If you are charged with developing a company and growing a business, an ISO (International Organization for Standardization) standard needs to be a consideration for any size business. A company that has been certified to an ISO standard is immediately recognized globally as a quality supplier. This is made possible, as the ISO standard you receive, is the same ISO standard that currently thousands of companies working around the world will be working towards, one standard, one language in order to meet your customers requirements
There are a number of ISO standards that are related to a number of disciplines. There are ISO standards that address (Quality) ISO 9001, (Medical Devices) ISO 13485, (Environmental) ISO14001, (Information Security) 27001, (Laboratory Competence) ISO 17025.
ISO 13485 is a medical devices standard, not a product standard. The standard is based on ISO 9001 and organized in the same way using the same numbering and most of the requirements directly from ISO 9001. Because ISO 9001 is the foundation of this standard, one should have a basic knowledge of ISO 9001 in order to fully comprehend and become comfortable with the fundamentals of ISO 13485.
ISO 9001:2008 Quality Management standards are not specific to products or services, but apply to the processes that create them. The standards are generic in nature so that they can be used by manufacturing and service industries throughout the world. ISO 9001;2008 philosophy is Say what you do, Do what you say and Prove that you have done it. It consists of a group of common sense and generally well-known principles laid out in an organized manner.
Medical device manufacturers who have yet to attain any ISO certification at all have a choice of implementing and registering to either ISO 9001:2008 or 13485:2003 alone, or as an option combining both ISO 13485:2003 and ISO 9001:2008 together.
It is generally recommended however to first become ISO 9001:2008 certified because of a few key factors: ISO 13485:2003 is based on the ISO 9001 model, ISO 9001:2008 is all about producing consistent standards of quality in order to meet your customer requirements, and ISO 9001:2008 is a recognized standard against which to evaluate the quality management systems of a business regardless of your specific business discipline.
There are several advantages of a business becoming ISO compliant and certified to any of the standards:
Potential 15-20% savings
Profit margins were shown to be 2-3 times higher than the industry average for ISO registered companies
Will enable you to gain entry to preferred contractor status
Increased quality thereby avoiding costly inspections and rework and reducing overheads
Improves time management, information flow, productivity, efficiency, training capacity, accountability, customer satisfaction and morale
IMSM (International Management Systems Marketing) is a full service ISO consultancy organization that specializes in servicing small and medium size companies (typical client size companies ranges from 4 to
400 employees) headquartered in the UK. IMSM was established in 1994 and to date has assisted over 8,000 businesses worldwide become ISO compliant and attain various ISO certifications.
IMSM credentials include being an active member of the American Society for Quality (ASQ), Society for the Plastics Industry (SPI), Security Industry Association, the British Quality Foundation (BQF), and has achieved the European Foundation for Quality Management, EFQM “Committed to Excellence” Award.
IMSM’s consulting services include the following:
IRCA (International Register of Certificated Auditors)
Assessment of documented procedures
Gap analysis/initial audit- Where are you meeting the standard?
Implementation of required procedures
Write Quality and Procedures manuals
Supply draft copies of manuals for client approval
Client approval of manuals/ Amendments as necessary
Presentation of manuals/Review of implemented required procedures
Internal audit advice/training
Submit final audit report and manuals for certifications
IMSM attributes its success as a full service ISO consultancy to the following:
Keeping it simple- The ISO process is based on your existing systems, it is flexible, additions or changes will only be made if required to meet the standard
Fast Track Certification- 120 days or less. Depending on client involvement and preparedness
Exact Cost up front- Your business will be quoted an exact cost for IMSM’s full service ISO consulting services including options for certification.
Guaranteed Satisfaction- Client satisfaction is guaranteed as well as our full service consulting services are available to address queries without an additional fee for the life of the agreement
To receive further information regarding IMSM full service ISO consulting services and arrangements for ISO certification, as well as a no obligation exact proposal please contact:
Charles Marasco @ 603-315-4574
Charlesmarasco@imsm.com
www.IMSM.com
