ISO 9001:2015 Implementation

ITG uses a lean approach that was popularized in the 1950’s by Dr. W. Edwards Deming regarding ISO 9001:2015 Implementation. He proposed that business processes should be analyzed and measured to identify sources of variations that cause products to deviate from ideal requirements. ITG uses this approach to help management define what improvements can be established to effectuate necessary changes to meet best practices, drive innovation, and continually improve processes and performance.

While each engagement is modified to fit, individual client needs, the core methodology is based on Deming’s use of the “Shewhart cycle”, the Plan-Do-Check-Act (PCDA), which is a continuous process model that is a combination of iterative and defined activities to manage and control processes to achieve operational excellence through continual quality improvements. It is a simple and effective technique that provides a strong foundation for optimizing processes, delivering complex products or services, and managing projects.

Plan-Do-Check-Act (PDCA) Cycle

The Plan-Do-Check-Act (PDCA) Cycle provides a simple and effective approach for managing change and ensuring that ideas are appropriately tested before committing them to full implementation. The PDCA method can be outlined as follows:

  • Plan: Identify and analyze the work. Activities: define goals and objectives, identify requirements and risks, set a schedule with milestones, and document planned activities.
  • Do: Develop and test a potential solution. Activities: implement planned activities, train personnel, collect measures, and maintain relevant records.
  • Check: Measure how effective the test solution is and determine if the solution can be improved. Activities: conduct audits, assess performances, evaluate data, and analyze reports.
  • Act: Implement the improved solution. Activities: prevent and correct issues, modify processes, retrain staff, implement improvements, and verify effectiveness.

In addition to understanding the philosophy behind this approach to quality and process management, it is important to understand what is required to achieve certification.

An organization ultimately needs to understand the ISO 9001:2015 requirements and apply the principles to the way operations are performed. Our certified ISO 9001 Consultants can show you how to successfully prepare for and achieve an ISO 9001 implementation, and strategically support your quality goals and objectives.

ISO 9001:2015 Major Sections

For an organization to successfully complete an ISO 9001 implementation, the organization must demonstrate adherence to the requirements of the ISO 9001:2015 Standard and its seven major sections (Clause 4 through 10) (plus general introduction to the ISO 9001 Standard – Clauses 1 through 3):

Section Expectations
1-3 ISO Scope, References, Terms General introduction notes to the standard
4 Context of the Organization Determining the scope of an organization’s Quality
Management System (QMS)
Plan and Implement QMS
5 Leadership Leadership Commitment
Quality Policy
Customer Focus
6 Planning Quality Risk Management
Quality Objectives
Change Management
7 Support Resource Management
Monitor and Measure
Maintain Organizational Knowledge
Communication
Document Management</td
8 Operation Operational Planning and Control
Planning and requirements for product/service
Production and Service
9 Performance Evaluation Customer Satisfaction
Analysis of Performance
Internal Audit
10 Improvement Corrective Action
Continual Improvement

Wondering how to manage an ISO 9001 implementation and get ISO 9001 Certified, as well as how to maintain an ISO Certification?

Learn more about how we can accelerate your ISO 9001 implementation. We will contact you the moment we receive your information to discuss. Let our certified and experienced ISO 9001, ISO 20000 and ISO 27001 Consultants show you how, and strategically support your quality goals and objectives.