PECB ISO/IEC 17025 Lead Implementer flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Impartiality

The presence of objectivity. Laboratories must identify risks to impartiality arising from their activities, relationships, or personnel, and eliminate or minimize such risks.

Confidentiality

The laboratory is responsible for managing all information obtained or created during its activities, releasing it only when legally compelled or authorized by the client.

Certified reference material

A reference material accompanied by a certificate providing metrological traceability and stated uncertainty for one or more property values, used to support calibration and validation.

Accreditation vs certification

Accreditation is third-party attestation of a laboratory's competence by an accreditation body; certification attests conformity of a management system, not technical competence.

Option A and Option B

Clause 8 offers two management system options: Option A implements Clause 8 requirements; Option B implements ISO 9001 plus Clauses 4 to 7 of ISO/IEC 17025.

Range of laboratory activities

The defined set of testing, sampling, and calibration activities for which the laboratory conforms to ISO/IEC 17025, established under Clause 4.1.

Metrological traceability

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

Technical records

Records containing original observations, data, and calculations sufficient to enable repetition of the activity and identify factors affecting the result; retained and protected from alteration.

Externally provided products and services

Items such as equipment, reference materials, and calibration services obtained externally; the laboratory must evaluate and select providers and verify conformity before use.

Method validation

Confirmation by examination and provision of objective evidence that a method is fit for its intended use, required for non-standard, laboratory-developed, or out-of-scope methods.

Gap analysis

A clause-by-clause comparison of current laboratory practices against ISO/IEC 17025 requirements, recording conformity status and evidence to define the implementation baseline.

Risks and opportunities

Clause 6.1 requires planned actions to address risks and opportunities affecting result validity and laboratory objectives, with evaluation of the actions' effectiveness.

Scope definition

The planned range of laboratory activities, methods, materials, and sites that the management system covers, which drives resource and validation planning.

Implementation roadmap

A sequenced plan covering leadership commitment, gap analysis, scope, process mapping, resource acquisition, method validation, documentation, internal audit, and management review.

Sampling plan

A documented plan specifying sampling methods, locations, timing, and quantities, with statistical basis where appropriate, to ensure representative samples.

Measurement uncertainty evaluation

Identification of uncertainty contributions and their evaluation, required where the client requires it, the method specifies it, or it is needed to interpret specifications.

Ensuring validity of results

Quality control activities such as reference materials, replicate tests, control charts, and interlaboratory comparisons used to monitor and confirm the reliability of results.

Nonconforming work

Work that does not conform to the laboratory's procedures or agreed client requirements; actions taken depend on the risk and significance of the nonconformity.

Complaints process

A documented process for receiving, acknowledging, investigating, and resolving complaints, with the complainant informed of progress and outcome.

Control of data

Validation of information management systems before use, protection of data integrity, and maintenance of systems supporting the laboratory's activities under Clause 7.11.

Internal audit

A planned, periodic, independent review of the management system to verify conformity and effectiveness, with results reported to management.

Management review

A top-management review at planned intervals covering defined inputs such as audit results, complaints, and risks, producing decisions on improvement and resources.

Proficiency testing

Evaluation of laboratory performance against pre-established criteria using interlaboratory comparisons; unsatisfactory results trigger investigation and corrective action.

Key performance indicators

Quantitative measures used to monitor management system performance, such as nonconformity rates, complaint trends, turnaround times, and proficiency testing performance.

Corrective action effectiveness

Verification that an implemented corrective action has eliminated the root cause and prevented recurrence, with the verification method and result recorded.

Continual improvement

Clause 8.6 requires identifying and selecting opportunities for improvement and implementing actions, using feedback from audits, complaints, and management review.

Root cause analysis

A systematic method to identify the underlying cause of a nonconformity, enabling systemic improvement rather than only correction of the immediate issue.

Improvement from data analysis

Trends in nonconformities, complaints, audit findings, and proficiency testing results are analysed to identify improvement opportunities and update controls.

ILAC MRA

The ILAC Mutual Recognition Arrangement among accreditation bodies; selecting a signatory body supports international acceptance of accredited laboratory results.

Accreditation scope

The precisely defined tests, calibrations, methods, materials, and sampling activities for which accreditation is sought and competence must be demonstrated.

Pre-assessment audit

An internal or external gap audit against ISO/IEC 17025 and the accreditation body's requirements, conducted before applying to close identified gaps.

Assessment findings closure

Correcting nonconformities identified during assessment, performing root cause analysis, implementing corrective actions, and providing objective evidence within the body's timeframe.