The ISO Edge Ltd.
ISO 9001:2008 Tips & Tools
Third & Final Installment
July, 2009 
in this issue
Highlights of Some Key Changes to ISO 9001
What the Certification Bodies are Expecting
Dear Lisa,
This is the third and final installment of our series of newsletters covering the transition from ISO 9001:2000 to ISO 9001:2008.  We sincerly hope that you have found each edition useful.
In our April Tips & Tools, we again made available our Gap Assessment Checklist to assist you in your assessment of your organization's compliance with the updated standard.  For those of you who have not yet made use of our checklist and would still like to access it, we have continued to include the link below.
Highlights of Some Key Changes to ISO 9001 
Our last newsletter focused on four of the more significant changes to the Standard, encompassing Clauses 4.1 through 6.3.  This newsletter is going to focus on four more of the more significant changes encompassing Clauses 7.1 through 8.5, with the goal of helping your organization to understand and comply with the changes.
1.  Throughout the new standard, the term "measuring device" has been changed to "measuring equipment".  This change is emphasized in clauses 7.5 and 7.6 and is intended to emphasize that calibration applies to a wider variety of instruments.  Devices are often considered as instruments such as micrometers, calipers, dial indicators, etc.  The word equipment is more encompassing, and clearly covers customized test rigs, dynomometers, tensile-testing machines, gas-chromatographs etc.   Also in Clause 7.6, an additional clarifying note was added to encourage the verification of the correct versions of computer software.  Refer to ISO 10007:2003 for guidance on configuration management.
2.  The second area of focus is on the measurement of customer satisfaction.  A new note was added to give examples of sources of data for monitoring customer perception.  These new examples include user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.   This new note provides more flexibility in determining customer satisfaction allowing organizations to look beyond traditional methods that have often been found to be un-popular, such as Customer Surveys.  ISO 10001:2007 provides guidance on customer satisfaction and codes of conduct for organizations.     
3.  The third area of focus refers to the monitoring and measurement of processes.  Clause 8.2.3 has a new note to encourage organizations to consider the best way to measure the effectiveness of processes vis a vis the relationship of those processes to product quality and the overall effectiveness of the Quality Management System.  This clause refers to measuring the processes of the QMS, not the manufacturing or product-realization processes.  An example of a Quality Management process is the Corrective Action process.  A typical measure of effectiveness for this process is the number of corrected processes that have recurred, or the average time taken to resolve and close corrective actions.   Monitoring Key Performance Indicators (KPI's) through Dashboards and Balanced Scorecards are very effective ways of tracking the effectiveness of non-manufacturing processes. 

4.  The final change in the standard that we will consider is in Clause 8.3, Control of Nonconforming Product.   The words "where applicable" has been added to qualify the need for action when nonconforming product is identified.  This acknowledges that in many industries (such as custom fabrication), a defective product may simply be scrapped and remade.  There is often no need for sophisticated controls.  We are also encouraged to assess the potential effects of our nonconformances on the customer.
What the Certification Bodies are Expecting
Over the past month, we have come to learn that at least one Certification Body is requiring upgrade training for at least one person in your organization.  This training can take the form of a webinar or attending a live half-day session.  For these Certification Bodies, completion of our checklist may not be enough to satisfy their expectations.  For further information, we strongly urge you to contact your own Certification Body and inquire as to their expectations.
Some additional requirements that Certification Bodies are looking for during a ISO 9001:2008 Transition Audit are:
  1. A completed gap assessment of your QMS against ISO 9001:2008
  2. Completed internal audits on the differences and any implemented changes
  3. Summarized/tabulated results submitted to Management Review
Up-Coming Internal Auditor Training Sessions 

 AIAGAdvanced Auditing:  A New Model Using Risks & Controls 

Date: August 27, 2009 & September 24, 2009
List Price: $495.00

ISO 9001:2008 Internal Process Auditing
Dates: August 10 & 11, 2009 & September 14 & 15, 2009
List Price: $895.00


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It is our pleasure to serve you, our clients.  You are encouraged to contact us if you have any questions related to the changes to ISO 9001:2008 or how they impact your particular organization. 

Kind Regards,
Lisa Velanoff

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phone: (416) 223-1508
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