IAF/ISO Joint Communiqué – Climate Change Considerations in Management Systems Standards

On 22 February 2024, the International Accreditation Forum (IAF) and the International Organization for Standardization (ISO) issued a joint communiqué announcing the addition of Climate Action Amendments to both new and existing ISO management systems standards, in support of the ISO London Declaration.

The aim is to ensure that climate change issues are evaluated by organizations in the context of management system effectiveness, alongside all other relevant issues. These new requirements emphasize that climate change must be addressed in the design, implementation, and continual improvement of management systems.

Key Amendments

These changes apply to all Management System Standards (MSS) listed below and are included in Chapters 4.1 and 4.2 of the High-Level Structure (HLS):

• Chapter 4.1: “The organization shall determine whether climate change is a relevant issue.”

• Chapter 4.2: “Note: Relevant interested parties can have requirements related to climate change.”

What Organizations Must Consider

Organizations must determine whether climate change is a relevant factor and, if so, include it in their risk evaluation and management system scope. This ensures climate change is not overlooked but integrated into operational and strategic decision-making.

Impact on Existing Certificates

There is no need for a new or revised certificate because:

• The publication year of the MS standard remains unchanged.

• The scope of certification is not affected.

• The change has no significant impact on the effectiveness of the certified management system.

• Actions required will be similar to other contextual updates already managed within existing systems.

Audit Evidence Requirements

During audits, evidence will include:

• Climate change considerations within the context of the organization.

• Updates in risk assessments and interested parties’ requirements.

• Relevant documented information integrated into the existing management system.

Auditors will verify compliance with the amended requirements and evaluate their relevance to the standard being assessed.

Applicable Standards

This amendment applies to a wide range of ISO management system standards, including but not limited to:

Source:

IAF and ISO Publish Joint Communiqué – 23 February 2024

A Complete Guide to ISO 31000 Risk Management Certification

In today’s rapidly evolving global business landscape, organizations face a wide range of uncertainties that can significantly impact their success. From economic fluctuations to technological disruptions and geopolitical tensions, the need for effective risk management has never been greater.

ISO 31000 Risk Management Certification, a globally recognized international standard, provides a framework that enables organizations to manage risks proactively and seize opportunities. This guide explores the significance, principles, and certification process for ISO 31000.

Understanding ISO 31000 Risk Management

ISO 31000 is a set of guidelines developed by the International Organization for Standardization (ISO) to help organizations establish, implement, and continually improve their risk management processes.

First introduced in 2009, ISO 31000 serves as a roadmap for organizations seeking to navigate the uncertainties inherent in their operations while ensuring sustainable growth.

The Significance of ISO 31000

• Holistic Risk Management – ISO 31000 promotes an integrated approach, encouraging organizations to proactively address both the negative and positive aspects of risk.

• Enhanced Decision-Making – Informed decisions are made possible through a deeper understanding of risks and their potential impacts.

• Improved Stakeholder Confidence – Certification demonstrates a strong commitment to risk management, increasing trust among customers, investors, and regulators.

• Cost Savings – Proactive risk control helps avoid unnecessary losses, leading to significant cost savings.

• Increased Resilience – Organizations adopting ISO 31000 are better prepared to respond to disruptions and adapt to changing circumstances.

Key Principles of ISO 31000

• Integration with Processes – Risk management is embedded into governance, strategic planning, and operational processes.

• Customization – Risk management strategies are tailored to an organization’s objectives, culture, and operating environment.

• Continuous Improvement – Regular reviews ensure that the risk management framework evolves alongside emerging risks and opportunities.

ISO 31000 Risk Management Framework

1. Establishing the Context – Define scope, objectives, and internal/external factors that influence risk.

2. Risk Identification – Recognize potential risks and opportunities from both internal and external sources.

3. Risk Assessment – Evaluate the likelihood and impact of risks to prioritize actions.

4. Risk Treatment – Decide whether to mitigate, transfer, accept, or avoid risks based on tolerance levels.

5. Monitoring and Review – Continuously evaluate the effectiveness of controls and adapt strategies as needed.

The Certification Process for ISO 31000

1. Gap Analysis – Compare existing practices with ISO 31000 requirements to identify improvement areas.

2. Documentation & Implementation – Develop policies, procedures, and train staff to embed risk management practices.

3. Internal Audit – Identify non-conformities and address them before the external audit.

4. External Certification Audit – Conducted by an accredited body to confirm compliance.

5. Ongoing Improvement – Maintain compliance through periodic reviews and updates.

Conclusion

ISO 31000 equips organizations with a proactive and structured risk management approach, enabling them to not only survive but thrive in uncertain environments.

At TUV Austria Bureau of Inspection & Certification (Pvt.) Ltd., we specialize in providing ISO 31000 certification in Pakistan, ensuring that organizations meet international standards and strengthen their reputation. Our expert team guides clients throughout the certification journey, offering tailored solutions for robust risk management.

In addition to ISO 31000 certification, we also offer:

• ISO 9001 Quality Management

• ISO 14001 Environmental Management

• ISO 45001 Occupational Health & Safety

• ISO 27001 Information Security Management

• Third-Party Inspection Services

• Technical Training

The Power of ISO 28000:2007 in Supply Chain Security Systems

In today’s rapidly evolving global marketplace, where supply chains span continents, the need for robust security measures has never been more critical. ISO 28000:2007 certification serves as a beacon for businesses striving for secure and resilient operations.

The Supply Chain Security Management System (SCSMS) is not just a standard — it is a strategic ally that empowers organizations to navigate supply chain complexities with confidence.

Let’s explore how ISO 28000:2007 certification can be a game-changer for businesses seeking not only compliance but also a true competitive advantage.

Guardians of Resilience

In an era marked by disruptions — from natural disasters to geopolitical tensions and global health crises — businesses must fortify themselves against uncertainty.

ISO 28000 equips organizations with the tools to identify vulnerabilities and implement preventive measures that mitigate risks. By proactively addressing potential threats, companies can navigate uncertainties with confidence, ensuring a strong and timely response to unexpected challenges.

Beyond Compliance – A Global Passport

The interconnectedness of modern markets demands a standardized security approach that transcends borders. ISO 28000:2007 acts as a global passport, demonstrating commitment to supply chain security standards recognized internationally.

This certification goes beyond mere compliance, opening doors to new markets, enhancing credibility, and building trust worldwide. In today’s environment, where transparency and responsibility are valued, ISO 28000:2007 is a symbol of ethical and secure business practices.

Safety Net for Operational Efficiency

Efficiency is the lifeblood of any supply chain. ISO 28000 helps streamline security processes, ensuring compliance while boosting operational performance.

Benefits include:

• Faster and more reliable supply chain operations

• Reduced delays and bottlenecks

• Optimized resource utilization

• Lower operational costs

Customer Confidence as a Competitive Edge

Informed customers demand security and reliability. ISO 28000:2007 certification builds trust by assuring clients that their products and sensitive data are handled with the highest integrity.

This trust becomes a competitive advantage, attracting partners and customers who prioritize secure, dependable supply chain relationships.

Mitigating Financial Risks

While implementing ISO 28000:2007 requires an initial investment, the long-term benefits far outweigh the costs. The standard helps prevent theft, tampering, and security breaches, thereby avoiding financial losses and reputational harm.

Certified organizations may also enjoy reduced insurance premiums, as insurers recognize the lower risk profile associated with compliance.

Fostering a Culture of Continuous Improvement

ISO 28000 promotes a proactive security culture, where regular assessments and audits drive ongoing enhancements.

This adaptability ensures that the Supply Chain Security Management System evolves alongside market changes, keeping businesses ahead of emerging threats.

Elevating the Brand

Certification is more than proof of compliance — it’s a statement of excellence. An ISO 28000:2007 certified brand signals reliability, responsibility, and a strong commitment to security.

In a world where trust is a currency, this certification enhances brand reputation, strengthens stakeholder relationships, and positions the organization as a leader in supply chain security.

Conclusion

ISO 28000:2007 is not merely a set of guidelines; it is a transformative framework reshaping the landscape of supply chain security. It empowers organizations to go beyond compliance, proactively addressing global challenges with resilience and foresight.

By embracing this standard, businesses protect their operations, enhance market opportunities, and position themselves as trusted leaders in an unpredictable world.

Related Services

In addition to ISO 28000 certification, TUV Austria BIC offers:

• ISO 9001 Quality Management Systems

• ISO 27001 Information Security Management

• Risk-Based Inspection Services

• Third-Party Inspection Services

Complete Guide to ISO 13485 Certification for Medical Devices

ISO 13485 Certification for Quality Management Systems (QMS) holds immense significance for medical device manufacturers, as it ensures compliance with stringent quality management standards specific to the industry.

The certification process involves several key steps:

Understanding ISO 13485:2016 Quality Management for Medical Devices

1. Familiarization

Organizations must fully understand the standard’s requirements, which cover quality management systems tailored for medical devices.

2. Preparation

• Gap Analysis: Assess current processes against ISO 13485 requirements to identify gaps.

• Documentation: Develop and document a quality management system compliant with ISO 13485 standards.

• Training: Train employees on ISO 13485 requirements and effective implementation strategies.

3. Implementation

• Process Implementation: Integrate necessary changes across all departments and processes to meet the standard’s requirements.

• Internal Audits: Conduct internal audits to evaluate the QMS’s effectiveness and identify areas for improvement.

4. Certification Process

• Selection of Certification Body: Choose an accredited certification body to conduct the audit.

• Audit – Documentation Review: The certification body reviews documentation to verify compliance.

• Audit – On-Site Assessment: Evaluates QMS implementation in practice, interviews personnel, and checks process compliance.

• Audit Findings: The certification body provides findings and recommends improvements if required.

• Certification Decision: Based on findings, the certification body decides whether to grant certification.

• Certification Issuance: Upon compliance, ISO 13485 certification is issued, followed by scheduled surveillance audits.

5. Maintenance and Surveillance

• Surveillance Audits: Periodic audits ensure ongoing compliance.

• Continuous Improvement: Regularly assess and improve the QMS to maintain compliance and boost efficiency.

Benefits of ISO 13485 Certification for Medical Devices QMS

ISO 13485:2016 certification offers a range of benefits for organizations involved in the design, development, production, and distribution of medical devices.

1. Regulatory Compliance

• Legal Requirement: Many countries mandate ISO 13485 as a prerequisite for marketing medical devices.

• Market Access: Demonstrates adherence to regulatory requirements, facilitating entry into global markets.

2. Quality Management System (QMS)

• Enhanced Quality: Ensures consistent product quality and safety, minimizing risks.

• Continuous Improvement: Promotes a process-oriented approach for ongoing enhancement.

3. Customer Confidence & Market Access

• Customer Assurance: Shows commitment to product safety and efficacy.

• Global Recognition: Enables entry into international markets by aligning with global standards.

4. Risk Management

• Risk Mitigation: Adopts a risk-based approach for all stages of product life cycle.

• Traceability: Facilitates quick and effective resolution of product issues.

5. Improved Efficiency & Cost Savings

• Standardized Processes: Reduce errors and inefficiencies.

• Cost Reduction: Streamlined operations lower manufacturing and operational costs.

6. Competitive Advantage

• Market Differentiation: Sets your business apart in competitive tenders.

• Eligibility for Contracts: Many contracts require ISO 13485 certification.

7. Post-Market Surveillance & Compliance

• Ongoing Evaluation: Ensures consistent product safety and performance.

• Compliance Maintenance: Prevents penalties by meeting evolving regulatory demands.

8. Stakeholder Confidence

• Investor & Partner Trust: Strengthens relationships with stakeholders.

• Employee Morale: Encourages a strong quality-focused culture.

Conclusion

ISO 13485:2016 Certification is a cornerstone for ensuring the safety, quality, and effectiveness of medical devices. It provides a structured framework for implementing and maintaining a robust Quality Management System, enhancing customer confidence, market access, and operational efficiency in the medical device industry.

Relevant Services You May Be Interested In:

• ISO 9001 Certification – Quality Management Systems

• ISO 27001 Certification – Information Security Management Systems

• ISO 45001 Certification – Occupational Health & Safety

• Supplier Evaluation & Audit Services