ISO 13485 Implementation Plan


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A Flexible Program for Implementing an ISO 13485 Quality Management System on a Fast Track

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Introduction
Introduction

Introduction

ISO 13485 Implementation Plan with 12 Key Steps and 5 Essential Elements, which are concurrently executed.

12 Key Steps
12 Key Steps

12 Key Steps

Our implementation plan focuses the organization on (12) key elements, which are deployed through a series of on-site visits (OSV) and remote video sessions.

(1) Goals
(1) Goals

(1) Goals

Identification of Client (Your) Goals. Understanding the client’s goals and time-line for completion is essential for a successful implementation.

(2) Processes
(2) Processes

(2) Processes

Identification of Key Processes & Owners. Provide the client with guidance as needed to determine what the essential key processes in the business are and how do these processes interact with the QMS.

(3) Checklist
(3) Checklist

(3) Checklist

Guidance for the Quality Management Essentials. Provide the client with guidance as needed to determine if fundamental documents for employees, quality and work instructions are in place and, or practice.

(4) Planning
(4) Planning

(4) Planning

Identification of the Requirements for Planning Product Realization. Provide the client with guidance as needed to determine how customer requirements and product requirements are established, maintained and verified.

(5) Regulatory
(5) Regulatory

(5) Regulatory

In addition to customer and product requirements, provide the client with guidance as needed to determine what other requirements are imposed on the client and how they are fulfilled.

(6) Documentation
(6) Documentation

(6) Documentation

Identification of the Requirements for the Preparation of Documentation. Provide the client with guidance as needed to determine what documentation is needed to meet the requirements of the Standard, the client’s customer requirements and other requirement. Include quality checklist, work instructions and flow-charts as needed.

(7) Design
(7) Design

(7) Design

Identification of Requirements for Design & Development. Provide the client with guidance as needed to determine the flow of design input, design approval, design output and the necessary documentation to record the appropriate approvals.

(8) Measurements
(8) Measurements

(8) Measurements

Identification of Requirements for Measurement, Analysis & Improvement. Provide the client with guidance as needed to determine, from the client’s quality objectives, what are the appropriate metrics for measuring and monitoring quality effectiveness.

(9) Purchasing
(9) Purchasing

(9) Purchasing

Identification of Requirements for Purchasing. Provide the client with guidance as needed to determine the appropriate methodologies for evaluating suppliers and controls for verification of purchased products, which includes scoring suppliers and establishing acceptable quality levels (AQL) when appropriate.

(10) Records
(10) Records

(10) Records

Identification of Requirements for the Control of Documents & Records. Provide the client with guidance as needed to determine the controls for documents and records that are appropriate for the client’s environment and resources.

(11) Auditing
(11) Auditing

(11) Auditing

Internal Audit and Guidance for Internal Process Auditing. Provide the client with guidance as needed to establish and document a process for scheduling, planning and conducting an Internal Audit of the client’s key processes.

(12) Mgt. Review
(12) Mgt. Review

(12) Mgt. Review

Management Review & Assessment of the QMS Effectiveness. Provide the client with guidance as needed to establish and document a process for scheduling, planning and conducting a Management Review meeting, which includes review of QMS inputs, outputs and analysis of the QMS effectiveness.

(Final) Certification
(Final) Certification

(Final) Certification

Audit for Certification by an Accredited Certification Body

ISO 13485 specifies requirements for a Quality Management System for organizations required to demonstrate its ability to provide medical devices that consistently meet client and regulatory requirements.

ISO 13485 is the most accepted global standard of its kind and will bring your business a host of benefits, including:

  • Full ISO 13485 compliance – which is fast becoming a prerequisite for regulatory authorities everywhere
  • Be confident that your company has a quality system that meets the demands of legislation in every corner of the global market
  • ISO 13485 will establish robust development, manufacture, distribution and control processes
  • The standard will help to optimize efficiency and minimise costs
  • ISO 13485 will also help you to monitor your supply chain so that you are always in control

Patient safety is a priority in the medical device manufacturing industry

As a medical devices manufacturer, you have a responsibility and requirement to consistently deliver devices that are high quality, safe and effective. The medical device industry is made up of many different and complex regulations, standards and other requirements. The international medical device standard, ISO 13485, helps manufacturers to become compliant and open up global market channels.

Committed to quality and continual improvement

Achieving a certification to an ISO standard demonstrates that your company is serious about delivering quality products through tested processes. Internally, the implementation of ISO standards provide focus and discipline and externally you will achieve credibility, authority and “world class” recognition.

Increase customer confidence, improve customer satisfaction and maintain a market edge; find out more about how your company can achieve ISO 13485 compliance by contacting ABCI Consultants.

We have significant experience and resources for implementing Quality Management Systems, which meet the requirements of AS9100. Our ASQ international network of consultants and auditors has helped businesses across the USA improve their customer satisfaction, product realization quality and reduce their operating expenses by improving the development of their human resources through systematic processes.

We have developed a fast track program for the Implementation of Realistic Quality Management Practices, which shall prepare a business for AS9100 Certification by an accredited Certifying Body. The program designed to be on an accelerated fast pace. However, we can customize the program to meet your business requirements, scheduling requirements and time-line for completion. Our program includes:

  • An in-depth review of your business and quality management consultation.
  • A well documented Quality Management System (QMS), which includes a QMS policy manual, QMS Objectives, QMS procedures manual, required forms, logs and a cross-reference index to your external documents, process and work instructions.
  • Development of simple and easy to maintain metrics for the purpose of measuring and monitoring your quality effectiveness on a continual basis.
  • A series of three hour training workshops on your premises for your quality team members, which will insure your personnel are adequately trained to operate your Quality program and meet the requirements for AS9100C Certification.
  • Optionally, we will include QMSCAPA software for managing key elements of your system, which includes internal auditing, corrective and preventive records for management review.