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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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