ISO9001:2008

ISO 9001 is used to increase confidence in products and services offered by certified organizations and provide the framework for organizations to evaluate their quality management systems. This standard applies to any size organization—small, medium, or large—and all types of organizations—private or public sector. The 2008 version replaces the year 2000 version currently implemented in 170 countries worldwide.

All businesses registered to the ISO 9001:2000 standard must recertify to the ISO 9001:2008 version by November 14, 2010. Existing certifications to ISO 9001:2000 will be invalid after November 14, 2010.

Tanzco can provide training and implementation guidence that will prepare your organization for ISO9001:2008 certification.

Whether you decide on a traditional approach to certification or choose the Lean QMS approach that we offer with our partner the Pinnacle Enterprise Group you will gain insight and skills to use your certification effort to drive improved performance for your entire business and the skills to create and sustain continuous improvement.

As an incentive to start on the path, we are offering a free readiness assessment and brief overview of the requirements including:

  • Overview of the 8 Management Principles
  • The ISO 9001 Approach
  • Key changes between the 2000 and 2008 versions
  • An opportunity for Q&A

Call to day to request your free assessment.

Lean QMS® Advantage

"The more I see the system you helped us put together, the more I realize how much easier it is use and maintain." Peter Kucharik, VP Operations RAD Data Communications, Inc.   Lean QMS has 80% less documentation than a traditional ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 based QMS Manual. A 1-page Quality Manual = Lean QMS® Map that serves as a graphical interface for the QMS 1-2 page Process Maps and flowcharts instead of long text procedures Process focused instead of procedure and documentation focused elimination of non-value-added documentation. Easy to implement, train to, and navigate Visual management applied to QMS documentation

Smart document numbering system

Can be paperless on your existing IT infrastructure

no software or hardware to buy

All documents in MS Office applications

Quality objectives, key process indicators (KPI), and process measurement & monitoring are visually integrated into each process map

Platform for continual improvement and integration of advanced quality tools (e.g. Lean, Six Sigma, statistical techniques, etc.)

Seamless integration with ISO 14001 and OHSAS 18001

 

ISO 9000 / ISO 9001 - Based Lean QMS ® Curriculum 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. "...my 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 us today 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)
    • Document Control
    • Record Control
    • Control of Non-Conforming Product (or Service)
    • Internal Audits
    • Corrective Action
    • 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:  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. 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). "This auditor has conducted over 850 audits and I must tell you that the documentation system observed at Axcel is one of the finest I have ever seen. The way the 'Lean QMS Map' connects to all other documents and then to the records themselves is excellent." Edward Sykes, Lead Auditor TUV Rheinland of North America 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"): 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. 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. Schedule a Lean QMS® demo and see for yourself.

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Lean QMS reduces implementation time by over 50%