Accreditation Assistance – Labs, Certification Bodies, Inspection Bodies -
General Focus (Similar Programs Available for Registration & Certification Efforts)

The Quality and Technical Competence Program we will help establish will be in compliance with the appropriate requirements of ISO/IEC 17025, "General Requirements for the Competence of Calibration and Testing Laboratories" for Laboratories (both Test and Calibration). This is the internationally recognized standard for Quality and Technical Competence in Testing as well as Calibration.

This envelops earlier standards such as the International Standard ISO/IEC Guide 25-1990 and European equivalent, EN 45001-1989, "General Requirements For The Competence Of Testing And Calibration Laboratories", ; is also to be addressed in the proposed Integrity Solutions Group assisted program. For a calibration laboratory serving US industry our program also addresses ANSI/NCSL Z540-1-1994, "General Requirements for Calibration Laboratories and Measuring and Test Equipment" 

For Certification Bodies (CB), Product Safety, Telecommunication Certification Bodies (TCB), and similar certification programs the Quality and Technical Competence Program we will help establish will be in compliance with the appropriate requirements of ISO/IEC Guide 65, "General Requirements for Bodies Operating Product Certification Systems” and the specific and appropriate certification scheme.

For Inspection Bodies and similar Inspection Programs supporting quality control and verification activities the Quality and Technical Competence Program we will help establish will be in compliance with the appropriate requirements of ISO/IEC 17020, " “General Criteria For The Operation Of Various Types Of Bodies Performing Inspection” and the specific and appropriate inspection scheme or program.

 

The Integrity Solutions Program

This program includes a Phase I effort or Gap Analysis to the specific Laboratory, Certification, or Inspection Body Accreditation requirements and a Phase II Implementation effort. A degree of the phase II effort may be done by the Customer to enhance understanding of requirements and ensure implementation ownership.

It is prudent that your organization institute the requested phased program to assure that Accreditation will be attained in a cost-effective manner to satisfy your needs for international and growing national recognition of quality and technical competence. In addition, as the various industries continue to stress accredited labs, accredited certification bodies, and accredited inspection bodies, the assistance you obtain should be based on the knowledge, experience, credentials, and flexibility of a consultant with a well founded background of success.

Our assistance will preclude a prolonged and costly effort that may otherwise take place if preparation for Accreditation is not based on detailed knowledge of the standards and the appropriate assessment practices.

This proposal is based on our senior leadership leading the effort for Integrity Solutions Group. Our senior leadership's actual work is traceable to certification as a Quality Management System Lead Auditor (ISO 9000), ISO/IEC Guide 25 and ISO/IEC 17025 Lab Assessor, Registration as a Professional Engineer, ISO/IEC Guide 65 Certification Body, ISO/IEC 17020 Assessor, and Nuclear Certified Lead Auditor (ANSI/ASME NQA-1, ANSI N45.2.23). Our leadership has also led various joint ISO/IEC Guide 25 (and EN45001) Accreditation and ISO 9000 series Registrations. Our team has been involved in Accreditation of labs for HP, IBM, Intel, Lexmark, SCI, Intergraph, Motorola, UL, Delphi, Seimens, independent labs, US government organizations, and labs/organizations in Taiwan, Germany, United Kingdom, Japan, and Israel. Our team led the first known labs having a comprehensive program through Accreditation that addressed ISO/IEC Guide 25, EN 45001, and ISO/IEC 17025.  Our staff efforts support the accreditation of bodies under programs recognized in national and international Mutual Recognition Agreements.

Consequently, our team is able to bring specific insight into the proposed assignment, very appropriate to your organization. It is not anticipated that others would be necessary to assist in our effort which is likely to occur with technically immature professionals. A brief summary type resume for one of our leaders is available on this site.

Integrity Solutions Group will perform a Gap Analysis which compares the present state of your firm with the appropriate requirements of ISO/IEC 17025 for laboratories (and if appropriate) the ISO/IEC Guide 25-1990 standard, "General Requirements for the Competence of Calibration and Testing Laboratories". Also included will be the European equivalent to ISO/IEC Guide 25 which is EN 45001-1989, "General Criteria for the Operation of Testing Laboratories" for laboratories. 

For Certification Bodies or Inspection Bodies the Gap Analysis will be to ISO/IEC Guide 65, "General Requirements for Bodies Operating Product Certification Systems” or ISO/IEC 17020, " “General Criteria For The Operation Of Various Types Of Bodies Performing Inspection”, respectively.

The Gap Analysis will determine areas of recommended improvement in your programs from a quality and technical competence perspective. Improvements recommended will be based on prudent extension, revision, or upgrade of the existing quality (or process control) and other existing programs to maximize cost-effective resolution of areas of potential concern.

  1. Gap Analysis Initial Data As part of the Gap Analysis, the Customer will be asked to submit existing relevant quality documentation (or process control documentation), test and calibration procedures, certification procedures, and/or inspection procedures and past self assessments (if any) to areas of sought Accreditation prior to our on-site Gap Analysis assessment. This will enable us to both prepare for the Gap Analysis (which to a great extent, in our program, simulates an Accreditation assessment). Our preparation for the assessment, the considerations discussed above, and the performance of the assessment, described in Step 2.0 below will allow us to prudently recommend appropriate changes.

  2. Perform Detailed Accreditation Assessments - Existing systems will be assessed to ISO/IEC Guide 25, EN 45001, ISO/IEC 17025, ANSI/NCSL Z540-1, ISO/IEC Guide 65, ISO/IEC 17020, as appropriate and the major method standards and areas for improvement will be identified. This assessment typically takes three to four days and will simulate (as prudent) the standard process of an assessment. It will not be what some Registrars call a Pre-Assessment, which is generally an orientation only with a limited on-site review of documentation and does not include a simulation of an audit. The Assessment will lead to a Detailed Assessment Report described in Step 3 below.

The purpose and scope of an actual On-Site Assessment (and Gap Analysis) for Accreditation is to provide a reasonable degree of confidence that the Lab, Certification, or Inspection Body meets the requirements for Accreditation. The Accreditation enveloping both quality management systems and technical competence. The Accreditation process being primarily based on the international standards listed above as well as the accreditation body generated requirements. The specific criteria for Technical Competence assessment aspects (i.e. ability to perform specific tests/types of tests) are based on the draft scope of accreditation to be established with the accreditation body, including the Accreditation Application Documentation.

The Assessment will also be based on the draft or available Organization Quality Manual and related documentation sent to the gap analysis assessor, if available, for the desired scope of Accreditation. Other documents supporting the competent performance of testing within the planned scope of Accreditation will be reviewed to provide a meaningful assessment or Gap Analysis.

  1. Prepare a Detailed Assessment Report - Nonconformance or deficiencies will be documented along with recommended corrective action to bring systems into compliance with the required standards (ISO/IEC Guide 25, EN 45001, ISO/IEC 17025, ISO/IEC Guide 65, ISO/IEC 17020, and/or ANSI/NCSL Z540-1). Unlike a standard audit report which is deficiency oriented only, our report will briefly review all major elements of the appropriate standard with recommended actions for improvement, as well as development of the Corrective Action Plan of Step 5. As our assessment is led by a Certified Assessor to ISO/IEC 17025, ISO/IEC Guide 65, ISO/IEC 17020, and ISO/IEC Guide 25, a Registration Accreditation Board Certified Quality Management System Lead Assessor (QMS-LA), and Registered Professional Engineer, you will be able to use our assessment as part of the documentation of internal audits by properly trained and independent auditors.

  2. Conduct Management Seminar - The management team will be presented with a review of the appropriate standard (ISO/IEC Guide 25, EN 45001, ISO/IEC 17025, ISO/IEC Guide 65, ISO/IEC 17020, and ANSI/NCSL Z540-1) with emphasis on the technical area of sought accreditation. Although this may be done theoretically before the Assessment, it will have more impact after completion of Steps 1-3 to allow a customized and actual facility knowledge based presentation. Alternately, a very brief overview can be provided on the first day of the assessment (prior to the beginning of the entrance interview for the simulated assessment) with a brief follow-up orientation using examples from the Gap Analysis after the assessment simulation exit meeting. The approach to take is somewhat dependent on organization dynamics. Because of the technical competence focus, the technically responsible staff must be actively involved (unlike ISO 9000 type audits, which may lack technical substance).

  3. Develop a Corrective Action Plan - Working closely with local management, a plan will be developed to bring areas of non-conformance (or deficiency) into line with the standard. This is a simulation of an Accreditation effort, as well as a Gap Analysis product. Nonconformance with (or deficiencies against) the standard, or program commitments, will be shown traceable to the requirements. "Recommendations only" will be treated differently than non-conformance, if implementation is not considered mandatory or otherwise necessary for cost-effective short-term implementation.

  4. Create a Time Phased Implementation Schedule - Working with Local Management or others, work content in the corrective action plan will be compared with available resources to establish a realistic implementation schedule.

Phase II – Lab Accreditation Implementation

This phase addresses activities required to implement the Customer system to Accreditation ready status. It is based on the specific Gap analysis completed in Phase I, including identification of required Corrective Actions and Recommendations. The following highlights the steps for this phase; although, some modification is normal based on specific details gathered in the Phase I effort.

  1. Form Project Leadership Committee - Establish the organization that will carry the responsibility for achieving Accreditation in the timeframe defined.

  2. Prepare a Laboratory Accreditation Compliant Systems Manual - The quality manual specifies how the system is operated and managed, where responsibilities are assigned and establishes a blueprint for the entire system. This will build on existing data and not "re-invent the wheel". The basis for development will be our staff experience and efficient interview of Customer staff to provide a unique and effective custom product for the Integrity Solutions Group Customer.

  3. Conduct Employee Training - Training will be required to fully understand the standard(s), manage the implementation and Accreditation process, develop and document procedures, and perform internal audits. Different levels of training vary from the general orientation for all employees, procedural training, and internal auditor training to assure that the Integrity Solutions Group Customer becomes self-sufficient.

  4. Provide Support in the Preparation of Quality Documentation - In addition to a quality systems manual, Laboratory Accreditation standards require documented general operating procedures, work instructions, calibration or test method documents, and various types of quality records where the absence of same may be detrimental to quality.

  5. Assist in Providing Specific Related Implementing Work Procedures - In addition to a quality systems manual, and the quality documentation of paragraph 4.0, above, we will assist you in the provision of unique Specific and Related Implementing Work Procedures.

  6. Perform Implementation Reviews - To insure laboratory efforts meet all requirements of the standard, periodic implementation reviews must be conducted.

  7. Conduct Internal Accreditation Simulation Assessments - Periodic assessments (audits) are essential to build the corrective action history needed to obtain Accreditation. We will lead the first series of such assessments/audits and train the Integrity Solutions Group Customer staff to perform this function in the future. Note, if you believe it is prudent to have a truly independent group perform this function periodically, we can provide an independent assessment on behalf of you at least on a yearly basis.

Cost Proposal

Cost of Phase I and II programs are available by contacting our staff to start a dialog to determine an appropriate customized offering.


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