Mastering Product and Service Requirements According to ISO 9001: A Guide to Defining, Reviewing, and Managing Customer Needs
Introduction
Effectively defining, reviewing, and managing product and service requirements is essential for ensuring customer satisfaction and operational success. In line with ISO 9001, the internationally recognized standard for quality management systems, this process involves understanding customer needs, confirming organizational capabilities, and adapting to changes in requirements.
Whether you’re a small business or a large enterprise, adopting a structured approach aligned with ISO certification helps maintain quality, meet deadlines, and exceed customer expectations. This guide explores key steps, tools, and strategies to streamline this critical process while complying with ISO 9001 requirements.
Determining the requirements of Products and services
Subclause 8.2.2 requests the Organization to determine requirements related to products and services.
The Organization needs to:
- a) Comprehensively define the requirements
- b) ensure the actual organization’s ability to meet the defined requirements
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As applicable, the objective a) could be achieved through:
- An effective communication with the customer (see clause 8.2.1)
- Market surveys and analysis
- Mandatory requirements surveys
- Analysis of calls for tenders
As applicable, the objective b) could be achieved through:
- strategic and operational planning
- process analysis and engineering
- resource management
- internal communication
- supply network management
- review of requirements related to products and services (including order and contract review)
In a complex and/or large Organization the above should be addressed by adopting specific tools and competencies.
In a small and simple Organization, a Risk-Based Thinking and a PDCA approach should be adopted, as a minimum, in order to ensure and continually improve the organization’s ability to fulfill the requirement.
Review of the Requirements for Products and services
A requirement for producer, customer; regardless of that, it is up to the organization to be sure that all requirements will be fulfilled.
When the customer does not express a requirement in documented information, the Organization needs to be sure that what the customer actually needs has been clearly understood by the organization and, as appropriate, by the customer itself, therefore, the organization shall confirm to the customer its requirements.
Although the clause does not request the organization to retain documented information of that, evidence of the confirmation above should be made available, as necessary.
In general, some of the things that the Organization might check for are
- availability of parts or raw materials
- The current equipment capacity
- conditions of payment,
- If the product can be delivered by the customer’s due date
- unspecified customer expectations or post-delivery activities
- If any externally provided processes need to be considered in the schedule (See also 8.4-Control of externally provided products and services)
Requirements should refer to the entire product and service lifecycle, as applicable, to ensure customer satisfaction (ref. clause 9.1.2—Customer satisfaction)
All parts of a customer’s order or contract need to be reviewed to ensure that they can be met.
Needs and expectations of relevant interested parties, other than the customer, might be crucial in order to satisfy the customer; consequently, the Organization might need to address these needs and expectations (including, as applicable, sustainability issues), as arising from the context analysis.
For example, a customer might discriminate between two products or services, with the same performance and might prefer the one that have less environmental impact. In this case, addressing the expectations of the community and regulatory bodies is a condition for customer satisfaction.
There might be many ways for conducting the requirements review; it depends on several conditions, including:
- The complexity of the organization
- The industrial sector
- The criticalities and risks related to the products and services
- Legal and regulatory requirements and liabilities applicable to the agreement with the customer
- The interested parties involved
- Internal and external cultural issues
- The interface with the customer and the related technologies (for example, the review of internet transactions could need to focus on the offer stage)
- The repetitiveness of the process, etc.
In a complex situation, the review process might imply:
- The use of detailed checklists
- The involvement of all relevant functions in the organization and of external experts, if necessary
- The involvement of the customer
- The involvement of other relevant interested parties, etc.
In simpler situations, the review could be done quickly and automatically, and the evidence of its affirmative results could be provided by signing the order or contract, or similar.
It is up to the organization to decide how to conduct and document the review process; nevertheless, the organization should be able to justify its decisions, as necessary.
Subclause 8.2.3.2 states that documented information describing the results of the review, including any new or changed requirements for the products and services, shall be retained.
The Organization is not requested to retain detailed documented information about the requirements themselves and their changes, if any, as determined and reviewed by the Organization. Consequently, it is up to the Organization to make decisions about the details of the records to be provided.
These decisions should take into account the organizational and external conditions, including
- The complexity of the process and the related risks
- the expectations of the customer and of the other relevant interested parties, as applicable, including the necessity to provide evidence to internal and external parties.
Changes to requirements for products and services.
There is a risk that a requirement previously determined by the organization is changed in progress by the customer, or because of changes in the context, etc.
In these cases, the organization shall timely identify the impacts on the process and consequently update any element of the process that is affected by the change:
- to ensure the integrity of the process
- to avoid misunderstanding.
- to confirm its ability to meet the defined requirements, including the new or changed ones,
- to ensure the conformity of the products and services and customer satisfaction.
This refers to any involved element of the QMS, including:
- documented information (Clause 7.5—Documented Information)
- people’s awareness (Clause 7.3-Awareness)
- Operational planning (8.1 Operational planning and control).
- competencies needed (7.2 Competence)
- external and internal communication (7.4-Communication)
Design and development of products and services
The object of design and development:
The organization should make clear what their products and services are.
For example, for a personal computer maker their product is the computer and this will be the object of the design and development. On the other hand, an organization which assembles a computer unit by the offer from the computer maker. The object of the design and development for this organization would be the assembling method of the unit. Because what this organization is providing to the customer is “appropriately assembled” unit.
When the organization determines the object of the design and development, it is important to consider what values their customer are acquiring through the products and services.
Activities for design and development
After determining the object of the design and development, next is to identify which activities in the organization corresponds with the requirements of this clause.
If the organization is able to start the production or service provision only by the information given by their customer requirements, the activities for design and development may not exist in this organization.
However, in the case of this, there is a possibility that the organization is ignoring what they really have to do in the present situation. In this case, current state analysis will be need.
Example, in a house construction, the customer requirements would be various. How many floors, the number of toilets, the living room measures, the walls color and material and so on.
Could the organization build a house by only this information? When the qualified architect draws the detail plan for the house by following the building regulations, it would identify what materials are needed, how many days and workers are necessary for the construction, and so on. And then, it will make possible to start building the house.
Therefore, it can say, activities of the Design and development are determination of achievement methods for realizing the requirements.
Design and development for service industry
The term “design” is unfamiliar for the service industry. However, of course most service industry’s organization has design and development activities in their service provision operation. To control these activities appropriately is very important for maintaining and improving the quality of the service. For example, in medical service, is it possible to realize the requirement only by the requirement from the patient “cure my disease”.
When a medical service includes operation, it has to make a suitable consultation planning based on application of techniques and resources. This action is just the design and development activities that are required in this clause. The below are other examples of design and development activities in service industry.
- Making guidance for instructors. (Educational Institutions)
- Planning a customer service manual. (Restaurants, Hotels, etc.)
- Establishing room making procedure. (Hotels)
- Planning an inheritance according to the customer assets, age, and so on. (Trust Banks)
Conclusion
Defining, reviewing, and managing product and service requirements is a cornerstone of delivering high-quality outcomes and ensuring customer satisfaction. By adopting a systematic approach—whether through detailed checklists, customer communication, or risk-based thinking—organizations can effectively meet customer needs and adapt to changes. Integrating these practices into your quality management system not only enhances operational efficiency but also builds trust and long-term relationships with customers.
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FAQ
Why is it important to review product and service requirements?
Reviewing requirements ensures that the organization can meet customer expectations, comply with regulations, and deliver products or services on time and within scope. It also helps identify potential risks and opportunities for improvement.
How can organizations handle changes to product or service requirements?
Organizations should promptly identify the impact of changes, update relevant processes, and communicate with stakeholders to ensure clarity and maintain the integrity of the delivery p
What role does design and development play in service industries? In service industries, design and development involve plan
In service industries, design and development involve planning and structuring service delivery methods to meet customer needs effectively. Examples include creating service manuals, consultation plans, or operational procedures tailored to customer requirements.