Unit Leader
Support Unit for Quality Management
Introduction
Activities
The Support Unit for Quality Management was established in
February, 2007 for the maintenance and management of the
quality of work concerning the collection, preservation and
distribution of biological resources; it also provides support
for techniques used in such work.
ISO stands for an internationally uniform standard
promulgated by the International Organization for
Standardization, and ISO9001 is a standard for Quality
Management System. Obtaining the ISO9001 certification
endorses that RIKEN BRC is an organization with high
● ISO certification and its maintenance
● Document management, and preparation of Quality Manual
and common BRC Procedure Documents on ISO
● Record keeping on ISO
● Planning and implementation of common BRC trainings on
ISO
Members
Unit leader
Tsutomu KUBOTA (2007.2~2008.3)
Hisao MOTEGI (2008.4~) (2007.6~2008.3 Chief)
[Dotted line members]
Senior Research Scientist
Motofumi SUZUKI (2007.6~)
Masako TAKASHIMA (2007.6~)
Technical staff
Ⅱ
Emi IIMURA (2007.6~)
Kanae KURITA (2007.6~)
Ayae IHARA (2007.6~)
Agency Staff
Satoko TSUZUKI (2007.6~)
Kanako ISHIKAWA (2007.6~)
Koji SASAKI (2007.6~)
Sumiko AKIMOTO (2007.6~2008.3)
Hisao MOTEGI
reliability, thus ensuring that cells and microorganisms to be
distributed from RIKEN BRC meet certain quality standards.
To improve the reliability of RIKEN BRC and promote
wider utilization of biological resources for research and
development purposes by improving the quality of biological
resources distributed by RIKEN BRC, the Support Unit
leads and takes all possible measures to ensure the QMS’s
continuing suitability, adequacy and effectiveness. QMS
stands for Quality Management System.
● Secretariat of Internal Audit
● Secretariat of Management Review
● Support for Corrective Action and Preventive Action
● Support for Quality Control
Support Unit for Quality Management
Suzuki, Tsuzuki, Akimoto, Ihara, Kurita, Ishikawa Sasaki, Motegi, Yamada(Consultant), Kubota, Iimura, Takashima
Specific Aims
1. ISO9001 certification
Cells and microorganisms as biological resources are widely
used in basic to applied research studies, and have high
demands particularly in the field of translational research. In
this field, high-quality biological resources are needed, since
the deterioration and dispersion of quality affect the accuracy
of experiments and the reliability of papers using such data.
Thus, two of RIKEN BRC’s divisions, namely, the Cell
Engineering Division and Microbe Division/Japan Collection
of Microorganisms, supplying many biological resources
to the industrial world, have applied for the certification of
“ISO9001” from the Bureau Veritas Japan Co., Ltd. (hereafter
referred to as BVJC), and received it in August, 2007 (see
Figure1). The press release on the receipt of the “ISO9001”
certification was conducted on August 29, 2007.
Figure 1. Scope of ISO certification with LOGO mark
■ORGANIZATION：RIKEN BRC CELL ENGINEERING DIVISION, and MICROBE DIVISION / JAPAN COLLECTION OF MICROORGANISMS
■STANDARDS： ISO9001:2000, JIS Q 9001:2000
■SCOPE OF SUPPLY：
COLLECTION, PRESERVATION AND DISTRIBUTION OF BIOLOGICAL RESOURCES
■INDUSTRIAL CLASSIFICATION：38. MEDICAL TREATMENT AND SOCIAL WORK
■EXPIRATION DATE： July 19, 2010 (Certificate number：378358)
Support Unit for Quality Management
RIKEN BRC Annual Report 2005
～
2007
Incidentally, the results of the ISO Certification Audit are
good as listed below (see Table 1).
QM Document Audit: nonconformity score, 0
Preliminary Audit: nonconformity score, 0
Main Audit: minor nonconformity score, 2
We immediately conducted proper corrective actions against
the minor nonconformities and filed corrective action reports
to BVJC. As a result, we succeeded in receiving the ISO
certification without any follow-up visit by BVJC.
Table 1. Summary of ISO9001 certification audit by Bureau Veritas Japan Co., Ltd.
Type of audit Date BVJC auditor Location Conclusion and findings QM document audit May 11-25, 2007 Ms. Kazue ITO BVJC The number of nonconformities raised is zero.
Preliminary audit June 12, 2007 Ms. Kazue ITO TSUKUBA campus The number of nonconformities raised is zero.
Main audits including field ones
July 18, 2007
Ms. Kazue ITO Mr. Katsuo ONODERA
TSUKUBA
campus Confirmed that BRC QMS complied with ISO and was also driven following ISO requirements.
Completed the certification in correcting the two minor nonconformities raised.
July 19, 2007 TSUKUBA campus
July 20, 2007 WAKO campus
2. Design of BRC Quality Management System
The Quality Management System is organized as follows (see
Fig. 2).
Top management: Director of BRC
Management representative and audit manager:
Deputy Director of BRC
Middle managements: Head of Cell Engineering
Division
and Head of Microbe Division
Mr. Tsutomu KUBOTA, the previous Deputy Director of
BRC, worked as “Management representative and audit
3. Control of documents and quality record
keeping
Table 2 shows the preparation status of documents and quality
Records. In addition, Table 3 shows the history of the Quality
Manual, which is the most important document of all QMS
documents.
manager on ISO” from February, 2007 through March 31,
2008. He retired from RIKEN on March 31, 2008. Dr. Kuniya
ABE, current Deputy Director of BRC, was appointed to the
vacated position on April 1, 2008.
Hierarchy Document/Record Number of items Remark
Class 1 Quality manual (QM) 1 (Also needed RIKEN approval)
Class 2 (BRC or each division)Procedure documents
BRC 7 Six documents required by ISO: including documents control, quality record keeping, internal audit, nonconformity product control, corrective action and preventive action + documents needed by this organization
Cell Engineering
Division 17
Microbe Division 17 Class 3 Standard operation procedure documents (SOPs)
Cell Engineering
Division 34 Documents needed by this organization Microbe Division 60
Class 4 Quality record
BRC 11
Records required by ISO9001 + records needed by this organization
Cell Engineering
Division 71
Microbe Division 26
Total 244 Details (documents: 136, quality records:108) Table 2. Preparation of documents and quality records
Support Unit for Quality Management
Figure 2. Quality Management System
Version Major reason for updating Issue date
1 Newly created. February 23, 2007
2 Considered the findings of the internal review (April, 2007) and 1st Internal Audit. May 10, 2007 3
Considered the findings of the ISO Certification Audit and internal review, and reflected the change in the quality policy.
October 19, 2007
4
Considered the change in the Tsukuba Institute organization and the findings of the internal review (April, 2008).
May 22, 2008 Table 3. History of updating the Quality Manual
Support Unit for Quality Management
RIKEN BRC Annual Report 2005
～
2007
4. ISO common education
Table 4 shows the summary of ISO common education in
BRC.
Course of Education Location executed Number of participants ISO Introduction Education Internal 63
ISO Normal Education External 9
ISO9000 Internal Auditor External or Internal 38 ISO9000 Certification Auditor External 3 ISO9000 Top Management
Education External 6
Total 119
Table 4. Summary of ISO common education executed in BRC (as of April 1, 2008)
Figure 3. View of ISO9001 common education in BRC
5. Internal Audits
Table 5 lists the internal audits that have been executed in
BRC QMS thus far.
Sequence number (Timing planned)
Plan
tracking # Date executed Department audited Audit team leader
Number of nonconformities raised Number of Opportunities for Improvement raised 1st (before ISO Certification Audit)
1 May 11, 2007 Director of BRC Dr. Yoshimi BENNO 0 0 2 April 20, 2007 Management representative and Support Unit Ms. Kaoru SAIJO 2 4 3 April 20, 2007 Cell Engineering Division Dr. Masako TAKASHIMA 6 1 4 April 24, 2007 Microbe Division Ms. Emi IIMURA 18 1 2nd
(before 1st ISO Surveillance Audit)
5 November 8, 2007 Director of BRC Dr. Yukio NAKAMURA 0 0 6 November 6, 2007 Management representative and Support Unit Dr. Yoshimi BENNO 0 0 7 November 7, 2007 Cell Engineering Division Dr. Motofumi SUZUKI 2 2 8 November 12, 2007 Microbe Division Dr. Kaoru FUKAMI 1 2 3rd
(before 2nd ISO Surveillance Audit)
9 June 20, 2008 Director of BRC Dr.Yukio NAKAMURA 0 1 10 June 4, 2007 Management representative and Support Unit Dr. Takashi HIROYAMA 1 2 11 May 29, 2008 Cell Engineering Division Dr. Takashi ITO 1 5 12 May 30, 2008 Microbe Division Dr. Kazuhiro SUDO 3 4
Table 5. List of internal audits executed
6. Management Reviews
Table 6 lists the management reviews that have been executed
in BRC QMS thus far. We have strongly promoted the
continual improvement of BRC QMS by executing these
management reviews appropriately.
Sequence
number Timing planned Date executed Main participants 1st After 1st Internal Audit, and before ISO Certification Audit May 21, 2007 KUBOTA, Dr. Yukio NAKAMURA, Dr. Yuichi OBATA, Mr. Tsutomu
Dr. Yoshimi BENNO 2nd After 2nd Internal Audit, and before 1st ISO Surveillance Audit December 18, 2007
Dr. Yuichi OBATA, Mr. Tsutomu KUBOTA, Dr. Yukio NAKAMURA,
Dr. Yoshimi BENNO 3rd After 3rd Internal Audit, and before 2nd ISO Surveillance Audit June 27, 2008
Dr. Yuichi OBATA, Dr. Kuniya ABE, Dr. Yukio NAKAMURA, Dr.
Yoshimi BENNO Table 6. List of management reviews executed
Support Unit for Quality Management
7. Support for Quality Control
We have just started a feasibility study of introducing the use
of Statistical Quality Control software.
8. ISO9001 Surveillance Audits
The 1st and 2nd ISO Surveillance Audits were conducted by
BVJC as scheduled.
In conclusion, we continue to maintain our ISO certification
(see Table 7).
Surveillance Audit Date Auditor
Department audited Conclusion and finding 1st
January 8, 2008 Mr. Tomoaki MIZUSHIMA (Lead
Auditor of BVJC)
Director of BRC Management representative
(Deputy director of BRC) Cell Engineering Division
Microbe Division
Although BRC QMS is still young, it is supported well by all the members and is implemented completely. No nonconformity was found in this audit. Thus, it is concluded that BRC QMS is suitably maintained. 2nd
July 18, 2008 Ms. Kazue ITO (Lead Auditor of
BVJC)
Same as above
No nonconformity finding was found in this audit. BRC QMS is effectively functioning in achieving the objectives of the organization.
Thus, continuous maintenance of the ISO9001 certification was concluded.
