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Management Systems

Table of Contents

ISO Management Systems
ISO Success Factors
Why has ISO failed, in the real world, to live up to its full potential?
PQA’s 8-Step ISO Implementation Program
Learn how PQA's ISO Expertise can help you

ISO Management Systems

PQA provides implementation assistance for a wide range of ISO management systems:

  • QS-9000   Based on ISO 9001 for Ford, Chrysler, GM, Navistar, etc. suppliers

  • ISO 9001:2000 Quality Management System

  • ISO/TS 16949 for Automotive

  • ISO 13485/88 for Medical Devices

  • ISO 14001 Environmental Management System

  • ISO 17025 for Testing, Calibration, Measurement, & Certification laboratories

  • ISO 46001 for CE Mark

  • Good Manufacturing Practices (GMP)

  • Hazard Analysis Critical Control Point (HACCP)

ISO Success Factors

The ISO 9000 series of standards (including ISO 9001:2000) has been the most widely adopted set of quality management systems ever conceived. Implementing an ISO based system can be a tremendous benefit to organizations.  Some organizations have achieved as high as a 1700% ROI by implementing ISO. 

For the average organization however, ISO has become a mediocre initiative for helping an organization remain effective &/or competitive.  On average, PQA estimates that ISO has helped companies achieve only a 16.25% return on investment.

When management, stockholders, and accountants are demanding pay backs of 100% to 300% (ie. 1 year to as short as a 4 month payback), ISO can easily become an “also-ran”, or a non-starter.

Why has ISO failed to live up to its full potential?

Go to PQA's White Paper on “Return on Investment from Implementation of an ISO-based Quality Management System”

Buy a copy of PQA's Whitepaper on: Why ISO has failed to live up to its full potential

Based on our research in why some companies had such great success with their ISO implementations and others failed spectacularly, PQA has identified  10 Critical Success Factors that make an ISO implementation successful. They are, in order of importance:

  • Management's recognition of their crucial role in the ISO system management process

  • Involvement of people at all levels in the organization

  • Developing a better understanding of the organizational processes and the critical points in the process that must be controlled to satisfy customer needs & expectations

  • People trained in how to do their job (including ISO Training)

  • A willingness to provide the effort and self-discipline to change the system for the better

  • Focusing on organizational development & improvement, not on just getting to the ISO certification finish line

  • Finding the right balance between too much ISO paperwork, and not enough information to do the job consistently.

  • Dedication to following the agreed procedures at all levels in the organization

  • Keeping the organization focused on meeting the ISO implementation timeline

  • Effective ISO Audits

  • Timely management response on feedback of how the system is functioning, and how it can be improved

PQA’s 8-Step ISO Implementation Program

PQA has developed an 8-step ISO implementation program that can be applied to all management system implementations. This 8-step program encompasses all of the critical success factors:

  1. Develop Implementation Strategy with Senior Management   PQA will work with the senior management team to determine the strategy for implementing your quality or environmental management system, so that it become an integrated part of the business operations and is recognized as a crucial element to the company’s success. PQA has developed several proprietary analysis tools to assess an organization’s recognized strengths and significant sources of problems/ frustrations. They include:

        21 Success Factors    9 Competitive Factors    7 Deadly Sins of Customer Communication & Service

  2. Perform a Gap Analysis   PQA will perform a gap analysis of your current quality or environmental management system to determine the frequency, consistency & effectiveness of compliance to the requirements, the root causes of any shortcomings, and what will have to be developed to meet your business needs and the needs of the management system requirements.

  3. Project Schedule  PQA will work with the Project Coordinator to prepare a project schedule. The schedule will list the actions identified from the Strategy session and Gap Analysis, the “Process Owners” responsible to perform the action, and a timeline.

  4. Establish Implementation Teams   PQA will help you identify the personnel at all levels in the organization who will be on the “Process Teams”. This ensures input, involvement & buy-in throughout the organization.

  5. Develop Process Maps   PQA will assist the “ProcessTeams” to develop Process Maps. There will be 2 levels of Process Maps:

    • Define the high-level processes and their interactions. These would include, for example, Quotation, Design, Purchasing, Manufacturing, etc.

    • Each block in the high-level map becomes a Process Map of its own.

  6. Develop Documentation   PQA will help the Process Teams identify and prepare the level of documentation required. This will include:

    • Policy Manual.

    • Procedures to cover the ISO requirements for documented procedures.  For some processes, this may be just the Process Maps.  In other processes, explanatory step-by-step instructions may be needed.

    • The numerous forms which may be needed for recording the results of the process measurements that will be performed  (where possible, we will use existing forms as is, or modify them to meet the new requirements).

  7. Employee Training   PQA will help you identify the training needs of your employees so they will be able to fulfil their responsibilities in the ISO system. PQA offers a wide range of Training Workshops to address most training needs.

  8. Pre-Registration Internal Audit   PQA will provide pre-registration internal audit services as follows:

    • PQA will provide internal quality auditors with Internal Quality Audit Training, focusing on the process approach and the ISO requirements.

    • PQA will act as Lead Auditor, using your internal audit team, to conduct a Dress Rehearsal Audit of the entire quality system. Performing a Dress Rehearsal Audit that involves the your Internal Quality Auditors serves three purposes.

      • Provide your internal auditors with practice in performing audit

      • Determine those elements of your ISO system which need to be fine-tuned prior to the Registrar’s audit.

      • You will have completed an internal audit of your entire ISO system prior to your registration audit - this is a requirement to obtain your registration.

    • PQA will conduct a Post Audit Meeting, presenting the results of the Dress Rehearsal Audit to your Management Review team, and assist in identifying corrective actions needed.

Learn how PQA's ISO Expertise can help you

PQA has more than 18 years experience in ISO consulting, training, and implementation.  We know what works, and how to get an ISO system to quickly work better.

Contact PQA.  Ask about your ISO opportunities.  Tell PQA your ISO frustrations.  Free initial consultation.  Send PQA an e-mail at dwhitred@pqa.net, call us, or call Don Whitred at dwhitred@pqa.net

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