Introduction
Introduction
ISO 9001 Implementation Plan with 5 Essential Elements & 12 Key Steps, which are concurrently executed.
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
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
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
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
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
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
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
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
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
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
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
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
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
Audit for Certification by an Accredited Certification Body
We have significant experience and resources for implementing Quality Management Systems, which meet the requirements of ISO 9001. 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.
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.
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