Define ISO 9001 Audit Scope

Overview

Define ISO 9001 Audit Scope to set the boundaries of the audit and identify the object in focus.

The object includes the people, data, system, or product in review. The scope definition allows the auditors to focus on an aspect of the organization rather than the whole. It is important to clearly define the scope of review for your given audit.

Determining your ISO 9001 audit scope requires your organization to specify the product, the data, the systems, vendors, location, department, internal and external parties, etc. in scope.

The following screenshot shows the audit dashboard for ISO 9001 in TrustOps.

Read below for guidance on how to determine each scope item. A table listing each item is provided below to use as a template for this exercise.

Product(s) in scope

For a Software as a Service (SaaS) provider, the scope is typically the software application(s) offered to clients. Some organizations have multiple products, and it is important to define for your ISO 9001 what product is in focus and what product isn’t.

Data in scope

ISO 9001 is an internationally recognized standard for quality management systems. It provides a framework for organizations to establish and maintain an effective quality management system. One important aspect of ISO 9001 is the requirement for data control and management. Data plays a crucial role in decision-making and ensuring the effectiveness of the quality management system.

Under ISO 9001, organizations are required to determine the data that is necessary for the operation of their processes and for monitoring, measuring, and analysing their performance. This data can include various types of information, such as customer feedback, product or service performance data, internal audit results, and employee training records.

By collecting and analysing this data, organizations are able to identify trends, track performance, and make informed decisions to improve their processes and overall quality. It is important for organizations to establish procedures for collecting, storing, and analysing data in a systematic and reliable manner. This includes ensuring the accuracy, completeness, and confidentiality of the data.

Organizations should also establish mechanisms for regular review of the data to identify any issues or opportunities for improvement. By effectively managing data within the scope of ISO 9001, organizations can enhance their ability to meet customer requirements, improve customer satisfaction, and drive continuous improvement. Data-driven decision-making allows organizations to identify areas of improvement and take proactive measures to prevent nonconformities or customer complaints. Overall, effective data management is a key component of ISO 9001 and contributes to the success of an organization’s quality management system

In order to identify the data in scope, the ideal step is to focus on the type of data and people that flow through the product or service identified. For a SaaS provider, it’s typically all the data held in it (i.e., customer data, etc.) and the people that support it, such as vendors and employees.

Systems in scope

To identify all your systems in scope, take an inventory of all the various systems and internal controls that are critical to delivering your service or product in scope. This includes email and Slack. The key is to focus on the systems and tools that are essential to delivering your service / product. Production systems have a direct impact on your product or service in lieu of non-production systems.

For HR systems, focus on systems that manage employee onboarding and training processes. Everything else, such as time off requests and benefits, is out of scope since it is not critical to delivering a service or product.

For a SaaS provider, it’s typically all the infrastructure that hosts it and the procedures that support it, such as AWS, Github, JIRA, etc.

Vendors in scope

ISO 9001 is a widely recognized international standard for quality management systems. It provides a framework for organizations to establish and maintain processes that ensure customer satisfaction and continuous improvement. While ISO 9001 primarily focuses on the internal operations of an organization, vendors play a crucial role in achieving the desired level of quality. Therefore, it is essential to include vendors in the scope of ISO 9001.

When determining the vendors to include in the ISO 9001 scope, organizations should consider those who directly impact the quality of their products or services. This includes suppliers of raw materials, components, and equipment, as well as service providers involved in the production or delivery process. By involving these vendors in the quality management system, organizations can ensure that their products or services meet the required standards from start to finish.

Incorporating vendors in the ISO 9001 scope also helps establish effective communication and collaboration between the organization and its suppliers. This promotes a shared understanding of quality requirements and expectations, leading to better coordination and alignment throughout the supply chain. By working together, organizations and their vendors can identify areas for improvement, address potential risks, and implement corrective actions to enhance overall quality performance.

Including vendors in the scope of ISO 9001 demonstrates a commitment to delivering high-quality products or services to customers. It not only helps organizations meet regulatory requirements but also enhances their reputation and competitiveness in the market. By ensuring that vendors adhere to quality standards, organizations can minimize defects, reduce waste, and improve customer satisfaction. Therefore, it is crucial for organizations to carefully consider which vendors should be included in their ISO 9001 scope to achieve the desired level of quality performance.

In order to identify the vendors in scope, focus on the critical vendors, such as cloud hosting and production related organizations, that support the product or service in scope.

Internal and External Parties in scope

You need to list out all internal stakeholders (i.e., employees, Board of Directors) and external parties (i.e., customers, regulators, government) needs and interests that are relevant for your QMS.

Relevant laws and regulations

You need to list the most relevant laws and regulations for quality according to your business and describe how you are willing to fulfill those requirements

Physical Office / location in scope

There is no mandatory requirement to include an organization’s headquarters in the scope of the QMS for ISO 9001. The physical location can usually be carved out of the scope. However, an office site can be added to the scope depending on its relevance to the QMS (i.e., whether it hosts a server or serves as a satellite office).

Scoping guidance template

Scoping guidance

Provide a detailed description of your organization’s products or services. Focus on the product or service under review

Provide the type of data and people that flow through the product or service under review

Please provide a list of systems / tools that flow through or support the product or service under review

Please provide the list of critical vendors being used to support the product or service under review

Please provide a list of internal and external parties with needs relevant to the QMS

Please provide a list of relevant laws and regulations regulating the product or service under review

Please provide a list of locations serving as operation centers to support the product or service under review

In conclusion, defining the ISO 9001 audit scope is crucial to establishing the boundaries and focus of the audit. This involves identifying the specific object of review, which can include people, data, systems, or products. By clearly defining the scope, auditors can concentrate on specific aspects of the organization rather than the entire entity. Determining the audit scope requires specifying the product, data, systems, vendors, location, departments, and internal and external parties involved.

For a Software as a Service (SaaS) provider, the scope typically includes the software application(s) offered to clients, relevant data, critical systems and tools, essential vendors, internal and external stakeholders, applicable laws and regulations, and operation centres. It is important to follow scoping guidance and provide detailed descriptions for each scope item.