ISO 9001:2015
Company: Client-no.: Order-no.:
Audit type (standard / Revision): Audit date (on site): Company / customer: Street / P.O. box: Zip-Code / state / city: Audit representative: Leadauditor/ auditor: Technical expert/ trainee: Site / Subsidiary, etc. :
Certification Audit (ISO 9001:2015) NA/ NA Certification based on sampling Total and effective number of employees: Date
Lead Auditor(s)
Note:
1 2
Objective audit evidence shall be documented and uploaded to iCert. 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.
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. 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 The final result of the evaluation shall always be documented in the action list (Annex1)
3
4
5
crt_f_07.96e Revision 1
Valid from 01/01/2016
page 1 of 15
ISO 9001:2015
Company: Client-no.: Order-no.:
Requirements 4 4.1 (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) Context of the organization Understanding the org. and its context determine external and internal issues monitor and review info. Understanding the needs and *Min. of 1 ex.: expectations of interested parties context of the org. determine: *Min. of 1 ex.: a) the interested parties relevant to the QMS interested parties b) the req. of these interested parties *Min. of 1 ex.: monitor and review info. about interested statutory/regulatory req. parties and their relevant req. 4.2 Determining the scope of the QMS 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. 4.3 *Appropriateness of scope: 4.4 QMS and its processes *Min. of 1 ex.: crt_f_07.96e Revision 1
Valid from 01/01/2016
page 2 of 15
ISO 9001:2015
Company: Client-no.: Order-no.:
Requirements 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. (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) checked process(es) 5 5.1 5.1.1 Leadership and commitment Top 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 5.1.2 Customer 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 5.2 Policy crt_f_07.96e Revision 1
Valid from 01/01/2016
page 3 of 15
ISO 9001:2015
Company: Client-no.: Order-no.:
Requirements 5.2.1 5.2.2 (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) Top mngt. shall maintain a Q-policy : *Date of last review: a) appropriate to the purpose and context of the org. and supports its strategic direction b) provide a framework for Q-objectives c) include a commitment to satisfy applicable req. d) include a commitment to continual improvement The Q-policy shall: a) be available as docu. info. b) be communicated, understood and applied c) be available to relevant interested parties 5.3 Organizational roles, responsibility and authorities Top mngt. shall ensure that responsibilities *Min. of 1 ex.: and authorities are assigned, communicated and understood for:a) ensuring that the QMS conforms to req. b) ensuring that the processes are delivering outputs c) reporting on the performance of QMS and opportunities for improvement. d) ensuring customer focus e) ensuring integrity is maintained when changes to QMS are planned and implemented 6 6.1 6.1.1 Planning Actions to address risks and opportunities *Min. of 1 ex.: When planning, the org. shall consider 4.1 and 4.2 and determine the risks and opportunities to: a) achieve its intended result(s) b) enhance desirable effects c) prevent, or reduce, undesired effects d) achieve improvement 6.1.2 The org. shall plan: a) actions to address these risks and opportunities b) how to: 1) integrate and implement the actions into its QMS processes (see 4.4) 2) evaluate the effectiveness of these actions Quality objectives and planning 6.2 6.2.1 to achieve them *Date of last update: crt_f_07.96e Revision 1
Valid from 01/01/2016
page 4 of 15