Accreditation FAQs

Introduction

What is laboratory accreditation?

Laboratory accreditation is one of several mechanisms under the broader field of conformity assessment for ensuring a product's compliance with design or specification. These mechanisms include inspection, testing (a) , quality management systems and product certification .

Accreditation provides an independent, third party evaluation of a laboratory's quality system and technical competence, resulting in a formal recognition by a recognized authority. Characteristics distinguishing accreditation from other forms of conformity assessment are, that it is based on an internationally recognized documentary standard, it is performed with respect to a specific scope of accreditation conducted by qualified peer assessors, and it involves review of proficiency testing activities performed by the laboratory

(a) Calibration is considered a specialized form of testing.

What is the purpose of accreditation?

Accreditation provides an objective way of showing clients, employees, the community and the government that your laboratory is capable and competent to provide calibration and testing services. By becoming accredited, a laboratory should be able to reduce multiple external audits and assessments. For calibration laboratories, this means practicing sound metrology; for testing laboratories this means practicing sound testing procedures and supporting tests with sound and appropriate metrology. For example, accreditation may enable a laboratory to demonstrate its qualifications to perform certain types of work, to bid on specific contracts or to ensure its own work is being performed correctly.

Who may be accredited?

Laboratory accreditation is generally available to any calibration or testing laboratory from the private sector, government, company internal or independent business for which the accreditation body offers service in a given field of calibration or testing. Fields of testing that are covered may vary somewhat between accreditation bodies depending on their client base, available technical expertise and their ability to respond to changes to various laws and regulations. Typical fields of testing for which accreditation is granted are as follows:

• Acoustics and vibration
• Biological
• Calibration
• Chemical
• Construction materials
• Electrical
• Environmental
• Geotechnical
• Mechanical
• Nondestructive
• Thermal

Each field of testing is associated with a specific scope of accreditation. The scope of accreditation is a document issued to an accredited laboratory by an accreditation body that lists the test methods or services, or calibration services for which the laboratory is accredited, including test parameters, ranges and best measurement uncertainty achievable.

Why should my laboratory become accredited?

Your laboratory should become accredited if:

• Your laboratory, organization or parent company needs to export calibration or test data across international boundaries;
• Your clients operate quality systems that require their calibrations or tests to be conducted by an accredited laboratory or if you are seeking this type of client;
• A law, government regulation or contract you intend to enter into requires it;
• Your clients (internal or external), your parent organization, or your superiors are asking you to;
  • You seek to reduce the number of redundant assessments of your laboratory by clients or other second party assessors;
  • You care deeply about quality and want to do everything possible to improve your laboratory, company or organization.

What are clients of calibration and testing laboratories looking for?

Clients of calibration and testing laboratories are no different than consumers of any other commodity, product or service. Simply put, they are looking for value. Value means having their requirements competently met at a level of convenience, and at a price they are willing to pay. In other words, getting what is expected for their money.

Consumers of calibration and testing services look for a laboratory than can perform the types of tests, measurements or calibrations they are seeking, at a suitable level of uncertainty, at a cost they can afford, and to have their equipment or results returned within a suitable period of time. Other important criteria, such as requirements for measurement traceability, are often found or specified in a client's quality system. Therefore, besides the obvious technical and economic considerations, operators of testing and calibration laboratories should seek to fulfill the applicable requirements of their client's quality systems.

Who does the accrediting?

Accreditation is performed by qualified government agencies or private sector professional or trade organizations operating in accordance with appropriate international requirements such as ISO/IEC 17011 [1], having themselves been assessed for compliance with applicable documentary standards, and having established suitable mutual recognition arrangements (MRAs) with peer accreditation organizations on national and international levels.

In most countries outside the United States , laws are enacted assigning this responsibility to an agency of the national government. Within the US , accreditation may be accomplished by any individual, group or organization, including the government, having established the requisite mutual recognition arrangements, and having proven their compliance to applicable documentary standards to the satisfaction of other national and world wide accreditation bodies.

A listing of international accreditation bodies that are signatories to the ILAC MRA [3] may be found on the ILAC website, www.ilac.org.

What are the roles of the various national accreditation bodies?

Many countries around the world have one or more organizations responsible for the accreditation of their nation's laboratories. Most of these accreditation bodies have now adopted an international documentary quality standard, designated as ISO/IEC 17025 [2] as the basis for the accreditation of their country's testing and calibration laboratories.

Adoption of this international standard has helped countries implement a uniform approach to determining laboratory competence. This uniform approach allows countries with similar accreditation systems to establish agreements between themselves, based on mutual evaluation and acceptance of each other's accreditation systems.

Such agreements, called mutual recognition arrangements or MRAs, are crucial in enabling calibration and test data to be accepted between these countries. In effect, each partner in such an agreement recognizes the other partner's accredited laboratories as if they themselves had undertaken the accreditation of the other partner's laboratories.

This developing system of international mutual recognition arrangements between accreditation bodies enables accredited laboratories to achieve a form of international recognition, and allows calibration and test data accompanying exported goods to be more readily accepted on overseas markets. This effectively reduces the costs for both the manufacturer and the importers, as it reduces or eliminates the need for products to be re-calibrated re-tested in another country.Countries without viable accreditation systems can also seek to have their laboratories accredited by established accreditation systems so that their calibration and test data and associated goods can be accepted on foreign markets. These countries can also endeavor to develop their own accreditation system based on the structure and experience of these systems in other countries.

What is their organizational structure?

1) International organization of accreditation bodies

Accreditation bodies from nations with accreditation systems may apply for membership and become organized under the International Laboratory Accreditation Cooperation (ILAC). ILAC is the principle international forum for the development of laboratory accreditation practices and procedures, the promotion of laboratory accreditation as a trade facilitation tool, the assistance of developing accreditation systems, and the recognition of competent test facilities around the globe.

Recognition by ILAC is usually achieved through participation in an established regional accreditation co-operation, such as Europe (EA), Asia-Pacific (APLAC) and Inter-American (IAAC). These regional co-operations work in harmony with ILAC. (See Diagram 1) It should be noted that, as of this writing, not all of their member accreditation bodies have completed the prerequisites for recognition by signatories to the ILAC multilateral recognition arrangement, which is the key to acceptance of their accredited laboratories' data throughout the major economies of the world.

2) Organization of US national accreditation bodies

The National Cooperation for Laboratory Accreditation (NACLA) [4] is a non-profit corporation whose mission is to provide coordination, recognition and worldwide acceptance of competent laboratory accreditation in the United States . In pursuit of its mission, NACLA is supported by a number of private and public sector organizations, including the National Institute of Standards and Technology (NIST). NIST is the lead federal agency in the area of conformity assessment activities, including laboratory accreditation. In essence, NACLA is a voluntary partnership of the public and private sectors.

Who recognizes whom?

There are a number of mechanisms used to facilitate the acceptance of calibration and test data produced by laboratories across international borders. In some cases, a laboratory in one economy will buy or establish a subsidiary within the physical boundaries of another economy. Calibration and test data can then be exchanged and accepted between the parent laboratory and its subsidiary. In other cases, an agreement can be established between two or more organizations located in different economies to accept each other's test data.

Mutual acceptance of calibration and test data also results from the establishment of bilateral or multilateral arrangements between recognized authorities, such as between a recognized accreditation body and the signatories to ILAC [3]. These arrangements require each party to promote the acceptance of test results from laboratories accredited by the other party or parties. Mutual confidence in the competence of the other party's testing laboratories is vital to the success of such agreements. The principle thing that one has to look at here is who will accept the accreditation? Who are your customers, who wants the accreditation, and who do they recognize? The user of the calibration and test data produced by the accredited laboratory has the ultimate responsibility to accept the data, or not.

Mutual recognition is not the only criteria one must look at when making a decision to apply for accreditation. Companies having customers overseas or beyond national borders whose accreditation bodies have yet to establish mutual recognition agreements with the corresponding accreditation bodies of those nations, may wish to consider dual or multiple accreditation of their supporting laboratories until such time as those arrangements are in place.

For a listing of current MRAs and their signatories refer to the websites of the various cooperations or additional information may be obtained by visiting the websites of the accreditation bodies and/or the regional accreditation organizations.

What companies, institutions or government agencies recognize accreditation?

The decision to require suppliers of calibration or testing services to be accredited rests with the company, institution or agency seeking the service. When specified in a purchase order or contract, this requirement is generally based on a cost (or risk) benefit decision on the part of the purchaser of the service. The same company, institution or agency may require it for testing one type of product and not for another.

Laboratory accreditation is only one of a complex set of possible conformity assessment requirements or tools. Most companies and agencies use a mix of such tools in their requirements. Therefore, laboratories should determine the regulatory requirements (if any) that may impact the product testing that will be conducted by the laboratory, and conduct market research of their customer base to determine if accreditation is required .

What specifically is meant by certification, registration and accreditation?

The process of determining whether products, processes, systems, or people meet specified requirements is called conformity assessment . Certification, registration, and accreditation are three separate and distinct conformity-assessment schemes to describe the quality and reliability of what they do. The processes can be conducted by the supplier (called first party ), purchaser (called second party ), or independent organization (called third party ). The following definitions are recognized:

Certification : Procedure by which a third party gives written assurance that a product, process or service conforms to specified requirements.

Registration : Procedure by which a body indicates relevant characteristics of a product, process or service, or particulars of a body or person, in an appropriate, publicly available list.

Accreditation : Procedure by which an authorative body gives formal recognition that a body or person is competent to carry out specific tests.

What is the difference between certification, registration and accreditation?

Product certification : Applies to an organization whose product or service can be defined in terms of a standard or specification. Certification is performed by a third party qualified to declare that the product or service meets the specification. However, laboratories are not “certified” to ISO/IEC 17025, because certification does not entail assessment of the laboratory's quality system (and because certification bodies are not otherwisr qualified to do so).

Self-certification : Applies to any organization whose product or service can be defined in terms of a standard or specification. Self-certification is achieved when the organization declares their product or service meets the specification. For example, any laboratory may self-declare that its calibrations or tests conform to ISO/IEC 17025. Whether they actually do is up to the client to accept or otherwise determine.

Quality system registration : Entails having the quality system assessed by third-party quality professionals without regard to the product or service produced by the organization. It included registration in a list of similarly qualified organizations by a nationally recognized body commonly referred to as a registrar.

Laboratory accreditation : Entails having the quality system assessed, and the test methods and conformance of the end product evaluated, by a technically qualified third party. It introduces recognition by an internationally recognized accreditation body.

References:

[1] ISO/IEC 17011:2004, “Conformity Assessment – General requirements for accreditation bodies accrediting conformity assessment bodies;” ISO, Geneva , Switzerland .

[2] ISO/IEC 17025:2005, “General requirements for the competence of testing and calibration laboratories;” ISO, Geneva , Switzerland .

[3] “ILAC Mutual Recognition Arrangement (Arrangement): Terms of Reference and Composition of the Arrangement Management Committee;” ILAC Web site: www.ilac.org .

[4] National Cooperation for Laboratory Accreditation (NACLA), NIST-NACLA Memorandum of Understanding (MOU); NACLA Web site: www.nacla.net.