BUSINESS MANAGEMENT SYSTEM FOR YOU: ISO/IEC 17025

“What am I missing?” I'm often asked. “My compliance to this standard isn’t improving my systems, and it isn’t increasing my customers' satisfaction.” The answer to this question varies by company and types of implementation, but the solution is straightforward.

Companies that aren't getting the desired results of standards registration are generally one or more of the following:

Companies that overdocumented the management system
Lean companies with ambitious schedules and deadlines
Businesses with strong management styles that have become disillusioned with customer-required standards and programs. Personnel charged with implementing documented systems don't have any more respect for them than top management demonstrates.
Inadequate training and unnecessary restrictions through overdocumentation can set any quality system up for failure. Additionally, employees must understand the benefits and restrictions of the system. International standards are written to allow the flexibility needed for companies to be compliant without giving up efficiency and effectiveness.

Once this ineffective, formal ISO 9001 or ISO/TS 16949 documented system is in place, what's on paper hinders getting products shipped or services completed. It becomes almost impossible to deliver products or perform services efficiently, and to complete all of the paperwork and other system requirements. In the end, management begins telling staff, “Just get the job done, get the paperwork later.” This may be appropriate in the short term. If all the extra paperwork and requirements are completed, the company may not be around to solve the overdocumentation issue.

Overdocumentation can be a result of many different factors, including:

Incomplete understanding of the requirements and intent of the standards
The wrong approach to corrective actions
Not fully addressing what's important to the business or management when creating the documentation
Consultants focusing on delivering more paperwork for your implementation dollar

If the quality system is set up based on any combination of these situations, personnel begin to ignore it and companies begin taking short cuts.

Eventually, employees become uncertain of what's required, what's a guideline and what can generally be ignored. This can be done while maintaining good quality products and services, but, again, only for the short term. Employees, over time, don't know what paperwork or system to attend to and which to overlook. Nothing written can be considered important. The overriding culture requires pleasing management, shipping product and ignoring paperwork and other system requirements. Such companies end up worse off because they've lost the informal systems and culture that made them successful in the first place. The implicit culture familiar to employees holds that no paperwork is valuable and the “boss” doesn't do what he says through the formal, documented system.

One telltale sign of this condition is a scramble to prepare for registrar audits by completing requirements and paperwork. The company may do well on an audit, but it’s like winning money you can’t spend. Fabricated paperwork after the fact adds no value for the company or the customer.

The natural progression from this scenario is that these documented systems begin to fail. The usual issues, like employee turnover and new product launches, add to the bottleneck. Negative trends show up in your metrics, quality concerns increase and profits diminish. Safety and environmental issues may begin to surface. Your documented system has become an exceptional-looking “show car” that has nothing inside. It looks good, but it won't take you anywhere. You spend all of your time fixing problems instead of improving your processes. Your company culture doesn’t support the system or the changes. This adds to the idea that ISO 9001 or ISO/TS 16949 isn’t working when, in fact, it was never properly implemented.

In truth, if a good system is put in place and if employees are trained and motivated to use it properly, compliance to the standards should benefit the entire company. A correctly documented and implemented system will take no additional time and will be able to drive improvement and keep a company competitive.

Following are some solutions to keep your documented system working properly:

Get rid of all unnecessary paperwork. It's better to start with less and fine-tune as you go.
Train everyone—management and employees—on a simpler system.
Motivate employees to follow the system and to recommend changes.
Set goals and keep everyone in the company accountable.
Continuously improve systems.

I would rather see a company reduce more paperwork than it should. At least this way its employees would always have time to complete their tasks, with no contradictions from management. We can always add as we find the need. This isn't an extraordinary amount of work, but it requires a true commitment by the management team.

This can be done effectively in several ways, including:

Implementing lean or kaizen events
Reducing documentation girth during an upgrade to a new revision of the standard (e.g. QS 9000 to ISO/TS 16949)
Constantly asking why. A very effective trainer, lean guru and planner once told me that most adults should take a lesson from a 6-year-old child and start asking

“Why?” again. Why do we need to fill out four forms to accept a $1,000 order from a loyal customer? The answer is, “You don’t.” When companies are properly documented, the culture will be one of reinforcement. Employees will be completing procedures and forms because they support the company’s management and business goals. It doesn’t mean that they’ll understand the purpose of every document they touch, but it does mean that the overwhelming majority of the documentation makes good sense to the staff who use them.

So next time you pick up a procedure or complete a form, take a second glance at it and ask why it's there. If you don't know the answer, find someone who should. If you can't find anyone who knows and the document isn't legal in nature, try removing it from your system and determine the effects.

When formal documented systems are implemented to meet ISO 9001 or ISO/TS 16949 in the proper way, they add value to a business and make great sense to all concerned.

About the author

Brandon Kerkstra has extensive experience in product testing, inspection and quality in the military, nuclear, aerospace and automotive industries. He is the president of Management Solutions Group Inc., a training and consulting firm based in Grand Rapids, Michigan.

Source : www.qualitydigest.com

Henry Troemner LLC has been in the precision measurements and calibration business since 1838. The company’s work is done under the strict guidelines prescribed by ISO/IEC 17025--“General requirements for the competence of testing and calibration laboratories,” with a view toward providing its customers with the lowest possible measurement uncertainties. Before undergoing the ISO/IEC 17025 registration process, however, Troemner first sought to become an ISO 9001-registered company.

“We were one of the first organizations in the Philadelphia area to achieve ISO 9001 registration,” says Tracey Hill, Troemner’s quality coordinator and lead internal auditor. “Once the critical step of ISO 9001 registration was successful, the company’s focus shifted to the rigorous requirements of ISO/IEC 17025 accreditation. The guidelines make an organization take a critical look at every aspect of performing a calibration.”

This resulted in a list of processes that required additional documentation, and procedures that needed to be written for the first time. In addition to the documentation, detailed testing data were required by the National Voluntary Laboratory Accreditation Program (NVLAP) and United Kingdom Accreditation Service (UKAS) to provide evidence that the measurement assurance program had the proper controls in place.

From the first contact with a customer to the delivery of the customer’s device with a calibration certificate, every step of the process can have an affect on the quality of the calibration. The requirements of ISO/IEC 17025 provided Troemner with a framework to develop procedures to fully cover all the diverse aspects of the calibration process and the generation of calibration certificates.

However, the development of a documented ISO/IEC 17025 quality system is not enough in the metrology industry. The key to having a successful quality system is to become accredited. In the field of metrology, a third party such as NVLAP, administered through the National Institute of Standards and Technology (NIST), ensures that technically competent individuals are performing the calibrations correctly.

“Accreditation translates to a cost savings in minimizing or even eliminating the need for on-site visits by the customer,” says Hill. “If a calibration service provider is not accredited, customers are taking a significant risk with their own quality control program.”

Once the decision was made to seek ISO/IEC 17025 accreditation, Troemner’s registered ISO 9001 quality management system (QMS) was reviewed, expanded, and enhanced to meet the specific requirements for calibration laboratories. The goal was for Troemner to become ISO/IEC 17025-accredited by both NVLAP and UKAS for mass calibrations. Accreditation is a formal recognition by an authoritative entity that an organization or individual is competent to carry out specific tasks. Troemner pursued both of these accreditations to obtain the domestic and international recognition that NVLAP and UKAS carry. By having this double accreditation, Troemner’s mass calibration services could be provided all over the world.

Troemner’s customer base was keenly interested in their accreditation status. “Recognition from an external body is really what our customers want,” says Hill. “We are giving them the peace of mind that they are dealing with somebody who has a system in place and has had that system checked, double-checked, and triple-checked by external people.”

Of the 25 clauses within ISO/IEC 17025 that Troemner met for accreditation, five speak directly to customers: subclause 5.6--“Measurement traceability”; subclause 5.3--“Accommodation and environmental conditions”; subclause 4.4--“Review of requests, tenders, and contracts”; subclause 4.14--“Internal audits”; and subclause 5.10--“Reporting the results.”

Measurement traceability

Troemner maintains a strong chain of traceability back to nationally recognized standards. To uphold this traceability chain, the company performs intralaboratory comparisons of its own standards and interlaboratory comparisons with other accredited facilities. These comparisons demonstrate stability in its standards and laboratory practices.

“For example,” explains Hill, “if you need to meet requirements by the FDA, they will tell you that the device that you use in your lab needs to be controlled, and one of the main means of ‘control’ is knowing the exact value and uncertainty that the device provides.”

The process starts with the nationally recognized standard device that has a value and uncertainty. That device is measured and compared to Troemner’s reference standard, resulting in a value and uncertainty for the Troemner device. Next, in Troemner’s calibration laboratory is the measurement of the customer’s device that provides a value and uncertainty that is reported on the customer’s calibration certificate. This series of measurements completes the traceability chain from national standard to every customer device.

“When we return a product back to a customer with our calibration certificate,” says Hill, “they have confidence that the data on the certificate has been generated in accordance with our quality assurance program and the ISO/IEC 17025 requirements, which in turn provide evidence of traceability back to nationally recognized standards.”

Accommodation and environmental conditions

Troemner’s mass laboratories were specifically constructed to create an environment of stable temperature and humidity, low vibration, and low air velocity, which is suitable for making precise mass measurements. The quality control metrology manager is responsible for monitoring and maintaining the environmental conditions for all calibration services.

To meet the prescribed range of environmental conditions set out by NVLAP, Troemner moved to a new facility in 1999 and specifically constructed a calibration lab as a building-within-a-building design.

“The area that our mass laboratory actually sits on is a separate foundation that is insulated with sand, and has various materials underneath, so it will not be affected by vibrations” says Hill. “The area has its own HVAC system to very precisely control the temperatures and the humidity of the environment. We have alarms built into our software programs so that if something happens we know about it and stop calibrations and fix it. This ensures the accuracy of the measurements and calibrations.”

Review of requests, tenders, and contracts

It is critical for the laboratory to fully understand the customer’s requirements for the calibration. Contract review by Troemner’s inside sales department is where this important activity takes place. The contract review process helps to establish a consistent format for the review and understanding of what customers need.

“This is our first interface with the customer,” states Hill. “We ask ‘What do you need?’ and try to gain an understanding by having a very detailed and complete contract review process. ISO/IEC 17025 plays into this because the standard makes you think of all the different areas that can affect your customer. It give you the tools you need to develop a procedure so that there’s consistency among your staff. It’s important that everybody is asking the customer the same set of questions and going through the same process to ensure that we receive consistent information.”

Internal audits

Under the direction of the lead internal auditor, every section of ISO/IEC 17025 is audited once a calendar year. Any problems that arise during internal audits are treated as corrective actions to ensure that the issue is documented, addressed, resolved, and verified. Internal audits are an important opportunity to identify areas for improvement and to implement preventive action.

Auditing is a regular activity that keeps a company’s finger on the pulse of what’s going on. “We have the chance to check up on ourselves to be sure we’re in excellent shape for when an external assessor or one of our customers comes in and wants to audit us,” says Hill. “It’s an opportunity to learn and to make sure that training has been effective. It lets you sleep at night. You know you’re doing everything you can to make sure that the system is operating at its highest level. You know you’re identifying problems and nipping them in the bud.”

Reporting the results

In the field of calibration, the certificate is everything. It is imperative to present the data properly. ISO/IEC 17025 includes very specific requirements as to what shall be included on the certificate. NVLAP and UKAS look closely at the certificates to make sure that all the requirements are met.

“Say you have a pipette and you want it calibrated,” says Hill. “You ship it to Troemner, and we perform a series of measurements and perform the calculations. You get your pipette back with a calibration certificate. Then, if you need to have data entered into your programs based on the work that you do with that pipette, the numbers that we give you are hugely important. For example, FDA requirements are critical for our customers. So, those certificates mean that the pipette we calibrated has been assigned a value and an uncertainty, and the quality of the measurement process is ensured.”

Since 1995, when Troemner’s Mass Calibration Laboratories received accreditation from both NVLAP (Lab Code 105013-0) and UKAS (a UKAS-Accredited Calibration Laboratory No. 0516), Troemner has continued to meet and maintain the most rigorous testing and manufacturing standards for all of its calibration services.

Troemner’s journey with ISO/IEC 17025 has been essential in maintaining the highest quality standards.

“Each one of the clauses within the standard plays a role in how we look at and pursue quality within our organization,” concludes Hill. “Our experience and success with ISO/IEC 17025 for mass services prompted us to expand our calibration labs so that we can now provide accredited calibration services for other measurement disciplines.”