| The management has developed a system to determine, provide and maintain the infrastructure. It includes buildings, workplace, associated utilities, process equipment and supporting services. |
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| WORK ENVIRONMENT |
| Management identifies and manages the work environment needed to achieve conformity to product requirements. |
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| PRODUCT REALIZATION |
| PLANNING OF PRODUCT REALIZATION The management has developed the process needed for product realization, planning to determine quality objectives and requirement for the product. The management has also developed the sub-processes, documents and provided resources needed for product realization such as verification, validation, monitoring, inspection and test activities besides the criteria for product acceptance. The document records of all these activities are maintained (Ref. Ch. No. QM/MR/11). |
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| CUSTOMER-RELATED PROCESSES |
| DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCTS The management determines the customer requirements (stated, implied and statutory) for product and delivery. No statutory or regulatory requirement related to the product has been presently identified. In case such requirements become applicable in future, they shall be complied with. |
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| REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT |
Review of customer requirements related to the product are conducted prior to submission of quotation, acceptance of contracts or orders and acceptance of any changes therein to ensure that requirements are well under stood and organization has a capacity to meet them The records of these review activities are maintained. |
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