ISO 9001:2015 Certificate Consultant

Introduction

ISO 9001:2015 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems. Organizations of all types and sizes find that using the ISO 9001 standard helps them:

• Organize processes
• Improve the efficiency of processes
• Continually improve

All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.

We provide authoritative, comprehensive and value-added consulting, training and certification services for either new certification for ISO 9001:2015 or helping organizations migrate from ISO 9001:2015 standard.

We provide awareness training, implementation training, internal auditor training, lead auditor training to impart a required level of skill, knowledge, and competence for the employees. We also provide a complete set of consulting services to help your organization identify requirements as per ISO 9001:2015 new standard and map the compliance requirements as per ISO 9001 revision to your current processes.

Start your ISO 9001:2015 certification journey today in the most effective manner. Contact at preteshbiswas@gmail.com to get started with ISO 9001 revision, ISO 9001 up-gradation and ISO 9001:2015 certification.

ADDENDUM TO ISO 9001:2015 in January 2024

This addendum takes into account the notion of climate change and concerns clauses 4.1 and 4.2, i.e. the understanding of the organization and its context, as well as the needs and expectations of stakeholders. Non-prescriptive, these changes only require taking into account global warming as a potential problem or as a subject of possible requirements of said stakeholders. ISO has published an amendment to clause 4.1 of ISO 9001 (ISO 9001:2015/ Amd1:2024), along with all other management system standards, adding the requirement for the organisation to determine if climate change is a relevant issue (when determining the issues relevant to its purpose and that affects its ability to achieve the intended results of its management system). The amendment also adds a note to clause 4.2 of the standard, indicating that relevant interested parties may have climate change-related requirements. This change takes effect immediately, and it would appear from the International Accreditation Forum(IAF)’s decision log that there will be no lead-in period for the change for certified organisations, certification bodies(CBs) and accreditation bodies (ABs) and that certification bodies can raise findings about the new requirement with immediate effect. These amendments should not be confused with the current ongoing revision of ISO 9001 which is expected to be published in around 2 years and would then be subject to the usual 3-year transition period. So, what is the real-world impact of this amendment for certified organisations? In a nutshell, you need to be able to demonstrate to your third party that you have specifically determined whether or not climate change is an issue relevant to your management system or or not. There is no actual requirement to document the issues you have determined to be relevant, although many organisations choose to do so. You could include it in your next management review, or schedule an additional review to make this assessment. IAF have indicated that ABs expect to ensure that CBs have assessed how the decision has been made. If it is a relevant issue, or you identify that interested parties do have requirements you would then need to demonstrate how the quality management system is addressing them, if you haven’t done so already.

how could climate change relate to a Quality management system?

Climate change can relate to a Quality Management System (QMS) in several ways, impacting both internal processes and external factors that influence product and service quality. Here are some key ways in which climate change can intersect with a QMS:

1. Resource Management: Climate change can affect the availability and quality of resources used in production processes, such as water, energy, and raw materials. A QMS can incorporate measures to monitor and optimize resource usage to mitigate the impact of climate-related resource constraints or fluctuations.
2. Supply Chain Management: Climate change can disrupt supply chains through extreme weather events, changes in agricultural productivity, transportation disruptions, and shifts in demand patterns. A robust QMS can include risk management processes to identify, assess, and address climate-related risks in the supply chain, ensuring continuity of supply and minimizing disruptions to product quality and delivery schedules.
3. Product Lifecycle Assessment: Climate change considerations can be integrated into product lifecycle assessments within the QMS, evaluating the environmental impacts of products from raw material extraction to end-of-life disposal or recycling. This can involve assessing carbon footprints, energy consumption, emissions, and waste generation associated with products and identifying opportunities for reducing environmental impacts throughout their lifecycle.
4. Regulatory Compliance: Climate change-related regulations, standards, and reporting requirements can impact product design, manufacturing processes, and business operations. A QMS can ensure compliance with relevant environmental regulations and standards, such as emissions limits, energy efficiency requirements, waste management regulations, and carbon reporting obligations.
5. Customer Expectations: Increasingly, customers are demanding environmentally sustainable products and services, driving businesses to adopt greener practices. A QMS can help organizations understand and meet customer expectations related to climate change by incorporating environmental criteria into product specifications, quality criteria, and customer satisfaction metrics.
6. Risk Management: Climate change poses various risks to organizations, including physical risks (e.g., extreme weather events, supply chain disruptions), regulatory risks (e.g., compliance obligations, carbon pricing), reputational risks (e.g., negative public perception, brand damage), and financial risks (e.g., increased costs, market volatility). A QMS can include risk assessment and mitigation processes to proactively identify, evaluate, and manage climate-related risks to ensure business continuity and protect product quality and brand reputation.
7. Continuous Improvement: Climate change adaptation and mitigation efforts require ongoing monitoring, evaluation, and improvement. A QMS facilitates continuous improvement by establishing processes for setting environmental objectives, monitoring performance indicators, conducting audits and reviews, and implementing corrective and preventive actions to enhance environmental sustainability and resilience in response to climate change.

In summary, climate change can significantly impact the effectiveness of a Quality Management System by influencing resource availability, supply chain resilience, regulatory compliance, customer expectations, risk management, and continuous improvement efforts. Integrating climate change considerations into a QMS helps organizations adapt to environmental challenges, enhance product quality, and ensure long-term business sustainability.

ISO 9001:2015/Amd 1:2024(en) Quality management systems — Requirements — AMENDMENT 1: Climate action changes

4.1

Add the following sentence at the end of the subclause:

The organization shall determine whether climate change is a relevant issue.

4.2

Add the following note at the end of the subclause:

NOTE Relevant interested parties can have requirements related to climate change.

Determining whether climate change is a relevant issue

Determining whether climate change is a relevant issue while identifying external and internal issues relevant to the Quality Management System (QMS) involves systematically evaluating factors that may impact the organization’s ability to achieve its quality objectives. Here’s how an organization can determine the relevance of climate change as an issue during this process:

1. External issues:
   • Market Trends and Regulatory Landscape: Assess how climate change may influence market trends, customer preferences, and regulatory requirements relevant to the organization’s products and services. Consider whether there are emerging regulations related to environmental sustainability, greenhouse gas emissions, energy efficiency, or other climate-related issues.
   • Supply Chain Vulnerability: Evaluate the vulnerability of the organization’s supply chain to climate-related risks, such as disruptions in raw material availability, transportation delays, or changes in supplier reliability. Consider whether climate change impacts on suppliers or transportation routes could affect the organization’s ability to deliver quality products and services.
   • Stakeholder Expectations: Consider the expectations of stakeholders, including customers, suppliers, investors, regulators, and communities, regarding the organization’s response to climate change. Assess whether there is increasing pressure from stakeholders for businesses to address environmental sustainability and climate-related risks.
2. Internal Issues:
   • Operational Impacts: Evaluate how climate change may directly or indirectly affect the organization’s operations, facilities, and resources. Consider whether changes in weather patterns, extreme weather events, or resource constraints (e.g., water scarcity) could impact production processes, quality control measures, or infrastructure resilience.
   • Resource Management: Assess the organization’s resource management practices, including energy usage, waste generation, and water consumption, in the context of climate change. Identify opportunities to improve resource efficiency, reduce greenhouse gas emissions, and enhance environmental sustainability as part of the QMS.
   • Risk Management: Evaluate the organization’s risk management processes to identify and mitigate climate-related risks that could impact product quality, customer satisfaction, or business continuity. Consider whether existing risk assessment methodologies adequately address climate-related hazards and vulnerabilities.
3. Integration with QMS:
   • Alignment with Quality Objectives: Determine whether addressing climate change aligns with the organization’s quality objectives, strategic goals, and commitment to customer satisfaction. Consider whether improvements in environmental sustainability and resilience to climate-related risks can contribute to enhancing overall product and service quality.
   • Documentation and Monitoring: Document the organization’s assessment of climate change as a relevant issue within the context of the QMS. Establish mechanisms for monitoring and measuring performance related to climate-related objectives, targets, and key performance indicators (KPIs) to ensure continuous improvement and compliance with relevant standards.

By systematically evaluating the external and internal factors relevant to the QMS, including climate change considerations, organizations can effectively identify and prioritize issues that may impact their ability to deliver quality products and services while managing associated risks and opportunities.

 Relevant interested parties can have requirements related to climate change.

Relevant interested parties in the context of a Quality Management System (QMS) can indeed have requirements related to climate change. Here are some examples of interested parties whose needs and expectations might involve climate change considerations:

1. Customers: Customers may increasingly prioritize environmentally sustainable products and services. They may expect the organization to demonstrate environmental responsibility by minimizing greenhouse gas emissions, reducing energy consumption, using renewable resources, and implementing eco-friendly practices throughout the product lifecycle. Climate change concerns could influence their purchasing decisions, making it essential for organizations to address these expectations to maintain customer satisfaction.
2. Regulators and Government Agencies: Regulatory bodies may impose requirements related to climate change mitigation, adaptation, and reporting. These requirements could include regulations aimed at reducing greenhouse gas emissions, improving energy efficiency, promoting renewable energy sources, managing waste and emissions, or disclosing environmental performance metrics. Organizations must ensure compliance with relevant regulations and anticipate future regulatory developments related to climate change.
3. Investors and Shareholders: Investors and shareholders may consider climate change risks and opportunities when evaluating the organization’s financial performance and sustainability practices. They may expect transparency and disclosure regarding the organization’s exposure to climate-related risks, its resilience strategies, and its commitment to environmental stewardship. Addressing climate change concerns can enhance investor confidence and support long-term financial sustainability.
4. Suppliers and Business Partners: Suppliers and business partners may be subject to climate-related risks and regulatory requirements that could impact their ability to fulfill contractual obligations. Organizations may need to assess the climate resilience of their supply chain, collaborate with suppliers to mitigate shared risks, and incorporate climate considerations into procurement practices and supplier selection criteria.
5. Employees and Labor Organizations: Employees and labor organizations may have concerns about the organization’s environmental impact, workplace safety, and job security in the context of climate change. They may expect the organization to provide a safe and healthy work environment, support sustainable practices, offer training on climate-related issues, and engage in meaningful dialogue and collaboration on environmental initiatives.
6. Local Communities and Non-Governmental Organizations (NGOs): Local communities and NGOs may advocate for climate action and environmental protection initiatives that affect the organization’s operations and reputation. They may expect the organization to be a responsible corporate citizen, engage in community outreach and partnerships, address environmental concerns, and contribute positively to local sustainability efforts.

In summary, understanding the needs and expectations of interested parties in the context of a QMS requires recognizing the relevance of climate change considerations. Organizations must engage with relevant stakeholders, assess their climate-related requirements, and integrate climate change considerations into their quality objectives, processes, and performance measurement mechanisms to effectively address stakeholder expectations and ensure long-term sustainability.

Benefits of ISO 9001:2015

Competitive advantage

ISO 9001 should be top-management-led, which ensures that senior management takes a strategic approach to their management systems. Our assessment and certification process ensures that the business objectives constantly feed into your processes and working practices to ensure you maximize your assets.

Improves business performance and manages business risk

ISO 9001 helps your managers to raise the organization’s performance above and beyond competitors who aren’t using management systems. Certification also makes it easier to measure performance and better manage business risk.

Attracts investment, enhances brand reputation and removes barriers to trade

Certification to ISO 9001 will boost your organization’s brand reputation and can be a useful promotional tool. It sends a clear message to all interested parties that this is a company committed to high standards and continual improvement.

Saves you money

Evidence shows that the financial benefits for companies that have invested in and certified their quality management systems to ISO 9001 include operational efficiencies, increased sales, higher return on assets and greater profitability.

Streamlines operations and reduces waste

The assessment of your quality management system focuses on operating processes. This encourages organizations to improve the quality of products and the service provided and helps to reduce waste and customer complaints.

Encourages internal communication and raises morale

ISO 9001 ensures that employees feel more involved through improved communication. Continued Assessment visits can highlight any skills shortages sooner and uncover any teamwork issues.

Increases customer satisfaction

The ‘Plan, Do, Check, Act’ structure of ISO 9001 ensures that the needs of the customer are being considered and met.

How to achieve ISO 9001 certification – ISO 9001 implementation / Certification steps

I can offer a well-defined and globally proven implementation methodology for ISO 9001:2015 certification.

• Gap Analysis
• Awareness Training
• Process Identification and Definition
• Documentation Design and finalization
• Implementation
• Internal Auditor Training and conduct of the internal audit
• Management Review Meeting
• Review of Implementation
• Pre-assessment
• Stage 1 – certification audit
• Stage 2 – certification audit
• Award of ISO 9001 certification
• Continual improvement of the system through value-added consulting and training services

What are the requirements of the ISO 9001 standard?

• determine the internal and external context that affects the organization
• determine the need and expectations of interested parties
• determine the scope of the quality management system
• determine the input required and output expected of these processes
• determine the interaction of these process
• determine the criteria, and methods, including measurement and related performance indicators needed to ensure effective operation and control of these processes
• determine the resources needed for these processes and ensure their availability
• assigning responsibilities and authorities for these processes by adopting a Stakeholder approach to quality management.
• determine risks and opportunities in accordance with these processes and appropriate actions to address them.
• Determine the methods to monitor, measure and evaluate the processes
• Determine opportunities for improvement in processes and quality management system
• Makes it easier for the Service industry with the word product replaced by goods and services.
• Determine the amount of documented information on processes.

Documents needed by the organization to ensure the effective planning, operation and control of its processes:
There are several requirements of ISO 9001:2015 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:

• Process maps, process flow charts and/or process descriptions
• Organization charts
• Specifications
• Work and/or test instructions
• Documents containing internal communications
• Production schedules
• Approved supplier lists
• Test and inspection plans
• Quality plans

Integrate ISO 9001 with other management system standards

ISO 9001 is designed to be compatible with other management systems standards and specifications, such as OHSAS 18001, ISO 22000, ISO 17025, ISO 27001, ISO 14001 Environment and other ISO standards. They can be integrated seamlessly through the Integrated Management system approach. They share many principles so choosing an integrated management system can offer excellent value for money and an easier approach to implement, manage and improve multiple standards simultaneously.

What is offered in the field of ISO 9001 standards and certification?

I can provide unmatched expertise and technical competence to ensure that your ISO 9001 quality management system certification project adds value to your organization. We provide consulting, training, internal audits, pre-assessment audits and facilitation during the ISO 9001 certification audit.

Contact now, to get your organization ISO 9001:2015 certified most effectively and efficiently while realizing the true benefits of the certification using our specialized ISO implementation methodology that is less time-consuming, fast, easy to understand and implement, result-oriented, time-bound and cost-effective. Get ISO 9001 certified now