Wednesday, May 2, 2018

Definition References to Documented Information - ISO 9001:2015


3.03 Requirement
Requirement is the need or expectation that is stated, generally implied, or obligatory.

A note to this definition states that a specified requirement is one that is stated, for example, in documented information.

3.47 Product
Product is the output that is a result of activities where none of them necessarily is performed at the interface between the provider and the customer.

A note to this definition states that software consists of information and is generally intangible and can be in the form of approaches, transactions, or documented information.


3.54 Verification
Verification is the confirmation, through the provision of objective evidence that specified requirements have been fulfilled.

A note to this definition states the objective evidence needed for verification can be the result of an inspection or of other forms of determination, such as, performing alternative calculations or reviewing documented information.

3.55 Validation
Validation is the confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.

A note to this definition states the objective evidence needed for a validation is the result of a test or other form of determination, such as, performing alternative calculations or reviewing documented information.

3.60 Audit Criteria
Audit criteria is the set of policies, documented information, or requirements used as a reference against which audit evidence is compared.

3.64 Release
Release is the permission to proceed to the next stage of a process.

A note to this definition states in the context of software and documented information, the word release is frequently used to refer to a version of the software or the documented information itself.







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