| |
|
Q2 Consultants, Inc. Press Releases and News |
| |
|
Q2 Consultants, Inc. named Best in State |
06/26/03 |
Q2 Consultants, Inc. was named the winner of the Service Subcategory “Consultants” last week when the winners were announced of the first ever Utah Best of State Awards. Medals were awarded to the winners in a gala held in their honor on June 21, 2003. The Best of State Awards were created to recognize outstanding individuals, organizations and businesses in Utah . The criteria for the winners consisted of the Best of State Judges looking for businesses and organizations that excel in their endeavors, use innovative approaches or methods and contribute to a better quality of life in Utah . Being named as one of this year's winners Q2 Consultants, Inc. was recognized as a leader in their industry in meeting the requirements of the criteria as was confirmed by referrals provided during the nomination phase. Q2 Consultants, Inc. has been in business since 1999 and has shown continual growth from year to year. Q2 Consultants, Inc. specializes in quality and environmental management systems auditing, consulting and training and has provided numerous services to companies and organizations not only in the great state of Utah, but throughout the US, Canada, Puerto Rico, Mexico, South and Central America and Asia as well. |
|
President of Q2 Consultants, Inc. passes the Accredited
Persons FDA Training Exam
|
02/06/04 |
Don E. Hall, the president and founder of Q2 Consultants, Inc. has passed the Accredited Persons FDA Training Exam in Gaithersburg Maryland . The exam was given after 4 days of intense training provided by FDA inspectors, local and regional management. By passing the exam, as well as fulfilling the prerequisite requirements of attending and passing the AAMI QSR 5-day training and exam, Mr. Hall is now qualified to participate in the witness and participation of investigations portion of the Accredited Persons FDA program and become qualified to conduct QSIT investigations in behalf of the FDA with an Accredited Persons third party partner. Only 14 third party registrars were invited to the Accredited Persons Training and about 45 people participated in the course and exam process, only 14 of which were from the United States . Once Mr. Hall has completed the requirements for witnessing and auditing with the FDA field agents, he will become qualified to conduct FDA investigations of Medical Device Manufactures for third party registrars making him only one of the 14 auditors qualified to conduct investigations for the FDA in the United States . |
|
President of Q2 Consultants, Inc. Invited to be Member
of Accreditation Advisory Board
|
04/22/04 |
Don E. Hall, the president and founder of Q2 Consultants, Inc. has been invited by the International Accreditation Registry (IAR) to be a member of their advisory board. In a letter from Marisol Valenzuela, Executive Director of the IAR Ms. Valenzuela stated that “ The International Accreditation Registry (IAR) is in the process of enhancing the membership of its various boards and committees, in order to better represent the technical areas of interest. The IAR would be honored to have someone with your background and experience to contribute as a member of our Advisory Board.” As a member of the Advisory Board Mr. Hall will be involved in the review and approval of documentation describing the accreditation processes of IAR in accrediting training organizations and registrars. The board is made up of 7 other professionals with extensive backgrounds in food, aerospace, automotive, environmental and other industries. Mr. Hall brings with him the experience of being a RAB QMS Certified Lead Assessor, as well as extensive auditing experience, particularly audits of medical device manufacturers required to comply with USFDA and Health Canada requirements and the European Medical Device Directives. Ms Valenzuela went on to comment that “We feel that the contributions by someone of your expertise would be a key ingredient to the success of the program.” The term of an Advisory Board member is typically 3-years with options of continuing after the three year term has been completed. |
|
President of Q2 Consultants, Inc. Successfully Completes
FDA Training for Premarket Notification (510(k)] Reviewer for Third Party Organizations
|
11/24/2004 |
|
|
| On October 27, 2004, Don E. Hall, President of Q 2 Consultants, successfully completed the FDA Training for Premarket Notification (510(k)] Reviewer for Third Party Organizations. This training was a two day activity where only a select number of individuals were allowed to participate that allows an option to manufacturers of certain medical devices of submitting their 510(k) to private parties (Recognized Third Parties) identified by FDA for review instead of submitting directly to CDRH. On August 1, 1996, FDA began a voluntary Third Party Review Pilot Program for selected medical device 510(k)s. The purpose of the program is to: (1) provide manufacturers of eligible devices an alternative 510(k) review process that could yield more rapid marketing clearance decisions; and (2) enable FDA to use its scientific review resources for higher-risk devices, while maintaining confidence in the review by third parties of low-to-moderate risk devices. Under the program, all class I devices that were not exempt from 510(k) at that time and 30 class II devices were eligible for third party review. Mr. Hall is now one of less than 50 accredited persons world-wide that can perform such reviews that will allow medical device manufacturers the opportunity to get their devices approved in a more timely manner and into the market place where they can benefit the population. |
|
President of Q2 Consultants, Inc. Successfully Passes ISTO
ISO 9001:2000 Exam
|
4/22/2005 |
On April 3, 2005, Don E. Hall, President of Q 2 Consultants, successfully passed the ISTO ISO 9001:2000 exam. The exam was presented at the 2005 ISO Summit in Atlanta , Georgia where 7 people sat for the exam, where only 3 passed. Mr. Hall is only one of 37 people world-wide that have successfully passed this exam. The exam is divided into several sections of 180 questions and is required to be completed within 2 hours. The exam was used to evaluate the ability of the candidates to demonstrate their understanding of the eight quality management principles on which the ISO 9000:2000 series of standards is based, the fundamentals of a quality management system, the terminology utilized in ISO 9001:2000 and ISO 9004:2000, as defined in ISO 9000:2000. Candidates were also tested on the familiarity with the ISO/TC176 Guide to the Terminology used in ISO9001:2000 and ISO9004:2000, as well as the requirements of ISO 9001:2000, as applicable to each of the generic product categories defined in ISO 9000:2000 for different kinds of organizations. The examine also included the role of ISO 9004:2000 guidance in helping organizations to go beyond ISO 9001:2000 requirements towards performance improvement, including the application of ISO 9001:2000 requirements within an organization. And finally the candidates were tested on their understanding of the principles of the Process Approach to quality management systems, their understanding of the type and amount of documentation required by ISO 9001:2000, and the interpretation of these requirements to different kinds of organization the arrangements for the transition to ISO 9001:2000, as defined by the IAF (International Accreditation Forum) and their familiarity with the relevant IAF documents, as well as the implications for conformity assessment of quality management systems based on the process approach, with reduced emphasis on documentation. |
|
President of Q2 Consultants, Inc. Selected as RABSA Certified QMS Skill Examiner
|
4/27/2005 |
RABQSA International (RABQSA) is a Personnel Certification Body (PCB) accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) as meeting the requirements of the international standard for personnel certification bodies, ISO/IEC 17024:2003 ‘General Requirements for bodies operating the certification of persons' . Certification with RABQSA provides certified persons with an internationally-recognized qualification.
ISO 17024 requires a PCB to define specific competencies for personnel seeking certification and to ensure that each candidate demonstrates these competencies, both prior to certification and as part of the ongoing surveillance and re-certification processes. For most schemes developed by RABQSA, required competencies are identified as knowledge competencies, skill competencies and personal attributes.
The most effective method of demonstrating skill competencies is to observe the candidate performing the required tasks, called a Skill Examination. The criteria for each scheme define the specific competencies to be examined by a Skill Examiner, who is a person confirmed as competent to conduct the Skill Examination and is independent of the candidate being examined.
Mr. Hass is one of 52 Skill Examiners approved world-wide RABQSA with the appropriate competencies to undertake Skill Examinations for candidates in all personnel certification schemes across all regions of the world.
Skill Examiners must demonstrate the knowledge competencies defined in TPECS module for RABQSA-AS and RABQSA-SE including:
• Prepare for assessment
• Organize assessment arrangements
• Establish and maintain the assessment environment
• Gather evidence
• Support the Candidate
• Make the assessment decision
• Record and report the assessment decision
Skill Examiners conduct witness activities by being able to:
• Understand how to complete the current Skill Examination report
• Understand Skill Examination processes
• Understand Skill Examination procedures
• Determine conflict of interest
• Understand Skill Examiner performance requirements
The demonstration of defined personal attributes contributes to the competent performance of a Skill Examiner. Skill Examiners are expected to demonstrate the RABQSA-defined personal attributes (which relate to those defined in ISO 19011:2002),through completion of the PAAS Master ® Examination. Evidence of successful completion of PAAS Master ® Examination within the 12 months prior to Application will be accepted.
Skill Examiners must also hold current Lead Auditor certification with RABQSA (or equivalent with a PCB accredited by a member of IAF as meeting the requirements of ISO17024) in the scheme covering the scope sought. |
|
.
|
