ISO 9001 Quality Systems Implementation

Certified MBE

We can work with you in two ways to help implement ISO 9001 in your organization

  1. Work directly with you to implement ISO 9001 by developing a custom system that meets the minimum requirements of the 9001 standards.
  2. Use our skill sets (i.e. process identification, process mapping, process measurement & monitoring, problem solving & root cause analysis, Lean, Six Sigma, etc.) to help you engineer or re-engineer a business management system that achieves ISO 9001. Our service deliverables typically include the seamless integration of advanced methods and rapid deployment & implementation techniques.

What is ISO 9001?

ISO 9001 is an international quality management system (QMS) standard. It offers fundamental management and quality assurance practices that can be applied to service and manufacturing organizations. The requirement offers a powerful foundation of planning, control, and improvement for just about any organization. Without a QMS, organizations may have little chance of sustaining any improvements or innovations they might attain.

Because ISO 9001 is generic it is also quite flexible. In very few places does the standard specify exactly what your organization must do. In most cases, the standard allows a great deal of discretion to your organization in terms of how to design your processes and procedures. This enables you to customize your approach to ISO 9001 compliance.

In supplying products or services there are three fundamental parameters that determine their salability. They are price, quality and delivery. Customers require products or services of a given quality to be delivered or be available by a given time and to be of a price that reflects value for the money.

While price is a function of cost, profit margin, and market forces, and delivery is a function of the organization’s efficiency and effectiveness, quality is determined by the extent to which a product or service successfully serves the purpose of the customer. Price and delivery are both fleeting features, whereas the impact of quality is sustained long after the attraction or the pain of price and delivery has subsided.

Quality in ISO 9001 is defined as the degree to which a set of inherent characteristics fulfills customer requirements. The implication is that quality is relative to what something should be and what it is. This could be a product, service, document, piece of information or any output from a process.

Implementing an ISO 9001 quality system can be very beneficial to small-medium size middle market companies faced with the challenges of employee retention, business growth, and cost concerns. Some of the benefits that impact these challenges are:

  • Increased quality/reduced cost of poor quality (scrap, rework, and inspection)
  • Increased marketability—Nearly all observers agree that ISO 9000 registration provides businesses with markedly heightened credibility with current and prospective clients alike. Provides a competitive advantage and could increase sales and market share.
  • Reduced operational expenses—The cost of defects, scrap, rework, returns, and the employee time spent analyzing and troubleshooting various products are all considerably reduced by initiating the discipline of ISO 9000
  • Improved customer service—The process of securing ISO 9000 registration often serves to refocus company priorities on pleasing their customers in all respects, including customer service areas. It also helps heighten awareness of quality issues among employees.
  • While people want to have security at work, most employees also want to be satisfied with the work they do. And engaging the employees in the processes of the Quality Management System can improve their job satisfaction.
  • As well, employees who receive training within their organization feel as if they are more a part of the overall team. If the company management is willing to put the time and resources into training employees, then the employees will feel more appreciated and valued. These employees will be engaged in their work and more focused and integrated with helping the company succeed.

Good quality is an outcome of your processes that is why we focus on improving your processes before documenting your quality system.

ISO 9001:2015

The standard’s structure has changed and now encapsulates 10 general divisions: scope, normative references, terms and definitions, support, performance evaluation, performance improvement, context of the organization, leadership, planning, and operation.

One of the key notions encompassed in the developing language of ISO 9001:2015 involves a more explicit definition of the “process approach.” An organization’s QMS must be built around processes where products or services are the output. The primary objective, and in fact the overarching reason for these processes, is to meet customer requirements. The process approach as described in the 2008 version of ISO 9001 left many organizations confused about this requirement. The 2015 version provides

ISO 9001

ISO 9001 international quality management system

clarity and better guidance.

Some of the key points of the standard are as follows: 

  • Risk management has been added with a focus on risk-based thinking. Identification of risk and risk control is now a requirement.
  • Standardized core text, structure and definitions.
  • There is a major focus on organizations creating value for their customers.
  • The 2015 revision has more applicability to service organizations.
  • Primary focus remains on customers.

The ISO 2015 Transition deadline is fast approaching, and all ISO 9001 certificates must transition to the new standard by September 14, 2018.  After that date, all 9001:2008 certificates will no longer be valid, and this may affect your ability to supply to all markets.

“After my first phone call to Willie Carter I knew I was in good hands. Willie was very easy to work with and his response time was excellent, his experience and knowledge is second to none. When I first contacted Willie I wanted to improve our quality management system as well as streamline our quality manual. Both of these objectives were achieved, shortly after we finished this project we had an ISO 9001 continuous assessment with no findings and plenty of compliments.”– Tony Mallon – Quality Manager – Nimlok – Niles, IL

Want to learn more about our ISO 9000 services? Call us 847-919-6127 or complete our contact form.