(Company Name)

QSP-3

Internal Audits

INTERNAL AU ITS
PURP!SE The following procedure is designed to verify the compliance, conformance and effectiveness and efficiency of our Quality management System (QMS) as well as to improve our ability to satisfy our customers and run our business effectively. Internal audits of the QMS are systematically performed to ensure conformance with the IS !""# Standard and planned arrangements and to determine the overall effectiveness of the QMS. The overall intent of the internal audit program is to provide top management with relevant information on which to ma$e sound business decisions. RESP!NSI"ILIT# The Quality Manager is responsible for the management of the internal audit program and has the authority to change this procedure and any forms used for internal audits. E$INITI!NS Complian%e % &vidence that the QMS and planned arrangements ('uality manual, procedures, wor$ instructions, prints, etc.) fulfill legally binding re'uirements such as contract and regulatory re'uirements. Con&orman%e % &vidence that the QMS and planned arrangements fulfill voluntary re'uirements such as IS !""# and applicable industry standards. E&&e%ti'eness % &vidence that the QMS processes consistently achieve their desired outputs including customer re'uirements. E&&i%ien%y % &vidence that the QMS processes consistently achieve their desired outputs using a minimum amount of resources (cost, productivity, etc.). INTERNAL AU IT PR!(RA) Audit S%*edulin+ The audit program is designed so that the QMS processes are audited at an appropriate fre'uency based on their status (process performance metrics, complaints, changes, previous audit results, etc.) and importance (ris$ ( effect of potential failure). )n audit schedule using QS*+#" is maintained by the Quality Manager and regularly reviewed and updated as part of the Management ,eview -rocess. Auditor Sele%tion and Competen%y )ana+ement The Quality manager assigns auditors who are independent of the functions being audited and assessed for their competence to audit a particular process or function and its associated re'uirements and technologies. )uditor competencies are managed using the internal auditor competency matri., QS*+#/. Internal audits may also be conducted by 'ualified subcontractors (see QS-+0). Audit Reportin+ and Per&orman%e )udits of each QMS process are recorded using the -rocess )udit Summary *orm, QS*+##. The Quality Manager records relevant information from each process audit on the )udit )nalysis and Scoring *orm, QS*+#1 and provides this as an input to management review. Trainin+ E&&e%ti'eness E'aluations
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(Company Name)

QSP-3

Internal Audits

ne of the activities that should be regularly performed during process audits is evaluation of training effectiveness. This is accomplished by sampling recently hired and(or trained employees and as$ing them relevant 'uestions on the procedures, measures and improvement goals relating to their 2ob function as well as customer feedbac$ relevant to their 2ob. )dditionally, recently changed or issued procedures should be sampled and implementation ( training effectiveness assessed in the same manner. )ny deficiencies or *Is should be noted in the audit report and(or issued as audit findings. Audit Non%on&orman%es and !pportunities &or Impro'ement (!$Is) )ny deficiencies or improvement opportunities identified during audits are recorded using the -roblem Solver and Improvement *orm, QS*+#, and promptly reported to the process owner and(or other responsible management. )n action timeline is established between the process owner and Quality Manager and corrective action is ta$en per procedure QS-+3, 4orrective and -reventive )ction. *Is are trac$ed and acted upon in the same manner as nonconformances. Audit $ollo2-up A%ti'ities The Quality Manager is responsible to ensure that all audit findings are followed up upon in a timely manner and that action plans are verified for implementation and effectiveness. 5erification of effectiveness normally occurs during the ne.t scheduled audit of a process but may be conducted sooner at the discretion of the Quality Manager. )ll audit follow+up activities are recorded on the -roblem Solver and Improvement *orm. REC!R S )ll audit program records are maintained in accordance with QS-+1, ,ecords Management.

Re'ised 3,-.,/0

Pa+e 1 o& 1