INSIGHT REPORT
Vol 5  No. 4
April
2002

INSIGHT REPORT

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Insight Report Vol.  5  No.4  

ISO 9001:2000 Quality Management Systems-Requirements Transition Planning

Introduction

Just when you think you got things all straightened out and you have your quality system complete and fully implemented to meet the requirements of the ISO9000 standard and the FDA GMP, along comes the next wave of changes.

First came the FDA GMP. Once we got used to that quality standard you had to learn how to apply the ISO 9000 standard if we wanted to sell you devices in the European Union. Then in 1997 the FDA decided to revise their GMP and added Design Control among other new regulatory requirements for you to comply with.

Now it is the ISO’s turn to bring “havoc” to the industry. The ISO9000 standard is being changed and that change goes into effect in 2003. But, before you think that you should implement this new standard as part of your quality system, you should become familiar with and understand the new ISO13485 standard. This new standard, ISO13485, will combine the ISO9000:2000 and the EN46000 standard and be used for active medical devices. So which way do you go to assure continued compliance and international recognition? Do you implement the new ISO9000/2000 standard or wait until the ISO13485 is finalized?

We hope that the following provides you some guidance on how to plan for these changes and provide for a smooth transition.

Background

On December 13, 2000, the 1994 version of the ISO9000 Series of Quality System Standards and Guidelines was revised. The new ISO 9000:2000 QMS (Quality Management System) Series consolidates multiple standards/guidelines found in the 1994 series into one standard (ISO 9001:2000 QMS - Requirements), and two guidelines, (ISO 9000:2000 QMS-Fundamentals and Vocabulary and ISO 9004:2000 QMS-Guidelines for Performance Improvement).

Sector Schemes

Various sector scheme (industry-specific) standards, such as Automotive and Aerospace (AS9000/QS9000), have also been impacted by this change and have been similarly revised to reflect the new requirements.

Medical Device Manufacturers

The Medical Device-Related Standard, ISO13485/88:1996, is also scheduled for revision sometime during the year 2003. Active Medical Device manufacturers will have to be certified to this revised standard (ISO13485:2000), and not to the ISO9001:2000 Standard. ISO13485: 2000 will be a “stand-alone” document and it is expected to incorporate what the Global Harmonization Task Force (GHTF) has classified as the “enforceable” elements of both the 1994 and 2000 ISO9000 Standards. A copy of the current Draft “AAMI/CDV-2 13485 -- Quality systems - Medical devices - System requirements for regulatory purposes” is available from www.aami.org

December 13, 2003 Deadline

Current ISO9000 registrants have until December 13, 2003 to comply with the new requirements. Companies are now beginning to focus on the impact of ISO9001:2000 QMS on their organizations and identify what changes need to be made to their current Quality Systems in order to incorporate the new requirements. In early 2001, ISO Registrars began to issue transition guidelines to their clients. During this transition period, companies must work very closely with their Registrars to assure a smooth and uneventful transition to ISO9001:2000.

Impact on Current Registrants

So what is the impact of ISO9001: 2000 QMS on your company, and what changes to your QMS must be made? First, the good news: You may not need to rewrite all the documents in your current system if the system was structured using a customer-focused,
Performance metrics -driven, process model approach to define, document, implement and continually improve the various processes that comprise your QMS. The current documents may be adequate (with some editing to address new or modified requirements) and could be referenced in the required Quality Manual, which will need to be rewritten to address the specific ISO9001:2000 QMS requirements.

Companies who did not utilize such methods may need to restructure their approach and begin to focus on the following areas that represent a significant shift in emphasis from the 1994 requirements:

• Process Orientation (General Requirements - Sequence & Interactions, Section 4.1)
• Expanded Management Responsibilities (Commitments, Section 5.1)
• Performance Measures (Measurable Quality Objectives, Section 5.4.1)
• Customer Satisfaction & Communications (Sections 7.2.3 and 8.2.1)
• Analysis of Data (Section 8.4)
• Continual Improvement (8.5.1)

Compliance Planning

A plan to achieve compliance with the new requirements by the December 13, 2003 deadline is the first step in revising your QMS. The following considerations should be addressed in the plan:

• Contact your Registrar to begin the transition planning
• Understand the new and changed (new emphasis) requirements
• Determine the scope and identify any permissible exclusions
• Conduct an analysis of your current QMS and identify the gaps
• Develop new or revised QMS processes (using a process model approach) and document
• Develop a new Quality Manual
• Establish measurable objectives and process performance measures
• Implement the revised QMS
• Conduct compliance audits Establish registration audit dates with your Registrar
• Continue improvement of your processes

For more information or to answer any of your questions concerning this transition please contact me infoISO@mdiconsultants.com  to call us at 516-482-9001.

References

The following websites contain useful information concerning these new requirements and links to other websites for additional information:

www.rabnet.com  (Registrar Accreditation Board Site)
www.iso.ch  (International Organization for Standardization)
www.tc176.org  (ISO TC 176 Home Page)
www.aiag.org  (Automotive Industry Action Group)
www.sae.org  (Aerospace Standards)
www.GHTF.org  (Global Harmonization Task Force, RE: Updates to ISO 13485:1996)
www.aami.org  (Association for the Advancement of Medical Instrumentation)

The next Insight Report – What can we learn from the Olympus Recall

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