Define your ISO 9001 Audit Scope
Audit scope definition is always part of any audit. The scope sets the boundaries of the audit and identifies the object in focus.
The object can include 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. This is why it is important to clearly define the scope in review for your given audit.
Determining your ISO 9001 audit scope requires your organizations to specify the product, the data, the systems, vendors, location, department, internal and external parties, etc.. in scope.
Read below for guidance on how to determine each scope item. A table listing each item is provided down below to use as a template for this exercise.
Product(s) in scope
This should be relatively easy. 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
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, 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 could include email, Slack, the key is the focus on the systems and tools that are essential in delivering your service / product. Production systems have a direct impact on your product or service in lieu or non-production systems.
For HR systems, focus on systems that manage employee’s onboarding and training processes. Everything else such as time off requests, benefits are out of scope since they are not critical to delivering 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
In order to identify the vendors in scope, focus on the critical vendors such as cloud hosting, production related companies used to support the product or service in scope
Internal and External Parties in scope
You would need to list out all internal stakeholders (i.e employees, Board of Directors) and external parties (i.e customers, regulators; government) needs and interests and relevant for your QMS or quality
Relevant laws and regulations in scope
You should list the most relevant laws and regulations that are relevant 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 for the QMS. Physical location can usually be carve-out from the scope. However, an office site can be added to the scope depending on its relevance to the QMS (i.e hosts a server or serves as a satellite office).
Scoping guidance template
|Provide a detailed description of your organization’s products or services.
|Provide the type of data and people that flows through the product or service under review|
|Please provide the 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 the list of internal and external parties relevant with needs relevant to the QMS|
|Please provide the list of relevant laws and regulations regulating the product or service under review|
|Please provide the list of locations serving as an operation center to support the product or service under review|
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