ISO – News – New ISO 19011 standard adds value to management system audits

ISO has just published an updated edition of the ISO 19011 auditing standard which will save money, time and resources by providing a uniform approach to multiple management system audits.

In today’s business environment, many organizations incorporate a number of management systems, such as quality, environmental, IT services and information security. As a result, these organizations want to harmonize and, where possible, combine the auditing of these systems.

Compared to the first edition of the standard published in 2002 which applied only to ISO 9001 (quality) and ISO 14001 (environment) ,the scope of ISO 19011:2011, Guidelines for auditing management systems, has been expanded to reflect current thinking and the complexities of auditing multiple management system standards (MSS).

New auditing guidelines now include guidance to auditing multiple management systems.



ISO Compliance Tools

Having the right ISO Compliance tools at your fingertips will certainly make your job easy when implementing a new ISO 9001 Quality System in your organization.  I have bought many books over the years and wanted to share some of my favorites.
Getting educated on ISO 9001 compliance standards will help you pass the message to your management team.  Management committment is key to having a successful launch so have the right resource materials to support your message.  I truly believe that if the Quality Management team embracing the new requirements and understands the benefits within your organization, your company will suceed!

ISO 9001 Compliance Book ISO Compliance Tools


Check out the ISO 9001 Quality Systems Handbook by David Hoyle.

ISO 9000 Quality Systems Handbook – updated for the ISO 9001:2008 standard, Sixth Edition: Using the standards as a framework for business improvement ISO Compliance Tools

CAPA System Effectiveness

Determining the root cause and corrective action is critical so that nonconformities do not recur.  Having a robust root cause analysis procedure will improve CAPA results and effectiveness.  There are many root cause methodologies in existence so find one that your company is comfortable with.  Employing more than one methodology is perfectly acceptable.  Ensure the staff is trained on your CAPA system as well as how to conduct root analysis.  This is critical in determining the actions needed to implement an effective corrective action which will have long term improvement.

Corrective Action2 CAPA System Effectiveness

 ISO 9001 Section 8.5.2 – Corrective Action states:

The organization shall take action to eliminate the causes of non-conformances to prevent recurrence.  Corrective actions shall be appropriate to the effects of the nonconformities encountered.  A documented procedure shall be established to define requirements for

a) reviewing nonconformities (including customer complaints),

b) determining the causes of nonconformities,

c) evaluating the need for action to ensure that nonconformities do not recur,

d) determine and implement actions needed,

e) record the results of action taken, and

f)  review the effectiveness of the corrective action taken.