GENERAL
A process is "set of interrelated activities or interacting activities which transforms items inputs into outputs "(ISO 9000:2005).
Can be represented graphically as follows:
All processes have an object or purpose, a "something" that seek to achieve and that is given by the area and management of its own. ----------------------------------------------
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7.3.1 Design and development
7.3.1 Design and development
The organization shall plan and control the design and product development. In planning the design and development organization must determine
a) the stages of design and development
b) the review, verification and validation appropriate to each stage of design and development, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between the different groups involved in the design and development to ensure effective communication and clear assignment of responsibilities. The results of the planning should be updated, as appropriate, as the design and development progresses.
The organization shall manage the interfaces between the different groups involved in the design and development to ensure effective communication and clear assignment of responsibilities. The results of the planning should be updated, as appropriate, as the design and development progresses.
7.3.2 Input to the design and development
should be identified inputs related to product requirements and keep records. These inputs shall include
a) the functional and performance requirements,
b) the legislative and regulatory requirements,
c) information from previous similar designs, where applicable, and
d) other requirements essential for design and development. These items should be reviewed for suitability. The requirements must be complete, unambiguous and should not be contradictory.
7.3.3 Design and development
The results of the design and development should be provided in a form that enables verification against the inputs for the design and development, and should be approved prior to release . The results of the design and development should
a) meet the requirements of the inputs for the design and development,
b) provide appropriate information for purchasing, production and service provision,
c) contain or refer to product acceptance criteria, and
d) specify the product characteristics that are essential for safe and proper use.
7.3.4 Design and development
At suitable stages, systematic reviews should be designing and developing according to plan
a) assess the ability of the results design and development to meet the requirements, and
b) identify any problems and propose necessary actions. Participants in such reviews shall include representatives of related functions (s) stage (s) design and development that is (are) reviewing. Records of the results of the reviews and any necessary action.
7.3.5 Verification of design and development
verification shall be performed according to plan, to ensure that the design and development results meet the requirements of the input items design and development. Records of the results of the verification and any necessary action.
7.3.6 Validation of the design and development
should validate the design and development as planned to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, if known, whenever practicable, validation shall be completed before delivery or implementation of the product. Records of the results of the validation and any necessary action.
7.3.7 Control of design changes and development
design changes and development should be identified and records maintained. Changes must 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 the changes and any necessary action.
7.3 Design and development, ISO 9001:2000
DEFINITIONS
Design and Development
set of processes that transforms requirements into specified characteristics or specification of a product, process or system
NOTE 1 The terms "design" and "development" are sometimes used interchangeably and sometimes utilizanpara define the different stages of whole process of design and development.
NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (eg product design and development, or design and development process.) Verification
confirmation through the provision of objective evidence that they have met the requisitosespecificados
NOTE 1 The term "Verified" is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as:
* the development of alternative calculations, * comparing a new design specification with a specification of a similar design tested
* the completion of tests / trials and demonstrations, and
* Review documents prior to issue. Validation
confirmation through the provision of objective evidence that they have met requisitospara specific use or application intended
NOTE 1 The term "validated" is used to designate the corresponding status.
NOTE 2 The use conditions for validation can be real or simulated.
REQUIREMENT ANALYSIS - PROCESS DESIGN AND DEVELOPMENT
OBJECT
An organization should ensure a systematic and planned approach to control the design and development. This applies to all forms of design and product development, whether tangible (hardware or software) or intangible (eg a service)
If an organization has, or had details of product characteristics necessary for planning processes manufacturing and has to define those features based on customer requirements and / or regulatory bodies, has, by definition, the need for design and product development.
If an organization has, or had details of product characteristics necessary for planning processes manufacturing and has to define those features based on customer requirements and / or regulatory bodies, has, by definition, the need for design and product development.
DATA ENTRY
We may include among others:
* functional and performance requirements that may have been supplied directly by the customer or have been determined within the organization, for example as a result of initiative of markenting
* Any legal requirement that relates directly to the product
* Experiences from the design, development and manufacture of similar products before and
* Codes and design standards.
addition to the above, consider other inputs related to the design process, such as:
* Design forms and checklists
* Protocols and documentation processes.
* Protocols and documentation processes.
ACTIVITIES
The design and development process is a series of logical steps that include:
* Plan design and development
* Clarify what to achieve the design and development * Perform
the work required to produce results:
- Define the characteristics and criteria product acceptance necessary for its manufacture and
* To systematically review the progress and output data for the design and development and care of any problem is identified formally
* Check that the output data of the design and development meets the requirements
* Confirm the product / service actually does result was asked what to do. * Etc.
One of the key activities to control the design and development planning is to determine not only the general stages of design and development, if not well enough details of each stage, to allow:
* A clear allocation of responsibilities and authorities
The form and extent of the activities of review, verification and validation must be identified and, where appropriate, previously agreed with all stakeholders. ----------------------------------------------
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