ISO 20387 is a key standard for biobanking, which provides general requirements for the competence, impartiality, and consistent operation of biobanks. This standard is applicable to all organizations performing biobanking, including organizations that collect, store, and distribute biological materials as well as related data.

Key Aspects of ISO 20387 Accreditation for Biobanks:

1. Competence and Impartiality: The standard ensures that biobanks maintain a high level of competence in handling biological materials. It also emphasizes the importance of impartiality, meaning that all activities are conducted without any bias.
2. Quality Management System: Biobanks need to implement a quality management system (QMS) that ensures consistent processes and practices across all operations. This helps in maintaining the integrity of biological materials and data.
3. Technical Requirements: The standard outlines specific technical requirements, including the validation of methods, equipment calibration, and ensuring the traceability of biological materials.
4. Data Management: Proper handling and management of data associated with biological materials are critical. ISO 20387 ensures that biobanks have robust data management systems in place, which include data security and confidentiality measures.
5. Ethical Considerations: Ethical aspects are also addressed, including the consent of donors and the protection of sensitive information related to biological materials.
6. Accreditation Process: The accreditation process typically involves an assessment by an external body to verify that the biobank meets the requirements of ISO 20387. This can include audits of documentation, processes, and practices, as well as on-site inspections.

Benefits of ISO 20387 Accreditation:

• Increased Trust: Accreditation under ISO 20387 demonstrates that a biobank operates with high standards, which can enhance trust among stakeholders, including researchers, donors, and regulatory bodies.
• Global Recognition: ISO accreditation provides global recognition, making it easier for biobanks to collaborate internationally.
• Improved Efficiency: Implementing the standard can lead to more efficient operations, reducing errors and ensuring better management of resources.

If you’re involved in biobanking or considering accreditation, understanding the requirements of ISO 20387 is crucial for ensuring that your biobank meets international standards for quality and technical services.

WHAT IS ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND DATA COLLECTIONS TECHNICAL SERVICES

ISO 20387 accreditation focuses on ensuring that biobanks maintain high standards for the collection, storage, and management of biological materials and associated data. The standard outlines requirements for quality, competence, and consistency in biobanking operations. This accreditation is designed to ensure that biobanks are capable of providing reliable biological materials and data for research and other scientific purposes.

Key Elements of ISO 20387 Accreditation:

1. Quality Management System (QMS): Biobanks must implement a QMS that ensures consistent and reliable operations. This system helps in maintaining the quality and integrity of biological materials and data.
2. Competence of Personnel: The accreditation ensures that staff handling biological materials are adequately trained and competent in their roles, ensuring the proper management of samples.
3. Technical Requirements: This includes validation of methods, calibration of equipment, and ensuring that biological materials are handled under appropriate conditions. The goal is to maintain the viability and quality of the samples.
4. Data Management: Biobanks must have robust systems for managing the data associated with biological materials. This includes data security, traceability, and confidentiality, ensuring that the data is accurate and properly managed.
5. Ethical Considerations: Ethical aspects, such as obtaining proper consent from donors and protecting sensitive information, are a critical part of the accreditation process.
6. Impartiality and Consistency: The standard ensures that biobanks operate impartially and consistently, avoiding any biases in the collection, storage, or distribution of biological materials.

Importance of ISO 20387 Accreditation:

• Reliability: Ensures that biological materials and data from the biobank are reliable and of high quality, which is crucial for research and clinical applications.
• Global Recognition: Accreditation provides a globally recognized standard, making it easier for biobanks to collaborate with international partners.
• Trust and Transparency: Demonstrates to stakeholders that the biobank operates according to internationally recognized standards, enhancing trust and transparency.

In summary, ISO 20387 accreditation is crucial for biobanks that want to ensure the highest standards in their technical services related to biological material and data collections.

WHO IS ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND DATA COLLECTIONS TECHNICAL SERVICES

ISO 20387 accreditation for biobanks is provided by accredited certification bodies, which are organizations authorized to assess and certify that a biobank meets the standards outlined in ISO 20387. These certification bodies are themselves accredited by national or international accreditation bodies, ensuring they have the competence and authority to conduct the accreditation process.

Key Players in ISO 20387 Accreditation:

1. Biobanks: These are organizations or facilities that collect, store, and manage biological materials (such as tissue, blood, DNA, etc.) and related data for research, clinical, or other scientific purposes. Biobanks seek ISO 20387 accreditation to demonstrate their commitment to quality, competence, and consistency in their operations.
2. Accreditation Bodies: These are national or international organizations, such as the International Accreditation Forum (IAF) or national accreditation bodies (like UKAS in the UK or ANAB in the USA), that accredit certification bodies to perform ISO 20387 assessments. They ensure that the certification bodies are qualified to evaluate biobanks against ISO 20387 standards.
3. Certification Bodies: These organizations are responsible for conducting the actual assessment of biobanks to determine whether they meet the requirements of ISO 20387. Examples of certification bodies include SGS, TÜV, and Lloyd’s Register. They perform audits, evaluate documentation, and conduct site visits to verify compliance with the standard.
4. Researchers and Scientists: These stakeholders rely on the accredited biobanks for high-quality biological materials and data that meet international standards, ensuring that their research or clinical work is based on reliable resources.
5. Regulatory Authorities: Governments and regulatory bodies may require or encourage ISO 20387 accreditation to ensure that biobanks operate within legal and ethical guidelines and provide high-quality materials and data for healthcare, research, and other purposes.

Purpose of Accreditation:

• Ensuring Quality and Competence: Accreditation assures that the biobank operates with high levels of competence, quality, and consistency, which is critical for the reliability of biological materials and data.
• Compliance with Standards: Accreditation confirms that a biobank complies with the international standards set out in ISO 20387, which covers everything from technical requirements to data management and ethical considerations.
• Building Trust: Accredited biobanks can build trust with their stakeholders, including researchers, donors, and regulatory bodies, by demonstrating their commitment to quality and ethical standards.

In summary, ISO 20387 accreditation involves a network of biobanks, accreditation bodies, certification bodies, and other stakeholders working together to ensure that biological material and data collections meet rigorous technical and ethical standards.

WHEN IS ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND DATA COLLECTIONS TECHNICAL SERVICES

ISO 20387 accreditation is an ongoing process that involves periodic assessments rather than a one-time certification. Here’s a general timeline and overview of the accreditation process:

1. Preparation and Application:

• Initial Preparation: The biobank prepares by implementing a quality management system (QMS) and ensuring compliance with the ISO 20387 standards. This may involve training staff, establishing procedures, and documenting practices.
• Application: The biobank submits an application to an accredited certification body that offers ISO 20387 certification.

2. Pre-Assessment (Optional):

• Pre-Assessment Audit: Some certification bodies offer a pre-assessment audit to identify any gaps in compliance before the formal assessment. This is optional but can help in preparing for the full audit.

3. Formal Assessment:

• Document Review: The certification body reviews the biobank’s documentation to ensure that it meets the ISO 20387 requirements.
• On-Site Audit: An on-site audit is conducted by the certification body’s auditors to assess the implementation and effectiveness of the QMS and other practices. This includes inspecting facilities, interviewing staff, and reviewing records.

4. Certification Decision:

• Audit Report: After the audit, the certification body prepares a report detailing the findings. If the biobank meets the requirements, the certification body will issue an ISO 20387 certificate.
• Corrective Actions: If non-conformities are found, the biobank must address them and may need to undergo a follow-up audit.

5. Surveillance Audits:

• Periodic Surveillance: Once accredited, the biobank undergoes periodic surveillance audits (typically annually) to ensure ongoing compliance with ISO 20387. These audits are less comprehensive than the initial assessment but ensure that the biobank continues to meet the standards.

6. Re-Certification:

• Re-Certification Audit: Accreditation is generally valid for a specific period (usually three years). Before the certificate expires, the biobank must undergo a re-certification audit to renew the accreditation.

7. Continuous Improvement:

• Ongoing Compliance: The biobank must continuously maintain and improve its practices to ensure ongoing compliance with ISO 20387 and address any issues that arise between audits.

In summary, the ISO 20387 accreditation process is a continuous cycle involving initial assessment, periodic surveillance, and re-certification to ensure that biobanks consistently meet the required standards for quality and technical services.

WHERE IS ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND DATA COLLECTIONS TECHNICAL SERVICES

ISO 20387 accreditation is a global standard, and the process can be applied to biobanks in various locations around the world. Here’s where you can find ISO 20387 accreditation:

**1. Geographic Scope:

• Worldwide: ISO 20387 accreditation is available internationally. Biobanks in many countries can pursue accreditation through local or regional certification bodies that are recognized by international accreditation organizations.

**2. Certification Bodies:

• National Certification Bodies: Each country may have its own accredited certification bodies that offer ISO 20387 certification. For example, organizations like UKAS (United Kingdom Accreditation Service) in the UK, ANAB (ANSI National Accreditation Board) in the USA, or JAS-ANZ (Joint Accreditation System of Australia and New Zealand) provide certification services.
• International Certification Bodies: Several international certification bodies operate globally and provide ISO 20387 accreditation, such as SGS, TÜV SÜD, Bureau Veritas, and Lloyd’s Register.

**3. Accreditation Bodies:

• International Accreditation Forum (IAF): The IAF is a global organization that oversees the accreditation of certification bodies. Certification bodies accredited by IAF member organizations can issue ISO 20387 certificates.
• Regional Accreditation Bodies: In addition to IAF, there are regional accreditation organizations that work with certification bodies to ensure they meet international standards. Examples include the European Cooperation for Accreditation (EA) and the Asia Pacific Accreditation Cooperation (APAC).

**4. Biobanks Seeking Accreditation:

• Local Biobanks: Biobanks based in various countries, including research institutions, hospitals, and specialized biorepositories, seek ISO 20387 accreditation to enhance their credibility and ensure high standards in their operations.
• Global Biobanks: Large-scale, international biobanks that operate across multiple countries also pursue ISO 20387 accreditation to standardize their practices and facilitate global collaboration.

How to Pursue Accreditation:

• Identify Certification Bodies: Biobanks should identify accredited certification bodies that operate in their region or internationally and inquire about the process for ISO 20387 accreditation.
• Prepare for Assessment: The biobank will need to prepare by implementing a quality management system and ensuring compliance with ISO 20387 standards.
• Application and Assessment: Submit an application to the chosen certification body, undergo the necessary assessments, and address any identified non-conformities.

In summary, ISO 20387 accreditation can be pursued globally, with various certification and accreditation bodies available to assist biobanks in achieving and maintaining compliance with the standard.

HOW IS ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND DATA COLLECTIONS TECHNICAL SERVICES

ISO 20387 accreditation for biobanks is a structured process that ensures that biobanks meet high standards for quality, technical services, and data management. Here’s an overview of how the accreditation process works:

1. Preparation:

• Understanding the Standard: The biobank must familiarize itself with ISO 20387 requirements, which cover aspects like quality management, technical competence, data management, and ethical considerations.
• Implementing a Quality Management System (QMS): The biobank should establish and maintain a QMS that complies with ISO 20387 standards. This involves documenting procedures, policies, and practices related to the handling, storage, and management of biological materials and associated data.

2. Application:

• Choosing a Certification Body: The biobank selects an accredited certification body that is authorized to provide ISO 20387 certification. This body will perform the assessment and verify compliance with the standard.
• Submitting an Application: The biobank submits an application to the chosen certification body, including details about its operations, QMS, and any relevant documentation.

3. Pre-Assessment (Optional):

• Pre-Assessment Audit: Some certification bodies offer a pre-assessment audit to help identify any gaps or areas of non-compliance before the formal assessment. This step is optional but can be beneficial for preparing for the full audit.

4. Formal Assessment:

• Document Review: The certification body reviews the biobank’s documentation to ensure that it meets ISO 20387 requirements. This includes reviewing procedures, policies, and records.
• On-Site Audit: Auditors conduct an on-site assessment of the biobank. They inspect facilities, interview staff, and observe practices to evaluate compliance with ISO 20387. This audit assesses the implementation and effectiveness of the QMS and other relevant practices.

5. Certification Decision:

• Audit Report: After the assessment, the certification body prepares a report detailing the findings. If the biobank meets the requirements, the certification body issues an ISO 20387 certificate.
• Corrective Actions: If non-conformities are identified, the biobank must address them and may need to undergo a follow-up audit to verify that corrective actions have been implemented.

6. Surveillance Audits:

• Ongoing Monitoring: Accredited biobanks undergo periodic surveillance audits (typically annually) to ensure that they continue to comply with ISO 20387. These audits help to maintain the integrity and quality of the biobank’s operations.

7. Re-Certification:

• Re-Certification Process: ISO 20387 certification is generally valid for a period (usually three years). Before the certification expires, the biobank must undergo a re-certification audit to renew its accreditation. This process is similar to the initial assessment but focuses on verifying continued compliance.

8. Continuous Improvement:

• Ongoing Compliance: The biobank must continuously maintain and improve its practices to ensure ongoing compliance with ISO 20387. This involves addressing any issues that arise and adapting to changes in standards or regulations.

In summary, ISO 20387 accreditation involves a detailed process of preparation, assessment, and ongoing monitoring to ensure that biobanks maintain high standards in the management of biological materials and data. This structured approach helps to ensure quality, competence, and ethical practices in biobanking operations.

CASE STUDY ISO 20387 ACCREDITATION OF BIO BANKS TO ENSURE BIOLOGICAL MATERIAL AND DATA COLLECTIONS TECHNICAL SERVICES

Case Study: ISO 20387 Accreditation for Biobank

Background: BioCare Biobank is a mid-sized biobank located in a metropolitan area, specializing in the collection, storage, and management of human biological samples for research purposes. With a growing demand from researchers for high-quality, well-managed biological materials, BioCare decided to pursue ISO 20387 accreditation to enhance its credibility and operational standards.

Challenges Faced:

1. Standardization of Processes: BioCare had varied procedures for sample collection, storage, and data management, which needed to be standardized to meet ISO 20387 requirements.
2. Data Management: Ensuring robust data security and traceability for the large volume of samples and associated data.
3. Staff Training: Staff needed to be trained on the new procedures and standards required by ISO 20387.

Steps Taken:

1. Preparation:
   • Gap Analysis: BioCare conducted an internal gap analysis to identify areas where their current practices diverged from ISO 20387 requirements.
   • Quality Management System (QMS): Implemented a comprehensive QMS to address the identified gaps. This included developing and documenting procedures for sample handling, storage, and data management.
2. Application:
   • Certification Body Selection: BioCare selected an internationally recognized certification body, accredited by the International Accreditation Forum (IAF), to conduct the ISO 20387 assessment.
   • Submission of Application: The biobank submitted its application along with documentation of its QMS and relevant practices.
3. Pre-Assessment:
   • Pre-Assessment Audit: Opted for a pre-assessment audit to identify any remaining issues before the formal assessment. The audit revealed a few minor procedural inconsistencies which were promptly addressed.
4. Formal Assessment:
   • Document Review: The certification body reviewed BioCare’s documentation, including policies, procedures, and records related to sample management and data handling.
   • On-Site Audit: Auditors conducted an on-site visit, inspecting facilities, interviewing staff, and observing practices. They assessed compliance with ISO 20387 standards, including sample storage conditions, data security measures, and staff competencies.
5. Certification Decision:
   • Audit Report: The auditors prepared a detailed report, noting that BioCare had successfully met the ISO 20387 requirements with a few minor non-conformities related to documentation.
   • Corrective Actions: BioCare addressed the identified non-conformities by updating procedures and enhancing documentation practices. A follow-up audit confirmed that all corrective actions had been implemented.
6. Surveillance Audits:
   • Ongoing Monitoring: BioCare underwent its first surveillance audit six months after certification, during which the auditors verified that the biobank continued to adhere to ISO 20387 standards.
7. Re-Certification:
   • Three-Year Cycle: At the end of the initial three-year certification period, BioCare successfully completed the re-certification audit, demonstrating continued compliance with ISO 20387.

Results and Benefits:

1. Improved Quality and Efficiency: The implementation of standardized procedures and a robust QMS led to improved quality and efficiency in sample management and data handling.
2. Increased Credibility: ISO 20387 accreditation enhanced BioCare’s credibility and reputation among researchers and stakeholders, leading to increased trust and more research collaborations.
3. Enhanced Data Security: Improved data management systems ensured better security and traceability of biological materials and associated data.
4. Competitive Advantage: The accreditation provided BioCare with a competitive edge, distinguishing it from non-accredited biobanks and potentially attracting more high-profile research projects.

Conclusion:

The ISO 20387 accreditation process helped BioCare Biobank standardize its operations, improve quality, and enhance its reputation in the research community. By addressing initial challenges and maintaining ongoing compliance, BioCare successfully demonstrated its commitment to high standards in the management of biological materials and data.