ITG uses a lean approach that was popularized in the 1950’s by Dr. W. Edwards Deming for achieving ISO 9001:2015 certification. 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.
ISO 9001:2015 Implementation Steps
In order to implement an Quality Management System (QMS) that integrates and aligns quality with business needs, the following should be considered for an effective implementation:
- Start with a gap assessment to provide a starting point
- Understand the scope of your program
- Determine the level of support needed
- Outline your business plan (consider a SWOT analysis)
- Identify the expectations and requirements of stakeholders
- Assign a governance structure along with roles and responsibilities
- Align ISO 9001 with compliance requirements can help an organization integrate multiple demands for regulatory and customer requirements
- Establish a quality policy and measurable objectives that align to your business goals
- Evaluate risks and opportunities associated with your goals and objectives
- Capture the flow of existing processes and determine what processes should be documented
- Define how you will monitor and measure processes, plans, and performance
- Educate staff on expectations of the standard and their role in quality and continual improvement
- Implement methods to monitor the effectiveness of your QMS to ensure performance results are achieved
- Establish a method for managing changes, corrective actions, and improvements
- Develop an audit program to ensure your QMS is properly maintained and is continually successful
- Conduct audits, review performance, identify any actions needed, and continue to monitor performance and improvements
Conduct an initial gap analysis
One of the preliminary steps in an ISO implementation initiative is to conduct an initial gap analysis to strategically identify business operations and align quality directives. What your company will achieve after an initial gap analysis (or gap assessment)
- Reduce the timeframe for implementation;
- Minimize the costs associated with implementation and maintenance of requirements;
- Transform existing practices to meet requirements and minimize impact to the organization’s operations;
- Instruct staff on expectations of the standard; and
- Ensure successful achievement of certification.
Our approach to providing a gap analysis is broken into two key stages: planning and discovery. The intent of beginning with a gap analysis is to review your current policies, systems, applications, and existing controls.
We implement this practice to provide scope definition, assess gaps, strengths, and weaknesses, define the gap schedule, roles and responsibilities, determine level of effort required of internal staff, and evaluate if external support will be needed. The success of a project starts with how well it is planned, monitored for effectiveness, and communicated to stakeholders.
Phase One: Planning
Project planning begins at contract execution; we start with a kick off meeting to provide an executive overview and to ensure we have a full understanding of your expectations. Post kick-off, we work with your team to discuss scope, establish a schedule for document review and interviews to evaluate /the processes that need to be assessed.
The intent of this phase is to provide an opportunity for our team to meet with key stakeholders to review your objectives, discuss mission and goals, outline the schedule of activities, identify key personnel for interviews, and assess existing documentation for review to finalize a plan for conducting the gap analysis.
Phase Two: Discovery
The second stage consists of performing a gap analysis to identify gaps against the ISO 9001:2015 standard. We conduct interviews based on areas of responsibility, process ownership, and diversity of activities performed, including discussions on how the organization currently operates and any upcoming changes to your Quality Management System. Our approach will be to interview process owners and a sampling of personnel existing processes, focusing on the input and output of each process along with monitoring and performance measures.
During the gap analysis, we identify gaps against the requirements of the standard as well as identify recommendations on how to address any weaknesses or gaps. The gap analysis concludes with a report that details all gaps and recommended action plans. As we present the results, we make recommendations on timeline and any support your team requires to prepare for next steps. ITG’s experienced ISO Consultants can inform you about every detail in a gap analysis.
What you should avoid in an ISO 9001 Implementation
The common challenge of an ISO 9001 certification that many organizations face is the creation of complicated or unnecessary solutions in response to the guidance requirements of the ISO 9001:2015 Standard. These scenarios leave most companies needing ISO implementation help.
Over-engineering your ISO 9001 standard
By over-engineering your operations, organizations expend resources and time, as well as have a less favorable opinion of the benefits of implementing ISO 9001. Since each organization will have a different interpretation of the ISO 9001 requirements and clauses making the ISO Implementation difficult, many organizations choose to enlist the support of an ISO consultant to help.
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.