Recognize the 5 Best Ways that Laboratories Can Simplify ISO/IEC 17025 Compliance

The international standard ISO/IEC 17025:2017 establishes the standards for testing and calibration laboratories. Obtaining ISO/IEC 17025 certification simply signifies that your lab is acknowledged as being technically skilled in testing and calibration, assisting your business in facilitating easier test result acceptance and reducing the need for repeat testing. This ISO standard is divided into two major sections:

• Management requirements, which are largely concerned with how well the laboratory's quality management system functions.
• Technical requirements, which mostly concern the staff's training and the accuracy of the equipment

The organization must demonstrate compliance in both of these categories during an authorized third-party audit to meet ISO 17025 regulations. Unfortunately, this procedure sometimes takes a long time and is complicated. Let's examine five compliance suggestions to help your business be ready for audits and make sure you pass with high marks.

• Document the laboratory and employee competencies: Because ISO 17025 is all about testing and calibration competencies, the auditor will demand actual evidence of the lab's capabilities in these areas. So, when the organization goes about its daily operations, make sure to document each procedure that helps to:
  • Consistent processes
  • Valid results
  • Achievement of overarching lab goals

The process may comprise authentication of ISO 17025 documents, equipment maintenance, risk assessments, internal audits, safety, and so on. Additionally, to maintain constant laboratory operation and improvement, monitor and document employee competence. Set measurable quality targets for each job description under the company's umbrella and decide on several key performance indicators (KPIs) to assist to track whether professionals are fulfilling their required benchmarks. When it comes to ISO/IEC 17025 accreditation, having consistent methodologies and legitimate lab findings is not enough; you must be able to demonstrate to an auditor that your processes and people match ISO's requirements.

• Gather your quality documentation: The laboratory's quality documentation is the following element of the compliance puzzle. You'll be required to demonstrate not only your skills but also that your company produces work that adheres to a particular degree of quality. Your quality manual, job instructions, ISO 17025 audit checklist, and procedures are just a few examples of documents that are frequently included.

The quality manual is the most crucial document that any business should concentrate on developing. The manual offers an effective approach to reference and link policies, systems, documents, and records of your laboratory processes if it is well-structured and written. Essentially, this manual will serve as the foundation for your ISO 17025 audit, directing your auditor to the data they need to demonstrate compliance. Finding the right balance between simplicity and complexity will help to create a quality manual that will help the auditor fully understand the lab's quality procedures without having to go through a lot of paperwork.

• Keep your employee training up to date: There are very specific regulations established in ISO 17025 that specify exactly what they require in terms of employee training. Organizations must be able to show that their staff members received thorough training on your policies and procedures system during the audit. The ISO 17025 auditor training records must be thorough and easily available to confirm that each employee has completed all mandatory training activities and any subsequent training that may be required. 
• Perform an internal audit: Internal audits are an excellent approach to check that the organization's operations are up to the quality requirements and to get ready for an ISO inspection. An internal audit's main objective is to ensure that your company's policies and procedures are followed. It also serves to inform you of any gaps in policy compliance so that you can close them before they worsen. Instead of wasting time on areas that are already entirely compliant with ISO 17025, an internal audit can assist the business to identify gaps in its quality control methods and address high-risk areas of your lab processes. Accredited auditors are seeking labs to conduct internal audits by ISO 17025 Section 4.14, which is beyond simply being a useful tool. These are some of the key factors that should take into consideration when preparing an internal ISO 17025 audit:

• • Personnel training and competency (clause 6.2)
  • Laboratory facilities and environmental conditions (clause 6.3)
  • Sampling and handling of calibration items (clauses 7.3 and 7.4)
  • Traceability of measurement results (clauses 6.4 and 6.5)
  • Internal control procedure and acceptability of quality control results (clause 7.7)
  • Technical Records (clauses 7.5 and 7.11)
• Implement a strong quality management system (QMS): The final and possibly most crucial stage in ensuring ISO 17025 compliance is building a strong QMS. In addition to the requirements outlined above, ISO 17025 sets strict standards for the operation of a quality management system. When being audited, the organization must be able to demonstrate how they operate within those requirements. Employees can use a capable quality management system to assign, track, and verify action items, set up training requirements, and automate workflows to ensure that non-compliance concerns are eradicated. It can also help ensure the highest quality business processes are followed to fulfill the expectations of consumers, stakeholders, and ISO regulations. The entire quality management system may be created using software to swiftly and simply demonstrate ISO compliance every step of the way before an auditor even walks through the door.

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