Power of Quality Management System Implementation

By: Jeffrey P. Tuthill, Sr.

Whether you are modeling or maintaining your Quality Management System (QMS) with ISO 9001, ISO 13485, ISO/TS 16949, AS9100, or another internationally accepted standard for quality management systems; the power of your QMS must not be underestimated, or under-utilized.

Regulatory Aspects

The EU has certainly embraced the value of product suppliers applying QMS power in the Single Market with the inclusion of the Full Quality Assurance Module in their conformity assessment procedures for “New Approach” Directive compliance. Module H – Full Quality Assurance is the conformity assessment approach for placing the CE Mark on your equipment by utilizing the power of the company’s QMS.

Many “New Approach” Directives allow the use of Module H, such as the Medical Device Directive (93/42/EEC) and Pressure Equipment Directive (97/23/EEC), where both the design and production of the product is verified within the company’s QMS by the selected Notified Body to the Directive. Verification is completed by Certification and surveillance of the company QMS by the Notified Body.

The QMS is also of value to US domestic regulations as well in respect of Medical Devices. The Medical Device manufacturer will use ISO 13485 to attest compliance to the MDD with the Notified Body and QSR 21 CFR 820 (Quality System Regulation) to satisfy FDA Regulation. This does not mean that the Manufacturer needs to maintain two distinct systems, as the FDA QSR is based on the 20 clause requirements of the older versions of ISO standards. As long as the Manufacturer shows the QSR clause requirements are addressed in the ISO 13485 system, the FDA (CDRH) will be satisfied. This is usually done with a cross-reference table in the Quality Manual.

Market Demand

It is getting harder and harder to meet market demand, or be one up on your competition without having a QMS in place. Quality systems have become a basic element of doing business worldwide and any global market aspiration makes an internationally recognized QMS essential. Some common benefits of implementing a QMS are higher customer satisfaction levels, cost reductions, competitive advantage, and increased marketing and sales opportunities. QMS implementation is a formulaic means of improving market position.

Continuous Improvement

Possibly the most valuable benefit of QMS implementation and the most likely to be under-utilized is the power of continuous improvement. All QMS standards (ISO based) contain clause requirements for continuous improvement. The latest version of AS9100 (AS9100C) has made additional provision for continuous improvement with the formal monitoring of customer satisfaction data.

One of the key elements for improvement in a QMS is the preventive action process addressing potential non-conformances, before they become problems requiring corrective action. Some of the benefits of continuous improvement developed within a QMS are improved customer perception, productivity and efficiency, and improved communications, morale and job satisfaction. Preventive action and continuous improvement efforts are the driving forces within the company’s QMS feeding the goals of zero defect and customer delight. Without this emphasis the company’s QMS will stagnate and likely decline, and market positioning will suffer as a result.

Summary

In conclusion, the power of QMS implementation is captured in three categories; Regulatory Aspects, Market Demand and Continuous Improvement. There are many benefits to implementing a quality management system with the only two drawbacks, the investment in time and money to achieve Certification. The typical expense for QMS Certification will run into thousands of dollars for pre-license and annual audits by the Registrar.

The typical timeframe for implementation averages eighteen months and QMS awareness training should be included as an initial phase of the process. Without training the entire operation on how the QMS works, the company risks implementing a program that is not understood or supported by the workforce, which is a recipe for failure. Additionally, there should be an investment in refresher training as conditions and situations change within the company, the QMS and the quality standards.

If the product manufactured by the company contains electronics, additional certifications and tests may be required per UL, CSA and EU Harmonized Standards. Electronic equipment is also subject to the requirements of the RoHS (2002/95/EC) and WEEE (2002/96/EC) Directives, which address hazardous substances in electronic equipment and the safe disposal of electrical and electronic equipment waste material.

Author’s Bio: Jeffrey P. Tuthill, Sr. is a QMS/Compliance Professional with over eighteen years experience in product safety compliance, regulatory and QMS training, development and implementation. He has been employed by three Certification organizations, UL, NSAI (National Standards Authority of Ireland) and TÜV Essen, and has tested and Certified equipment in over seven product categories including ITE, ITTE, Lasers, Laboratory Instruments, Machinery, and MEE. Jeff is well versed in IEC Standard development having served on three IEC Committees as a U.S. Technical Advisor; IEC TC 62 (for IEC 60601-1 [M E Equip.], TC 74 (for IEC 60950 [I T Equip.]) and TC 66 (for IEC 61010 [A T/Lab, Process Equip]). He supported QMS disciplines for Quality System Certification with Medical Equipment, Aerospace/Defense, Light Industrial and Automotive industries; and brought 10 Firms through ISO Registration process. Jeff presently resides in the Puget Sound area and is seeking employment in QMS development, maintenance and improvement, or compliance/regulatory.