2. KRIBB is the Largest Government-funded Research
Institute for Biotechnology Research in Korea.
In accordance with the “Law on Establishment,
Management and Promotion of Government-supported
Research Institutes in the Science and Technology Sector”
2
Mission of KRIBB is to lead BT researches in KOREA
·R&D activities in bioscience and biotechnology
·Infrastructures to support research on bioscience
Fusion BT Pharma Green Bio National Agenda
Infrastructures
3. Korean Collection for Type Cultures (KCTC)
Korean Collection for Type Cultures (KCTC)
Korea Research Institute of Bioscience and Biotechnology (KRIBB)
Jeonbuk Branch Institute
KCTC/BRC (2016)
4. 4
KCTC Functions
Collection and preservation of biological resources,
their distribution to industries, academia and institutes
Development of core technologies for
valuable bio-resources
Construction of local and international networks of
biological resources and their related information
5. 5
KCTC History…1985~
1985.02. Obtained official approval from the MOST(Ministry of Science &
Technology) as a gene bank node
1985.02. Became a member of the WFCC (World Federation of Culture
Collections)
1986.01. Became a member of the WDCM (World Data Center for
Microorganisms)
1990.06. Designated as an International Depositary Authority from the WIPO
(World Intellectual Property Organization) based on the Budapest Treaty
2004.02. Obtained an ISO 9001:2000 certificate for Quality Management
System
2008.08. Designated as the National Repository for Bio-research Products
from the national R&D projects by the MSIT (Ministry of Science & ICT)
2013.03. Biological Resource Center, Division of Biological Infrastructure
2016.01. Moved to Jeonbuk branch Institute of KRIBB
16. ISO 9001(Quality Management Systems)
The ISO 9000 family addresses various aspects of quality
management and contains some of ISO’s best known standards.
The standards provide guidance and tools for companies and
organizations who want to ensure that their products and services
consistently meet customer’s requirements, and that quality is
consistently improved.
18. ISO 9001(Quality Management Systems)_KCTC
•The process for deposit, preservation and distribution of
biological resources(ISO 9001:2000, 2004. 2)
19. Quality Manual
Regulation
1. Quality management system operation
2. Quality records management
3. Quality document management
4. Education & training
5. Internal examination
6. Identification & traceability management
7. Corrective and preventive action
8. Nonconforming biological resource management
9. Equipment management
10. Media and reagent management
11. Computer program management
Procedure
1. Deposit of biological resources
2. Preservation of biological resources
3. Distribution of biological resources
4. Claim of biological resources
5. Deposit of patent strains
6. Distribution of patent strains
7. Certification of viability of patent strains
8. Change of name of patent strains
9. Deposit of bioproduct
10. Preservation of bioproduct
11. Distribution of bioproduct
12. Claim of bioproduct
21. Regulation
1. Quality management system operation
2. Quality records management
3. Quality document management
4. Education & training
5. Internal examination
6. Identification & traceability management
7. Corrective and preventive action
8. Nonconforming biological resource management
9. Equipment management
10. Media and reagent management
11. Computer program management
22. 1. Quality Management System Operation
1. Scope of application
2. Purpose
3. Definition of Terms
3.1. Quality Management System
3.2. Quality Management System Document
3.2.1. Quality Manual, 3.2.2. Regulations,
3.2.3. procedure
3.3. Managed document
3.4. Unmanaged document
4. Responsibility and authority
4.1. Director
4.2. Curators
5. Management Procedures
5.1. Basis of management
5.2. Relationship between quality policy and
quality management system
6. Management of documents
6.1. Document system
6.2. Managed Documents
6.3. Document classification system
(numbering method)
6.4. Enactment, revision and abolition of
documents
6.5. Issuance and distribution of quality
management system documents
6.6. Document Management
6.7. External quality document
6.8. Notice and compliance of quality
documents
7. Review and evaluation of quality
management system
7.1. Management review
7.2. Review input
7.3. Output of management review
7.4. Management review result processing
and post-processing
7.5. Internal examination
8. Record management
9. Related documents
10. Attachment: Related documents
23. 2. Quality records management
1. Scope of application
2. Purpose
3. Definition of Terms
4. Responsibility and authority
4.1. Curators
4.2. Persons in charge
5. Procedure
5.1. Identification and collection of quality records
5.2. Filing
5.3. Search
5.4. Storage and protection of quality records
5.5. Retention and disposition of quality records
6. Other
7. Records management
8. Related documents
24. 3. Quality document management
1. Scope of application
2. Purpose
3. Responsibility and authority
3.1. Director
3.2. Curators
4. Procedure
5. Records management
6. Related documents
25. 4. Education & training
1. Scope of application
2. Purpose
3. Responsibility and authority
3.1. Director
3.2. Curators
4. Internal lecturer qualifications
5. Type of education and training
5.1. Internal training, 5.2. External education
6. Procedure
6.1. Establishment of educational plan
6.2. Education
6.2.1. Internal training, 6.2.2. External training, 6.2.3. Training for new employees
6.3. Management of educational history
6.4. Evaluation and report of results
7. Eligibility
7.1. Eligibility criteria, 7.2. How to qualify
8. Records management
9. Related documents
26. 5. Internal examination
1. Scope of application
2. Purpose
3. Definition of Terms
3.1. Quality inspection
3.2. Objective evidence
3.3. Nonconforming
3.4. Auditor
4. Responsibility and authority
4.1. Director
4.2. Audit Team Leader
4.3. Auditor
4.4. Curators(Examineee)
5. Type of examination
5.1. Regular examination
5.2. Temporary examination
6. Auditor qualifications
7. Procedure
7.1. Establish a review plan
7.2. Preparation of execution of examination
7.3. Organization of the audit team
7.4. Planning of schedule
7.5. Preparation for examination
7.6. Execution of examination
7.7. Report of examination result
7.8. Subsequent screening activities
7.9. Reflecting quality management system procedures
8. Records management
9. Related documents
27. 6. Identification & traceability management
1. Scope of application
2. Purpose
3. Responsibility and authority
3.1. Director
3.2. Curators
4. Procedure
5. Identification number assignment method
6. Identification and history management
7. Traceability management
7.1. collection
7.2. Preservation and distribution
8. Records management
9. Related documents
28. 7. Corrective and preventive action
1. Scope of application
2. Purpose
3. Definition of Terms
3.1. Corrective action
3.2. Precautions
4. Responsibility and authority
3.1. Director
3.2. Curators
5. Target of corrective and preventive action
5.1. Corrective action
5.2. Precautions
6. Procedure
7. Records management
8. Related documents
29. 8. Nonconforming biological resource management
1. Scope of application
2. Purpose
3. Definition of Terms
3.1. Nonconforming product
3.2. Special
3.3. return
3.4. Disposal
4. Responsibility and authority
3.1. Curators
5. Criteria for nonconforming products
6. Procedures for handling nonconforming products
6.1. Identification and Isolation
6.2. Notification and handling of nonconforming contents
6.3. How to dispose of nonconforming products
6.4. Keep records and measures for nonconforming products
7. Related documents
30. 9. Equipment management
1. Scope of application
2. Purpose
3. Responsibility and authority
3.1. Director
3.2. Curators
3.3. Persons in charge
4. Equipment history card
5. Equipment management procedures
6. Records management
7. Related documents
31. 10. Media and reagent management
1. Scope of application
2. Purpose
3. Responsibility and authority
3.1. Curators
3.2. Persons in charge
4. Procedure
5. Records management
6. Related documents
32. 11. Computer program management
1. Scope of application
2. Purpose
3. Responsibility and authority
3.1. Director
3.2. Curators
3.3. Persons in charge
4. Procedure
5. Records management
6. Related documents
34. Procedure
1. Deposit of biological resources
2. Preservation of biological resources
3. Distribution of biological resources
4. Claim of biological resources
5. Deposit of patent strains
6. Distribution of patent strains
7. Certification of viability of patent strains
8. Change of name of patent strains
9. Deposit of bioproduct
10. Preservation of bioproduct
11. Distribution of bioproduct
12. Claim of bioproduct
35. 1. Deposit of biological resources
• Receive the strain with
application form
• Check the deposited strain
• Check viability and purity
• Assign the accession number
• Preservation
• Issue the certification
36. 2. Preservation of biological resources
• Cultivate the strain
• Check viability and purity
• Preservation
37. 3. Distribution of biological resources
• Receive the order
• Confirm the payment
• Prepare the distribution
• Send the strain
38. 4. Claim of biological resource
• Receive the claim
• Review the claim
• Check the strain
• Confirm the strain
• Resend the strain
39. 5. Deposit of patent strains
• Receive the strain with
application form
• Confirm the payment
• Check the deposited strain
• Check viability and purity
• Assign the accession number
• Preservation
• Issue the certification
40. 6. Distribution of patent strains
• Receive the order
• Confirm the payment
• Prepare the distribution
• Send the strain
41. 7. Certification of viability of patent strain
• Receive the order or strain
• Confirm the payment
• Check viability and purity
• Issue the certification
42. 8. Change of name of patent strain
• Receive the request
• Confirm the payment
• Change the name
• Issue the certification
43. 9. Deposit of bioproduct
• Receive the strain with
application form
• Check the deposited strain
• Check viability and purity
• Assign the accession number
• Preservation
• Issue the certification
44. 10. Preservation of bioproduct
• Cultivate the strain
• Check viability and purity
• Preservation
45. 11. Distribution of bioproduct
• Receive the order
• Confirm the payment
• Prepare the distribution
• Send the strain
46. 12. Claim of bioproduct
• Receive the claim
• Review the claim
• Check the strain
• Confirm the strain
• Resend the strain
47. ISO 20387 ISO 9001_KCTC OECD Best Practice
Guidelines(General best
practice guidelines for all
BRCs)
General requirements General requirements including
general, impartiality and
confidentiality
Quality Management System
Operation Regulations
Requirements of the BRC
Structural requirements Legal responsibility and
supervision
Quality Management System
Operation Regulations
Precondition
Resource Requirements Personnel, facilities / dedicated
areas, equipment, information
systems and support services
Quality records management
regulations, quality document
management regulations,
education and training regulations
Equipment use, calibration, test
operation and maintenance
records
Process requirements Collection of biological resources
and related information,
preservation management and
sale, quality control, validation and
verification, reporting, complaint
handling
regulations, corrective and
preventive action regulations,
inadequate biological resources
and biological material
management regulations,
preservation equipment operation
standards, medium and reagent
management regulations,
biological resources and
biological materials computer
program operating regulations
Document management, data and
life information, preparation of
badges and reagents, donation of
biological resources, preservation
and maintenance, supply, quality
audit and quality inspection
Quality management
system requirements
Bioresource Bank quality
management system minimum
requirements (documented
information on quality
management system, management
of quality management system
documents, records management,
measures to deal with risks and
opportunities, improvement,
corrective action on
nonconformity results, internal
audit , Quality control review),
Connected with ISO 9001
Quality management system
operating regulations and
procedures
Biosafety Best Practices
Guidelines, Biosafety Risk
Management Guidelines,
Approaches to Domestic
Certification
