Fear of Non-Conformance Then Meet the ISO 17025 Requirements

If a company wants to maintain sustainable in an increasingly competitive market for testing, calibration, or sampling industry, then the ISO 17025 certification is a necessary strategic aspect. The globally acknowledged certification helps to enhance the power of the reliability factor by setting guidelines and objectives. Building customer loyalty by providing them with valid and fast results is the ultimate way to strengthen sustainability power. The accreditation is therefore a strategic facet for maintaining a profit margin stable, high customer satisfaction, and market exposure.

The implementation process for the standard is hassle-free when the ISO 17025 requirements are met. Non-conformance is a serious offense considered by the government. Companies often pay steep penalties and lose their customer base when they fail to adhere to the fundamental regulations. Certification compliance is related to the rudimentary clauses of the ISO 17025. Each clause comes with several requirements, which define the process for the successful generation of valid test results.

Non-conformance is a pivotal issue that hinders the entire certification journey. The clauses that set the rules and guidelines are the core principles of the ISO 17025. The following blog has disclosed the mandatory requirements for implementing an effective system according to the international standard. The aim of the following content is to highlight the role of requirements in achieving 100% compliance.

What are the ISO 17025 requirements?

The requirements are associated with the clauses, and each clause encompasses a certain number of criteria. The following has emphasized the same.

Clause 1, 2, 3 – Scope of the program, normative references, and terms and definition

Clause 4 – General requirements

• A laboratory should not allow any external (financial and commercial) factors to manipulate the results. Therefore, maintaining impartiality is the major part.  

• Confidentiality of the test results is the second major requirement. The laboratory professionals must ensure that key components of the result and other associated aspects are kept under tight security.

Clause 5 – Structural requirements

• The basic organizational structure

• The fundamental components

• The process

• Adherence

Clause 6 – Resources

• General requirements

• Personal requirements

• Facilities

• Infrastructure

• Human resources

• Environmental conditions and equipment

• Metrological traceability

• Any product that is provided externally

Clause 7 – Process requirements

• Review of the tenders, contracts, and requests

• Sampling

• Verification, selection, and validation of the procedures

• Technical records

• Test handling

• Calibration items

• Complete analysis of the measurement uncertainty

• Validity of the test results is ensured

• Result reporting

• Any complaint left ignored

• Nonconformance identification

• Data control

Clause 8 – Management requirements

• System documentation

• Control of the management documentation

• Record control

• Actions to address opportunities as well as risks

• Improvement

• Corrective measures

• Internal audits

• Review of the management performance.

How to fulfill the requirements?

1.Gap analysis – To meet the clauses and their demands, determine the flaws and their root causes. Gap analysis is the easiest and most common process for analyzing the gap between your present system for calibration results generation and the objectives. Before implementing changes to accomplish requirements, it is necessary to find out how much and exactly which modifications are necessary.

2.Gap filling – This is a short process followed by the previous ones. The management team will look to fill the gaps found in the analysis round with the help of relevant resources and procedures.

3.Internal audit – Once the gap-filling is done, and progress is determined the existing areas of improvement are notified with the help of an internal audit. It essentially adds value to the overall process by determining results and deducted from the previous implementations.

To find the best professional support for attaining the ISO 17025 requirements, contact us at Compliancehelp Consulting LLC. We are the premium site for achieving any ISO certification in the US. Our bespoke solutions for ISO and other global certifications are ready to make the seemingly exhausting process of accreditation, comfortable and hit the prescribed timeline. From basic consultation to audit and analysis, we will cover everything. Get help to clear your concepts regarding the clauses of the ISO 17025 standard.