Procedure for Design and Development 1.

Objective: To ensure that the new services of the medical center are appropriately designed and existing programs or services are developed to comply with statutory requirements as well as to meet the needs of the hospitals clients and stakeholders, taking into account the quality, environmental and occupational health and safety dogma of _______. 2. Scope: This procedure applies to the design and development of new and existing services and programs of the ______.

3. Definition of Terms 4. Procedure Outline 5. Procedural Details: 5.1. Design and Development Planning 5.1.1. The organization shall plan and control the design and development of services. 5.1.2. During the design and development planning, the organization shall determine 5.1.2.1. The design and development stages. 5.1.2.2. The review, verification and validation that are appropriate to each design and development stage, and 5.1.2.3. The responsibilities and authorities for design and development. 5.1.3. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. 5.1.4. Planning input shall be updated, as appropriate, as the design and development progresses. 5.2. Design and Development Inputs 5.2.1. Inputs relating to services requirements shall be determined and records maintained. These inputs shall include: 5.2.1.1. Functional and performance requirements. 5.2.1.2. Applicable statutory and regulatory requirements. 5.2.1.3. Where applicable, information derived from similar designs. 5.2.1.4. Other requirements essential for design and development. 5.2.2. The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

5.3. Design and Development Outputs 5.3.1. The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release. 5.3.2. Design and development outputs shall: 5.3.2.1. Meet the input requirements for design and development. 5.3.2.2. Provide appropriate information for purchasing, production and service provision. 5.3.2.3. Contain or reference project acceptance criteria. 5.3.2.4. Specify the characteristics of the project that are essential for its safe and proper use. 5.3.3. Information for production and service provision can include details for the preservation of project. 5.4. Design and development Review 5.4.1. At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements. 5.4.2. Evaluate the ability of the results of design and development to meet requirements. 5.4.3. Identify any problems and propose necessary actions. 5.4.4. Participants in such review shall include representatives of functions concerned with the design and development stages being reviewed. Record of the results of the reviews and any necessary actions shall be maintained. 5.5. Design and Development Verification 5.5.1. Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development of input requirements. 5.5.2. Records of the results of the verification and any necessary actions shall be maintained. 5.6. Design and Development Validation 5.6.1. Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. 5.6.2. Whenever practicable, validation shall be completed prior to the delivery or implementation of the project. 5.6.3. Records of the results of validation and any necessary actions shall be maintained. 5.7. Control of Design and Development Changes 5.7.1. Design and Development changes shall be identified and records maintained.

5.7.2. 5.7.3.

5.7.4.

The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained.

6. References 7. Attachments Design and Development Process Model