南德TUV-ISO90012015外审检查表

Order-no.:
Audit type
(standard / Revision):
Certification Audit (ISO 9001:2015) Audit date (on site):
Company / customer:
Street / P.O. box:
Zip-Code / state / city:
Audit representative:
Leadauditor/ auditor:
Technical expert/
trainee:
NA/ NA
Site / Subsidiary, etc. : Certification based on sampling Total and effective number of employees:
Date Lead Auditor(s)
Note:
1 Objective audit evidence shall be documented and uploaded to iCert.
2 This Audit question list is recommended as the primary source of
documentation of objective audit evidences. Alternatively, audit notes, process sheets, etc. could be used.
3 As a rule, documented audit evidence (audit question list, audit notes or
process sheets) should be completed separately for each audit and for each site (if applicable), for the pertinent process elements.
4 The evaluation can be entered in the audit evaluation column (E):
1= Conformity (including potential for improvement, where
applicable).
2= Minor nonconformity (lower-level non-conformity).
3 = Nonconformity (major nonconformity)
n.a.= not applicable
5 The final result of the evaluation shall always be documented in
the action list (Annex1)
Order-no.:
Requirements
Audit notes
(Audit notes identified with “*” are to be reported in the Audit Report) (Implementation / Documented Information / reviewed evidence ...)
E
4 Context of the organization 4.1 Understanding the org. and its
context
determine external and internal issues monitor and review info.
4.2 Understanding the needs and
expectations of interested parties *Min. of 1 ex.:
context of the org.
*Min. of 1 ex.: interested parties
*Min. of 1 ex.: statutory/regulatory req.
determine:
a) the interested parties relevant to the QMS
b) the req. of these interested parties
monitor and review info. about interested
parties and their relevant req.
4.3 Determining the scope of the
QMS
*Appropriateness of scope:
determine the boundaries and applicability
of the its scope.consider:
a) the external and internal issues
b) the req. of relevant interested parties
c) the prods & servs of the org.
apply all the req. of this Standard if they
are applicable within the scope of its QMS.
The scope shall be docu. info. state the
types of prods and servs covered, and
provide justification for any req. not
applicable.
4.4 QMS and its processes *Min. of 1 ex.:
Order-no.:
Requirements
Audit notes
(Audit notes identified with “*” are to be reported in the Audit Report) (Implementation / Documented Information / reviewed evidence ...)
E
establish, implement, maintain and
continually improve a QMS, incl. the
processes their interactions.
determine the processes needed and their
application and:
a) determine inputs and outputs
b) determine sequence and interaction
c) determine and apply criteria and methods
(incl. monitoring, measurements and
performance indicators) to ensure operation
and control of processes
d) determine resources needed and their
availability
e) assign responsibilities and authorities for
processes
f) address risks and opportunities
g) evaluate processes and implement
changes needed
h) improve the processes
maintain docu. info. to support processes
retain docu. info. that processes are
carried out as planned.
checked process(es) 5Leadership and commitment
5.1 5.1.1Top mngt. shall demonstrate
leadership and commitment by:
*Min. of 1 ex.:
a) taking account the effectiveness of QMS
b) ensuring Q-policy and Q-objectives compatible with context and strategic direction of org.
c) integration of QMS req. into the business processes
d) use of the process approach and risk based thinking
e) ensuring resources for QMS
f) communicating importance of QM and conforming to QMS
g) ensuring QMS achieves results
h) engaging, directing and supporting persons
i) promoting improvement
j) supporting other relevant mngt. roles
5.1.2Customer focus
Top mngt. shall ensur:
a) customer and statutory and regulatory req. are determined
b) risks and opportunities that can affect prods & servs and customer satisfaction c) enhancing customer satisfaction。