Documents required as per ISO 9001 2015 Standard

ISO 9001 2015 standard has changed terminology of “documents” & “records”. A new term is introduced by standard “Documented information”. Wherever standard specifies ” Retain documented information” it means we need to maintain record at this point. Wherever standard specifies “Maintain documented information” it means we need to maintain process / procedure / document at this point.

Mandatory documented information as per ISO 9001 2015 is;

  • Maintain documented information to support the operation of its processes (4.4.2)
  • Retain documented information to have confidence that processes are being carried out as planned ( 4.4.2)
  • Quality policy shall be maintained as documented information (5.2.2)
  • Maintain documented information on the quality objectives (6.2.1)
  • Retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources (7.1.5.1)
  • Basis used for calibration or verification shall be retained as documented information (7.1.5.2)
  • Retain appropriate documented information as evidence of competence (7.2)
  • Determining and keeping documented information to the extent necessary to have confidence that processes have been carried out as per planned (8.1)
  • To demonstrate conformity of products and services to their requirement ( 8.1)
  • Retain documented information as applicable on results of the review, on any new requirement for products and services ( 8.2.3.2)
  • Documented information needed to demonstrate that design and development requirements have been met ( 8.3.2)
  • Retain documented information on design and development input (8.3.3)
  • Documented information on design and development controls ( 8.3.4)
  • Retain documented information on design and development outputs ( 8.3.5)
  • Retain documented information on design and development changes ( 8.3.6)
  • Retain documented information of supplier evaluation, selection, performance monitoring and action arising from same ( 8.4.1)
  • Availability of documented information that defines characteristics of the products to be produced / service to be provided and results to be evaluated. ( 8.5.1)
  • Retain documented information necessary to enable traceability (8.5.2)
  • Retain documented information on what has occured with customer property which damaged it / made it not suitable for use ( 8.5.3)
  • Retain documented information describing result of review of changes, the persons authorizing the change and any necessary actions arising from review ( 8.5.6)
  • Retain documented information on release of products and services ( 8.6)
  • Retain documented information on control of non conforming output ( 8.7)
  • Retain documented information as evidence of result of performance and effectiveness evaluation of quality management system. ( 9.1.1)
  • Retain documented information as evidence of implementation of audit programme and the audit results. ( 9.2.2)
  • Retain documented information as evidence of results of management review ( 9.3.3)
  • Retain documented information on non conformity and corrective action ( 10.2.2)

if it is noticed, there is no requirement of preparation of quality manual is there. Also it does not specify to have departmental procedures.

However we strongly agree that to implement , maintain and continually improve performance and effectiveness of quality management system, everything shall be defined in the documents transparently to avoid any confusion during implementation.  Principal of “Write what you do and do what you write” will slightly change to ” Write what you want to prevent (risk) and do what you write “. Documentation must specify prevention of all possible risks. A healthy quality management system will definitely have effective documentation.

If you look at clause 7.1.6- it talks about organizational knowledge. This knowledge is nothing but documentation only. Intention of this clause is that organization shall put everything on paper which lies in the minds of peoples Nothing should be person dependent. Everything should be system dependent. Hence it is required to have effective documentation ( not quantitative but qualitative ).

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