- All documents are written in MS Word or Excel format for ease of editing
- Blue text highlights areas that require your input
- Procedures list any required forms
- Directly referenced by our ISO 13485 Quality Manual
- Valuable in your ISO 13485 training efforts
- Meets your need to attain ISO 13485 certification
Save time and money with a complete procedures package!
- P-424 Document Control
- P-425 Control of Quality Records
- P-500 Management Responsibility
- P-620 Competence, Awareness and Training
- P-630 Infrastructure
- P-640 Work Environment
- P-710 Planning of Product Realization
- P-720 Customer Related Processes
- P-722 Risk Management
- P-730 Design and Development
- P-740 Purchasing
- P-750 Control of Production & Service
- P-756 Validation Processes For Produ
- P-758 Identification and Traceability
- P-7510 Customer Property
- P-7511 Preservation of Product
- P-760 Control of Monitoring and Measuring Equipment
- P-820 Post Production Feedback
- P-824 Internal Audits
- P-826 Monitoring & Measurement of Product & Realization
- P-830 Control of Nonconforming Product
- P-833 Product Recall and Advisory Notice
- P-840 Statistical Techniques
- P-841 Root Cause Analysis
- P-852 Corrective Action
- P-853 Preventive Action
13485:2016 Procedures are available individually:
We give you more! These individual Procedures Packs also include any forms referenced in the procedures. To see which forms are included with specific procedures, please view the 2016 procedures-forms matrix.
| Procedure | 13485:2016 | |
|---|---|---|
P-424 Document ControlThis procedure describes the process for controlling quality system documents. Includes forms:
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$39.00 Add to Cart |
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P-425 Control of Quality RecordsThis procedure describes the process for controlling records generated in the quality system. Includes Form:
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$39.00 Add to Cart |
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P-500 Management ResponsibilityThis procedure describes Management Responsibilities for the Quality Management System (QMS). Includes forms:
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$39.00 Add to Cart |
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P-620 Competence, Awareness, and TrainingThis procedure describes the process for ensuring that each employee is competent for the job they are performing. Includes forms:
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$39.00 Add to Cart |
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P-630 InfrastructureThis procedure describes the process for determining, providing, and maintaining the infrastructure needed to achieve conformity to product requirements. Includes form:
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$39.00 Add to Cart |
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P-640 Work EnvironmentThis procedure describes the process for determining, providing, and maintaining the work environment needed to achieve conformity to product requirements. Includes forms:
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$39.00 Add to Cart |
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P-710 Planning of Product RealizationThis procedure describes planning of all product realization processes. Includes form:
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$39.00 Add to Cart |
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P-720 Customer Related ProcessesThis procedure describes the process used for communicating with customers and reviewing information from the customer, including customer feedback. Includes form:
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$39.00 Add to Cart |
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P-722 Risk ManagementThis procedure defines the Risk Management process and application. Includes form:
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$39.00 Add to Cart |
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P-730 Design and DevelopmentThis procedure describes the process for controlling the design and development of product or services. Includes form:
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$39.00 Add to Cart |
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P-740 PurchasingThis procedure describes the process for controlling the purchasing process at Your Company to ensure that the purchased product conforms to requirements. Includes forms:
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$39.00 Add to Cart |
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P-750 Control of Production & ServiceThis procedure describes the process used to provide controlled conditions under which the key product realization processes are performed. Includes forms:
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$39.00 Add to Cart |
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P-756 Validation Processes For ProductThis procedure describes the process for validation of processes for production and service provision where output cannot be verified by subsequent monitoring or measurement. Includes form:
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$39.00 Add to Cart |
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P-758 Identification and TraceabilityThis procedure describes the process for identifying materials and product throughout production, service, and delivery. Includes form:
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$39.00 Add to Cart |
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P-7510 Customer PropertyThis procedure describes the process used to identify, verify, protect, and safeguard customer property. Includes form:
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$39.00 Add to Cart |
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P-7511 Preservation of ProductThis procedure describes the process for handling, packaging, storage, and protection of materials, parts, and products to preserve the conformity of product through delivery to its intended destination. Includes form:
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$39.00 Add to Cart |
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P-760 Control of Monitoring and Measuring EquipmentThis procedure outlines the requirements for control of measuring and monitoring equipment. Includes form:
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$39.00 Add to Cart |
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P-820 Post Production FeedbackThis procedure defines the process to collect feedback and review information on medical devices in post-production phases. It also defines the process for the handling of complaints and the review of information on medical devices and introduces the process for the reporting of complaints to regulatory authorities.
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$39.00 Add to Cart |
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P-824 Internal AuditsThis procedure describes the process for performing Internal Audits at Your Company. Includes forms:
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$39.00 Add to Cart |
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P-826 Monitoring & Measurement of Product & RealizationThis procedure describes the process of monitoring and measuring of product and product realization processes. Includes form:
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$39.00 Add to Cart |
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P-830 Control of Nonconforming ProductThis procedure describes the process used to ensure that the product that does not conform to product requirements, is identified and controlled to prevent its unintended use or delivery. Includes forms:
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$39.00 Add to Cart |
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P-833 Product Recall and Advisory NoticeThis procedure describes the process used to determine and control the recall and withdrawal of medical devices for cause, the issuance of advisory notices and generation of regulatory reports, as and when required. Includes form:
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$39.00 Add to Cart |
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P-840 Statistical TechniquesThis procedure describes and defines the techniques utilized in statistical analysis which are used to monitor and measure the QMS and related sub-systems. |
$39.00 Add to Cart |
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P-841 Root Cause AnalysisThe purpose of this procedure is to provide a method to assist assigned individuals in performing consistent, complete, and satisfactory Root cause analysis. Includes form:
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$39.00 Add to Cart |
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P-852 Corrective ActionThis procedure describes the process for eliminating the cause of nonconformances through the use of the Corrective Action system. Includes form:
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$39.00 Add to Cart |
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P-853 Preventive ActionThis procedure describes the process for preventing or eliminating the cause of nonconformances through the use of the Preventive Action system. Includes form:
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$39.00 Add to Cart |