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ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO/IEC 17025, Uncategorized

Laboratory accreditation for testing and calibration falls under the ISO IEC 17025 standard. Any laboratory that wants to demonstrate their conformity to the highest levels of quality for their results would be well-advised to seek ISO IEC 17025 accreditation. The accreditation was designed alongside eighteen liaison organizations, including the International Laboratory Accreditation Cooperation (ILAC).

Who Does the ISO IEC 17025 Apply To?

Accreditation should be a priority for labs that do testing, sampling, or equipment calibrations. Whether the lab is government-run or private doesn’t make a difference. While many labs believe they already run at peak efficiency, implementing ISO IEC 17025 usually reveals a lot of gaps in their processes and management methodologies. Among the perks of achieving ISO IEC 17025 accreditation are:

  • Quality control systems can anticipate problems and deal with preventative actions.
  • Methods of testing have specific accuracies, precision, and limits of detection.
  • The institution starts using globally published and accepted standards for their testing methodologies and calibration of instruments.
  • The accreditation similarly outlines an acceptable set of methods that the lab can use.

The Benefits that ISO IEC 17025 Brings to Institutions

Accreditation can take a lot of time, but the sheer benefits that it offers to an institution are second to none. An accredited lab is one that is afforded respect in their dealings with their business clientele. By starting on the path of ISO IEC 17025 accreditation, an institution removes any doubt that a client may have regarding their operation and methodologies. In the business of laboratory testing, trust is the most important thing for clients. The accreditation encourages trust in a laboratory because the accreditation shows that the company conforms to professional, accepted standards that are approved globally.

Clients will no longer have to worry about retesting leading to different results. The generated results from the labs’ test would be accurate and precise. This peace of mind is critical to a client’s decision to return for future business. Not only does ISO IEC 17025 affect the way a client sees the institution, but how other companies in the industry view them as well.

Institutions that are certified as ISO IEC 17025 compliant tend to be seen in a better light by other labs, both certified and uncertified. Cooperation and sharing of results will be a lot easier with other labs because of this accreditation. The partner labs will have peace of mind that their results will not end up in unauthorized hands. Since this accreditation is accepted globally, international boundaries don’t matter to this level of trust. A certified institution is accorded the same respect anywhere in the world they choose to do business.

How Long does ISO IEC 17025 Accreditation Take

Accreditation doesn’t have a specific timeline. There is no set number of days or weeks that can be applied to every organization. Accreditation depends on a handful of critical practices that may vary, depending on the institution. These are:

  • Number of locations where testing /calibration is done
  • How complex the testing methodologies and equipment calibrations are
  • How many employees the business employs
  • The number of tests or calibrations that are within the institution’s scope of operations

The 2017 Update to ISO IEC 17025

In 2017, the ISO IEC 17025 received a series of updates. Rapid progress in the technology and within the market’s demands made revamping the process of accreditation necessary to deal with these changes. The changes sought to incorporate developments within the realms of IT and technical methodologies while updating the accreditation’s vocabulary to meet the demands of the modern world. The new amendments integrated changes to the ISO 9001 standard, hoping to bring about further integration of both standards.

Significant Changes in the 2017 Amendment

With the ISO IEC 17025:2017 amendment, the industry saw the accreditation change some areas significantly, including:

  • Accreditation Scope: All of a laboratory’s sampling techniques, equipment calibration, and testing will now be covered under the new scope of the accreditation.
  • Alignment between ISO IEC 17000 and ISO IEC 17025: The accreditation was redesigned to bring about a closer alignment between the two standards.
  • Improved Approach to Processes: The accreditation system has been developed to synchronize more closely with existing accreditation systems, including ISO 15189 (Quality of Medical Laboratories), IEC 17000 (Standard of Conformity Assessment Activities), and ISO 9001 (Quality Management System).
  • Reduction in Paperwork: A broader focus on IT and software reduces the amount of paperwork a business needs to perform to conform to the accreditation’s standard.
  • Risk-Based Considerations: A section has been added to the accreditation that allows for closer integration with ISO 9001:2015.
  • Synchronization of Terms: Terminology and vocabulary have been updated to reflect standard conformity assessments.

Display of Accreditation

Once a lab has successfully achieved ISO IEC 17025, they can proudly display the certificate wherever they see fit. Additionally, they can include the accreditation in all their marketing materials, not limited to the company’s website and brochures. Accreditation puts the clients’ minds at ease since it allows them to trust the institution as an internationally recognized organization for their work.

Are you trying to get ISO IEC 17025 accreditation for your institution? Contact us today, and we can work through any questions you might have about the process or the application.

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ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO/IEC 17025, Uncategorized

Laboratory accreditation for testing and calibration falls under the ISO IEC 17025 standard. Any laboratory that wants to demonstrate their conformity to the highest levels of quality for their results would be well-advised to seek ISO IEC 17025 accreditation. The accreditation was designed alongside eighteen liaison organizations, including the International Laboratory Accreditation Cooperation (ILAC).

Who Does the ISO IEC 17025 Apply To?

Accreditation should be a priority for labs that do testing, sampling, or equipment calibrations. Whether the lab is government-run or private doesn’t make a difference. While many labs believe they already run at peak efficiency, implementing ISO IEC 17025 usually reveals a lot of gaps in their processes and management methodologies. Among the perks of achieving ISO IEC 17025 accreditation are:

  • Quality control systems can anticipate problems and deal with preventative actions.
  • Methods of testing have specific accuracies, precision, and limits of detection.
  • The institution starts using globally published and accepted standards for their testing methodologies and calibration of instruments.
  • The accreditation similarly outlines an acceptable set of methods that the lab can use.

The Benefits that ISO IEC 17025 Brings to Institutions

Accreditation can take a lot of time, but the sheer benefits that it offers to an institution are second to none. An accredited lab is one that is afforded respect in its dealings with its business clientele. By starting on the path of ISO IEC 17025 accreditation, an institution removes any doubt that a client may have regarding their operation and methodologies. In the business of laboratory testing, trust is the most important thing for clients. The accreditation encourages trust in a laboratory because the accreditation shows that the company conforms to professional, accepted standards that are approved globally.

Clients will no longer have to worry about retesting leading to different results. The generated results from the labs’ test would be accurate and precise. This peace of mind is critical to a client’s decision to return for future business. Not only does ISO IEC 17025 affect the way a client sees the institution, but how other companies in the industry view them as well.

Institutions that are certified as ISO IEC 17025 compliant tend to be seen in a better light by other labs, both certified and uncertified. Cooperation and sharing of results will be a lot easier with other labs because of this accreditation. The partner labs will have peace of mind that their results will not end up in unauthorized hands. Since this accreditation is accepted globally, international boundaries don’t matter to this level of trust. A certified institution is accorded the same respect anywhere in the world they choose to do business.

How Long does ISO IEC 17025 Accreditation Take

Accreditation doesn’t have a specific timeline. There is no set number of days or weeks that can be applied to every organization. Accreditation depends on a handful of critical practices that may vary, depending on the institution. These are:

  • Number of locations where testing /calibration is done
  • How complex the testing methodologies and equipment calibrations are
  • How many employees the business employs
  • The number of tests or calibrations that are within the institution’s scope of operations

The 2017 Update to ISO IEC 17025

In 2017, the ISO IEC 17025 received a series of updates. Rapid progress in the technology and within the market’s demands made revamping the process of accreditation necessary to deal with these changes. The changes sought to incorporate developments within the realms of IT and technical methodologies while updating the accreditation’s vocabulary to meet the demands of the modern world. The new amendments integrated changes to the ISO 9001 standard, hoping to bring about further integration of both standards.

Significant Changes in the 2017 Amendment

With the ISO IEC 17025:2017 amendment, the industry saw the accreditation change some areas significantly, including:

  • Accreditation Scope: All of a laboratory’s sampling techniques, equipment calibration, and testing will now be covered under the new scope of the accreditation.
  • Alignment between ISO IEC 17000 and ISO IEC 17025: The accreditation was redesigned to bring about a closer alignment between the two standards.
  • Improved Approach to Processes: The accreditation system has been developed to synchronize more closely with existing accreditation systems, including ISO 15189 (Quality of Medical Laboratories), IEC 17000 (Standard of Conformity Assessment Activities), and ISO 9001 (Quality Management System).
  • Reduction in Paperwork: A broader focus on IT and software reduces the amount of paperwork a business needs to perform to conform to the accreditation’s standard.
  • Risk-Based Considerations: A section has been added to the accreditation that allows for closer integration with ISO 9001:2015.
  • Synchronization of Terms: Terminology and vocabulary have been updated to reflect standard conformity assessments.

Display of Accreditation

Once a lab has successfully achieved ISO IEC 17025, they can proudly display the certificate wherever they see fit. Additionally, they can include the accreditation in all their marketing materials, not limited to the company’s website and brochures. Accreditation puts the clients’ minds at ease since it allows them to trust the institution as an internationally recognized organization for their work.

Are you trying to get ISO IEC 17025 accreditation for your institution? Contact us today, and we can work through any questions you might have about the process or the application!

Book A Call With An Expert Now
What Does QMS Stand For? 3 Quality Letters

What Does QMS Stand For? 3 Quality Letters

ISO 9001, Quality Management Standards (QMS), Uncategorized

What does QMS stand for? If you are looking for an answer to this question, you are definitely interested in making quality a focus in your organization.

Perhaps, you are planning to build a culture of quality, mentor ship, smooth communication, and have an overall well-structured organization. Or you are aiming to provide consistent quality services and products to your clients while minimizing costs, waste, and improving employee morale simultaneously.

If you have answered yes, then you can follow in the footsteps of the market giants like HFI, Vishay Dale Inc, and have a well-defined QMS implemented in your organization. But with all the different terms and certifications floating around in the industry, knowing what QMS stands for can be a bit challenging?

So, what does QMS stand for? Let’s get into the details.

What Does QMS Stand For? A Quick Understanding

Quality Management System (QMS) is a structured collection of policies, procedures, process, and their associated responsibilities, necessary for efficient planning and execution of the core business. A QMS works to improve specifically the areas that impact the organization’s ability to meet customer satisfaction.

The easiest way to understand QMS is to break down and take a closer look at the name. “Quality” refers to the degree of fineness of any product or service, whereas “Management” refers to the orchestrated activities to run and control any organization. Lastly, “System” is a network of interacting or interrelated elements essential for smooth operations. When looking for an answer to “what does QMS stand for”, you will usually come across the term ISO 9001:2015. ISO 9001:2015 is the world’s most widely recognized quality management system framework.

15 reasons why you should have ISO 9001:2015

Companies with ISO 9001:2015 quality management system enjoy the following benefits:

  1. An enhanced positive company image
  2. A well-defined procedure system
  3. A simplified organizational structure and chain of authority
  4. Articulation of responsibilities of every personnel and department
  5. An engaged, evolved, motivated, and conflict-free workforce
  6. Clarification of corrections and preventions of defects
  7. Cutting down of costs, wastes, and saving of valuable resources
  8. A smooth flow of communication within the company
  9. Increased accountability and transparency in records and data maintenance
  10. Boosted continual improvement
  11. Clear status of existing business performance
  12. Consistent delivery of quality services and products
  13. Improved customer satisfaction and business profits
  14. Better industry competitiveness
  15. Access to global markets

How Can You Get Quality Management System Certification?

Identify The Gap

If you have decided to get a certified quality management system, then we advise you to check for the proper establishment of the foundations of QMS, i.e., the 3P’s (policies, procedures, and processes) in your organization. You can have your internal executive management do this, or you may hire outside sources that specialize in gap identification. Either way, you need to review your current documentation, policies, and procedures. The areas that do not meet the standard should be highlighted and reported.

Implement Changes

After identifying the gaps, you need to make all the required changes, have them monitored, and evaluated for improvement. To assist in change management, you can use the templates provided by QMS. Align your documents, practices, and systems following the ISO 9001:2015 defined standards, and then apply for certification.

Get Certified

An auditor usually visits your organization to check that the compliance of all documented policies and procedures is in place. This auditor ensures the successful implementation of all the necessary changes. Upon satisfaction, the auditor issues and awards your company the certification you applied for.

After you get the desired certification, the year-round re-certification cycle starts. On the anniversary of your certification, you have to confirm your continued compliance and consistency in the quality management system to validate your certification. At this point, you have the answer to the question, “What does QMS stand for”. But more importantly, you now understand the importance of QMS too.

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How Do I Know If Our Current Quality Management System Will Pass ISO Certification?

How Do I Know If Our Current Quality Management System Will Pass ISO Certification?

Uncategorized

When you implement ISO, you aren’t going in empty-handed. You have a quality management system already. You want to know if your current quality management system will pass ISO certification.

That would bring down the costs of getting certified, in dollars and in man hours.

To be upfront: It is Unlikely that Your Current Quality Management System Will Pass ISO Certification.

Why?

While you may have a fantastic QMS, ISO standards are specific. Your organization will have the freedom to choose the best way to organize and communicate your processes. However, how you maintain and retain documents is laid out for you.

But here’s the good news: There are tools that make sure your current quality management system will pass ISO certification with just a few tweaks.

You just have to perform a Gap Analysis. (Click HERE to get your FREE Gap Analysis now.

What’s a Gap Analysis?

A gap analysis is simple. You look at where you are. You look at where you want to be.

  • What’s the gap between those 2 places?
  • How do you fill that gap?

Gap Analysis doesn’t just apply to getting you current quality management system will pass iSO certification. Let’s say you want to be able to run a 10k, but you can only run 5 miles now.

You have a 1.2-mile gap to fill.

Once you have that information, you can start changing parts of your running routine to meet your goals. Each day you run a little longer, you eat a little healthier, you sleep a little better.

Gap analysis is the same principle applied to organizational goals.

Click HERE to get your FREE Gap Analysis now.

Your Current Quality Management System Will Pass ISO inspection after a thorough gap analysis, corrective action, and an internal audit.

Understanding the standard is the most important thing you can do to perform a thorough gap analysis. Make sure that you select someone in your organization to manage the analysis who has quality experience. (Or get a FREE Gap Analysis by CLICKING HERE).

If you do go in-house, make sure to purchase a gap analysis checklist to help lead the way.

Whatever approach you take, your dedicated team will make sure your current quality management system will pass ISO certification in no time.

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What is the Cost of ISO Certification?

What is the Cost of ISO Certification?

Uncategorized

 

Before jumping head-first into the waters of ISO, you need to know: what is the cost of ISO certification?

The answer to this question and many others you have about ISO certification is the same: Depends.

How long does getting certified take? How much time do you have to invest to maintain certification? What is the best certification? The answer to all of these questions is dependent on your particular circumstances.

(Click HERE to get a FREE gap analysis).

Still, we always try to offer some guidelines. Here are a few rough estimates we made based on our years in business working with many different kinds of organizations.

Breaking Down the Cost of ISO Certification

  1. Copies of the Standard: To meet the standard, you have to know what the standard is. This alone can run up to $120.
  2. Hiring a Registrar: You need to hire a professional for 2-3 days for small size Organization at roughly $1,400 to $1800 a day based on the standard.
  3. Internal Costs: When calculating the cost of ISO certification, you need to figure out how much time your employees will be dedicating to the project. They must learn and implement the standard. Who are you going to assign the job to? Putting your most competent professionals in charge will save you a great deal of time and effort in gaining compliance. You’ll also have fewer mistakes to correct later on.

Depending on the size of your company, your current quality management system, and whether you get external help, expect to include 50 to 500 man hours in the cost of ISO certification.

How does your company stack up to the ISO standard? Click HERE to get a FREE gap analysis.

  1. External Costs: If you choose to hire an ISO consultant, you will save a lot of man hours. Your upfront costs may be higher. Consulting costs can range from $500 to $40,000 depending on how big and complex your company is. Price will also be affected by whether you want on-site or virtual consulting.

The Absolute Minimum Cost of ISO Certification

While we cannot tell you the cost of ISO certification for your company, we can put a lower limit on the price. As a small organization, you need to set aside an absolute minimum of $10,000.

This price tag may seem high, but the cost of ISO certification is dwarfed by long term pay out.

 

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Yes, ISO Certification is Tax Deductible

Yes, ISO Certification is Tax Deductible

Uncategorized

Is ISO Certification Tax Deductible?

Yes, ISO certification is tax-deductible.

A company is free to choose whether they get ISO certified, so you might expect to bear the cost of certification yourself. This was what the US government held believed for a long time.

Initially, ISO certifications were considered tax-deductible because the license is an “ordinary and necessary business expense under section 162 of the code.”, but that has changed to Code 41. If you are interested to learn how to qualify for R&D Tax credit keep reading.

ISO certification is tax-deductible and may qualify you for more tax benefits.

Your ISO certification is tax-deductible, and so are the quality improvements you make.

With changes in regulations, R&D tax credits were introduced.

(1) Qualified Research according to IRS code 41 is “The term “qualified research expenses” means the sum of the following amounts which are paid or incurred by the taxpayer during the taxable year in carrying on any trade or business of the taxpayer—

(A) in-house research expenses, and

(2) In-house research expenses

(A) In general

The term “in-house research expenses” means—

(i) any wages paid or incurred to an employee for qualified services performed by such employee,

(ii) any amount paid or incurred for supplies used in the conduct of qualified research, and

(iii) under regulations prescribed by the Secretary, any amount paid or incurred to another person for the right to use computers in the conduct of qualified research.

B) contract research expenses.

Per the definition above Qualifying R&D falls under the following categories:

  • new product development,
  • significant product improvement,
  • new process development, and
  • significant process improvement.

An example of the industry activity that will qualify for purpose of the R&D tax credit is Research and process development for ISO or other industry or regulatory certifications.

To qualify, you need to be able to answer yes to these questions:

  • Are you improving and developing components of the business?
  • Are you getting rid of technical uncertainty?
  • Are you comparing different ways to solve problems in your business?
  • Are you experimenting and relying on hard science like computer science to make decisions?

The tax code is complicated but with a professional, you’ll be able to capture all the hidden benefits that iso certification has to offer.

Tell Management ISO Certification is Tax-Deductible

Whether or not ISO certification is tax-deductible is important to you as a quality management professional because you need to get management on board. One of the biggest fears that they have is that expenses are too high. Bring these tax incentives to their attention to get them on board. Without their buy-in, you’re going to struggle to succeed.

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