Implementing a quality management system (QMS) provides regulatory benefits, improves market positioning, and enables continuous improvement. Regulatory bodies in the EU and US recognize QMS standards like ISO 13485 for medical devices. A QMS also increases customer satisfaction, reduces costs, and strengthens competitiveness. Continuous improvement, including preventative action, is a key benefit but also often underutilized aspect of a QMS. While establishing a QMS requires time and money for training and certification, the long-term advantages make it worthwhile for companies.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.