Journal of Biosafety and Biosecurity 1 (2019) 86–89

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Journal of Biosafety and Biosecurity

journal homepage: www.elsevier.com/locate/jobb

Research Article

Enhancing the capabilities of biosafety laboratories through the

established accreditation system: Development of the biosafety
laboratory accreditation system in China
Peijun Zhai, Rong Wang, Yongyun Zhou, Dongmei Hu, Junyan li, Yali Zhou
China National Accreditation Service for Conformity Assessment (CNAS), China

a r t i c l e i n f o a b s t r a c t

Article history: Accreditation is now widely used to attest for laboratory competence. Although accreditation was orig-
Received 27 November 2018 inally used to assess products in testing laboratories and still plays an increasingly important role in
Accepted 11 December 2018 international trade, it has been expanded to include laboratories in many social fields, including forensic
science, medicine, and animal quarantine reference. The accreditation process provides basic require-
ments for achieving global recognition for laboratory reports. This paper introduces the concept of
Keywords: accreditation and discusses the origins and development of the accreditation system in Chinese biosafety
Accreditation
laboratories. This study also reveals the important role of this system in national biosafety management
Management
Biosafety laboratories
through an examination of the 14-year development of the Chinese biosafety laboratory accreditation
system.
Ó 2019 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd. This is an open access article
under CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Accreditation worldwide an accreditation body is, by essence, not a conformity assessment

body.
1.1. The concept of accreditation During the accreditation process, an accreditation body carries
full responsibility for all accreditation activities, which must be
Accreditation is formal certification by a third party. It is the in full compliance with specific laws, regulations, standards, proto-
result of a conformity assessment performed to confirm capability cols, and agreements. The accreditation body should be equipped
in a specific field.1 Here, conformity assessment refers to the veri- with specific competence and is accountable for the impartiality
fication of whether certain products, processes, systems, personnel, of its service. Its decisions must be authentic, accurate, and valid.
or organizations comply with specific requirements. Conformity Meanwhile, accredited conformity assessment bodies are the
assessment bodies refer to institutions that engage in conformity actual undertakers of conformity assessment. They assume every
assessment services. This generally includes certification bodies, responsibility for their conformity assessment activities, which
laboratories, and inspection agencies. In short, accreditation is are to be conducted impartially and in full accordance with any
used to confirm that a conformity assessment body meets specified accreditation requirements. They should also meet any compe-
requirements and is technically capable, thus lending credibility tence specifications.3
from the government, management, general public, users, and con-
sumers about the data and results in reports issued by the confor-
mity assessment body. Accreditation is a crucial driving force by 1.2. Global accreditation system
which conformity assessment bodies can improve managerial
and technical capability. Accreditation bodies, conformity assess- Accreditation originated in 1947. There are thus over 70 years of
ment bodies, and clients are connected through their different accreditation history. Cooperative global and regional laboratory
roles and responsibilities in the conformity assessment scheme accreditation organizations were gradually established during a
(Fig. 1).2 period of surging international trade and communication during
As evident in Fig. 1, accreditation remains at the top throughout the 1990s. Today, the global accreditation system consists of the
the entire chain of the conformity assessment and verification pro- International Laboratory Accreditation Cooperation (ILAC) and
cess. It is also included in a broader conformity assessment sense; many regional organizations, including the Asia Pacific Laboratory

https://doi.org/10.1016/j.jobb.2018.12.008
2588-9338/Ó 2019 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.
This is an open access article under CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
 P. Zhai et al. / Journal of Biosafety and Biosecurity 1 (2019) 86–89 87

resents China in global accreditation affairs and is a full member of

the ILAC and APLAC.
In accordance with ISO/IEC 17011 (GB/T 27011), CNAS estab-
lished a standardized accreditation system and now conducts
accreditation activities with internationally accepted principles
and procedures. By December 31, 2017, CNAS had accredited
9543 conformity assessment bodies in a variety of industries. As
one pillar of the National Quality Infrastructure (NQI), accredita-
tion plays a progressively important role in national quality
enhancement and economic development. It also provides essen-
tial technical support for government administration. There are
currently 46 Chinese laws, regulations, and administrative orders
that either directly or indirectly accept accreditation results.
Fig. 1. Conformity assessment scheme.
CNAS has always attached great importance to exchanges and
cooperation with international organizations and counterparts. It
Accreditation Cooperation (APLAC) and the European Accreditation has signed multilateral mutual recognition agreements (MRAs)
Cooperation Organization (EA). with 101 international accreditation institutions in 97 countries
The ILAC currently consists of 120 member-accreditation bodies and economies. CNAS also sends staff to critical posts in many
across the globe. Its mission is to promote the coordination of glo- international organizations and actively participates in the devel-
bal accreditation activities and the recognition of accreditation opment and revision of various international accreditation policies
results across national borders (i.e., ‘‘tested once and accepted and requirements. It also works on some ISO standards.
everywhere”). The pillar measure to achieve that goal is the ILAC CNAS places special emphasis on science and technology; it has
Mutual Recognition Arrangement (ILAC MRA). To date, over 100 recently organized or participated in relevant research in different
accreditation bodies have signed the ILAC MRA and have been peer fields. CNAS continues to identify the evolving conformity assess-
evaluated. ment needs for national economic development by establishing
ILAC standards include the following: ISO/IEC 17025 for testing and innovating new mechanisms and measures to create a solid
and calibration laboratories (General competency requirements for technical foundation for high-quality Chinese progress. For exam-
testing and calibration laboratories), ISO 15189 for medical testing ple, CNAS established the Chinese national biosafety laboratory
laboratories (quality and competence requirements for medical accreditation system in 2004.
laboratories), ISO/IEC17020 for inspection bodies (conformity
assessment requirements for the operation of various types of bod- 2.2. The Chinese national biosafety laboratory accreditation system
ies performing inspection), ISO/IEC17043 for proficiency testing
providers (conformity assessment and general requirements for The Chinese biosafety laboratory accreditation system is a
proficiency testing), and ISO/IEC17034 for producers of reference result of the need to prevent and control major epidemics. The
materials (general competency requirements for reference mate- SARS epidemics in 2003 painfully alerted China to an urgent weak-
rial producers). ness in biosafety laboratory capacity. There was a total lack of uni-
As indicated by the list above, the ILAC accreditation system fied laboratory biosafety standards and relevant evaluation
focuses on institutional capabilities and laboratory and inspection systems in China at that time. Authorized by the Ministry of
service quality. This generally involves no direct safety or biosafety Science and Technology, CNAS organized the development of the
concerns. national laboratory biosafety standards with the cooperation of
The ILAC also specifies that accreditation bodies across the Chinese health, agricultural, and quality inspection departments.
globe should operate in accordance with ISO/IEC 17011 (confor- National Compulsory Standard GB19489-2004 ‘‘Laboratories –
mity assessment requirements for accreditation bodies that General requirements for biosafety” was officially released on
accredit conformity assessment bodies) and follow all relevant May 28, 2004. This signified the initiation of a unified and author-
policies and requirements. The ILAC indicates that all complying itative basis for the construction and evaluation of high-level bio-
bodies should use international standards to accredit both labora- safety laboratories in China.
tories and inspection bodies. The ILAC system is now the most In 2004, the State Council of China promulgated Order 424,
prestigious accreditation system for laboratories and inspection ‘‘Regulations on the Bio-safety Management of Pathogenic Microbe
bodies worldwide. ILAC accreditation is recognized by interna- Labs” (hereinafter referred to as the ‘‘Regulations”).4 According to
tional and regional organizations across the globe. its Article 20, (A)BSL-3 and (A)BSL-4 laboratories shall be required
to pass national accreditation. In essence, this constitutes compul-
sory accreditation requirements for high-level biosafety laborato-
2. Accreditation in China ries in China. Upon standardizing its laboratory accreditation
system, CNAS developed a series of accreditation documents in
2.1. The Chinese accreditation system accordance with GB19489-2004 ‘‘Laboratories – General require-
ments for biosafety.” By the end of 2004, CNAS had established a
China established its own accreditation system in the 1990s to Chinese national biosafety laboratory accreditation system that
meet the development needs of the socialist market economy. In was capable of accrediting high-level biosafety laboratories.
accordance with the Regulations of the People’s Republic of China CNAS issued the first national accreditation certificate for high-
on Certification and Accreditation and upon integration of relevant level biosafety laboratories on June 2, 2005. As of April 30, 2018,
branches from various government departments, the National Cer- after more than 10 years of conscientious efforts made in accor-
tification and Accreditation Administration (CNCA) approved the dance with the ‘‘Regulations,” CNAS had accredited a total of 80
establishment of the China National Accreditation Service for Con- biosafety laboratories, including 23 BSL-2 and 57 (A)BSL-3/4
formity Assessment (CNAS). The CNAS was then named as the sin- laboratories.
gle state authority in charge of conducting accreditation for During its biosafety laboratory accreditation years, CNAS has
conformity assessment bodies across China. Since then, CNAS rep- been active in scientific research and has organized or participated
88 P. Zhai et al. / Journal of Biosafety and Biosecurity 1 (2019) 86–89

in a number of national or provincial-level biosafety projects. With department. The next step is to obtain verification for full compli-
its continuous contribution and the constant flow of scientific out- ance with relevant standards, including GB19489-2004 ‘‘Laborato-
puts, CNAS has experienced significant progress in its technical ries – General requirements for biosafety” and GB50346
capabilities. This has brought increasing credibility to its services. ‘‘Architectural and Technical Code for Biosafety Laboratories.” Enti-
ties seeking accreditation are then required to obtain inspection
and acceptance by the construction department. After completing
3. Operation of the national biosafety laboratory accreditation
the above procedures, biosafety laboratories should establish bio-
system
safety management systems and begin trial operation according
to the accreditation requirements for biosafety laboratories. Biosaf-
3.1. Biosafety laboratory accreditation requirements
ety laboratories may submit accreditation applications to CNAS
upon self-evaluation and obtaining satisfactory results during the
The Accreditation Criteria for Laboratory Biosafety (CNAS-CL05)
trial period.
is the current document used by CNAS for biosafety laboratory
Considering the high complexity and huge investments
accreditation. It includes relevant terms from GB19489-2008 ‘‘Lab-
involved in constructing (A)BSL-4 laboratories, CNAS may initiate
oratories - General requirements for biosafety”5 and the
accreditation activities as soon as a laboratory design is complete.
Regulations.
It can then perform the accreditation review process according to
Chapter 3 specifies the requirements for laboratory risk assess-
three phases (i.e., design document review, installation and trial
ment in CNAS-CL05. This includes risk identification, analysis, con-
operation review of key protective equipment, and safety manage-
trol, and management, thus requiring laboratories to establish risk
ment system and containment capability confirmation). Accredita-
management procedures. These measures emphasize risk assess-
tion certificates may be issued upon completion of the third phase.
ment as a basis for laboratory management and requires risk con-
trol to be an integral part of laboratory biosafety management.
3.2.2. Acceptance and review
Thus, risk assessment management is laboratory management;
Once an application for laboratory accreditation meets accep-
Chapter 6 provides construction specifications for BSL2-4 biosafety
tance requirements, CNAS will issue an acceptance notice to the
laboratories, including those for floor plans, environmental param-
applicant and organize an accreditation review team.
eters, HVAC, electrical controls, and water supply and drainage sys-
The review process is divided into the document review and on-
tems. Chapter 7 deals with the establishment and operation of the
site inspection stages. Document review refers to a process of ver-
biosafety management system, including organizational, docu-
ification by which the compliance review team assesses the pro-
ment management, personnel management, activity management,
vided application materials through relevant accreditation
housekeeping, internal audit and management review, corrective
criteria. On-site inspection refers to a compliance verification by
actions, waste disposal, and emergency response issues. Chapter
which the review team inspects the floor plan, structure, facilities,
7 also incorporates relevant requirements into ISO/IEC17025 (gen-
equipment, and other hardware. The team will also review the
eral competency requirements for testing and calibration laborato-
safety management system of the applicant laboratory according
ries). Also considering the unique characteristics of biosafety
to relevant accreditation requirements.
laboratories, this offers detailed specifications on laboratory safety
plans, safety inspections, waste disposal, and incident reporting.
3.2.3. Appraisal and certification
CNAS has progressively built on its accreditation specifications
The review team inspects documented corrective actions pro-
and procedures according to identified problems and emerging
vided by the applicant laboratory and then determines whether
demands during its years of involvement in biosafety laboratory
to recommend the laboratory to CNAS for accreditation. The CNAS
accreditation. It offered implementation details for CNAS-CL05 by
Appraisal Committee will evaluate the overall compliance of each
releasing CNAS-CL05-A001 ‘‘Guidance on the Application of Labo-
recommended laboratory within the accreditation requirements
ratory Biosafety Accreditation Criteria: Evaluation of Mobile Labo-
before making its final decision. The CNAS Secretariat issues a
ratories.” It also issued CNAS-CL05-A002 ‘‘Guidance on the
notice of the accreditation decision along with an accreditation
Application of Laboratory Biosafety Accreditation Criteria: Evalua-
certificate for each successful accreditation result. Accreditation
tion of Key Protective Equipments” concerning biosafety devices
is valid for 5 years.
(e.g., biosafety cabinets, autoclaves and animal isolation equip-
ment). CNAS facilitated understanding of relevant accreditation
3.2.4. Surveillance assessment and reassessment
documents by publishing supporting documents such as the
A surveillance assessment is conducted to verify that accredited
Accreditation Guide for ABSL-2 Biosafety Laboratories (CNAS-
laboratories continue to meet requirements throughout the valid-
GL031) for the accreditation of animal biosafety laboratories.
ity period of the accreditation certificate. Accredited (A)BSL-2 and
(A)BSL-3 biosafety laboratories should receive regular surveillance
3.2. Biosafety laboratory accreditation procedures and cycles reviews before 12-month, 30-month, and 48-month periods after
obtaining accreditation. BSL-4 laboratories should receive surveil-
3.2.1. Application lance reviews every 12 months. Surveillance reviews for (A)BSL-3
An applicant for laboratory accreditation should have clear legal and (A)BSL-4 laboratories should be conducted after terminal dis-
status and the ability to assume any corresponding legal responsi- infection of the laboratory. Surveillance reviews do not require
bilities. Such an applicant can be either an independent legal entity application and are often conducted on site.
or an institution authorized by an independent legal entity. Accredited laboratories shall apply for reassessment six months
The Regulations indicate that (A)BSL-2 biosafety laboratories before the accreditation certificate expires. The reassessment pro-
should file necessary documents at the health/veterinary depart- cess employs the same cycle and procedures performed upon ini-
ment of their local municipality prior to application. (A) BSL-3 tial accreditation.
and BSL-4 laboratories should first become listed in the national
biosafety laboratory system development plan. They should then 3.2.5. Changes
clear a construction review conducted by the Ministry of Science Accredited laboratories must notify the CNAS Secretariat in a
and Technology before passing the environmental impact assess- written form if any of the following changes take place during
ment and gaining approval from the environmental protection the validity period of the accreditation certificate:
 P. Zhai et al. / Journal of Biosafety and Biosecurity 1 (2019) 86–89 89

a) Changes in laboratory name, address, or legal status 4. Summary

b) Changes in key management, technical personnel, or safety
personnel The notion of accreditation originated in the West. It has laid a
c) Changes in biological agents or laboratory activities within theoretical foundation and provided evaluation principles for the
the same hazard level (according to the List of Pathogenic mutual recognition of both quality and capability. China has
Microorganisms issued by the national health/veterinary addressed the demands of social and economic development by
department) embracing international standards and technical innovations. The
d) Changes in equipment or facilities with potential impacts on nation has further innovated its own biosafety laboratory accredi-
biosafety containment tation system, which has created a solid basis for relevant laws and
e) Other changes with potential impacts on the safety of labo- regulations while providing substantial support for administrative
ratory operation and activities approval. This has played a critical role in the national biosafety
framework. The continuous evolution of accreditation standards
Upon notification and verification of the above changes, the and requirements has resulted in significant improvements to
CNAS Secretariat may require another on-site inspection or simply the design, construction, operation, and management of Chinese
ask for any necessary documents. biosafety laboratories. Numerous accredited laboratories in China
have recently played active roles in worldwide disease control, dis-
3.3. Quality assurance for biosafety laboratory accreditation aster relief, and counterterrorism. The Chinese national biosafety
laboratory accreditation system will soon play an increasingly
3.3.1. Quality management system for institutional operation important role in the national biosafety framework.
CNAS established a standardized quality management system
that applies to quality manuals, procedures, and tables in accor- Conflict of interest
dance with GB/T 27011 (ISO/IEC 17011), ‘‘Conformity assessment
– Requirements for accreditation bodies accrediting conformity The authors declare that the research was conducted in the
assessment bodies.” The accreditation documents and procedures absence of any commercial or financial relationships that could
listed in the previous chapter are developed in accordance with be construed as a potential conflict of interest.
this document approval process. All key steps of the accreditation
service cycle are recorded and traceable to guarantee the validity Acknowledgments
and accuracy of the biosafety laboratory accreditation process.
This work was supported by grants from the Ministry of Science
3.3.2. Professional biosafety technical support committee and Technology, People’s Republic of China (the National Key
The CNAS Biosafety Professional Committee consists of more Research and Development Plan, 2016YFC 1202202).
than 40 experts from a variety of government agencies, health
and agricultural laboratory management departments, laborato-
ries, and inspection bodies. All entities have rich biosafety labora-
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