9001:2015 documents requirements

ISO 9001:2015 Documents

ISO 9001:2015 Standard is a latest version of Quality management system Standard. Tough there is no mandatory documentation guideline but in the clause no 7.5.1 it is told about documentation requirements of ISO 9001:2015 as below:

  1. documented information required by this International standard
  2. documented information determined by the organization as being necessary for the effectiveness of the quality management system

In the above first sub clause of 7.5.1 it is telling that documented information is required by this QMS standard but it is not specifying what are the requirements.

In the second sub clause it is telling documented information is requirement for an organization . The organization will determine what are necessary for effective implementation of quality management system.

According to the second sub clause we can summarize that the documented information will be prepared by the organization by follow the following things:

a) size of organization and its type of activities, processes, products and services;
b) complexity of  processes and their interactions,
c) competence of persons.

All the documented information what are the part of ISO 9001:2015 should be controlled following the 7.5 clause. Now lets know what are said in the sub clause a of 7.5:

  • scope of QMS
  • Process operation related documentation
  • Quality Policy
  • Quality Objectives

In the sub clause of b of 7.5 it is told about the documents are required to communicate information or instruction for successful operation of the processes. According to the clause 4.4 though ISO 9001:2015 does not specify the requirements but following documents may add value in the organization:

Organization charts
Process maps, process flow charts and/or process descriptions
Work and/or test instructions
Documents containing internal communications
Production schedules
Approved supplier lists
Test and inspection plans
Quality plans
Quality manuals
Strategic plans