In This Issue.......

GENERAL UPDATES, NOTICES AND PRESS RELEASES:

- Detroit Testing Lab Celebrates 100 Year Anniversary
- Solicitation to Laboratories on Notable Achievements
- NELAC Recognizes A2LA Proficiency Testing Provider
          Accreditation Program
- A2LA's 25th Anniversary
- Credit Card Payments Accepted by A2LA
- Certificates of Accreditation on the A2LA Website

MEETING SUMMARIES:

- NCSLI Meeting

UPDATES ON A2LA OPERATIONS & POLICIES:

- New & Updated Documents
- New 2004 Fee Structure
- Explaining the Assessor Deposit

ACCREDITATION REQUIREMENT INTERPRETATIONS & EXPLANATIONS:

- Accredited vs. Non-Accredited Calibrations
- Key Points of the A2LA Advertising Policy
- Keeping Up with Standards

Detroit Testing Lab Celebrates 100 Year Anniversary

A2LA would like to congratulate Detroit Testing Laboratories in celebrating its 100th anniversary this year. The lab was first accredited by A2LA in August of 1985 with Certificate of Accreditation number 38.01. Founded in 1903 as a metallurgical lab, Detroit Testing was in the right place at the right time to participate in the growth of the Detroit automobile industry providing laboratory services to Cadillac, Ford, Buick, Oldsmobile, Durant, and Hupp. In the late 40s, the lab expanded into mechanical engineering and chemical and environmental testing and again in the 60s into electronic testing.

Solicitation to Laboratories on Notable Achievements

As evident in this issue of A2LA News, A2LA takes pride in the achievements of its accredited laboratories. Are you celebrating a milestone? Has your A2LA accreditation helped you to reach a noteworthy goal? If so, let us know! We would be happy to share your accomplishments with our readers.

Please feel free to send any notices to the attention of the A2LA News editors, Teresa Barnett (tbarnett@a2la.org) or Tim Rasinski (trasinski@a2la.org).

NELAC Recognizes A2LA Proficiency Testing Provider Accreditation Program

A2LA is now formally recognized by the National Environmental Laboratory Accreditation Conference (NELAC) Board of Directors (BOD) as a NELAC Proficiency Testing Provider Accreditor / Proficiency Testing Oversight Body (PTPA/PTOB). On behalf of the NELAC BOD, Lara P. Autry, Director, made the announcement at the Plenary Session of the NELAC 9 Annual Meeting held in San Diego, California on June 3, 2003.

As a PTPA, A2LA will conduct on-site assessments of applicant proficiency testing providers. Our assessment teams will assess providers to the requirements of ISO Guide 43, ISO Guide 34, ISO 17025, the EPA National Standards for Water Proficiency Testing Studies Criteria document, and the NELAC Chapter 2 requirements. All assessment teams will consist of at least one A2LA technical assessor and an A2LA statistician. Full assessments will be conducted on a two-year cycle.

Our role as a PTOB includes ongoing statistical monitoring of proficiency testing provider’s study data to see trends. Some of the requirements outlined in the NELAC Chapter 2 are: timeliness in the operations of the programs, use of homogeneous and stable materials, and consistency of unacceptable rates just to name a few. The PTOB is also responsible for reviewing unresolved complaints exceeding ninety days that are received by the proficiency testing providers.

In order to attain the NELAC recognition, A2LA was required to conduct an assessment of a proficiency-testing provider that was witnessed by representatives from three of the NELAC Accrediting Authorities (AAs). A2LA was then audited by an AA representative at our headquarters. This was to determine if we have effectively implemented the procedures and policies that we established to execute the program. In addition to interviewing staff and management, the AA reviewed records of our assessor corps, contracts, financial statements, and aspects relating to the witnessed assessment. The AAs issued a report to the NELAC AA Committee for review, which then forwarded the report to the NELAC Proficiency Testing Committee that recommended A2LA to the NELAC BOD.

Interested applicants for the A2LA NELAC Proficiency Testing Provider Program may contact Randy Querry at 301 644 3221 or by email at rquerry@a2la.org. In addition please visit our website, www.a2la.org, for the established timetable for assessing and accrediting the first group of providers. Please note that the timetable is subject to change; however, we will provide updated information as it becomes available.

A2LA's 25th Anniversary

As the American Association for Laboratory Accreditation (A2LA) enters its 25th year of operation, this is a good time for reflection on the past and the future of the Association.

A2LA members can take great satisfaction in the success and progress achieved over the last several years. The founders of A2LA had terrific foresight. Formal establishment of A2LA as a non-profit, third-party organization open to all types of membership was a crucial attribute to developing credibility and laying the foundation for national and international recognition.

Testing (and calibration) is an activity conducted in almost all sectors of the economy. Accreditation must meet the needs of the various laboratories and the markets in which they operate. A2LA has taken this into account since its creation, in the belief that, while at first activities would be limited essentially to the industrial field, in particular the automotive and construction industries, the scope of activity would soon broaden. This has been confirmed in the last two decades, during which there has been a very high diversification of sectors using accreditation, the most recent being the calibration industry.

The developments in the world of accreditation show that accreditation is going to play an increasingly important role in society. A2LA is very aware of this because of US Government policy established in the 1996 National Technology Transfer and Advancement Act encouraging reliance on private sector conformity assessment activities and the recent efforts of the US government in negotiating more and more bilateral trade agreements in which accreditation serves as one basis for mutual recognition and cross-frontier acceptance of test data. Accreditation is also prominently cited in reviews of the Technical Barriers to Trade (TBT) Agreement Word Trade Organization (WTO). Non-governmental organizations, such as A2LA, are being increasingly used to perform accreditations that support the public’s need for reassurance of competent laboratories supplying accurate data so that valid decisions related to safety, health and the environment are made. Effective accreditation also provides significant economic benefits, not only to laboratories, but also to their users.

There is no doubt that accreditation serves an important public purpose, but to have confidence in any accreditation system that serves the public interest, it must operate with integrity, impartiality, and independence from any one interest (even government) including freedom from undue financial or other pressures. These are prerequisites for international recognition. A2LA is fortunate to have been designed with these attributes already well established.

A2LA is very well positioned to live up to the next generation of standards for accreditation bodies, i.e., ISO/IEC 17011, General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies and related application documents of the International Laboratory Accreditation Cooperation (ILAC). Our commitment to global standards and practices is unwavering. It has been key to our success and will continue to be.

A2LA has been and will continue to be a big supporter and contributor to the global system of mutual recognition agreements for laboratory accreditation. MRAs among accreditation bodies are the best way to facilitate trade and reduce complexity and redundancy of testing. A2LA is proud to be an initial signatory to the MRAs of ILAC, APLAC (Asia Pacific Laboratory Accreditation Cooperation), and IAAC (Inter-American Accreditation Cooperation). Although perhaps not necessary in the long term, A2LA continues to be the only US-based accreditation body with a bilateral MRA with the European cooperation for Accreditation (EA), the oldest regional cooperation serving a growing European trade area.

A2LA is built upon a quintet of excellence: a truly outstanding assessor corps, a superb Accreditation Council, an effective governing Board, an exceptionally wide range of members and volunteers, and a staff who are unusually dedicated and accomplished. Assessors are very carefully selected and then trained and closely monitored. The 50+ members of the Accreditation Council (all volunteers) represent a vast array of technical expertise and make many difficult decisions. The Board of Directors, meeting three times per year, provides overall guidance and policy direction. The members and volunteers on our Criteria Council and advisory committees offer outstanding guidance on challenging technical issues. The staff continues to distinguish itself, both nationally and internationally.

These five interdependent ingredients, assessors, Council, Board, volunteers and staff, are what make accreditation by A2LA unique. One of the few internationally recognized accreditation bodies that receives no government subsidy, A2LA has never been stronger thanks to the effectiveness of this quintet, which positions A2LA as a leader in accreditation. I am very excited to be part of this and expect to see even greater things happen in the future.

Certificates of Accreditation on the A2LA Website

In response to requests made by our accredited laboratories, A2LA will begin including the official Certificates of Accreditation (in addition to the formal Scopes of Accreditation) on the A2LA website for each accredited laboratory. Similar to the Scope format, each Certificate will be linked as a pdf document and will contain the A2LA seal and signature of A2LA President, Peter Unger. This process is expected to commence on October 1, 2003, and will be phased in for each laboratory that is accredited or reaccredited as of that date.

It is important to reiterate, however, that A2LA encourages each laboratory to promote its accreditation through use of its Scope(s) wherever possible since this document lists the specific tests and/or calibrations that are accredited. While the Certificate does attest to a laboratory’s accredited status, it will not assure a potential customer that the accreditation includes the work he/she is seeking to have done.

NCSLI Meeting

Timothy Osborne - Senior Laboratory Services Officer - Calibration

On August 17-21, 2003, A2LA participated in the National Conference of Standards Laboratories (NCSL) International Conference in Tampa Florida. Despite the downturn in the economy, we were encouraged by the contribution of laboratories, consultants and other service providers that frequented our exhibit. Not only did we support our own booth, but also staffed the exhibit for the Asia Pacific Laboratory Accreditation Cooperation (APLAC) throughout the conference. Lino Severino and Tim Osborne represented the calibration laboratory service officers for A2LA while Roxanne Robinson, A2LA Vice President, and Peter Unger, A2LA President, played dual roles in representing A2LA and APLAC.

In addition, A2LA staff presented several papers. Roxanne Robinson presented a paper entitled Anatomy of a Peer Evaluation, which received the best paper award in the quality management category, describing in detail the process used to evaluate accreditation bodies, and she held a workshop entitled 17025 - Keeping it Simple. Peter Unger presented his paper on Accreditation Standards: Recent Developments. We received nothing but positive feedback on the clarity and depth of information these presentations offered. Some of our assessors also presented papers. Mr. John Wehrmeyer, past NCSLI president, offered a tutorial on the accreditation process called Accreditation: View by a Lead Assessor. Dr. Henrik Nielsen’s Determining Consensus Values in ILCs and Proficiency Testing was awarded best paper on theoretical metrology at NCLSI this year.

As a tradition, NCSLI presents its annual William A. Wildhack award to an individual who has been recognized as providing outstanding contributions to the field of metrology and measurement science consistent with the goals of NCSL International. Also a tradition in the award ceremony is the secrecy in the identity of the recipient. Much to everyone’s surprise, Peter S. Unger became the 28th recipient of this award. In a modest speech, and perhaps his shortest ever, Pete graciously accepted the award and planned to donate it to A2LA.

A2LA plans on attending and presenting again at NCSL International’s next annual meeting in Salt Lake City, Utah from July 11 – 15, 2004. One of the presentations currently being discussed is Succeeding in the Laboratory Accreditation Process: A Primer on Applying and Finishing Well. We look forward to seeing you there.

New, Updated, and Withdrawn Documents

Changes have recently been made in several areas of the A2LA accreditation program that may affect you:

• The A2LA Conditions for Accreditation have been revised to specify that a laboratory is expected to begin compliance with the Conditions as of the date they are signed by the laboratory contact. Assessors performing an on-site assessment will expect to see evidence of this compliance as of the date the form was signed. The revised form has been incorporated into the A2LA application for accreditation, annual review and renewal of accreditation documents.

• As of July 1, 2003, the transition to the third edition of the Automotive EMC Laboratory Accreditation Program (AEMCLAP) Requirements (dated January 2003) has been completed. Laboratories participating in this program will no longer be assessed to the June 2001 edition, and the 2001 requirements document and associated checklist have been removed from the A2LA website. All assessments within this program will now be to the January 2003 edition of the AEMCLAP requirements.

• As of June 1, 2003, the transition to the A2LA Food Testing Program Requirements (incorporating the AOAC requirements) has ended. Laboratories participating in this program will no longer be assessed to the former A2LA Food Chemistry Program Requirements or Food Microbiology Program Requirements and these documents with their associated checklists have been removed from the A2LA website. All assessments within this program will now be to the A2LA Food Testing Program Requirements (dated December 2002).

The A2LA staff has also been working hard to update current requirement documents and issue new and much needed guidance in certain areas. The following are a few of the documents that have recently been submitted to the A2LA Criteria Council for review and approval for use and distribution:

• A revision to the A2LA Proficiency Testing Requirements for Accredited Testing and Calibration Laboratories,      which we expect to release by mid-October with an implementation date of January 1, 2004;
• A new document entitled Mandatory Guidance on Editorial Principles for Calibration Scopes of Accreditation;
• A new document entitled Guidance for Calibration Scopes of Accreditation for Hardness Measurements.

The Criteria Council is also being asked for any comments it may have on a new policy paper, clarifying the definitions of ‘standard method’ and ‘procedure’ and how each is or is not impacted by the requirements of 5.4.4 and 5.4.5 of ISO/IEC 17025.

The voting process by the Criteria Council can be lengthy at times if significant discussion results from the material that is provided to it, but each of these documents is expected to go a long way toward improving consistency and addressing areas of concern to A2LA staff, assessors, Accreditation Council members and laboratories alike. Watch for updates from A2LA on the status of these documents in the coming weeks

Fee Schedule for Laboratory Accreditation Services
         Effective January 1, 2004

Lisa C. Drake - Financial Manager

In order to maintain the high level of service its customers expect, A2LA is adjusting its fee schedule. A2LA does not change its fees often (the current fee schedule has been in place since January 1, 2000), and such changes are not made lightly.

In response to the concerns voiced by many of our customers regarding high up-front costs, many of the fixed fees have been lowered by as much as 40%. Likewise, the deposit for assessment services has been decreased by 50%. In an effort to have the overall cost of accreditation more closely reflect the size of the laboratory and its requested Scope(s), the assessment daily rate has been increased.

At its June 6, 2003, meeting the A2LA Board of Directors approved the following fee schedule, effective January 1, 2004, for laboratory accreditation services:

For renewal laboratories with an anniversary date after January 1, 2004, invoices for 2004 fees (generated approximately 6 months prior to the anniversary date) will reflect the new annual fee(s) and assessor deposit(s). Assessments for those laboratories will be charged at the new daily assessment rate ($960 per day).

Also, any interim assessment and follow up assessment from an action taken in 2003 but conducted in 2004 will remain at $800 until April 30, 2004. Effective May 1, 2004, any interim or follow up assessment will be at the rate of $960.

Any new applications for accreditation received after January 1, 2004, will be subject to the new fees. Any laboratories submitting new applications prior to December 31, 2003, must have their on-site assessment completed by April 30, 2004, to receive the daily assessment rate in effect at the time of application ($800 per day). After May 1, 2004, all initial assessments will be charged the new daily assessment rate ($960 per day).

For any laboratory that achieves initial accreditation between July 1, 2003, and December 31, 2003, the daily assessment rate for the surveillance visit in 2004 will remain at $800.

The Board of Directors also approved a change to the A2LA refund policy. After January 1, 2004, the initial application fee will be non-refundable. If a laboratory withdraws its application before completion of an on-site assessment, it may apply for a refund of up to 50 % of the A2LA annual fee(s) and the balance of the unexpended assessor deposit. There will be no refund of annual fee(s) after the assessment has been completed. Refunds of any balance remaining on the assessor deposit will be made at the time of the accreditation decision. Any withdrawal or refund request must be in writing.

If you have any questions regarding the fee schedule changes, please contact Lisa Drake, A2LA Financial Manager, at 301 644 3209, or ldrake@a2la.org.

Explaining the Assessor Deposit

As you know, A2LA has a new fee structure starting January 1, 2004. The new structure reduces the amount of assessor deposit required up front to $2,000 per field of testing. This does not mean the cost of the assessment will only be $2,000. The average cost of a single Scope assessment is still about $4000 excluding annual fees. As always, the actual cost of the assessments will depend upon the size of the Scope(s) and how prepared a lab is for the assessment. The labs will receive a final invoice based upon actual assessor time and expenses when the assessment has been completed.

Accredited vs. Non-Accredited Calibrations

Sections T1 and T2 of the A2LA Policy on Measurement Traceability require:

…that all calibrations and verifications of measuring and test equipment, reference standards, and reference materials be conducted by accredited calibration laboratories…or by a recognized national metrology institute. These calibrations or verifications must be documented in a calibration certificate or report endorsed by the accreditation body’s logo, or otherwise makes reference to accredited status.

The vernacular that has evolved from these requirements classifies a calibration meeting T1 and T2 above as an “accredited calibration” and one that does not meet T1 and T2 as a “non-accredited calibration”. It is critical for users of calibration services to understand the difference.

To illustrate, suppose that a testing laboratory is seeking a calibration service provider to calibrate its set of reference weights. It searches the A2LA website and identifies a calibration laboratory accredited to calibrate the appropriate range of weights, and so it contracts the calibration provider’s services. The resulting calibration certificate, however, arrives at the test lab without the A2LA logo and without any reference to A2LA accreditation. If the testing laboratory does not pursue this further with the calibration service provider, a deficiency will be cited for not meeting the Traceability Policy since this is considered a non-accredited calibration. Although the calibration laboratory is accredited to perform the calibration in question, the calibration certificate does not indicate that the service was performed in accordance with accreditation requirements for a calibration lab. Thus, there is no assurance that traceability has been maintained.

With the recent push for accreditation that many calibration laboratories have felt and continue to feel, it is not uncommon for an accredited calibration laboratory to offer its customers either an accredited calibration or a non-accredited calibration, usually at very different costs to the customer. The former service is performed in accordance with all requirements for accreditation and the resulting calibration certificate meets all requirements for maintaining traceability, including use of the logo. The latter may or may not, and there is no transparent means of knowing either way.

This issue is closely related to the article, Recalibration Intervals on Calibration Certificates, published in the June issue of A2LA News in that it becomes incumbent upon both the calibration lab and its customer to ensure that T1 and T2 are met. As the customer, a lab must stipulate up front that an accredited calibration is needed and that a calibration certificate with the appropriate logo (or reference to accredited status) must be issued. Simply contracting with a calibration laboratory chosen from the A2LA website may not, ultimately, be sufficient if the lab’s needs are not made clear to the calibration provider from the start and a non-compliant calibration certificate results. Calibration service providers must ensure that their contract review process is adequate to determine exactly what their clients need before a calibration is performed and certificate issued.

If you have any questions about the distinction between an accredited and non-accredited calibration and how this may impact your compliance with the requirements for accreditation, please contact your A2LA Laboratory Services Officer.

Key Points of the A2LA Advertising Policy

There may be nothing more frustrating than working months, if not years, to achieve A2LA accreditation, only to be faced with the A2LA Advertising Policy.

As part of our commitment to uphold and promote internationally agreed upon guidelines for accreditation and accreditation bodies, A2LA created the current version of its Advertising Policy (dated January 1, 2003) primarily from ILAC-G14 (International Laboratory Accreditation Cooperation, Guide 14), Guidelines for the Use of Accreditation Body Logos and for Claims of Accreditation Status. A2LA’s five-page policy contains many ‘shalls’ and ‘shall nots’, but the basic premise is the same throughout:

“It is the ethical responsibility of accredited and applicant laboratories to describe their accredited status in a manner that does not imply accreditation in areas that are outside their actual scope of accreditation or for other testing/calibration facilities not covered under A2LA accreditation.”

Everything that follows in the A2LA Advertising Policy, Sections 1 through 8, is simply elaboration of this basic theme - attempts to describe the most common situations where use of the “A2LA Accredited” logo may cause problems. It is certainly not our intention to discourage a laboratory from promoting its accredited status through use of the logo, but every laboratory must be held to the same requirements. We understand that, unfortunately, many laboratories find the easiest way to comply with the policy is not to use the logo at all. But in some cases, there is no way around a laboratory’s need to use it. For example, the policy also states:

“While inclusion of the A2LA logo on test or calibration reports is not mandatory, only test or calibration reports bearing the A2LA logo can benefit from the acceptance established through mutual recognition agreements/arrangements among accreditation bodies, and only those calibration reports bearing the A2LA logo can be confirmed to meet the A2LA Traceability Policy.”

When a laboratory wishes or is required to include the “A2LA Accredited” logo on a test or calibration report, we strongly recommend that it review the following questions related to its report format:

• Does it meet the requirements of ISO/IEC 17025, Section 5.10?
• Is the accreditation unambiguously linked only to the laboratory location identified on the    Scope of Accreditation?
• Is it clear to anyone who reviews the report which tests/calibrations are covered by the    accreditation and which are not and/or which tests/calibrations were done by the accredited    aboratory and which were subcontracted?

In essence, is there anything in the report that could imply accreditation for something other than items specifically listed on the Scope or that could imply work is accredited when it was done somewhere other than at the lab listed on the Scope?

Using the “A2LA Accredited” logo on materials (e.g., letterhead, business cards, advertisements, brochures, labels, etc.) other than test/calibration reports introduces another set of factors to consider:

• Is the logo implying personnel certification?
• Is the logo implying that a specific product or material has been certified?
• Is the logo being used in conjunction with any organizational activities or locations beyond the    Scope of Accreditation?

Common examples of this type of misuse of the “A2LA Accredited” logo include:

• Use of the logo on a very general advertisement that lists all services a company offers (e.g.,    sampling, consulting, equipment repair, etc. in addition to testing/calibration services), with    no distinction of what the accreditation does and does not encompass;

• Use of the logo in a general advertisement for a multi-location organization when only one    specific location is accredited.

As mentioned above, it is never A2LA’s intention to discourage use of the logo in promoting a laboratory’s accredited status. Such use furthers the awareness of the importance of accreditation in a very competitive marketplace. As such, if there are ever questions or doubts as to the appropriate use of the logo, A2LA welcomes submission of any proposed use for review against the Advertising Policy before precious time and resources are further expended by the laboratory. If any potential problems are noted, we will be happy to discuss them further with the lab to reach a mutually agreeable format for displaying the logo.

If you have any questions or if you wish to discuss any proposed use of the logo, please feel free to contact your A2LA Laboratory Services Officer or the A2LA Quality Manager at tbarnett@a2la.org.

Keeping Up with Standards

We received an e-mail from one of our assessors a few weeks ago saying that he has been citing an increasing number of deficiencies against ASTM E18-02, Standard Test Methods for Rockwell Hardness and Rockwell Superficial Hardness of Metallic Materials. There are new reporting requirements in this revision and laboratories are not including them on test reports. This presents an opportunity to discuss the requirements of ISO/IEC 17025 and A2LA regarding the updating of standardized test methods using this method as a specific example.

Section 5.4.2 of ISO/IEC 17025 states, “The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so.” We understand that it is not practical to rush out and get a standard as soon as it is released, so the A2LA policy is that laboratories have one year from the release date to update standards.

Many labs subscribe to the yearly editions of the ASTM volumes to ensure having the latest methods. ASTM also offers a free e-mail service with a weekly notification of new and revised standards. The service can be tailored to specific fields of interest. As part of a lab’s periodic review of documents it may want to go to the publishers’ websites and review the latest revision dates for the standards in use.

There are also commercial services available, such as, Global Engineering, ILI, NSSN, and Document Center, which provide monitoring of standards and notification of updates on a regular basis.

Having the latest standard is only half of it. A lab also needs to ensure it is implementing any changes. In the case of E18, this is fairly simple. The standard contains a summary of changes at the end of the document. In this case there are two changes regarding reporting. Section 9.1.3 has been added and requires the reporting of any lubricants on the test surface. The second is not part of section 9 on reporting. Rather it is part of section 3 on terminology illustrating the importance of reviewing all sections of a standard. Section 3.1.2.2 has been amended to require the addition of the letter “S” if a steel indenter is used or a “W” if a tungsten carbide indenter is used. For example, HRBW indicates that the testing was performed on the Rockwell B scale using a tungsten carbide ball indenter. No letter indicates a diamond indenter was used.

Unfortunately, the summary of changes does not appear to be a mandatory practice and is not included in all standards. In that case it will be necessary to compare the old standard to the new section by section. For members of the ASTM committee responsible for the standard, the changes are easy to track as they go through the balloting process but get lost once incorporated into the standard.

While A2LA may from time to time provide information on updated or new standards, it is ultimately the laboratory’s responsibility to remain current on the standards it uses.