Accreditation Assistance – Labs, Certification Bodies, Inspection Bodies
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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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- Form Project
Leadership Committee - Establish the organization that will carry
the responsibility for achieving Accreditation in the timeframe defined.
- 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.
- 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.
- 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.
- 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.
- Perform
Implementation Reviews - To insure laboratory efforts meet all
requirements of the standard, periodic implementation reviews must be
conducted.
- 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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