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13 lis 2023 · A nonconformance report (NCR) is a document used to report, investigate, and address nonconformances. Nonconformance reports help Life Science companies to address areas where improvement is needed, improve product quality, and comply with regulatory requirements.
This White Paper focuses on regulations according to 21 CFR 820.90, ISO 9001 § 8.3, ISO 13485 § 8.3 and the Medical Devices Directive 93/42/EEC. Please Note: Nonconforming Material Reports are sometimes referred to as NCMRs.
1 mar 2024 · A Nonconformance Report (NCR) is a record that identifies and documents any deviation from specified requirements or standards in the design, production or distribution of medical devices and it serves as a critical tool for quality control and regulatory compliance.
30 sie 2022 · Non-conformance reporting acknowledges an area for improvement and allows the team to identify the root cause for defining a corrective and preventive action plan. This results in improved product quality and process efficiency.
Non-conformances (NCs) and non-conformance reports (NCRs) are important for medical device manufacturers to understand and manage correctly. They can endanger your CE marking status, lead to higher costs, penalties from authorities, and potential device recalls.
1 mar 2024 · A Non-Conformance Report (also known as a Non-Conformity Report or NCR) is a document that identifies and reports any discrepancies between the actual condition of a product, service or process and the requirements defined by quality standards.
Here's a non conformance report example which shows you what a good NCR looks like, which you can copy and use for your own quality jobs.
