Environmental Assessment

Laboratory Compliance under ISO 17025

Manufacturers that bring new products to market must consider the various Environmental Product Regulations that might apply. A company that lacks on-site testing facilities might need to send samples to an off-site laboratory as part of the fabrication process. Often, this step is to secure compliance with programs like RoHS, REACH, POP-Halogen Free, TSCA-PBT, or California Proposition 65. The ISO 17025 standard provides the most recognized practices for ensuring accuracy in such tests.

AN INTRODUCTION TO ISO 17025

The ISO 17025 standard lays out “general requirements for the competence of testing and calibration laboratories”. The International Electrotechnical Commission (IEC) has worked closely with the International Organization for Standardization (ISO) to develop specific methods and requirements for eligible laboratories.

These standards fall into four major categories:

  • Structural requirements
  • Resource requirements
  • Process requirements
  • Management system requirements
ISO 17025 - Testing Lab
ISO 17025 laboratory - clean room

Testing laboratories may choose to follow ISO 17025 guidelines internally. They may also opt to seek third-party certification. Importantly, these are not mandatory actions, although official ISO 17025 accreditation has its advantages.

A fifth category, the General requirements, is also worth mentioning. These requirements are broader and include:

  • guaranteeing the confidentiality of the results obtained from the analysis, and all agreements between the laboratory and client
  • maintaining the confidentiality of internal activities and documentation (control of documents)
  • identifying and minimizing experimenter bias during analysis

Let us examine the four main categories (excluding the general requirements) in further detail!

ISO 17025 - Main categories

STRUCTURAL REQUIREMENTS OF ISO 17025

The laboratory should be a legal entity. Personnel should identify ISO 17025 standards as a priority, and work to fulfill the requirements. Members of an identified management should oversee the daily operations. Here are some examples of what that looks like:

  • Management should designate a defined authority for obtaining the results in the lab. Management should delegate this authority to appropriate personnel. Resources to identify deviations, minimize them, and report on the performance should be in place.
  • The laboratory should have personnel responsible for maintaining and improving operational procedures. Duties include monitoring and reporting performance in obtaining accurate testing results. Such checks are usually done periodically through internal audits.
  • All employees involved in such a management system should understand its principles and pledge to uphold them.

The laboratory must document all activities performed. Procedures should comply with client requests and regulatory authorities. For example, analytical methods used in RoHS testing should follow IEC 62321 standards.

RESOURCE REQUIREMENTS OF ISO 17025

The laboratory must have all resources required to perform testing. Requisites include proper equipment and sufficient personnel.

STAFFING

The laboratory must employ qualified personnel to conduct analytical procedures. Managers should document evidence of competence under the laboratory management system. Staff should receive regular training and skills refreshers. Relevant training documents should be archived.

For example, active lab technicians should demonstrate sufficient knowledge and experience in chemistry. Such expertise is shown traditionally by holding a degree. If a staff member receives new training, an instructor should evaluate their learning progress. Finally, a registered chemist should validate all results before sending the final report to the client.

FACILITIES AND ENVIRONMENTAL CONDITIONS

The operating conditions in a laboratory should not affect the validity of results. Staff must be able to access methods for controlling humidity, light, or particle contamination where appropriate. Stable ambient conditions are a primary goal; personnel should take periodic measurements to verify a proper working environment.

Consider a laboratory that requires constant room temperature (within a given tolerance) during the workday. A digital thermometer can perform this screening passively by monitoring and recording the lab temperature. At the same time, it could help personnel detect whether the ambient temperature might affect the samples (like changing their viscosities) or the testing methods (as with sensitive chromatography instruments).

EQUIPMENT

The laboratory must have access to proper equipment. Industry-standard instrumentation, paired with appropriate software, is a minimum requirement for data analysis and obtaining valid results. Periodic maintenance and calibration of laboratory equipment are also required, especially when the reported results might become affected by the accuracy of measurements.

Traditionally, instruments used for sample testing under RoHS compliance include XRF, ICP-MS, and GC-MS. Such machines should always run the latest version of compatible software provided by the manufacturer. Also, quality assurance experts should calibrate and maintain these instruments regularly and document the results. The calibration validity period should always be visible on the instrument nameplate.

METROLOGICAL TRACEABILITY

This term defines

the property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty.

Recordkeepers must ensure results are easily traceable, and all figures should use SI (International System of Units). All operations must follow certified referenced material, like standard calibrations. For example, values recorded for mass should use magnitudes of grams (e.g., kilograms, milligrams) rather than pounds.

EXTERNALLY PROVIDED PRODUCTS AND SERVICES

The laboratory should document any external products and services used for site maintenance. Third-party organizations that perform any calibration process and measurements must be duly qualified. Highly-sensitive instruments may require additional annual maintenance by the manufacturer.

PROCESS REQUIREMENTS OF ISO 17025

A laboratory will execute most efficiently when operated under guidelines for planning and performing each step in a workflow. ISO 17025 contains process requirements that organizations can use to define which approach they follow to attain their results. These guidelines fall into several categories:

ISO 17025 - sample

REVIEW OF REQUESTS, TENDERS, AND CONTRACTS

A lab should have a proper procedure for processing client requests. This procedure should exist in a form that is understandable to the client. Additionally, the lab should ensure they have the necessary equipment to execute a contract before promising to fulfill it. Personnel must be prepared, if requested, to disclose and describe the analytical methods used to the client. Whenever applicable, the lab should inform the client about changes in procedure or unexpected deviations that appear during analysis.

For example, consider a new product that requires environmental testing before release. The lab might employ methods aligning with RoHS Directives through IEC standards (e.g., via XRF or GC-MS). Personnel must communicate this strategy in detail to the client. In addition, if analysts notice any deviation or system interruption (e.g., variance observed while performing sample injections for GC-MS), they must convey this event to the client and document the incident.

SELECTION, VERIFICATION, AND VALIDATION OF METHODS

A lab should provide analysis using those methods that align with industry best standard practices. Labs should always use the most current and appropriate methods for a given analytical process. The selection of such methods should reference relevant literature or standards.

Sometimes a client will not have expertise or preference when choosing a course of analysis. In this case, the laboratory must be able to design a plan of action and communicate the thought process to the client.

SAMPLING

A laboratory should follow a uniform sampling plan during the analytical process. A lab should design its sampling methodology to align with industry-standard practices. Sample batches should be well-documented, with any variations in testing and calibration noted.

ISO 17025 - Verification

COMPLAINTS

A laboratory should have a structured system for receiving and recording complaints. When selecting an appropriate response, personnel should follow similar measures.

NONCONFORMING WORK

Consider a new product submitted for REACH SVHC analysis. Testing shows some species with more than 0.1% at the article level. Personnel must communicate this discrepancy with the client by reporting the results. In fact, the laboratory should define a system for handling nonconformities that might occur in the workflow. Tasks might include repeating the analysis and risk evaluation. If a sample is declared nonconforming, then corrective plans should be implemented and communicated with the client.

EVALUATION OF MEASUREMENT UNCERTAINTY

A laboratory should evaluate any contributions to uncertainty. They should be listed and detailed in the final report.

ENSURING THE VALIDITY OF RESULTS

The laboratory should have a system to evaluate the validity of results obtained using their equipment. Personnel should follow industry-standard methods, such as blind sample testing and intermediate checks during sample measurement.

CONTROL OF DATA AND INFORMATION MANAGEMENT

The laboratory should document and protect client results from unauthorized access. They should also take steps to archive their various correspondences securely in case they need access in the future.

Product Compliance deviation

HANDLING OF TEST OR CALIBRATION ITEMS

A laboratory should have a procedure for correctly receiving, storing, and returning samples and equipment. Staff must duly record any deviations from the process.

TECHNICAL RECORDS

A laboratory should maintain organized archives of past analyses They should contain sufficient and pertinent information across all stages of a procedure and must be traceable to previous document versions.

REPORTING OF RESULTS

Results should be clear and accurate. They should include all information about the analysis and follow standard best practices for reporting and formatting.

For example, reports should contain records of all correspondence between a laboratory and a client after finalizing the contract. Information such as the date(s) of the analysis, the date of report issue, and contact information of all contracted parties allows for easier document tracing. Supplementary data like these also help provide context for the test results obtained; this is useful when further analysis is required.

MANAGEMENT SYSTEM REQUIREMENTS OF ISO 17025

A lab that seeks to deliver all of these requirements needs to be structured and well-organized. Best practices involve constructing a set of routines that constitute a management system with planning, execution, verification, and adjustment activities.

This definition is clearly broad, and different organizations may seek compliance in different ways. For example, the ISO 14001 standard guides companies in implementing an effective environmental management system. If this scope is too narrow, some organizations may choose the ISO 9001 standard to demonstrate product consistency and reliability.

Finally, ISO 17025 also provides a separate management systems framework that includes the following elements:

DOCUMENTATION AND CONTROL OF DOCUMENTS

Management should produce policy documents that align with the management system. These must be accessible to all personnel involved in the laboratory, and they should understand what responsibilities are involved.

ISO 17025 INTERNAL AUDITS

Policy documents should be reviewed periodically and evaluated for validity. The lab should plan regular internal audits to ensure that policies are respected and aligned with the management system.

CONTROL OF RECORDS

The laboratory should have a structure for archiving and accessing recorded documents. These documents should be readily available and easily accessible.

ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

The laboratory should conduct risk assessments for relevant lab activities. Management should enact suitable plans of action to mitigate potential failures.

IMPROVEMENT OF THE ISO 17025 MANAGEMENT SYSTEM

The laboratory should have proper channels for receiving feedback from clients. Personnel should use this system to reflect on lab activities and help drive advancement.

CORRECTIVE ACTIONS

The laboratory should take immediate action when analysis results are invalid. The laboratory should have protocols for finding the causes of any discrepancies and tracing the errors. This step helps to track similar nonconformities across samples or clients.

MANAGEMENT REVIEWS

The laboratory should review the management system periodically to ensure the effectiveness of policies and procedures.

Enviropass can help you to do your RoHS, REACH, and Prop.65 testing in labs certified under ISO 17025!