∞Element 4.17 – Internal Quality Audits
∞The
supplier shall establish and maintain documented procedures
for planning and implementing internal
quality audits to verify whether quality activities and related results comply with planned arrangement and to determine the
effectiveness of the quality system.
∞Internal quality audits shall be scheduled on
the basis of the status and importance of the activity to be audited and shall be carried out
by personnel independent of those having direct
responsibility in the activity being audited.
∞NOTE: “Activity” can refer to departments,
areas, processes, functions, etc. in a company.
∞NOTE: There is no specified check list that
MUST be used for internal auditing purposes.
∞The
results of the audits shall be recorded (see 4.16) and brought to the attention of
the personnel having responsibility in
the area audited. The management personnel responsible for the area shall take timely
corrective action on the deficiencies found during the audit.
∞Follow-up
activities shall verify and record the implementation and effectiveness
of the corrective action taken (see
4.16).
∞NOTES:
∞20
The results of internal audits form an integral part of the input to management
review activities (see 4.l1.3.)
∞21 Guidance on quality
system audits is given in ISO 10011.
∞4.17.1
– Internal Audit Schedules
∞Internal auditing should cover all shifts and
be conducted according to an audit schedule updated annually. When internal/external
nonconformances or customer complaints occur, the planned audit frequency should be
increased.