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Quality & Environmental Systems Consulting Group
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QSC Group LLC has a new website. Please visit us at www.qscma.com or you can still use this site if you wish. Call QSC
Group LLC at 978-766-4164 or email us at qualitysystem@comcast.net
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QSC Group has a 100% success rating for ISO 9001 certifications since 1991 ... that is over 20 years!
The 3-Page Quality Manual
Years ago quality manuals tended to cover the entire standard even though the level 2 procedures were in place to
do that. The details found in the manual were also
very
similar to the procedures. What this did is it made those responsible for maintaining the manual to have to check every revision
in all procedures to be sure to also
make similar
revisions to the manual when necessary. It also made it such that finding discrepancies between the manual and procedures
was easy for auditors. Not good.
Looking at the requirements for a quality manual in section 4.2.2 in the various standards (ISO 9001, ISO 13485 and AS 9100C) we see just five (5) requirements.
These are to include: the scope, the list of exclusions and justifications for the exclusions, the documented procedures or a reference to them (this is what is being done now, simply
refering to them), a description of the interaction of the QMS processes.
QUALITY SYTEMS CONSULTING GROUP LLC has been using a 3-page Quality Manual for about 5 years now. Most people love how simple we have made the manual.
Let us show you our manual ... you will be glad that you did !
QSC Group specializes in
AS9100C - Aviation, Space and Defense Industry standard.
We also have the resources to assist with NADCAP compliance.
.
Need ISO certification quickly and painlessly? We can do it ... 3 months is possible
Just call Bill Goss at 978-766-4164 and let him know your
needs, we will help you
attain
certification faster and with less costs than most other consulting companies!
.
We assist Aerospace companies implement
the new requirements for the revision "C"
of the standard and we have all the tools needed to make it happen quickly. If you
are
in
need to comply with AS9100C soon, call us! We can help easily, quickly and without
distrupting your existing
business. AS9100C is our specialty ! ! ! QSC = AS9100C
.
Our ISO 9001:2008 Registration
Certificate is shown on the Documents & Files Tab ..
we are proud of
this!
.
QSC Group is ISO 9001:2008 Certified ! That means we have processes in place to ensure
your satisfaction. Our Registration number is NO-800566.
Bring on-board a consulting company
who "walks the walk".
.
Need ISO Certification Quickly?
That is what we do.
Just call Bill Goss at 978-766-4164 and we will show you the way.
Whether you need
ISO 9001, ISO 13485, ISO
14001 or other, call us first and do not waste time.
We will help you become certified with a system
that is value-added for your company
and compliant with the standard you seek. No BS here, call Bill
now at 978-766-4164.
FDA GMP (21 CFR 820), ISO 13485, ISO 9001, ISO 14001 and more.
.
We are happy to be one of just a
handful of Consulting Companies assisting companies
with ISO certification that is actually ISO 9001:2008 certified ourselves! Just one of a
few consulting
companies in the world to "walk the walk" ! ! !
.
NEWS: Quality Systems Consulting
Group has opened offices in 2011 in Surakarta, Indonesia and Kentucky, USA.
We are now operating in USA, Mexico, Canada, Puerto Rico,
South Asia, Africa and Europe.
Our major focus remains here in New England, mainly in Massachusetts, New Hamshire & Maine.
.
Contact one of our local or regional
offices for service in your part of the world.
Need assistance implementing, training, procedure writing, etc. for ISO 9001, ISO 13485, FDA
GMP
(21 CFR 820), ISO 14001,
ISO 27001 or ISO 19770-1 ? Then you have just found the right business to
accommodate your needs.
.
We are certified to ISO 9001:2008 ... try to find another consulting business who has done what we
did.
We are just
one of a few in the world. Our consultants
quickly learn about your business, then, and only then, can we
help you to create the management
system procedures, manual, forms and other documents.
.
GMP (21
CFR 820), ISO 14001, ISO 27001 or ISO 19770-1 ? Then you have just found the right business
to
accommodate
your needs.
.
QSC Group specializes in no-nonsense, value-added management systems
and we have the knowledge,
tools, electronic solutions and resources to get the job done right and on time, with no bureaucracy.
.
Contact us today and we will come to speak with you quickly regarding
your needs AND we are able to
start on your project without delay. Our long list of successes allow us to get the project going and going
right without a long waiting period.
Call or email us today, you will be happy you did.
Call 978-766-4164 or email us at: qualitysystem@comcast.net
.
.CUSTOMERS: Paradigm
Precision Inc., Medtronic, Inc., Stryker, New England Biolabs, Inc., Cell Signaling, Inc., D&R Products, Inc,
BioHelix Corp.,
Guidewire Technologies, ISO-MED Manufacturing Inc., Interactive Motion Technology, Inc., OSRAM SYLVANIA Inc.,
Bakken Research Center, XTECH Corporation,
MacDiarmid Machine Corp., Tradecraft, Inc., Steelcraft, Inc., G.E. HealthCare,
Mass Medical Compliance Corporation, Tradeport USA, Nova-Bus, Volvo, and so many more.
Join our long list of satisfied customers, being ISO 9001 certified, our position is Total Customer
Satisfaction. Thank you !
.
Need the lowest cost CRM (Customer
Relationship Management System) available in the US? Call us.
We have it and
it takes just 1 week to implement, plus it will save you tens of thousands of dollars as well
as being ready for use in one week!
.
Need to comply with the Protection of Personal Information law in Massachusetts (201 CMR 17.00)?
We are ready and able to assist companies
of all sizes and we do this in one to two weeks!
Call us now, and save a lot of time and money!
.
CRM for less than $10,000? Is this really possible? Yes it is, with QSC Group!
Call us now.
We are the lowest cost and most successful CRM (Customer Resource Management) implementation
company in the country. If you want results and the lowest cost in this nation, call us.
We can get you going in less than one (1) week.
.
Also, looking for ISO 9001, ISO 13485, AS9100 or ISO 14001 Certification
Quickly and Properly?
This
is the place to be ... QSC Group specializes in a no nonsense approach and we deliver.
Call for a quotation and a timeline, we will be happy to review
your business requirements,
status and needs so that we can create a plan to help you get to certification as quickly and
as best as possible, this is what
we do every day.
.
.
We are focused on the environment ... we focus on best practices for toxins use reduction,
pollution prevention, energy efficiency and water conservation.
We also help our clients
understand, and comply with, the US EPA, Massachusetts DEP and
local environmental
regulations. Going Green is a thousand times more than recycling
and having an energy
audit done. That's where we come in ... if you want to be
really green, stop the 5% effort
and step up to the "real
deal" ... call us, we can help.
.
.
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WELCOME TO QSC GROUP !
We have senior-level, knowledgeable and down to earth consultants
ready to
assist you with the following:
ISO 9001
ISO 13485
FDA GMP - 21 CFR 820 (QSR)
ISO
14001
ISO
19770-1
ISO
27001
AS9100C
We
can provide training, create your management system,
and everything in between.
We work quickly to get you to
the certification point in as little as 4 months.
Contact Bill Goss @ 978-766-4164 or qualitysystem@comcast.net
.
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MARCH 2010 - COURSE EVALUATION SURVEYS FROM A RECENT 3-DAY COURSE ON
ISO 14001.
..
All 13 participants stated that they would take another course with Bill Goss,
here are the comments:
..
"Bill made a dry subject enjoyable."
..
"I liked the interaction in the classes the most."
..
"Bill is extremely well versed in EMS standards and successful implementation."
..
"Bill is a great trainer".
..
"I like how I was able to grasp the concept of the standard. I came into this very intimidated by the
subject but am leaving feeling very knowledgeable."
..
"How might
this course be improved? I can't think of any way this could be improved."
..
"What I liked most about this course was the comprehensive information to start ISO 14001."
..
"What I liked most about this course is the level of commitment that
Bill has in making sure that all was understood."
..
"How might
this course be improved? Serve Beer!"
..
Thanks
to all of you who offered me such nice praise in this recent course. As for the beer idea, that's out of my control, sorry!
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Does your business have personal
information of Massachusetts Residents?
.
If
the answer is yes, you MUSTbe compliant with the 201 CMR 17.00 Regulation by March 1, 2010.
This
law becomes effective on March 1, 2010 and it requires all organizations that contain
or have access to personal information of Massachusetts residents to have all the necesssary
policies and procedures in place to protect this information.
.
QSC Grouphas the resources to assist companies of all
sizes to comply with 201 CMR 17.00
.
.
.
Medical Device Quality & Regulatory, FDA GMP, 21 CFR Parts 11, 210/211 and 820 Experts
Medical Device Quality & Regulatory, FDA GMP, 21 CFR Parts 11, 210/211 and 820 Experts
.
Member of the Association for the Advancement of Medical Instrumentation (AAMI)
and ASQ Biomedical Division
.
We understand the times companies are going through these days and how the bottom line matters more than ever.
We also realize that resources are tight and that a consulting group needs to "do it all". That is why we have decided
to hold our costs to our clients to the 2008 rates and to be in a position to do the work whether it be writing procedures,
calibrating equipment, creating databases, training, you name it, we do it all. Our clients will receive the same
effective expertise and professionalism from our consultants. We only win when our clients win, we understand that and we
are here for you.
We are the one business that focuses on value
added at a low cost to our customers! Our business was established in 1994, and we pride ourselves on providing customers
with outstanding customer service and very reasonable rates. We have offices in Massachusetts and New Hampshire and all
consultants have a minimum of 15 years experience in their respective areas of expertise and many have substantially
more. These include Quality Assurance and Environmental Management Systems, Software Asset Management, Software License
and Maintenance Contact Negotiations, Negotiations with Utility Companies, Data Center Management and Optimization, IT Security,
Sarbanes-Oxley Act Compliance, Electronic Documentation Systems, Electronic CAPA Systems, Electronic Record Management Programs,
and much more. We are your "One Consultant Company for All Aspects of Business Improvement".
In addition to working on location for our clients, we hold holding workshops and courses in the Boston area for companies looking to upgrade from their ISO 9001 system to ISO 13485. We will be showing the dates and locations of the courses at least 1 month in advance on this web site. You can also contact us at qualitysystem@comcast.netto inquire as to the next course. Minimum signup is 8 participants.
Whether you need to implement a management system to comply with ISO 9001, ISO 13485, ISO 14001, AS9100, ISO 19770-1, ISO 27001 or FDA cGMP we are ready to help. Not only do we have the resources to facilitate the implementation of quality management systems, we also have the expertise to help you with training, internal auditing, database development, process and instrument validation and so much more. We are unlike most quality management consultation businesses in that we have experienced consultants for every aspect of your company's needs. We pride ourselves as being able to provide consultation and implementation resources for all of your needs, at a cost that will not break your budget. Our focus is on value-added processes and we avoid the bureaucracy that slows down progress.
In addition to working on location for our clients, we hold holding workshops and courses in the Boston area for companies looking to upgrade from their ISO 9001 system to ISO 13485. We will be showing the dates and locations of the courses at least 1 month in advance on this web site. You can also contact us at qualitysystem@comcast.netto inquire as to the next course. Minimum signup is 8 participants.
Whether you need to implement a management system to comply with ISO 9001, ISO 13485, ISO 14001, AS9100, ISO 19770-1, ISO 27001 or FDA cGMP we are ready to help. Not only do we have the resources to facilitate the implementation of quality management systems, we also have the expertise to help you with training, internal auditing, database development, process and instrument validation and so much more. We are unlike most quality management consultation businesses in that we have experienced consultants for every aspect of your company's needs. We pride ourselves as being able to provide consultation and implementation resources for all of your needs, at a cost that will not break your budget. Our focus is on value-added processes and we avoid the bureaucracy that slows down progress.
Providing outstanding service means taking time to listen. We work with you every step of the way to ensure you receive the services you expect and avoid the bureaucracy many quality systems incorporate. Our business is client-oriented and we maintain strict confidentiality.
Bill Goss - CEA, CQA, CSAM, PCSAM
President and Senior Consultant
Quality & Environmental
Management Systems & Software Asset Management
Massachusetts Office: 14 Amidon Avenue,
Amesbury, MA - Phone: 978-766-4164
New Hampshire Office: 29 Cottonwood Road, Plaistow, NH 03865 - Phone: 978-766-4164
Kentucky Office: 769 Walker Park Road, Richmond, KY40475 - Phone: 978-766-4164
(Member of the Association for the Advancement of Medical Instrumentation (AAMI)
Indonesia Office: Pucang
Sawit rt03 / rw12, Solo Jawa Tengah 57125, Indonesia - Phone: +011 978-766-4164
Our Goals
- To provide the best customer service possible.
- To make each client feel like the only client.
- To promote an awareness of the need to help to improve the community.
- To treat every employee and consultant with the utmost of respect and to provide an environment that fosters trust and motivation to succeed in all the challenges that face us throughout our work week.
What's a Pre-assessment? (The value of a pre-assessment audit) Article by Andy Nichols of NQA USA:
OUR SPECIALTIES:
- Simple and value-added lean quality and environmental management systems.
- No Bureaucracy, no unnecessary documents or records. Just Value-Added lean and compliant processes.
This
is our promise to you and this is what sets us apart from the rest.
ISO 9001 (Quality - General)
ISO 13485 (Medical Device Quality)
AS9100 (Aerospace Quality)
ISO 27001 (Information Technology Security)
Praxiom
Website for ISO Resources:
NEW ! ! !
Data Center Management - We now have the resources to design, set up, install, monitor and measure the performance of your data center. Senior consultants with proven success in one of the most critical component of your business' computing infrastructure are now available.
Contact QSC now for a free analysis on the health of your data center! Do not wait for a breakdown due to power overload, excessive heat buildup, inadequate ventilation, etc. Take preventive action now and set up this free analysis by Quality Systems Consulting Group.
Software Applications
Development (SharePoint & Lotus Notes):
* Document Control * Corrective and Preventive Action * Calibration of Measuring Devices * Internal Audit * Device History Records * Device
Master Records * Design History Files * Technical Files * Customer Satisfaction * Process Improvement and Lean Operations * Management Review * Training * Risk Management * Sarbanes-Oxley Compliance Most systems are already designed and can be installed,
set up, customized, training completed and put into production in less than one (1) week. ___________________________________________
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Proud member of the International Association of Information Technology Asset Managers
(IAITAM)
Please also go to www.assurx.com/ondemand for quality system pre-configured solutions. Now here is a tool that can help all companies with quality statistics! www.minitab.com |
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