Compliant and ISO 17025 Configured Contact Starlims for Lab Compliance
www.starlims.com
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ICAEL, ICAVL, ICANL, AIUM Let us do all the work
nationalhealthcareconsultants.org
B.S. in Clinical Laboratory Science Designed for Laboratory Technicians
www.CLSonline.UC.edu
World BioHazTec provides laboratory certification worldwide.
www.worldbiohaztec.com
Certified testing laboratory. Water metals, organics, solids, more.
www.basiclab.com
Association of accreditation bodies and other interested parties whose objective is to facilitate trade and commerce among economies in the Asia Pacific region.
www.apec-pac.org
Government institution with the task of developing standardization in Indonesia, which includes metrology, standards, testing and quality.
www.bsn.or.id
Provider of resources and programs for accreditation of testing and calibration laboratories, certification bodies operating certification of products, quality systems and personnel, inspection bodies and environmental verifiers for EMAS program...
www.cai.cz
Multisector, independent, nonprofit federation of Italian organizations for the certification of quality and company management system, each operating in its own sector of responsibility.
www.cisq.com
Provider of resources and programs for accreditation of laboratories and organizations, providing certification and inspection services.
www.cofrac.fr
National CAI accreditation body providing certification of implemented quality management systems.
www.cqs.cz
National accreditation body and public authority in the Danish Agency for Trade and Industry under the Ministry of Business and Industry.
www.danak.dk
Independent, nonprofit accreditation body responsible for the accreditation of testing and research laboratories, of certification bodies for products and of inspection bodies in the voluntary area.
www.dap.de
Working group established by the Federal Government to coordinate the accreditation and recognition of testing and calibration laboratories, certification and inspection bodies in Germany.
www.dar.bam.de
Provider of resources and programs for accreditation in Spain, sponsored by the Science and Technology Ministry.
www.enac.es
Provider of resources and programs for all European conformity assessment activities.
www.european-accreditation.org
Nonprofit organization assisting industry and commerce in the development of quality management systems and providing certification services.
www.hkqaa.org
World association of conformity assessment accreditation bodies developing a worldwide program of conformity assessment to promote the elimination of nontariff barriers to trade.
www.iaf.nu
New Zealand national authority for the accreditation of laboratories, inspection bodies and other technical competence based activities.
www.ianz.govt.nz
Private nonprofit organization establishing procedures of standardization, certification and metrology in Colombia.
www.icontec.org.co
International cooperation organization formed between the laboratory accreditation schemes operated throughout the world to enhance and facilitate the international acceptance of test data, and the elimination of technical barriers to trade.
www.ilac.org
Association of worldwide certification bodies.
www.iqnet-certification.com
Institute establishing technical norms for industries in Argentina and regulating certifications and accreditations.
www.iram.com.ar
Self-funding international organization established to act as the joint accreditation body for Australia and New Zealand for certification of management systems, products and personnel.
www.jas-anz.com.au
Federation of national committees that administers accreditation and certification, participates and contributes in international standardization activities, and develops measurement standards and technical infrastructure for standardization.
www.jisc.org
Nonprofit, private accreditation agency providing services in accreditation, international cooperation, auditor registration, research and publications.
www.kab.or.kr
Independent company whose activities focus on providing customers with solutions to their technical problems.
www.kema.nl
Provider of resources and programs for accreditation in Iceland.
www.ls.is
Body that accredits laboratories, quality system, product and personnel certification bodies, and inspection bodies on the basis of EN 45000 series of standards, the international guides on accreditation and the internal regulations of the schem...
www.nat.hu
Australia's only nationally and internationally recognized provider of laboratory accreditation.
www.nata.asn.au
Online information source for the National Association of Testing Authorities, Australia (NATA), a government-sponsored accreditation body for laboratory and testing centers in Australia.
www.ncsi.com.au
Organization that provides third-party accreditation to testing and calibration laboratories.
ts.nist.gov
Organization of the Ministry of International Trade and Industry of Japan that provides accreditation of laboratories.
www.nite.go.jp
Austrian accreditation organization.
www.oeqs.at
Intergovernmental treaty organization established to promote the global harmonization of legal metrology procedures.
www.oiml.org
National organization that supervises the system of testing and certification in the territory of Poland.
www.pcbc.gov.pl
Nonprofit, autonomous body establishing the national accreditation structure.
www.qcin.org
Organization that supervises organizations engaged in assessing the quality of products, working procedures and measuring systems for the benefit of government, business and consumer organizations.
www.rva.nl
Company providing certifications and accreditation services for laboratories and organizations.
www.sanas.co.za
Official accreditation body in Switzerland responsible for all types of accreditation in areas both legally and not legally regulated.
www.sas.admin.ch
Italian accreditation body set up by the Commission of the European Economic Community in order to permit the free circulation of goods and products within the territory of the Community without the need for repeated tests by the authorities of ...
www.sinal.it
National organization for the accreditation of certification bodies that focuses on strengthening the credibility of bodies operating in the certification sector.
www.sincert.it
Independent, nonprofit organization for the testing and certification of products, metrology and management systems.
www.siq.si
Swedish national accreditation body.
www.swedac.se
Worldwide organization for private-sector testing and calibration laboratories and for scientific consultants.
www.uili.org
UK national body responsible for assessing and accrediting the competence of organizations in the fields of calibration, measurement, testing, inspection and the certification of systems, personnel and products.
www.ukas.com
Compliant and ISO 17025 Configured Contact Starlims for Lab Compliance
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Laboratory accreditation can open the doors for your analytical business. Every year, corporations and the government spend billions of dollars on environmental and clinical monitoring, and often times only an accredited lab can gain access to those projects.
For those new to the system, lab accreditation can be a daunting process full of bureaucracy and multitasking. To get accreditation for a laboratory you need to have certain things in place. Consider this:
1. No accrediting body will consider giving laboratory accreditation without a Quality Management Plan.
2. You need Standard Operating Procedures for all of your laboratory and management functions for any type of accreditation for laboratory.
3. You should create a system for record keeping and archiving as an accredited laboratory.
Action Steps
The best contacts and resources to help you get it done
Download the requirements for the type of lab accreditation your lab wants
Depending on what kind of laboratory you have, you can pursue one of more than a dozen organizations to find the laboratory accreditation program that's right for your laboratory. Go to your accrediting body's website to get information you need for laboratory accreditation.
I recommend: The FDA offers medical laboratory accreditation for implantable medical devices. CLIA offers the leading clinical laboratory accreditation for processing human biomonitoring samples. You can pursue environmental laboratory accreditation through NELAC. Laboratories with more a more general scope might seek American Association for Laboratory Accreditation instead.
Develop the documentation you need to become an accredited lab
No matter which laboratory accreditation program you choose, you'll need to develop certain documents before you can apply to become an accredited laboratory.
I recommend: Get to work on your QMP, or Quality Management Plan. A QMP outlines your business's plan for following the requirements for accreditation for laboratory. Although your QMP should reflect the specific requirements you've found on your accrediting body's website, the EPA website has good resources to guide you through your first iteration of your QMP. Once you have your basic QMP, you'll need to fill in the blanks with specific Standard Operating Procedures, or SOPs. The SOPs should more completely address the accrediting body's concerns. You can find examples of SOPs for Good Clinical Laboratory Practices here.
Develop an electronic backup system in preparation for lab accreditation
Nearly every laboratory accreditation program requires you to have backup files of all of your laboratory data maintained offsite. This allows you to recover files, even if your laboratory suffers fire, flood, or vermin infestations.
I recommend: Data Deposit Box, MozyPro, and EVault represent only a tiny fraction of the online data backup options available. Each provides software that when installed in your computer, automatically uploads your computer's files to the server several times a day. You'll backup your files without ever having to think about it.
Find a consultant to help you wrap up your laboratory accreditation process
To prepare for lab accreditation, you simply need to prepare all of the procedural and management documents, and train your staff to understand those procedures. If you feel as if you're forgetting something, hire an accreditation consultant to give your laboratory a mock site visit and help you prepare for the real thing.
I recommend: Knapp Frazer Consulting helps laboratories gain CLIA certification. Laboratories seeking NELAC accreditation can choose from one of the NELAC recommended consultants. Consultants at FDAinspections.com can also help you prepare for your official onsite accreditation inspection.
Tips & Tactics
Helpful advice for making the most of this Guide
- • Devote some time to tailoring your QMP and SOPs to address the specific requirements of the accrediting body for which your business seeks lab accreditation.


