PECB ISO/IEC 17025 Foundation flashcards
PECB ISO/IEC 17025 Foundation · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- ISO/IEC 17025 scope
- Applies to laboratories that perform testing, sampling or calibration, regardless of size or number of personnel, including first-, second- and third-party laboratories.
- Definition of laboratory
- A body that performs testing, sampling or calibration activities; the standard's requirements apply to the activities it performs, not to its organizational form.
- Impartiality principle
- Laboratory activities are undertaken without bias; risks to impartiality from ownership, relationships, personnel or commercial pressure are identified and addressed.
- Confidentiality principle
- The laboratory manages information obtained or created during its work and releases it only when authorized by law, the customer or the contract.
- Documented information
- Information that the laboratory is required to control and maintain, covering both documents (how to do things) and records (evidence that things were done).
- Risk-based approach
- The laboratory plans actions to address risks and opportunities linked to its activities and evaluates whether those actions are effective; no single risk method is mandated.
- Process approach
- Managing laboratory activities as interrelated processes, using the Plan-Do-Check-Act cycle to set objectives, implement, monitor and improve.
- Accreditation versus certification
- Accreditation is third-party attestation of a laboratory's competence against ISO/IEC 17025 by an accreditation body; certification of a management system is a different activity.
- Legal entity requirement
- The laboratory must be a legal entity, or a defined part of one, with defined responsibilities and management accountable for the management system.
- Defined scope of activities
- The laboratory documents the range of testing, sampling and calibration activities it performs, so that its competence and management-system coverage are unambiguous.
- Personnel competence
- Competence is established from education, qualification, training, technical knowledge, skills and experience, with records retained and re-evaluation where needed.
- Environmental conditions
- Conditions that can affect the validity of results are monitored, controlled and recorded, and activities are stopped or results treated as suspect when limits are exceeded.
- Equipment calibration programme
- Equipment affecting results is calibrated or verified at defined intervals before use, with identification and calibration status known and traceable to a reference standard.
- Metrological traceability
- An unbroken, documented chain of calibrations, each contributing to stated measurement uncertainty, linking results to a national or international measurement standard.
- Reference material definition
- A material sufficiently homogeneous and stable to be used for calibration, method validation, quality control or assigning values to other materials; certified versions have characterized property values.
- Method validation
- Confirmation, by examination and provision of objective evidence, that a method's performance characteristics meet the requirements for its intended use.
- Method verification
- For standard methods used outside their intended range or otherwise modified, the laboratory confirms its ability to operate the method correctly before use.
- Measurement uncertainty
- A non-negative parameter characterizing the dispersion of values attributed to a measurand, evaluated and reported where the customer or the specification requires it.
- Sampling plan
- A documented approach specifying what, how, where and how much to sample, so that results are representative of the material or population sampled.
- Handling of test items
- Procedures for transport, receipt, identification, protection and storage of items prevent deterioration, loss or unintended alteration of the item under test.
- Technical records
- Records containing original observations, data and calculations allow the reporting process to be reconstructed; they are retained and include the identity of personnel performing the work.
- Reporting results
- Reports and certificates contain the required information: identification, methods, conditions, results, uncertainty and conformity statements where relevant, with clear and unambiguous presentation.
- Decision rule
- A documented rule describing how conformity with a specification is decided when measurement uncertainty is present, stated whenever a conformity statement is made.
- Nonconforming work
- Work that does not meet the laboratory's own procedures or the agreed customer requirements; it is halted, evaluated, corrected and, where relevant, reported to the customer.
- Complaints process
- A documented process for receiving, evaluating and deciding on complaints, with the outcome communicated to the complainant and records retained.
- Internal audit
- Planned, periodic audits of the laboratory's activities against its own management-system requirements, performed by trained personnel independent of the activity being audited.
- Management review
- Top management reviews the management system at planned intervals, considering inputs such as audit results, complaints, risks and quality control data, and records decisions and actions.
- Control of records
- Records are legible, protected from alteration, retained for defined periods and disposed of in accordance with the laboratory's documented rules and applicable requirements.
- Externally provided services
- Products and services from external providers that affect laboratory activities are controlled through defined criteria, evaluation and monitoring of the provider's performance.
- Customer service requirement
- The laboratory cooperates with customers to clarify requests, monitors its performance against agreements and seeks customer feedback on its work.
- Quality control data
- The laboratory monitors the validity of results using internal quality control and, where appropriate, external proficiency testing or interlaboratory comparisons, and acts on adverse trends.
- Improvement requirement
- The laboratory identifies opportunities for improvement and implements actions, using the outputs of audits, management reviews, corrective actions and risk evaluation.