How should quality system scope be defined when customers design the product, another site manufactures it or one company offers several services? These questions help establish actual responsibilities before applying.
Receiving a drawing is not sufficient justification by itself. You may retain design responsibility if you determine or change functions, materials, dimensions or acceptance conditions. Compare orders, specifications and change approvals. Document any justified conclusion that design is inapplicable, while retaining control of process planning and production changes.
Yes, assessment can cover the activities the company actually manages. Outsourced production still affects customer commitments, so supplier selection, technical communication, acceptance checks and nonconforming product controls are needed. The scope must not suggest ownership of the factory. Define testing, change notification and defective batch responsibilities in the contract.
A common legal name is not enough. Show both activities' processes, personnel, locations and shared management arrangements. Software release acceptance and physical goods receipt and dispatch require different evidence. The certification body assesses scope and audit planning accordingly. Do not imply certification of an activity excluded from the scope.
Start with the addresses and activities on the current certificate. Bring the branch's processes, authorities and personnel, and the new product's purchasing-to-delivery flow, into the system. Update internal audit and management review and notify the certification body. Do not claim an extended scope before the required review and decision.
A single return does not automatically result in cancellation. First assess use-related risks and effects on other batches, including whether dispatch should stop or customers need information. Record correction, root cause and preventive action against recurrence. Systemic failures, ineffective follow-up or breached certification conditions can affect status following the body's review.
Identify the exact specification, accepted accreditation conditions and certificate deadline. Provide system records, internal audit, management review, site and workforce information. Preparation, audit, findings closure and the certification decision are separate stages. Check the assumptions and dates for each; signing a contract or booking an audit is not certification.
Quality management is not limited to factories. Define how the service is specified, delivered and checked. For software support, requests, interventions and acceptance records may provide relevant evidence. Scope must reflect real activities, and the management system certificate must not be presented as a product approval or professional licence.
Share the subject, organisation or product, target market, current evidence and target date. The team can then separate consultancy, official fees, independent evaluation and realistic timing.
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