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Iso 13485 sop documents
Iso 13485 sop documents








iso 13485 sop documents

If the Operations team is not sure how toĬlassify a ticket, it consults the QMO. high - medium - low)Īll feedback is classified into one of the following categories. Feedback prioritization ( optional, e.g.Ideally, inquiries should be responded to in the same way of Also considerĬhannels independent from internet connection. Think about the most commonly used contact channels for your product and organization.Contact channels: describe the primary way to contact your customer support (e.g.Customer support ticket system (if applicable, consider GDPR requirements for sensitive data).Customer support availability (typically e.g.In this section, provide general information about how you intend to set up your company’s feedbackĬonsider sub-sections that describe more specifically:

iso 13485 sop documents

This SOP describes how to respond to feedback and complaints. The following parameters can be added on a needed basis.Template preview SOP Feedback Management and Customer Complaints ISO 13485:2016 Section SOP refers to Standard Operating Procedures.The letter “N” denotes any number (0 through 9).Handling and Dealing with Global Regulatory Matters Under the Firm’s Name “MAGIC PILL COMPANY” In this scheme, RA-POL-001 refers the following. The following shows representative examples. Under the organizational name, the number should point to the document types (POL, MAN, SOP or WI, etc.) followed by the number systematically assigned as follows. Tier Four – Work instructions (“WI”), data, reports or related.Tier Three – Procedures (“SOP”) or related.

iso 13485 sop documents

Hierarchical structures/systems – four tier systems.Organizational structure/elements need to be reflected.Easily scaleable to as many documents as needed later.

iso 13485 sop documents

Applicable Under 21 CFR Parts 210 and 211, ISO 13485, or 21 CFR Part 820 Factors to consider when implementing document numbering as part of document control under the umbrella Quality (Management) Systems (QS or QMS).










Iso 13485 sop documents