Testing and Calibration Laboratories (ISO/IEC 17025)
ISO/IEC 17025:2005 has been revised better align with the ISO 9001standard. Thus,
Testing and Calibration Laboratories can harmonize their lab system accreditation
by recognizing the ISO 9001:2008 standard as the basis for sound management of lab
systems, which can now found in Clause 4 of ISO/IEC 17025. Clause 5 contains all
of the requirements that testing and calibration labs have to meet if they wish
to demonstrate that they operate a management system, are technically competent,
and are able to generate technically valid results.
ISO/IEC 17025 promotes cooperation between laboratories and other bodies to assist
in the exchange of information & experience and the harmonization of standards &
procedural goals. As a rule, within an organization any technology should be subjected
to calibration & testing and measured by a sampling scheme that results in data
collection and analysis. It is then possible to gauge the effect on the activities
or goods produced and plan appropriately for improvement. Essentially, this is the
goal of all standards introduced in the business environment.
Click here to see how Omnex can assist with
Implementation Support and/or Assessments
Training and Workshops
17025 Lab Standards are being widely accepted by everyone from the FDA, to governmental
water testing to electronic labs. In fact, Omnex has supported and helped all of
them implement ISO 17025 Lab Quality Management Standards. Other labs that Omnex
has helped include:
- Henkel Corporation Michigan plants and corporate, Wisconsin and Illinois
- Lucent Allentown and Bethlehem, PA
- Lucent Allentown and Bethlehem, PA
- Magna Corporation Toronto, CA
- Nascote Nashville, IL
- Liens Woodbridge, CA
- Frudenberg NOK Ligonier, IN
- TAKAO Bangkok, Thailand
- Yazaki NA - Canton, MI
- Inspec, Inc., Canton Michigan
- FDA, USA
Omnex recommends that Labs implement both ISO 17025 and
Measurement Systems Analysis as best practices.
Omnex provides management consulting that elevate the performance of client organizations
Omnex specializes in a number of key methodologies and can implement a QMS with
integrated New Product Development, Disciplined Problem Solving or Quality/Business
Operating System management system. Click here to see more on the
Disciplined Problem Solving (8D)
Integrated Management Systems
Integrated Management Systems (IMS) is the integration of QMS,
EMS, OHSAS and other regulations / standards and requirements into a single management
system. IMS fosters the approach that an organization should establish one integrated
system that is best for the business and not set up separate, often duplicate, processes
or documentation to satisfy each management standard. IMS contains company-wide
processes that conform to various management system standards such as AS9100, ISO/TS
16949, ISO 22000, ISO 9001, ISO 14001, and OHSAS 18001 but are primarily established
in support of the business goals.
At Omnex, integration means developing common organizational processes based on
standardized work flows, conducting integrated risk analysis (using FMEAs and Control
Plans for quality, environmental and health and safety risks) and conducting integrated
audits. At Omnex, we are continuing to pioneer ever more effective and efficient
ways of defining, implementing and auditing integrated management systems.
Integration and standardization not only reduce confusion and redundancy in the
workplace, but cost an estimated 50% less to implement and most importantly
cost 50% less to maintain. Furthermore, the cost for registration is reduced by
as much as 33%.
Omnex has been implementing integrated management systems since the 1990s, beginning
with the integration of QS-9000 and ISO 14001 in the Americas for Yazaki. Since
then, we have integrated ISO 9001, ISO 14001 and OHSAS 18001 for organizations around
the world including General Motors and TRW. Lately, we have integrated ISO 9001
and Food Safety Management Systems including an implementation where Food Safety,
Quality (ISO 9001), Environmental (ISO 14001), and Health and Safety (OHSAS 18001)
were integrated into one management system. Omnex recently helped Swiss Colony
a 100 year-old Food Catalog and Bakery implement FSMS and QMS standards in a record
six months that included QOS/BOS and Phase Gate New Product Development methodologies
and 8D Problem Solving techniques.
Omnex provides training for top management in the understanding and integration
of multiple integrated management systems, as well as the worlds only lead auditor
course in Integrated Management Systems (ISO 9001, ISO 14001 and OHSAS 18001).
for more information on Omnexs approach to Integrated Management Systems
Omnex Methodologies and Practices
Omnex offers training for each of the different methodologies as shown in this link.
Keep in mind, some of these methodologies may be known by different names within
Omnex specializes in the following methodologies:
Click here to view Omnex Training and Workshop Offerings
Omnex can help you conduct an ISO/IEC17025:2005 Discovery Analysis (or Assessment)
or conduct a Best-In-Class assessment to assist your company in making
process improvements that result in efficiency and savings.
Omnex will conduct a Discovery Analysis during an initial assessment. Omnex will
study your current processes to see the gaps in the systems as well as review Best-In-Class
practices depending on the scope of the assessment. Omnex assessments always focus
on savings and improvements within the organization. The last day of the assessment
centers around feedback and planning with the customer team. An implementation plan,
team, and next steps are completed as a part of the Discovery. Of course, this can
also be conducted at the beginning of an implementation, when the standard is revised
or when the customer is ready for an overhaul of their systems.
Omnexs core strengths are spelled out in the 12 methodologies in
which we specialize. Each of these practices are Best in Class practices
that can be implemented based on the needs of a specific organization in any industry.
Let us know how we can help you!