ISO 9001:2015 Documented Information

In ISO 9001:2008, clause 4.2.1 identifies the required documents for a quality management system as the quality policy, quality objectives, quality manual, and the procedures required by the standard. The required documented procedures are identified in later clauses as 4.2.3 (Control of Documents), 4.2.4 (Control of Records, 8.2.2 (internal Audit), 8.3 (Control of Nonconforming Product), 8.5.2 (Corrective Action), and 8.5.3 (Preventive Action).

The Committee Draft of ISO 9001:2015 makes use of the term “documented information” to refer to both documents and records. You have to read the context to understand which type is being required.

For example, clause 4.3 states the Scope must be available as documented information, implying a document, not a record. By the way, this Scope section is what remains of the current Quality Manual requirement. Clause 5.2 states the Quality Policy must be available as documented information, and 6.2 states the Quality Objectives must be available as documented information.

The new standard does not identify any documented procedures as being required. It does in many places refer to requirements for documented information.  For example, clause 8.8, Nonconforming Goods and Services (the replacement for 8.3 Control of Nonconforming Product), states documented information must be maintained on the nature of the nonconformity, subsequent actions, and any concessions. This implies records as in the past, not a continued requirement for a documented procedure.

Management system standards, including ISO 9001, are to use the clause structure and common text in an ISO document called Annex SL. Its definitions are included in the draft ISO 9001:2015 for ease of reference, but will be moved later to an updated ISO 9000 Fundamentals and Vocabulary standard.

The audit definition in 3.17 of the draft ISO 9001:2015 refers to an audit being a “documented process”, however, clause 9.2 on Internal Audit doesn’t support that definition. It only mentions documented information in terms of audit evidence (records).