/ SELF ASSESSMENT QUESTIONNAIRE FOR TRANSITION
EN9100 series 2016 / FORM-SYS00-TRA-01
Rev. 1
Page1/3

This document has to be filled in all sections and any documents that are required and/or deemed to be necessary must be attached.

This document must be submitted to RINA before the transition audit is carried out.

ORGANIZATION DATA
ORGANIZATION
ADDRESS(ES) OF SITE(S)
Is the number of employees and the QMS scope unchanged considering the data of the last audit?
YES NO / If NO please specify the changes:
PERSON WHO FILLS IN THE FORM / Surname and name:
Organization role:
DATE
APPLICATION FOR TRANSITION
Specify when you need to perform the transition audit:
During a scheduled surveillance audit
During a scheduled recertification audit
During an extra audit to be scheduled between two scheduled audits
Question 1
In relation to the context, have you determined any external and internal issues that are relevant to your QMS? / YES NO
Have you prepared any QMS document on the matter? / YES NO
If YES please attach the relevant document.
Please write the reference of any attached document: ______
If NO please write a brief description in the space here below
Question 2
About the context, have you determined the needs and expectations of interested parties relevant to your QMS? / YES NO
Have you prepared any QMS document on the matter? / YES NO
If YES please attach the relevant document.
Please write the reference of any attached document: ______
If NO please write a brief description below
Question 3
Have you determined your QMS scope? / YES NO
Please attach any documented information that describes all activities, products and services included in the QMS as required by clause 4.3 ofEN9100:2016, with a justification for the non-application of any requirements of the standard
Please write the reference(s) of any attached mandatory document(s): ______
Question 4
How does top management demonstrate leadership and commitment with respect to QMS?
Please write a brief description below:
Question5
Did you plan any actions to face any risks and opportunities which are proportionate to possible impacts on the conformity of your product and/or service? / YES NO
Have you prepared any QMS document on the matter? / YES NO
If YES please attach the relevant document.
Please write the reference of any attached document: ______
If NO please write a brief description below
Question6
Does your QMS include the documented information requested by EN9100:2016? / YES NO
What are the documents? (write the list or attach it)
Does your QMS include any other documented information that is deemed to be necessary for its effectiveness? / YES NO
If YES, what are the documents? (write the list or attach it)
Question 7
In the process of nonconformity management are they taken into account aspects related to Human Factor? / YES NO
Have you prepared any QMS document on the matter? / YES NO
If YES please attach the relevant document.
Please write the reference of any attached document: ______
If NO please write a brief description below
Question 8
In relation to the context, have the procedures been defined for managing operational risk? / YES NO
Have you prepared any QMS document on the matter? / YES NO
If YES please attach the relevant document.
Please write the reference of any attached document: ______
If NO please write a brief description below
Question 9
Was it defined a necessary process to ensure the safety of the product throughout its life cycle? / YES NO
Have you prepared any QMS document on the matter? / YES NO
If YES please attach the relevant document.
Please write the reference of any attached document: ______
If NO please write a brief description below
Section to be filled in by RINA
SCOPE:
 CONFIRMED (as per SELF-ASSESSMENT QUESTIONNAIRE FOR TRANSITION)
 MODIFIED FOLLOWING CONTACTS WITH THE ORGANISATION:
______
Availability of qualified auditors: / DM competency:
Man/days proposed
Justification of man/days for transition:
AR RESPONSIBLE FOR THE APPLICATION REVIEW: / DATE: