ISO 9001:2015

Clause Available
Minimum documentation requirements Action plan
No. (Y/N)

4.3 Maintained scope (of certification)

Maintained documented information to the extent

necessary to support the operation of processes, and
4.4 retained documented information to the extent necessary
to have confidence that the processes are being carried
out as planned

5.2 Maintained quality policy (5.2.2)

6.2 Maintained quality objectives (6.2.1)

Retained evidence of fitness for its purpose, as a

monitoring and measurement resource (7.1.5.1)
7.1 Where no such standard exists (measurement standards),
the basis used for calibration or verification (7.1.5.2 a) -
retained

7.2 Retained appropriate evidence of competence

Required by this International Standard (7.5.1 a)

Determined by the organization as being necessary for the
effectiveness of the QMS (7.5.1 b)
7.5
Documented information of external origin determined by
the organization to be necessary for the planning and
operation of the QMS (7.5.3.2)

Determining, maintaining and retaining documented

information to the extent necessary to have confidence
8.1 that the processes have been carried out as planned, and
to demonstrate conformity of products and services to
requirements (8.1 e)

Retained the results of the review, including any new

8.2 requirements for the products and services, relevant
amended documented information (8.2.3.2/8.2.4)
Clause Available
Minimum documentation requirements Action plan
No. (Y/N)

Demonstrate that design and development requirements

have been met (8.3.2 j)
Retained documented information on design and
development inputs (8.3.3)
Design and development control activities – retained
8.3
(8.3.4 f)
Retained documented information on design and
development outputs (8.3.5)
Design and development changes, results of reviews,
authorizations and actions taken (8.3.6)

Retained documented information of the evaluation,

8.4 selection, monitoring, re-evaluations of external providers,
and any necessary actions (8.4.1)

Availability - defining the characteristics of the products

and services, or the activities to be performed (8.5.1 a) 1))
Availability – defining the results to be achieved, (8.5.1 a)
2))
Retained to maintain traceability (where traceability is a
8.5 requirement) (8.5.2)
Customer, or external providers property (lost, damaged
etc.) on what has occurred (8.5.3)
Retained description of the results of the review of
changes, the persons authorizing the change, and any
necessary actions (8.5.6)

Retained evidence of conformity with the acceptance

criteria
8.6
Traceability to the person(s) authorizing release of
products and services

Describing the: nonconformity, actions taken, concessions

8.7 obtained, and on the authority that decided the action in
respect of the nonconformity – retained (8.7.2)

Retained evidence of the results of monitoring,

9.1
measurement, analysis and evaluation activities (9.1.1)
Clause Available
Minimum documentation requirements Action plan
No. (Y/N)

Audit programme (9.2.2)

9.2 Retained evidence of the implementation of the audit
programme and the audit results (9.2.2 f)

Retained evidence of the results of management reviews

9.3
(9.3.3)

Retained evidence of the nature of the nonconformities

10.2 and any subsequent actions taken and the results of any
corrective action (10.2.2)
 INPUTS AUDIT ACTIVITY OUTPUTS

Audit Criteria
(Requirements)
EVALUATION Audit Findings
Audit Evidence
(Objective)

Documented Interview
Information Audit
Evidence
Triangle

Observations
Questioning: Funnel Approach

OPEN

Gathering

Probing

Verifying
Parroting
CLOSED Finding