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Design and development proposals.
Serial number: Serial number:
Project Name Start and End Dates.
Budgeted Expenses Responsibilities Design Developers Responsibilities Design Developers.
Resource allocation (including personnel, production and testing equipment, design budget allocation and information exchange means, etc.) requirements:
The division and main content of the design and development stage Design and development personnel Responsible person Cooperate with the department Completion deadline.
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Design and development.
Design and development planning.
The organization should plan and control the design and development of the product.
When designing and developing planning, organizations should determine:
a) design and development phase;
b) Review, verification and validation activities appropriate to each design and development phase;
c) Responsibilities and authority for design and development.
Organizations should manage the interface between the different groups involved in design and development to ensure effective communication and a clear division of responsibilities.
As design and development progress, the curated outputs are updated as appropriate.
Design and development inputs.
Inputs related to product requirements should be identified and records kept. These inputs should include:
a) functional and performance requirements;
b) as required by applicable laws and regulations;
c)where applicable, information provided by previous similar designs;
d) Other requirements necessary for design and development.
These inputs should be reviewed to ensure their adequacy and appropriateness, and the requirements should be complete, clear and not contradictory.
Design and develop outputs.
The output of the design and development should be presented in a way that can be verified against the input of the design and development and should be approved prior to release.
The design and development output should:
a) meet the requirements of design and development inputs;
b) provide appropriate information on procurement, production and services;
c) include or reference the Product Acceptance Guidelines;
d) Specify the characteristics of the product that are necessary for the safe and normal use of the product.
Design and development review.
At the appropriate stage, a systematic review should be carried out in accordance with the planned arrangements (see Design and Development) in order to:
a) Evaluate the ability of the design and development results to meet the requirements;
b) Identify any problems and propose necessary measures.
Participants in the assessment should include representatives of functions related to the design and development phase of the assessment, and a record of the results of the review and any necessary actions should be maintained.
Design and development validation.
To ensure that the design and development outputs meet the requirements of the inputs, they should be validated against the proposed arrangements (see Design and Development). A record of the results of the verification and any necessary measures shall be maintained.
Design and development confirmation.
In order to ensure that the product meets the requirements for specified use or known intended use, it should be based on the planned arrangement (see Confirmation of Design and Development. Whenever feasible, confirmation should be done prior to product delivery or implementation. A record of the confirmation of the results and any necessary measures shall be maintained.
Design and develop control of change.
Design and development changes should be identified and documented, where appropriate, design and development changes should be reviewed, validated, and validated and approved prior to implementation, and review of design and development changes should include an evaluation of the impact of changes on product components and delivered products.
A record of changes to the assessment results and any necessary measures should be maintained.
If you don't understand anything, you can contact me again.
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Design and development is the process from product conception to realization, which needs to be reviewed and recorded. From the project proposal to the verification and confirmation process after the product comes out, you should follow the ** after the program, you can probably understand a little bit by looking at it**!
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The thing you mentioned is more difficult to solve.
First of all, different industries, industry standards are also different, and the system standards to be fulfilled are also different, of course, ISO9001 is proposed for all industries.
Secondly, timely is the same industry, but different companies have different conditions, and the content in the manual is also different. After all, the organizational structure of a company will certainly not be the same.
Third, when the certification company audits, it is based on your quality manual and program documents, as well as the third document and other documents to audit, so if your above documents do not meet the actual situation of your company, then, during the audit, it is easy to make mistakes. This is a matter of principle, and as a result, it will lead to the failure of the certification audit.
In summary, you can ask the company to hire a certification body to help you do the work on these documents. Please ask a certification company, ** is not expensive, about 8000 to 12000.
Of course, if you are a senior auditor, you can find some similar industries that you have experienced and change these materials according to the specific situation of your company, but this is undoubtedly a huge amount of work, please think carefully.
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The dragon altar is good, and there is a special complete information in it. But the type and scale of each enterprise are different, so you have to refer to it. Paint the tiger according to the cat.
If you want to do certification, you can't solve it from the Internet, or you hire a system manager, and you may have to ask a certification company if you need to.
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If you want to do certification, it is useless to just take the quality manual program documents.
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You can take a look at the "Qilong Altar", which is very comprehensive and will help you.
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There are a lot of them, see for yourself.
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Tell me what type of products your factory produces, leave your email address, and I'll send it to you.
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