Organisation must maintain a list of products / services delivered for customers. Product / service owners are designated and responsible for completing the related documentation and possible other quality actions directly related to the product / service.
Product / service documentation must include at least:
Some of organization's stakeholders can have an effect on the organization’s ability to consistently provide high quality products and services.
The organization needs to identify:
The organization reviews stakeholder information and related requirements regularly.
The organization has established, implemented and maintains a design and development process that is appropriate for delivering its products and services. The nature, duration and complexity of the design and development activities need to be taken to account when defining the needed detail of the process.
The design and development process has a clearly defined owner and other related authorities.
The sequence of the design and development process includes at least:
To control the design and development process, the following controls should be considered:
Organization has clearly defined the ways for gathering customer feedback relating to products and services, including customer complaints.
Organization has also defined plans for contingency actions (e.g. for disgruntled customers) for relevant situations.
Organization's top management demonstrates leadership and commitment to customer focus by ensuring that:
The organization has defined which checks need to be implemented to verify that product / service requirements have been met. The release of products / services to the customer doesn't happen until the planned checks have been satisfactorily completed, unless separately approved.
Checks can also include delivery-related acceptance criteria e.g. for product training or other onboarding.
The organization shall retain documented information on the release and acceptance of its products / services. The documented information shall include:
The organization shall review and control changes for products and services or their provision, to the extent necessary to ensure continuing conformity with requirements.
The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.
The organization needs to identify and fill also the post-delivery requirements associated with its products / services. These can include include warranty-related actions, contractual obligations (e.g. support or maintenance services) and supplementary services such as recycling or final disposal.
To identify the extent of required post-delivery activities, the organization needs to consider:
To ensure the organization can deliver high quality products, it needs to define a process for reviewing product / service requirements thoroughly before committing to supply the related product / service.
The review needs to include at least:
The organization confirms customer’s requirements before acceptance, when the customer does not provide a documented statement of their requirements.
N.b.! For example in internet sales, when orders are recurring with similar contents, reviewing each order can be impractical, but the reviews can be focused on related product information (e.g. product catalogues).
The organization has defined a process for monitoring design and development outputs. The organization also retains documented information of all design and development outputs.
This process ensures that outputs at least:
The organization has determined the requirements for products and services to be designed and developed.
To define the requirements, the organization should consider at least:
Any conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.
The organization's product / service provisioning needs to happen under controlled conditions. To ensure this, the organization has defined what controlled conditions mean in their operations.
To define controlled conditions, the organization should consider:
The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.
The organization has defined suitable means to identify outputs when it is necessary to ensure the conformity of products and services. This may involve assigning unique identifiers, such as serial numbers, batch codes, or physical labels, to products or batches.
The organization needs to also identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
When traceability is a requirement, the organization also needs to define controls for the unique identification of outputs, and shall retain the documented information necessary to enable traceability.
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