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- Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant
Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
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The ISO 13485 Installation Qualification (IQ) Procedure governs the installation of equipment used to manufacture medical devices and all test equipment used to release product.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
SKU:
SOP 7-014
Installation Qualification ProcedureThe Installation Qualification (IQ) Procedure governs the installation of equipment used to manufacture medical devices and all test equipment used to release product and complies with the requirements of ISO 13485:2016 and FDA 21 CFR Part 820.
Installation Qualification Procedure OverviewThe Installation Qualification Procedure applies to the installation of new equipment, moving or relocating equipment, or after equipment modifications. The Installation Qualification (IQ) Procedure provides instruction on the requirements of conducting Installation Qualifications (IQ's).
The Installation Qualification (IQ) Procedure ensures equipment is installed with appropriate utilities, is entered into the calibration and preventive maintenance systems, is installed in accordance with manufacturers requirements, and is installed with consideration to operator space requirements and safety. ISO 13485 Installation Qualification (IQ) Procedure ComplianceThe Installation Qualification (IQ) Procedure is FDA QSR and ISO 13485:2016 compliant.
To learn more about our ISO 13485 Installation Qualification (IQ) Procedure contact us at [email protected]
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The ISO 13485 Process Validation Procedure Bundle includes 4 procedures related to the validation of medical device processes. The process validation procedures are ISO 13485:2016 and FDA QSR compliant.
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Calibration System Procedure | ISO 13485 | FDA QSR Compliant
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- The ISO 13485 Calibration System Procedure establishes the process and methodology used to ensure medical device manufacturing and test equipment is calibrated to defined specifications. ISO 13485:2016 Compliant
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Validation Protocol and Report Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 Validation Protocol and Report Procedure governs the structure and content of all validation protocols and reports (IQ, OQ, PQ and PPQ) made part of product development and process validation.
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Medical Device Process Validation Procedure
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The Medical Device Process Validation Procedure provides guidance on medical device process validations. The ISO 13485Process Validation Procedure applies to all medical device manufacturing processes requiring validation prior to the commercial release of product.
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