Internal Audits

SuppAss

Internal Audits

Internal Audits (audits of implemented Quality Management System) provide information about the performance and status of compliance of Quality Management System. Planned and effective Internal Audits are the vital part of ISO 9001 compliance. Internal Audits are performed periodically to evaluate the adequacy and effectiveness of Quality Management System and, according to the ISO 9001 Standard…”shall be carried out by personnel independent of those having direct responsibility for the activity being audited.”

Personnel performing Internal Audits must be intimately familiar with ISO 9001 requirements and their interpretation, and adequately trained in auditing (formal Auditor or Lead Auditor qualifications are optional but expected by many Registrars). Internal Audits may be also performed by an independent and properly qualified “third party” such as QUEXX. Our Auditors are formally certified and will perform professional audits of your Quality Management System in compliance with applicable standards and regulatory requirements. Professionally.  Objectively.  Efficiently.

SCOPE OF SERVICES:

  • Internal Audits in line with requirements of pertinent standards and ISO 10011 guidelines
  • Internal Audits tailored to reflect customer-specific requirements
  • Internal Audit Report
  • CAPA activities

We will:
a) assist in developing a documented procedure for Internal Audits
b) perform comprehensive Internal Audits reflecting your specific needs, applicable standards, and
the requirements of your customers and the regulatory bodies
c) develop Internal Audit Plan which will review individual elements of the Quality Management
System at appropriate planned intervals. It will reflect, where applicable,  results of previous Audits,
non-conformance reports, performance data, etc.
d) provide detailed Internal Audit Report:
– Quality Management System compliance
– identified discrepancies and observations, if any
– recommended corrective/preventive actions and related deadlines
e) perform follow-up on the above, verify actions taken, etc., as required

     BENEFITS:

–          Unbiased audit of the Quality Management System by professional auditors
–          Compliance with ISO 9001/ISO 13485 / ISO 16949, and related requirements
–          Known effectiveness of the Quality Management System
–          Defined foundations for Quality Management System improvement
–          Reduced internal training and Quality Management System compliance costs
–          Economical solution which does not use your own limited resources
–          Flexibility to use Quexx services on “as needed” basis

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