil
Director ISO Programme for Developing Countries

2. Customer-related processes
Design & Development
Customer-related processes
Planning of Product Realization
Control of measuring devices
Design & Development
Realization
Purchasing

3. Design and development (7.3)
Design review
User requirements
Design input
Design process
Design output
Product
Verification
Validation

4. 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 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

5. 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

6. Design and development inputs (ISO 9004) (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

7. Design and development inputs (ISO 9004) (cont.)
Other inputs, such as
operation, installation and application
storage, handling and delivery
physical parameters and the environment
requirements for the disposal of products

8. Design and development inputs (ISO 9001 – 7.3.2)
The organization shall define and document:
functional and performance requirements
regulatory requirements
information derived from previous similar designs
other essential requirements
Inputs should be reviewed; incomplete, ambiguous and conflicting requirements shall be resolved

9. Design and development outputs (ISO 9001 – 7.3.3)
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 approved before they are made available

10. Design and development verification (7.3.5)
Verification shall be performed to ensure that design and development outputs satisfy design and development input requirements
Records 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

11. Design and development validation (7.3.6)
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

12. Design and development review (7.3.4)
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 recorded
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

13. Control of design and development changes (7.3.7)
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
Records of the results of the review of changes shall be maintained

14. Customer-related processes
Purchasing
Customer-related processes
Planning of Product Realization
Control of measuring devices
Design & Development
Realization
Purchasing

15. Purchasing (7.4)
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 recorded

16. Purchasing Processes (ISO 9004)
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

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

18. Supplier Control Process (ISO 9004)
The organization should establish processes to
identify potential suppliers
develop existing suppliers
evaluate their ability to supply the required products

19. Supplier Control Processes (ISO 9004) (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

20. Purchasing Information (7.4.2)
Purchasing information should include
Requirements for apporval of
product
procedures
processes
equipment
Requirements for qualification of personnel
Requirements of supplier QMS

21. Verification of Purchased Product (7.4.3)
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