ISO 9001:2015 Clause 7.1.3 Infrastructure

ISO 9001:2015 Requirements

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
NOTE: Infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.

1) Determine the infrastructure needs

Determining the infrastructure needs of an organization involves a systematic process of assessing its operational requirements and considering various factors that contribute to its efficient functioning. Planning for new and/or modification of existing facilities are normally conducted with capacity or work force expansions and product or process changes. Facilities may also be expanded or modified to improve productivity, quality and the work environment. All requests for modifications or expansions of facilities must be reviewed and approved by the Department Head and the Quality Manager at a minimum. Requests for significant modifications or expansions must also be reviewed and approved by Top management. Consider all the things needed in order to deliver a product to the customer. This includes:

1. Buildings and workspaces;
2. Gas, water, electricity, etc.;
3. Tools and process equipment, e.g. hardware or software;
4. Supporting services, e.g. transport, I.T. and communication.

Here are the steps an organization can take to determine its infrastructure needs:

1. Identify Operational Processes: Begin by identifying all the key processes and activities that are essential for the organization’s operations. This could include production, service delivery, communication, data management, and more.
2. Gather Requirements: Engage with relevant stakeholders, such as department heads, process owners, employees, and customers, to gather detailed requirements for each process. Understand their needs, expectations, and any specific infrastructure needs they have.
3. Assess Current Infrastructure: Evaluate the existing infrastructure to determine what is already in place and how well it supports the current operations. Identify any gaps or areas that require improvement.
4. Future Growth and Changes: Consider the organization’s future plans, growth projections, and potential changes in operations. Anticipate any changes that might impact infrastructure requirements, such as increased production volumes, new product lines, or expansion to new markets.
5. Industry Standards and Regulations: Research relevant industry standards, regulations, and compliance requirements that the organization needs to adhere to. This can help ensure that the infrastructure aligns with industry best practices and legal requirements.
6. Technological Advancements: Stay updated on technological advancements and trends that might impact the organization’s operations. New technologies could lead to more efficient and effective ways of managing processes.
7. Risk Assessment: Identify potential risks and vulnerabilities related to the organization’s infrastructure. This could include risks related to equipment failure, data security, natural disasters, and more. Develop strategies to mitigate these risks.
8. Budget and Resources: Consider the organization’s budget constraints and available resources. Determine how much investment can be allocated to infrastructure improvements and acquisitions.
9. Prioritize Needs: Rank the infrastructure needs based on their importance and potential impact on the organization’s operations and outcomes. This will help in making informed decisions about where to allocate resources.
10. Consult Experts: If necessary, involve experts or consultants who specialize in infrastructure planning and management. They can provide insights and recommendations based on their expertise.
11. Develop a Plan: Create a comprehensive plan that outlines the specific infrastructure requirements for each process, the proposed solutions, estimated costs, implementation timelines, and responsible parties.
12. Regular Review: Infrastructure needs can change over time due to evolving technology, market conditions, and organizational growth. It’s important to regularly review and update the infrastructure plan to ensure it remains aligned with the organization’s goals and needs.

By following these steps and involving key stakeholders in the process, the organization can effectively determine its infrastructure needs and make informed decisions to support its operational excellence and growth.

2) Provide and maintain the necessary infrastructure

Providing and maintaining the necessary infrastructure involves a combination of planning, execution, monitoring, and continuous improvement efforts. Here’s a step-by-step guide on how an organization can effectively provide and maintain its required infrastructure:

1. Planning:Based on the assessment of infrastructure needs, create a detailed plan that outlines the specific requirements, resources, and timelines for providing and maintaining the infrastructure.
2. Resource Allocation: Allocate the necessary budget, manpower, and other resources to procure and set up the required infrastructure. Consider both initial costs and ongoing maintenance expenses.
3. Procurement and Setup: Depending on the infrastructure needs, acquire the required equipment, technology, facilities, and tools. This could involve purchasing, leasing, or building facilities, as well as implementing software systems and hardware.
4. Installation and Implementation: Ensure that the installation and implementation of the infrastructure components are carried out efficiently and according to best practices. This may involve working with external vendors, contractors, or internal teams.
5. Training and Documentation: Train employees on how to use and maintain the new infrastructure effectively. Create documentation, guidelines, and manuals to ensure proper usage and troubleshooting procedures.
6. Monitoring and Maintenance: Implement a regular maintenance schedule for all components of the infrastructure. This includes routine inspections, servicing, repairs, and replacements as needed.
7. Performance Monitoring: Continuously monitor the performance of the infrastructure to identify any issues or inefficiencies. This could involve using monitoring tools, collecting data, and analyzing performance metrics.
8. Issue Resolution: Address any problems or breakdowns promptly. Have a clear process in place to report issues, escalate them if necessary, and ensure that they are resolved in a timely manner to minimize disruptions.
9. Lifecycle Management: Understand the lifecycle of different infrastructure components. Plan for upgrades or replacements when equipment becomes outdated or no longer meets the organization’s needs.
10. Adaptation to Change: Be prepared to adapt the infrastructure as the organization’s needs evolve. This could involve scaling up or down, integrating new technologies, or re configuring the infrastructure to accommodate changes in processes.
11. Security and Compliance:Implement security measures to safeguard the infrastructure against threats and vulnerabilities. Ensure that the infrastructure complies with relevant industry regulations and standards.
12. Feedback and Improvement: Encourage feedback from employees who use the infrastructure daily. Use this feedback to make iterative improvements to the infrastructure to enhance usability and effectiveness.
13. Continual Improvement: Regularly review the infrastructure strategy and its effectiveness. Identify opportunities for efficiency gains, cost savings, and enhancements to support the organization’s goals.
14. Emergency Preparedness: Develop contingency plans for unexpected events, such as power outages, natural disasters, or cyber security breaches. Ensure that the infrastructure can quickly recover from such disruptions.
15. Cross-Functional Collaboration: Foster collaboration between departments involved in infrastructure management, such as IT, facilities, operations, and management. Effective communication is essential for seamless infrastructure provision and maintenance.

By following these steps and maintaining a proactive and adaptive approach, organizations can ensure that their infrastructure supports efficient operations, adheres to quality standards, and contributes to overall business success.

3) Infrastructure can include buildings and associated utilities; equipment, including hardware and software; transportation resources; information and communication technology.

Infrastructure encompasses a wide range of physical and technological components that are essential for the smooth operation of an organization.

a) Buildings and Associated Utilities: This refers to the physical structures where an organization conducts its operations. Buildings house offices, manufacturing facilities, warehouses, and other spaces needed for different activities. Associated utilities include electricity, water supply, heating, ventilation, and air conditioning systems.

b) Equipment, Including Hardware and Software: Equipment involves the tools, machinery, and devices necessary for various processes. This can range from production machinery and laboratory equipment to computers and office equipment. Software is an integral part of modern infrastructure and includes applications, operating systems, and other digital tools used to manage operations.

c) Transportation Resources: Transportation infrastructure includes vehicles, fleets, and systems needed to move goods, services, and personnel. This can include trucks, vans, ships, airplanes, and even internal logistics systems within a facility.

d) Information and Communication Technology: Information and communication technology (ICT) infrastructure covers the digital systems and networks that enable communication, data storage, and information sharing. This includes hardware like servers, routers, and switches, as well as software applications, databases, and communication platforms.

All of these components are interconnected and play a crucial role in an organization’s daily operations. Effective management and maintenance of these elements contribute to the organization’s ability to deliver products and services efficiently while ensuring quality and compliance with standards.

Documented Information required

There is no mandatory requirement of Documented Information in this clause. This clause emphasizes that an organization should ensure that the infrastructure needed to achieve conformity to product and service requirements is determined, provided, and maintained. This includes both physical resources and resources related to information and communication technology.

1. Infrastructure Determination:Document the process by which the organization determines its infrastructure needs based on various factors, such as processes, products, services, and applicable regulations.
2. Infrastructure Provision:Record the steps taken to provide the necessary infrastructure. This could include purchase orders, contracts, agreements with suppliers or contractors, and internal requisition forms for acquiring physical resources, software, or services.
3. Infrastructure Maintenance:Document the maintenance schedule and activities related to ensuring the continued functionality and effectiveness of the infrastructure. This could include maintenance records, service reports, and logs of inspections or repairs.
4. Monitoring and Measurement of Infrastructure:Establish a process for monitoring and measuring the performance of the infrastructure. Record any measurements or assessments taken to ensure that the infrastructure remains in good working condition.
5. Evidence of Conformity:Maintain records that demonstrate that the infrastructure contributed to achieving conformity of products and services. This could include data related to the infrastructure’s impact on product/service quality, efficiency, or customer satisfaction.
6. Training and Competence:If infrastructure use requires specific skills or training, document the training programs provided to employees and any records of their competency assessments.
7. Change Management:If changes are made to the infrastructure, document the change management process, including any risk assessments, approvals, and testing conducted before implementing the changes.