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 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 Omnex Methodologies

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 Stage 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).

Click here 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 the industry.

Omnex specializes in the following methodologies:

• Quality/Business Operating System (QOS/BOS)
• Stage Gate Risk-Based New Product Development Process
• Integrated Management Systems
• Quality/Business Management Systems
• Environmental Management Systems (ISO 14001) including Social Responsibility (ISO 26000), Energy Management (ISO 50000) and Sustainability
• Audit Processes and Methods
• Disciplined Problem Solving
• Lean and Six Sigma
• Functional Safety
• Business Excellence
• Supply Chain Practices and Outsourcing
• Software: Enterprise-wide Integrated Management Systems and MediniAnalyse

Implementation Support

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!