ISO 9001 vs. ISO 17025 Calibration Requirements
Following the 2017 update of ISO 17025, many were left confused about the standard's purpose and how it relates to the Quality Management System (QMS) and the ISO 9001 standard requirements.
If a business deals with measurements or derives data from measurements, it’s crucial to understand how these standards can help in your calibration solutions. Furthermore, in some regions, one might not even be allowed to operate without the required accredited calibration.
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What is ISO 9001:2015 all about?
Developed by the International Organization for Standardization (ISO), this standard aims at providing a framework for the development of guidelines for effective management systems. ISO 9001 represents a set of acceptable good management policies and is accepted as a business standard worldwide.
Simply put, this standard helps businesses keep records, set policies and procedures, and manage production, quality, and service. Still, it’s important to note that the standard's guidelines are only a benchmark for continuous improvement.
standard that specifies requirements for a quality management system.
Getting this certification is certainly a big deal as it demonstrates a business’s capability to consistently deliver products and services that meet the customer’s needs. Adopting the standard further allows organizations to use a process approach when creating or improving their management systems.
One distinctive aspect of this standard is its wide scope - it applies to all businesses regardless of size, type and product/service provided. Nevertheless, it’s prudent to carefully evaluate its parts when implementing the standard in your business, owing to this broad generalization.
What is ISO 17025, and how does it benefit your company?
ISO 17025 is the primary international standard for the competence of testing and calibration laboratories. Laboratories of all sizes use it to assure their customers they operate competently and generate valid results, thus promoting confidence in their work.
In many regions, most major laboratories need certification to qualify as competent. This list includes in-house laboratories whose result assurance is a must-have.
Unlike the generalized ISO 9001, ISO 17025 contains specific requirements demonstrating the competence of testing and calibration laboratories.
The standard's original release was in 1999, but two updates have since been released, with the latest edition being in 2017. The most significant areas of focus include management and meeting technical requirements.
The five elements in the standard include:
- Normative references
- Terms and definitions
- Management requirements
- Technical requirements
The standard also includes general requirements for impartiality and confidentiality (clause 4), structural requirements (clause 5) and resources such as personnel, equipment, technical, facilities, as well as environmental conditions (clause 6).
Clause 7 further outlines crucial process requirements:
- Reviewing requests, tenders and contracts: Ensure delivery of what customers want.
- Method suitability: Ensure the proper calibration procedure is being used. Verify and validate the procedures.
- Record keeping: What technical records need kept, what should they contain, and how long to keep them?
- Handling items: Procedures for the proper handling of calibration items.
- Measurement uncertainty: Evaluating and reporting the measurement uncertainty for all calibrations.
- Result validity: Are results valid? How can one be certain?
- Result reporting: What are the reporting procedures and how will they be updated?
- Complaints and nonconforming work: How are complaints and nonconformities handled
ISO 9001 VS ISO 17025: Similarities and Differences
Given the numerous similarities of the requirements, things can get confusing. Knowing when to apply each can be daunting. Although both can work in any industry, their scope is very different.
For instance, while ISO 9001 applies to all types of businesses in all sectors, ISO 17025 is more specific and is tailored to testing and calibration laboratories.
For both, minimum management requirements include:
- Management reviews
- Management system documentation
- Handling of management system documents
- Corrective actions
- Addressing risks and opportunities
- Records control
- Internal audits
Depending on a given certification scheme, ISO 17025 allows for two options:
- Option A: If an organization has yet to implement ISO 9001, its ISO 17025 QMS must demonstrate adherence to certain management requirements (listed above) that are applicable to the scope of laboratory activities.
- Option B: If an organization already has ISO 9001 certification, it is all set.
ISO 9001 implementation and certification are nice to have but not mandatory to comply with ISO 17025. Still, some organizations will find it beneficial to implement all of ISO 9001 rather than only meeting the minimum management requirements.
By doing so, such businesses will be equipped on how to address various factors, including:
- Identifying internal and external issues
- Identifying interested parties
- Establishing a QMS
- Formulation of quality objectives
- Leadership commitment including a quality policy
- Monitoring and measurement
Furthermore, ISO 17025 on its own does not include all the requirements from ISO 9001, for instance, organizational knowledge is not part of ISO 17025.
Thus, implementing ISO 9001 is a plus in empowering a company to apply risk-based thinking in managing risks and driving improvement. It might not be a must, but it’s undoubtedly a valuable asset when seeking ISO 17025 certification.
ISO 9001 vs. ISO 17025: Which is better?
Both of these international standards are excellent. As such, organizations should do proper research to determine which standard best meets their quality requirements. Remember to educate and train personnel in the company on the chosen standard for the smooth operation of the business. In some cases, they may even need special training to perform specific tasks.