March 2017

Temecula Valley Section 0713

March 2017 Monthly Dinner Meeting

Topic: “Raising the Bar with Standards for Quality Management Systems”

Who: Sheryl LaFond

When: Thursday, March 16th,, 2017 at 6:00 PM

Where: Temecula Library
30600 Pauba Road,
Temecula, CA 92592

Dinner Cost: $20.00 for members
$25.00 for non-members

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Presentation Title: “Raising the Bar with Standards for Quality Management Systems”

Having a Quality Management System is good for business regardless of the industry.  A critical element of a robust QMS includes the application of smart standards, such as those recognized globally and considered state of the art. ISO 9000 and ISO 13485 are among the most common QMS standards for business and medical products; QMS standards can be strong tools for regulated operations subject to governmental inspections, for focus on core values, and for putting customer needs in parallel with business sustainability.

Presentation Speaker: Sheryl LaFond

Having worked in the regulatory field for medical device industry for 25 years, large and small firms, technology and regulatory requirements have evolved and continue to challenge us all.  Experience includes compliance audits / inspections, advisor to large corporations on use of industry standards, and development of regulatory intelligence key processes for emerging markets.

Join us for a wonderful presentation of Raising the Bar with Standards for Quality Management Systems” on March 16th, 2017 at 6:00pm!!!

This lively training presentation teaches how to use all six – yes, six! – senses when conducting external conformity assessments or internal QMS audits, in order to maximize the gathering of objective evidence, and to ensure the highest level of confidence in the final audit results.
This eye-opening and invaluable discussion will give even seasoned auditors a new perspective, and will help improve the audit experience not only for clients, but also dramatically reduce problems with Certification Body internal review committees and Accreditation Bodies.
As a clinic participant, you will:
The “angle of perception” used by auditors, and how to expand it using the “missing senses” to soak up evidence like a sponge.
Learn how auditees hide nonconformities in plain view, based on predicted auditor behavior.
Never again have your audit findings challenged because of weak evidence.
Speaker Bio: Christopher Paris is a former Chemical Process Engineer, and has worked with ISO 9001 systems since 1988.  In 1999, he founded Oxebridge Quality Resources, an ISO 9001 and AS9100 consulting firm whose clients include SpaceX, Lufthansa, L3 Communications, and
200 small and medium sized organizations. He was a member of the US TAG to TC 176,
and is an international speaker on the subject of quality and ISO 9001, primarily advocating
for the point of view of standards users.  Click Here for more on Christopher Paris bio.