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Incoming Inspection or
Quality Plan Template

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  2. Incoming Inspection or Quality Plan Template
Incoming Inspection or Quality Plan

An Inspection/Quality Plan lays out a programme of inspections at points of failure during the life-cycle of a medical device, in order to ensure that the process is in compliance with required specifications. Inspection/Quality Plans are used to comply with the requirements of the ISO 13485 standard related to control of production and service provision.

A common point of failure is ‘Incoming Goods”. In order to be sure that the incoming material complies with the documented specification, the manufacturer has to be sure that the supplied material is delivered as per the specification. If non-conforming material is delivered the same shall be returned to the supplier. This template contains provisions for test method, sampling quantity, test specification, test frequency etc.

This template is written specifically for early-stage medical device companies and is audit ready and is written by highly experienced professionals. Click below to get a preview of this template.

Incoming Inspection or Quality Plan Template

Incoming-Inspection-or-Quality-Plan-Template

Price: $150

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FAQ:

An incoming inspection plan in medical devices is a documented process used to check the quality of materials received from suppliers. It helps ensure that all incoming goods meet the required specifications before they are used in production. This includes defining what to inspect how often to inspect and the methods used. If any material does not meet the set standards it is rejected or sent back to the supplier. Such plans are important for maintaining compliance with ISO 13485 and ensuring consistent product quality.

Yes an incoming inspection plan is important for ISO 13485 compliance as it helps ensure that all materials received from suppliers meet the required specifications before use. This is a key part of controlling production and service provision. By checking materials at the incoming stage companies can avoid using nonconforming parts and maintain product quality and safety throughout the device lifecycle.

An incoming quality plan should include clear criteria for inspecting and testing materials received from suppliers. It typically covers the test methods, sample size, acceptance criteria, testing frequency, and documentation requirements. The plan helps ensure that only materials meeting the required specifications are used in production. It also outlines the steps to take if nonconforming materials are found, such as rejection or return to the supplier.

The incoming inspection plan is typically prepared by the Quality Assurance or Quality Control team in collaboration with the Procurement and Production departments. These teams work together to define the acceptance criteria for incoming materials based on product requirements and supplier capabilities. In medical device companies, the plan must align with ISO 13485 requirements to ensure all incoming goods meet the documented specifications before they are used in production.

To write a quality inspection report, start by clearly identifying the product or material inspected, along with the date and batch or lot number. Document the inspection criteria, test methods used, sample size, and results against the specifications. Highlight any non conformities found and the actions taken. Ensure the report is clear, objective, and includes signatures of responsible personnel. A well structured report helps demonstrate compliance with ISO 13485 and supports traceability and decision making in case of audits or investigations.