From documented procedure to documented information: the new approach of ISO 9001:2015

ISO standards are normally reviewed and revised every 5-10 years. In September 2015, after extensive review, ISO 9001:2015 standard was published. At the same time also new revision of ISO 14001 standard was published, by harmonizing their layout to the 9001 one. This paper focuses on the documents necessary for the implementation of a Quality Management System (QMS). The renewed standard defines documented information as relevant data that are required to be controlled and maintained by the organization to support the operation and to be confident that the processes are being carried out as planned. QMS needs to include documented information required by the standard as well as documented information determined by the organization necessary for the effectiveness of the system. According to ISO 9001:2008 it is possible to classified the specifically required documentation in a 3 levels pyramid: top tier included descriptive documentation (e.g. Quality Manual), tier 2 the set of procedures and work instructions (prescriptive documentation), tier 3 consisted of records. In the new standard, a new pyramid model is necessary to classify required documents: top tier concerns high level transversal documents (for the purposes of establishing a QMS), tier 2 contains specific documents (for the purpose of communicating the information necessary for the organization to operate), tier 3 remains of records (for the purpose of providing evidence of results achieved). An organization with an existing QMS should not need to rewrite all of its documented information in order to meet the requirements of the renewed standard, and it may be able to carry out some reduction and/or consolidation of existing documents, in order to simplify its QMS.