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ISO 13485:2016 Procedures Individual Packages

A proven, efficient system with all the necessary elements in place

$35.00

Our ISO 13485 procedures are designed for you to use with your ISO 13485 Quality Management System, as required by the ISO 13485 Standard. Our easy-to-customize procedures relate directly to a section of the standard with the following features:

  • 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!

 

Product Details

Product Type: Digital

Price: $35.00

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 Control

This procedure describes the process for controlling quality system documents.

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P-425 Control of Quality Records

This procedure describes the process for controlling records generated in the quality system.

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P-500 Management Responsibility

This procedure describes Management Responsibilities for the Quality Management System (QMS).

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P-620 Competence, Awareness, and Training

This procedure describes the process for ensuring that each employee is competent for the job they are performing.

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P-630 Infrastructure

This procedure describes the process for determining, providing, and maintaining the infrastructure needed to achieve conformity to product requirements.

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P-640 Work Environment

This procedure describes the process for determining, providing, and maintaining the work environment needed to achieve conformity to product requirements.

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P-710 Planning of Product Realization

This procedure describes planning of all product realization processes.

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P-720 Customer Related Processes

This procedure describes the process used for communicating with customers and reviewing information from the customer, including customer feedback.

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P-722 Risk Management

This procedure defines the Risk Management process and application.

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P-730 Design and Development

This procedure describes the process for controlling the design and development of product or services.

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P-740 Purchasing

This procedure describes the process for controlling the purchasing process at Your Company to ensure that the purchased product conforms to requirements.

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P-750 Control of Production & Service

This procedure describes the process used to provide controlled conditions under which the key product realization processes are performed.

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P-756 Validation Processes For Product

This procedure describes the process for validation of processes for production and service provision where output cannot be verified by subsequent monitoring or measurement.

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P-758 Identification and Traceability

This procedure describes the process for identifying materials and product throughout production, service, and delivery.

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P-7510 Customer Property

This procedure describes the process used to identify, verify, protect, and safeguard customer property.

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P-7511 Preservation of Product

This 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.

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P-760 Control of Monitoring and Measuring Equipment

This procedure outlines the requirements for control of measuring and monitoring equipment.

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P-820 Post Production Feedback

This 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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P-824 Internal Audits

This procedure describes the process for performing Internal Audits at Your Company.

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P-826 Monitoring & Measurement of Product & Realization

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P-830 Control of Nonconforming Product

This 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.

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P-833 Product Recall and Advisory Notice

This 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.

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P-840 Statistical Techniques

This procedure describes and defines the techniques utilized in statistical analysis which are used to monitor and measure the QMS and related sub-systems.

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P-841 Root Cause Analysis

The purpose of this procedure is to provide a method to assist assigned individuals in performing consistent, complete, and satisfactory Root cause analysis.

Root Cause Analysis Online Training

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P-852 Corrective Action

This procedure describes the process for eliminating the cause of nonconformances through the use of the Corrective Action system.

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P-853 Preventive Action

This procedure describes the process for preventing or eliminating the cause of nonconformances through the use of the Preventive Action system.

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