ISO 9001 – Clause 7 – Support

ISO 9001 and Clause 7, Support

As we delve into the world of Quality Management Systems (QMS), it’s imperative to understand the pivotal role of ISO 9001:2015. This standard acts as a foundational framework for establishing, implementing, and improving a QMS. At the heart of this standard is Clause 7: Support, which is integral to the effectiveness of a QMS.

Understanding the Significance of ISO 9001:2015

ISO 9001:2015 is globally recognised for setting the criteria for a QMS. It’s designed to help organisations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. As a cornerstone of quality management, ISO 9001:2015 is instrumental in streamlining processes, reducing errors, and facilitating a culture of continuous improvement.

What is Clause 7: Support?

Clause 7 focuses on the resources necessary for the establishment, implementation, maintenance, and continual improvement of the QMS. It underscores the need for adequate resources, competent personnel, necessary infrastructure, an appropriate working environment, and the monitoring and measuring of resources.

Aligning with Annex SL

Clause 7 aligns with Annex SL, which provides a high-level structure for ISO management system standards. This alignment ensures a degree of consistency and compatibility with other management system standards, making it easier for organisations to integrate multiple management systems.

Evolution of ISO 9001 Standard

As you delve into the world of quality management, it’s essential to recognise the historical milestones of the ISO 9001 standard. Since its inception in 1987, ISO 9001 has undergone several revisions, each reflecting the evolving needs of organisations worldwide.

Key Changes in the 2015 Revision

The 2015 revision was a significant update that introduced the concept of risk-based thinking and greater emphasis on leadership and management commitment. It also enhanced the applicability to service organisations and strengthened the integration with other ISO management system standards through the common framework of Annex SL.

Impact on Quality Management Systems (QMS)

These changes have made QMS more dynamic and integrated into the strategic direction of organisations. The focus on risk and leadership involvement ensures that quality management is a central part of organisational resilience and adaptability.

Adapting with ISMS.online

At ISMS.online, we’ve embraced these changes, ensuring our platform supports the current needs of QMS. Our tools and resources are designed to facilitate the risk management process and foster leadership engagement, aligning with the 2015 standards for a robust and effective QMS.

Resource Identification and Provision

Identifying and providing the right resources is pivotal for the effective functioning of a Quality Management System (QMS). ISO 9001:2015 lays down specific requirements to ensure that your QMS is well-equipped to meet its intended outcomes.

Assessing Internal and External Resources

Under ISO 9001:2015, you’re encouraged to conduct a thorough assessment of both internal and external resources. This involves evaluating current capabilities and identifying gaps where additional resources might be needed. It’s not just about having enough resources, but also about ensuring they are suitable for your specific QMS requirements.

Implications for QMS Effectiveness

The adequacy of resources directly impacts the efficiency and resilience of your QMS. Without the necessary support, processes may falter, leading to subpar product quality or service delivery. It’s crucial to align resource provision with the strategic objectives of your QMS to maintain its effectiveness.

ISMS.online: Facilitating Resource Provision

At ISMS.online, we understand the importance of resource optimization. Our platform is designed to help you identify the resources you need, manage them effectively, and ensure they contribute to the success of your QMS. With our tools, you can streamline the process of resource allocation, ensuring that your QMS is robust, responsive, and compliant with ISO 9001:2015.

Competency, Skills, and Knowledge Requirements for QMS Personnel

Ensuring that your personnel are competent is a cornerstone of ISO 9001:2015. The standard mandates that individuals performing work affecting product or service quality must be competent, based on appropriate education, training, or experience.

Defining Training and Competence Verification

ISO 9001:2015 requires you to: – Determine the necessary competence for personnel performing work under its control – Ensure that these individuals are competent on the basis of appropriate education, training, or experience – Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken – Retain appropriate documented information as evidence of competence

Actions for Acquiring Competence

To acquire and maintain the necessary competence, you may need to provide training or take other actions such as mentoring or reassigning currently employed persons. It’s crucial to evaluate the effectiveness of these actions to ensure they are delivering the desired outcomes.

ISMS.online’s Role in Personnel Competency

At ISMS.online, we provide a platform that supports the development and verification of your team’s competencies. Our system allows you to track training, maintain records of competence, and evaluate the effectiveness of competence-building actions, ensuring your QMS meets ISO 9001:2015 standards.

Infrastructure Requirements for QMS

Adequate infrastructure is a critical component of a Quality Management System (QMS). ISO 9001:2015 outlines specific requirements to ensure that the infrastructure supports the operation of processes and the achievement of product and service conformity.

Defining Necessary Facilities and Equipment

ISO 9001:2015 requires you to determine, provide, and maintain the infrastructure necessary for the operation of your processes. This includes:

• Buildings and associated utilities
• Equipment, including hardware and software
• Transportation resources
• Information and communication technology

Implications of Infrastructure on QMS Effectiveness

The infrastructure you put in place has a direct impact on the ability of your QMS to meet its intended outcomes. Properly maintained and suitable infrastructure ensures that processes run smoothly and efficiently, leading to consistent product quality and service delivery.

ISMS.online’s Support for Infrastructure Requirements

At ISMS.online, we provide a comprehensive platform that supports your infrastructure needs for an effective QMS. Our services include:

• Dynamic risk management tools to assess and address infrastructure-related risks
• Efficient document management for maintaining records of infrastructure maintenance and updates
• Robust policy and control management to ensure that your infrastructure policies are up-to-date and effectively communicated

By leveraging our platform, you can ensure that your infrastructure is aligned with the requirements of ISO 9001:2015, contributing to the overall effectiveness of your QMS.

Monitoring and Measuring Resources in QMS

In the realm of Quality Management Systems (QMS), the precision of monitoring and measuring resources is non-negotiable. ISO 9001:2015 sets forth stringent guidelines to ensure that these resources are managed effectively.

Guidelines for Monitoring and Measuring

ISO 9001:2015 requires you to determine:

• The monitoring and measuring to be performed
• The resources needed to ensure valid results
• The calibration or verification of measuring resources

Calibration and Maintenance of Measuring Instruments

Calibration is critical to maintain the integrity of measurement results. ISO 9001:2015 stipulates that measuring instruments must be:

• Calibrated or verified at specified intervals or prior to use
• Identified to determine their calibration status
• Safeguarded from adjustments that would invalidate the measurement result

Importance of Measurement Traceability

Measurement traceability is essential for:

• Validating the quality of products and services
• Providing a clear basis for decisions regarding products and processes
• Ensuring compliance with regulatory and customer requirements

ISMS.online’s Role in Resource Monitoring

At ISMS.online, we provide tools that assist you in:

• Tracking the calibration status of your measuring instruments
• Documenting the verification processes and results
• Ensuring traceability of measurements to recognised standards

By utilising our platform, you can maintain the rigour required for effective QMS monitoring and measuring, in line with ISO 9001:2015.

Organisational Knowledge in QMS

Organisational knowledge is the lifeblood of any Quality Management System (QMS). ISO 9001:2015 emphasises the importance of capturing, maintaining, and ensuring the accessibility of this knowledge to support the operation of processes and the conformity of products and services.

Capturing and Maintaining Organisational Knowledge

ISO 9001:2015 requires you to:

• Determine the knowledge necessary for the operation of your processes and to achieve conformity of products and services
• Maintain this knowledge and make it available to the extent necessary
• Consider the current knowledge and determine how to acquire or access any necessary additional knowledge and required updates

Sources of Organisational Knowledge

Organisational knowledge can stem from:

• Internal sources such as intellectual property, accumulated experience, and lessons learned from failures and successful projects
• External sources including standards, academia, conferences, gathering knowledge from customers or external providers

Contribution to QMS Effectiveness

This knowledge is a strategic asset that contributes to:

• Sustaining and improving existing products and services
• Supporting the development of new products and services
• Promoting continual improvement of processes and systems

ISMS.online’s Support for Knowledge Management

At ISMS.online, we provide a platform that helps you:

• Document and retain critical organisational knowledge
• Access and disseminate information effectively across your team
• Integrate knowledge management into your QMS processes seamlessly

By leveraging our services, you ensure that your organisational knowledge is an enabler of excellence within your QMS.

Further Reading

How ISMS.online Can Support ISO 9001 Compliance

Embarking on the journey to ISO 9001:2015 certification can be complex, but with ISMS.online, you’re not alone. Our platform is designed to simplify and support your path to certification.

Features of ISMS.online’s Integrated Management System

Our Integrated Management System stands out with features that make managing your QMS straightforward and effective:

• Pre-configured QMS templates that save you time and ensure compliance
• Assured Results Method (ARM) to guide you through each step of the certification process
• Dynamic risk management tools that help you identify and mitigate risks efficiently

Managing Your QMS Effectively with ISMS.online

We empower you to manage your QMS with confidence, offering:

• Robust policy and control management to maintain high standards
• Efficient document management for easy access and control of your QMS documentation
• Transparent reporting for clear insights into your QMS performance

ISO 9001 Clause Table