What is the mandatory documented information needed according to ISO 9001:2015?

Documented information stating the scope of quality management system4.3

Documented information to extent necessary to support operation of processes4.4

documented information available for quality policy5.2.2.a

Documented information required by this International Standard7.5.1.a Documented information determined by the organization as being necessary for the effectiveness of the quality management system7.5.1.b Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system7.5.3.2

Documented information needed to be maintained by the organization for the purposes of

establishing a QMS (high level transversal documents) include:

− The scope of the quality management system (clause4.3).

− Documented information necessary to support the operation of processes (clause4.4).

− The quality policy (clause5.).  

− The quality objectives (clause6.2).  

− This documented information is subject to the requirements of clause7.5.  

Documented information maintained by the organization for the purpose of communicating

the information necessary for the organization to operate (low level, specific documents). See

4.4. Although ISO: does not specifically requires any of them, examples of documents

that can add value to a QMS may include:

− Organization charts

− Process maps, process flow charts and/or process descriptions

− Procedures  

− Work and/or test instructions  

− Specifications  

− Documents containing internal communications

− Production schedules

− Approved supplier lists

− Test and inspection plans

− Quality plans

− Quality manuals

− Strategic plans

− Forms

Where it exists, all such documented information, is also subject to the requirements clause

7.5.