Home Products & Services
About PQA Search Website
Contact PQA Training Courses
ISO 13485 Medical Devices   PQA's Blog:
Thoughts on Excellence
Relative Links:


ISO Auditing

ISO Auditing for Maximum Rate of Improvement

Table of Contents

Why ISO Auditing?

How long would it take drivers to discover that police were no longer patrolling the freeways for speeders due to budget cutbacks?  What would happen to the freeway's average speed during this discovery period, and thereafter?  What would eventually happen to the accident rate on the freeways?  How long would this situation continue before taxpayers demand a change?

If the above four questions are so obvious for everyone to answer, is the similar need for effective auditing of an ISO system difficult to understand?

Effective ISO auditing will ensure that:

  • Sr. Management has a clear understanding on what is occurring in the organization's ISO system.
  • Everyone is motivated to continuously improve the ISO system
  • The relative priorities, focus, prerequisites, and attention is provided to the necessary improvement tasks
  • The improvement are completed in a timely manner
  • The improved ISO systems are effective at achieving the organization's goals

Effective ISO Audits can help achieve rapid organizational improvements.  Some organizations have achieved:

  • 7.65%/yr average improvement each year for more than 10 years (209% improvement over 10 years)
  • Doubling of sales, and quadrupling of profits
  • 650% ROI (Return on Investment)

Why do most ISO Systems Not Live up to their Capabilities?

ISO systems are based on simple, fundamental principles.  Unfortunately, many of the ISO implementations are not as simple as they could be.  PQA has done some basic research on why ISO systems are less effective than they should be.

If you aren't getting these kinds of improvements, chances are that 1 or more of the Pre-requisites for Effective ISO Audits is missing or ineffective.
 

Pre-Requisites for Excellent ISO Audits

  • Sr. Management who want an un-biased, comprehensive scorecard on their ISO system.
  • ISO Auditor who fully understands:
    • the ISO standard (what it says, what it means, and how best to achieve it)
    • the organization's business sector ie. what separates good from Great!
  • Adequate implementation of the ISO audit report recommendations

PQAs ISO Auditing Services

To overcome the limitations caused by poor or incomplete ISO implementations, PQA has developed ISO auditing techniques to help Sr. Management effectively respond to these significant challenges.

If you choose to utilize PQA's ISO Auditing services, PQA will:

  • Analyze your unique situation.  We do our homework before we decide to best audit for effectiveness.

  • Develop the audit checklists, process maps, and other necessary preparations, or review the ones you already have.

  • Arrange a mutually convenient time to conduct the audit.  PQA can provide recommendations so that you can adequately prepare for the audit date.

  • On ISO Audit Day, PQA will review the audit plan with the on-site personnel

  • PQA usually recommends 1 or more Managers accompany PQA on the audit.  They get to see 1st hand an effective audit being conducted (it may be very different from what they have previously experienced), and they see first hand the organization's response and status to the audit criteria.

  • When complete, PQA will provide a preliminary verbal audit report to all interested personnel

  • Off site, PQA will prepare the formal, written audit report and deliver it to Sr. Management

  • PQA can help drive the response to the audit findings (root cause analysis, options, project plan, measurements, document revision, compliance3 audits, effectiveness audits, etc.)

Find out about PQA's ISO Auditing Services.  Contact PQA for a free initial consultation.

1996 - 2006 Process Quality Associates Inc.     http://www.pqa.net      +1 (800) 837-7046    "We Engineer the Quality of Your Success"

Email PQA