Frequently Asked Questions

Please select from the following list of questions:

1. What is ISO 21501 for calibrating particle counters?
2. What is ISO 9001 and why is it so important to select a service provider that has this registration?
3. Does it make a difference where a company obtains its ISO registration from?
4. What is the difference between being ISO 9001:2008 registered versus compliant?
5. What is ISO 17025 accreditation?
6. Are any of your services subcontracted?
7. How long after the service is completed do I have to wait until I receive my calibration documents?
8. What type of test equipment do your technicians have?

While it may seem that there are a lot of choices when it comes to selecting equipment service providers, there are some significant differences. 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. You need to look for a company that:

• Specializes in FDA-regulated industries
• Has a Documented Quality System and a Quality Assurance Staff Experienced with Regulatory Agency Requirements
• Holds Registrations and Accreditations by Reputable Accrediting Organizations
• Has a Robust Infrastructure and Resources
• Is Financially Stable
• Owns it own 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

Many times, companies arbitrarily make their decisions based solely on the cost for a particular service; i.e, calibrations. But they overlook the total cost to their organization.

Q: What is ISO 21501 for calibrating particle counters?

There is a new ISO standard for calibrating particle counters. It is ISO 21501 and it is intended to provide a calibration procedure and verification method for particle counters, so as to minimize the inaccuracy in the measurement result by a counter, as well as the differences in the results measured by different instruments. Instruments that conform to ISO 21501 are used for the classification of air cleanliness in cleanrooms as well as the measurement of the number and size distribution of particles in various environments.

This enhanced standard has not yet been adopted by many of our customers. However, we have updated our SOP to include the seven (7) minimum data points required by the new standard. Integrated Service Solutions has the capability of calibrating particle counters to the new ISO standard both in our Metrology Lab and in the field.

If you are interested in adopting the new standard, please let us know and we’ll be happy to give you more details. Click here.

Q: What is ISO 9001 and why is it so important to select a service provider that has this registration?

A: 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.

For more information on ISO please click on:

http://www.iso.org/iso/en/prods-services/otherpubs/pdf/isoinbrief_2006-en.pdf

Q: Does it make a difference where a company obtains its ISO registration from?

A: Selecting a registrar is an important decision. We chose to work with the most respected and trusted registrar in the business; Underwriter’s Laboratories (UL). Since 1989, UL 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. Without this accreditation, certifications performed by the registrar are of no value.

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.

Q: What is the difference between being ISO 9001:2008 registered versus compliant?

A: 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 and therefore has made a commitment to our clients that we recognize the importance of servicing FDA-regulated companies.

Q: What is ISO 17025 accreditation?

A: 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 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.

In announcing the Accreditation, 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.”

Q: Are any of your services subcontracted?

A: No. Integrated Service Solutions, Inc. does not subcontract any of our services. All of our field service technicians are full-time employees and receive periodic training by our Quality Assurance staff as well as on-going industry training. In addition, all training is documented and is part of each technician’s training file.

By using subcontractors, you cannot maintain 17025 accreditation, etc. Subcontractors also jeopardize the documentation trail on training records management and test equipment asset management, etc. Also, don’t assume that if you select an Original Equipment Manufacturer (OEM), that you will get OEM employees to service your equipment. Be sure to ask if the services supplied by the OEM are by trained OEM employees and quality managed by the OEM.

Q: How long after the service is completed do I have to wait until I receive my calibration documents?

A: You receive all of the calibration reports the same day. Before the field service technician leaves your site, he/she reviews the work performed and you are given the original calibration reports. The reports can either be paper copies or electronic media. We retain copies of all calibration reports in the event that you are audited.

Q: What type of test equipment do your technicians have?

A: 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 techncian arrives at your facility with all the tools needed to perform the service. In addition, rapid deployment programs are provided so that emergency specialized needs calibrations are able to be accomplished in the same day, if required.