Such provisions include loss prevention (i.e. This is acceptable, but certain provisions have to be taken and shown to be effective. Many organizations choose to manage all or most of its documented information in electronic formats. Documents containing internal communicationsĭocumented information is the basis of the objective evidence presented during an audit or assessment of an organization to show that effective means are in place and compliance to the standard can be determined.Process maps, flow charts, and descriptions.Although the new standard does not specifically require any of these, here are some examples of documents that can add value to a QMS: The new standard enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation, and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.Īn organization’s need for, and the extent and type of, documented information will vary greatly due to the context of the organization, its size, culture, nature of products and services, applicable statutory and regulatory requirements, customer requirements regarding the risks on products, etc. When it mentions “retain” documented information it refers to a form, form record or data.ĭocumented information must be retained by an organization for the purpose of providing evidence of results achieved (records). When the standard discusses “maintaining” documented information, it is referring to procedures and documents.

The term “documented information” was introduced to replace “document, documented procedures and records needed” however, it’s still important to distinguish between documents and records, which are very important in the aviation, space and defense industry. The new standard allows flexibility in the way organizations choose to document their QMS.

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