Determine Your Documentation Needs

摘要

What Is the change? One of the more notable changes in ISO 9001:2015 will be the nonexistance of any reference to requirements for a quality manual, documented procedures and records to be maintained. Does this mean documented procedures, records and other QMS documents are not necessary? No, that is not the case. Consider the requirements of ISO/FDIS 9001:2015, subclause 4.4.2.1 This sub-clause requires an organization to maintain documented information (procedures) to support the operation of its processes and to retain documented information (records) to have confidence that processes were performed as planned.