ISO 9001 Clause 8.2.3 highlights the necessity for organizations to conduct a comprehensive review of the requirements related to the products and services they intend to supply to their customers.
Breakdown Clause 8.2.3
1. Review Scope: The organization must conduct a thorough review before committing to supplying products or services to a customer. This review involves several aspects:
Customer-Stated Requirements: The organization should understand and consider all requirements specified by the customer, including those for delivery and any post-delivery activities.
Unstated (implied) But Necessary Requirements: Requirements not explicitly expressed by the customer but essential for the intended or specified use should also be identified if known.
Organization-Specified Requirements: Any additional requirements set by the organization itself.
Statutory and Regulatory Requirements: This involves considering all legal obligations and compliance needs related to the products and services.
Variances in Contract or Order: If there are differences in the requirements stated in a contract or order from those previously communicated, these should be resolved.
2. Confirmation of Customer Requirements: When the customer's requirements aren't explicitly documented, the organization must confirm these requirements before acceptance. However, in some circumstances, like internet sales, a formal review for each order might be impractical. Instead, the review can encompass relevant product information such as catalogues.
3. Documented Information: The organization should maintain documented information pertaining to the review results and any new requirements identified for the products and services.
Manufacturing Example of ISO 9001 Clause 8.2.3
Consider a furniture manufacturing company dedicated to producing custom-made pieces for its clients. To comply with ISO 9001 Clause 8.2.3, the company follows a systematic approach:
1. Customer Interaction: When a client orders a piece of furniture, the company initiates communication to thoroughly understand and confirm the client's requirements in the purchase order. This includes design specifications, materials, size, delivery expectations, and any additional services requested.
2. Comprehensive Review: The company emails the order the engineering department for an internal review considering the explicit and implicit requirements. This covers:
Customer-Stated Requirements: These are documented on the purchase order placed by the customer.
Implicit Needs: The company might infer specific needs based on experience or previous orders. For instance, if a client orders a dining table for a large family, the implicit need could be a sturdy construction for durability.
Compliance with Legal and Quality Standards: The company ensures that the manufacturing process adheres to quality standards, such as material quality, and also complies with legal and regulatory requirements.
3. Documentation and Confirmation: All information collected during the review is documented for internal use. Engineering replies via email that the order is approved signifying that the company can accept the purchase order as written or notes any changes required. If any new requirements are identified or if there are variations from the initial specifications provided by the customer, the company contacts the customer for clarification and confirmation by the customer either they issue a new order or accept the changes via email. Note: Changes to a written order must be approved by the customer in writing. In many scenarios, like online sales, it is not feasible to do a formal assessment of every order. Alternatively, the review could discuss pertinent product details from materials like catalogs.
4. Record-Keeping: The company maintains records of the review results and any new requirements. This ensures that the final product aligns with the customer’s specifications and complies with any statutory or regulatory requirements.
By following this structured approach, the company ensures that all customer requirements are thoroughly reviewed and acknowledged before committing to the manufacturing process. This not only ensures compliance with ISO 9001 standards but also guarantees the delivery of a product that aligns with the customer’s expectations.
ISO 9001:2015 Clause 8.2.3 Review of Requirements Related to Products and Services
In essence, Clause 8.2.3 underscores the significance of reviewing and understanding all requirements - explicit or implicit - and ensuring their alignment with the products or services to be provided before committing to the customer. Additionally, it emphasizes the need to maintain records of this review process, any updated requirements, and all approvals or comments.