Making the Right Choice When Choosing a Service Provider
While it may seem that there are a lot of choices when it comes to selecting equipment service providers, there are some key differentiators. And the choice you make will have a long-lasting effect not only on your bottom line, but also in the event you are ever audited by the FDA or other regulatory agency. So here are some main points to consider:
- Owns a facility that is monitored 365/24/7 for security and file protection with built-in authentication used to control and secure access to laboratories, shipping and receiving areas and network services
- Has an established disaster recovery plan that details security of electronic information, as well as back up and redundancy of files to ensure file integrity
- Secure online access to electronic calibration reports
- Documented Quality System and a Quality Assurance Staff
- Experienced with Regulatory Agency Requirements; specializing in FDA-regulated industries
- Holds Registrations and Accreditations by Reputable Accrediting Organizations
- Robust Infrastructure and Resources
- Financially Stable
- In Business Long Enough to Enjoy Customer History
- Owns their Test Equipment
- Employs Technically Competent Field Service Staff (no temps or subcontractors)
- Occupies a Modern, Company-owned Facility Complete with Environmentally Controlled Laboratories to Calibrate Test Equipment
- Enjoys a Reputation in the Industry for Consistently Delivering Quality Services with cost consciousness
- Has a Dedicated Customer Service Staff to Notify You well in Advance of Your Next Calibration Due Date
Q & A:
- How long has your company been in business?
- What are some key differences between you and other service providers?
- Do you provide pricing over the phone?
- For equipment calibrated in your Metrology Lab, what is the typical turnaround time?
- Can my electronic calibration reports be accessed remotely?
- Are the photos on your web site really of your facility, your service vehicles, etc.?
- Are any of your services subcontracted?
- How long after the service is completed until I receive my electronic calibration reports?
- What type of test equipment do your technicians have?
- What is ISO 9001 and why is it so important to select a service provider that has this registration?
- Does it make a difference where a company obtains its ISO registration from?
- What is the difference between ISO 9001:2008 registered versus ISO compliant?
- What is ISO 17025 accreditation and why is it important to FDA-regulated companies?
- Do you have your own service vehicles that you use to pick up and deliver test equipment?
How long has your company been in business?
Integrated Service Solutions, Inc. was founded 19 years ago in May, 1998. We are located in a company-owned 20,000 sq. ft. facility conveniently located 1/4 mile from the Lansdale Interchange (Exit 31) of the Pennsylvania Turnpike.
What are some key differences between you and other service providers?
If you're doing a true "apples-to-apples" comparison here are some key points to consider:
* All of our electronic calibration reports detail As/Found and As Left Data with complete information and standards that are N.I.S.T. traceable. There are no additional charges for this data set.
* Secure online access to electronic calibration reports using our Certificate Management System (CMS). The password protected page where you can view your electronic reports are encrypted and are provided in PDF format NOT html like many other sites. This ensures you of a high-level of security and confidence in that your data cannot be altered.
* A disaster recovery plan that details security of your electronic information, as well as back up and redundancy of files to ensure file integrity.
* A facility that is monitored 365/24/7 for security and file protection and built-in authentication used to control and secure access to laboratories, shipping and receiving areas and network services.
Do you provide pricing over the phone?
All of our services are formally quoted in a written document. By doing this, you have all of the details and a document trail to ensure that nothing is overlooked or misunderstood.
For equipment calibrated in your Metrology Lab, what is the typical turnaround time?
Typical turnaround time for equipment shipped or delivered to our Metrology Lab is 3-5 business days. Rush service and 24 hour turnaround is available upon request and with a scheduled appointment. If equipment needs to be repaired, you will be notified via email and then a separate quote is sent so you can decide how to proceed.
Can my electronic calibration reports be accessed remotely?
Yes. Our Certificate Management System (CMS) allows you easy access to your electronic documents. Our IT department will set up password protected pages to current customers. These pages allow you to view, search and download your calibration records via your desktop, mobile device or smart phone. If you'd like to learn more about this, please email us at email@example.com
Are the photos on your web site really of your facility, your service vehicles, etc.?
Yes, all of the photos on our web site are actual pictures of our facility, the test equipment that we use, our laboratories, our service vehicles and our employees. We wanted to give our customers a first-hand, realistic look at the company.
Are any of your services subcontracted?
No. Integrated Service Solutions, Inc. does not subcontract any of our routine services. All of our technicians have documented training as provided for in our Training Management System (TMS). Our on-going training programs consist of instructor-led training and assessments by our senior technical directors as well as our Quality Assurance team. Field personnel are given regular training updates on our standard operating procedures and also attend training classes when applicable. Many of our technicians also have ISA-level accreditation.
By using only our own full-time technicians, you are assured of consistency in the documentation trail, quality assurance oversight, training records management and test equipment asset management.
How long after the service is completed until I receive my electronic calibration reports?
You receive all of the electronic calibration reports the same day of the service. Before the field service technician leaves your site, he/she reviews the work performed with you and provides you with the electronic calibration reports. We also retain copies of all electronic calibration reports in the event that you are audited.
What type of test equipment do your technicians have?
Each field service technician is outfitted with sophisticated test equipment with the highest level of accuracy available on a field/portable basis. Significant and on-going investments are made in purchasing new test equipment so that each technician arrives at your facility with all the tools needed to perform the service. In addition, rapid deployment programs are provided so that emergency calibrations are able to be accomplished in the same day, if required.
What is ISO 9001 and why is it so important to select a service provider that has this registration?
Certification to the prestigious ISO 9001:2008 standard requires a comprehensive assessment and annual routine audits ensuring that the company maintains the proper procedures and processes for a complete quality system. Only after stringent third-party assessment can ISO registration be received. Thereafter annual audits are conducted to ensure that the quality system is being correctly applied, maintained and improved. Integrated Service Solutions, Inc is audited by Underwriters Laboratories Inc. (Click here for a copy of our certificate.)
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from at least 157 countries. ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity.
Does it make a difference where a company obtains its ISO registration from?
Selecting a registrar is an important decision. We chose to work with the most respected and trusted registrar in the business; UL DQS, Inc. Since 1989, UL DQS, Inc. has issued more than 3,800 ISO 9000 series certificates-in 40 countries and in 135 product categories. It’s important to choose an internationally recognized registrar approved by the Registrar Accreditation Board.
It’s important to point out that there are quite a few non-accredited certification bodies that will award ISO certificates without performing a complete full assessment of a company’s quality system. That’s an important point when selecting a services provider.
What is the difference between ISO 9001:2008 registered versus ISO compliant?
The difference can be summed up quite simply.
REGISTRATION: Obtaining ISO registration involves an enormous amount of time, up to two years to complete the process, not to mention having a robust infrastructure, a documented Quality System and an on-going commitment by senior management to put in place continuous improvement plans. Then there’s the on-going costs associated with the initial assessment audit plus the on-going triennial audits. Registration signifies an unending commitment to quality.
COMPLIANCE: Just as the name implies, compliance means to demonstrate an adherence to regulations or policies. Companies that say they are ISO 9001 compliant, have not gone through any formal auditing processes by an accreditation body to document that they have systems and procedures in place. In other words, they simply say they are compliant without any documented proof that they understand the complexities to meet the rigorous standards of the FDA.
Driven by regulatory requirements, Integrated Service Solutions, Inc. has obtained its registration by an internationally recognized auditing body, UL DQS Inc., and therefore has made a commitment to our clients that we recognize the importance of servicing FDA-regulated companies.
What is ISO 17025 accreditation and why is it important to FDA-regulated companies?
While there are many commonalities with ISO 9001:2008, ISO/IEC 17025:2005 applies directly to Metrology Laboratories that produce testing and calibration results.
Certification to the prestigious ISO/IEC 17025:2005 is directly related to the quality management system within a laboratory. A prerequisite to qualification is to have a documented quality management system already in place. The comprehensive annual assessment conducted by The American Association for Laboratory Accreditation (A2LA) addresses the competence of the staff, an inspection of the facility, a review of calibration procedures, analysis of traceability and an appraisal of the methodologies used as well as the calibration equipment.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results and since the standard is about competence, accreditation is a formal recognition of that competence.
Accreditation by nationally recognized organizations provides customers with confidence in calibration reports and traceability. In addition, an unbiased assessment of a laboratory’s standards and procedures provides an impartial viewpoint as to how a laboratory functions.
Recently, when asked about the importance of A2LA 17025, Manny Cabanas, Director of Quality Assurance at Integrated Service Solutions, Inc. said, “accreditation under an ILAC (International Laboratory Accreditation Cooperation) recognized Registrar ensures us a 'no questions asked' status among world class calibration providers, and enables us to meet the needs of our GMP Clients for 'competent' & 'professionally’ rendered services. We are setting the bar higher, by this level of Accreditation.”
Do you have your own service vehicles that you use to pick up and deliver test equipment?
Yes. We have a fleet of service vehicles that are in use daily for pick up and delivery of customer test equipment. In addition, our technicians use these specially equipped vehicles to transport test standards and validation equipment to and from customer sites.