ISO 9001 Consulting | ISO 9001 Consultants

Understanding the requirements, needs, and implementation methods for an ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 based quality management system (QMS) can be a difficult task. Organizations spend a great deal of time and money in simply trying to understand what they need to do. This time and money is better-spent improving the business and providing products or services to the customer. In order to eliminate the time and expense of discovery, mistakes, and trial and error Pinnacle Enterprise Group (Pinnacle) has created the Lean QMS® Curriculum. The Lean QMS® Curriculum is a comprehensive approach that provides your organization with the knowledge and skills needed to effectively develop, implement, and maintain of a lean and high performance Business Management System.

" biggest concern, like in most companies, was how do you get through the bureaucratic documentation structure. Knowing the difficulty in managing this, I was immediately sold on Pinnacle's Lean QMS methodology and simplification in providing RAD with an effective and efficient solution in documenting the quality system. We achieved registration in seven months. This included dual registration to TL 9000 & ISO 9001. Thanks Pinnacle for an excellent job!"

Peter Kucharik, VP Operations
RAD Data Communications, Inc.

Pinnacle's approach is more than a simple QMS standard certification program. Simply addressing generic requirements and passing a Certification Audit just buys you an expensive certificate to hang on a wall. To bring long-term value the QMS must be rational, practical, and efficient. It must continually define, describe, and control all business processes (including quality, technical, and regulatory processes). Furthermore, maintaining registration (certification) mandates a sustained mind set and proficiency. Simply put, your staff must have the skills and knowledge needed to take ownership of the process and have the ability to maintain and improve it into the future.

To foster this organizational commitment, Pinnacle employs and assigns only seasoned professionals that will transfer the knowledge and skills necessary to achieve certification and support the continual improvement philosophy.

As part of the Lean QMS® Curriculum, a Pinnacle Project Director is assigned to your organization to serve as your teacher, coach, and mentor through each element of the project. He or she transfers the knowledge and skills to your staff by working hands-on with them at your facility(ies). Each element of the Lean QMS® Curriculum and each visit by the Project Director are customized to ensure that your organization can effectively develop, implement, manage, use, and improve your Quality Management System while maintaining certification. One of the objectives is to eliminate the dependence on additional outside assistance.

The Lean QMS® Curriculum can include the following elements. Each element is custom tailored to fit your organization's specific needs:

The world's top Registrars have certified Pinnacle's clients with a 100% success rate. This is why Pinnacle can guarantee that you will get certified the first time.

Furthermore, each custom tailored Lean QMS® Curriculum is delivered at a fixed cost and is typically completed within 3-6 months.

Contact Pinnacle to discuss your Lean QMS® Curriculum.

Schedule a Lean QMS® demo and see for yourself.

Lean QMS® Documentation - Overview

ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 require minimal documentation. For example, ISO 9001 only requires that, at a minimum, your QMS be rationalized and articulated by:

  1. A Quality Manual
  2. 6 Documented Procedures (Pinnacle refers to these as Support Processes)
    1. Document Control
    2. Record Control
    3. Control of Non-Conforming Product (or Service)
    4. Internal Audits
    5. Corrective Action
    6. Preventive Action
  3. At least 21 Records - List of ISO 9001 required records

Unfortunately, these requirements are traditionally misunderstood resulting in the following false paradigm being applied to a QMS:

Lean QMS

While this paradigm may be appropriate for describing a documentation structure, companies rarely operate in this way. In fact, this paradigm is typically the cause of over documentation. The resulting paperwork glut quickly becomes "shelf-ware" and a burden to the QMS.

Pinnacle developed a realistic and practical process-based model than consists of three major components:

  1. Management Policies or Processes (MP) - Policies or processes that set the mission, vision, and direction of the organization.
  2. Support Processes (SP) - Processes that facilitate, monitor, control, and improve the QMS, but do not directly impact the product/service or the customer.
  3. Core Processes (CP) - A set of sequenced and interrelated processes defining and controlling all product and service realization activities. These are processes directly impact the product/service and/or the customer.

The figure below illustrates the model and the relationship of these components:

ISO 9000 Consulting Services

In turn, these three components are supported by:

  1. Work Instructions (WI) - Specific or individual task level instructions that support the fulfillment of Core or Support Processes.
  2. Forms/Records (F) - Standardized forms that, when completed, collect information that is retained as records. A form becomes a record when it is written on or completed. When forms contain enough task level instructions they can replace Work Instructions.

This process model is the foundation for Pinnacle's Lean QMS® methodology. The resulting QMS documentation exceeds the requirements of ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 while laying the foundation for a rational, practical, and Lean BOS®.

Lean QMS® Documentation - QMS Map

ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 require an organization to describe "the interaction between processes" of the QMS at the highest level. This is the role of the traditional Quality Manual. The intent is to articulate and demonstrate that you view your business as a set of interrelated processes (vertical and lateral process integration).

Pinnacle's advanced methodology includes the replacement of the traditional Quality Manual with Pinnacle's excusive QMS Map. The QMS Map functions as an interactive interface for your QMS. The QMS Map:

  1. describes the scope your QMS,
  2. identifies how ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 is applied in your organization using a "smart number" system,
  3. identifies what processes make up your QMS, and
  4. describes the rational interaction between your QMS processes.

This unique approach eliminates the non-value-added traditional Quality Manual and the time organizations spend creating, editing, and maintaining it.

Below is Pinnacle's model of an interactive QMS/EMS Map that replaces a traditional Quality Manual (and "Environmental Policy Manual"):

ISO 9000

Schedule a Lean QMS® demo and see for yourself.

Lean QMS® Documentation - Process Mapping

ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 require an organization to follow a process approach when managing its business. Process Maps are ideal for this purpose.

A Process Map is a graphical representation of a process. It represents the entire process from start to finish, including:

  • process inputs and outputs,
  • activities and responsibility,
  • pathways, parallel processes, and process loops,
  • decision points,
  • key measures, metrics, objectives, and targets, and
  • interaction with other processes.

"While we had already achieved ISO 9000 registration, our text based processes were difficult to implement and maintain. This was causing our Quality Management System to be less efficient than we wanted. Pinnacle led us through a four month conversion process to a Process Map based system. Now all of our processes are easy to understand, easy to follow, easy to audit and maintain. Our new system is being used on a daily basis by people throughout the organization"

Kendall Ymker
Management Representative
RoMan Manufacturing, Inc.

Depending on your objectives, a Process Map can represent the entire process at a high or detailed level, allowing detailed analysis and process optimization. Furthermore, a Process Map is an ideal instructional tool for assuring effective training and process consistency. Once Process Maps are established, an organization can work towards ensuring its processes are effective (the right process is followed the every time), and efficient (continually improved to ensure processes use the least amount of resources).

Process Mapping is the fundamental QMS documentation methodology used of the Lean QMS® Curriculum. (Read "Process Mapping & Process Redesign" article)

Traditional text procedures do not serve your QMS well. In general, they are long, confusing, unable to show parallel processes, unavailable (in binders), and require strong reading comprehension and retention skills. These issues are magnified in companies that must also contend with language and cultural differences.

Process Maps on the other hand can be 1/5 the length, show a greater amount of detail and complexity, are easy to follow, and are readily available (posted on walls, accessed via intranet, etc.). Process Maps play on the strength of the brain to recognize and recall patterns. They take a very complex system and make it a simple step-by-step operation that is visually intuitive. Inconsistencies and open loop processes are easily identified when placed in a graphical model. The Process Maps are then easily modified and used to train people quickly. Consequently, improvements are introduced in a matter of minutes. Having the ability to develop and maintain process mapped documentation as your organization evolves is a key component of the Lean QMS® methodology.

Contact Pinnacle to discuss your Lean QMS® Curriculum.

Schedule a Lean QMS® demo and see for yourself.