Introduction to

Requirements of

ISO/IEC 17025:2005

Christina Oscroft

Campden Laboratory Accreditation Scheme

Manager

Tel: 00 44 1386 842087

Email: c.oscroft@campden.co.uk

International Laboratory Quality

Standard

ISO/IEC Standard 17025 : 2005

General Requirements for the Competence of

Testing and Calibration Laboratories

Outlines standards for management of laboratory

operations and control of technical activities

Used by Accreditation Bodies to

Assess Laboratories

Control of Laboratory Operations

Staff

Facility

Equipment

Media

Management

control

Document

Control

Quality

Control

Records Audits/Reviews

Improvement

ANALYSIS

Calibration

Methods Validation

Samples

Results

Bench

Practice Proficiency

data

Service to client

NCW Corrective

Actions

Quality System Top Level Quality Policy (Mission) Statement

• Management objectives in relation to quality of work,

standard of service etc etc.

Formalised documentation of quality system

• All aspects of laboratory operations to be documented

• Describe how lab works, what is to be done, how, when,

parameters for activities to be within and actions to taken if

not met

Document Control (identification, approval for issue,

amendment procedure,+ records, archive superseded

documents, policies to prevent unauthorised changes

TYPICAL QUALITY SYSTEM

Policy

Procedures

Instructions and/or

Training

Records/Completed forms

Quality

Manual The intent

What will be done

How it will

be done

Evidence that it

has been done

Operations

Manual

Ensures standardisation/consistency

Provides point of reference + assists training

Organisation/Management

Management

• Lab a clearly identifiable legal entity

• Provision of adequate resource

• Effective in maintaining operations + quality of work.

Organisation

• Defined and clear line management structure

(within lab and to production/factory/clients)

• Individuals assigned responsibility for:

i. Overall responsibility for lab

ii. Day to day management/supervision of laboratory

iii. Quality of work + quality system maintained

Organisation/Management

Laboratory Administration

• Ensure timely analysis of samples

• Effective in progressing work

• Identifying and timely resolution of problems

• Timely issue of results

Release of Results

• Individuals authorised to report/release results (internal/external in spec/out of spec).

• Competence / Ability to interpret results

Management of Personnel

Qualifications/Experience

• Appropriate for job/responsibilities

Training

• Approaches (Internal/external)

• Supervision

• Appraisal of competence + technical data to show competence

• Records

Assessment of Ongoing Competence

• In methods

• Following updates/amendments to procedures

• Records

Control of Facility

• Location (separate to production/chemistry; type of organisms handled, customer requirements )

• Containment (suitable for organisms handled/screened/Bio-security Act)

• Access control (restricted/controlled)

• Layout (separation of activities - time/space, cross contamination risks)

• Furnishing/fabrics (suitable, condition)

• Housekeeping (facility/equipment, cleaning schedule/records)

• Environmental Monitoring (swabs, air plates, frequency, criteria, records)

Control of Hygiene

• Hygiene Rules (eating, drinking, smoking, personal effects, sensory appraisals).

• Clothing (suitable, distinct from production/other lab coats, correctly worn, frequency of changing, provision for visitors/engineers).

• Hand-wash facilities (dedicated, bactericidal soap, non hand operated taps; correct handwash/coat change on entry/exit).

• Protective Equipment (gloves, masks, aprons, fume hoods, safety cabinets etc)

Confirmation of Work and

Client Requirements

• Ensure resource available to perform work.

• Tests required clearly defined/established .

If not take action to ensure requirements understood

• Show required tests were done on samples

• Provide reasonable co-operation with clients

Handling Test Items/Samples

Protect from contamination, maintain traceability, preserve

condition to ensure reliable results

• Lifting at source (trained staff, aseptic technique, sterile

implements/containers, labelling)

• Transport /Delivery (time, conditions, protection, identification, interim

storage)

• Receipt (registration; condition/suitability, rejection procedure, tests required

established, temperature checks, storage)

• Traceability (unique code, labelling, traceability of bulked or sub samples,

transfer between labs)

Handling Test Items/Samples

• Storage Pre/Post Analysis (appropriate, controlled,

contamination risks, shelf life requirements)

• Handling (aseptic, glp).

• Retention ( time, conditions, packaging, traceability)

• Disposal (safe, suitable, legal requirements)

Methods of Analysis

Method Selection

• Essential to use correct method

• Fit for required purpose

• Customer requirements/legislation

• Source/origin must be known

Demonstrating Suitability for Use

• Validation data and in house performance data

• Data to show ability to get good results and method fit for purpose

Documentation

• Fully documented

• Accessible to staff for reference

Methods of Analysis

Reviewed for continued suitability

• Update to source method

• Developments in methodology

Managing unauthorised deviations from methods

• Appraise impact on method performance + results,

• Corrective actions, records.

Management of authorised deviations

• Justification to show no impact on method performance,

• Records, client informed

Technical Records

• All data necessary to calculate, verify and defend

final results to be held

• Examples: – Dilution

– Colony count

– Number selected for confirmation

– Individual confirmation results

– Biochemical reactions

– MPN values

– Traceable to samples and people

Reporting of Test Results

Content

– Clear/unambiguous

– Traceable to individual samples

– Correct reporting of results (e.g. presumptive/confirmed; units of measurement; detection limits)

– Regular cross checks

– Authorised for release

Out of specification reporting procedures (if role of lab)

Correct use of Accreditation Logo and relevant

disclaimers

Assuring Quality of Test Results

Generates Data to Demonstrate Ongoing Lab Competence,

Method Control and Staff Proficiency

• Carry out to defined plans + frequencies

• Design approaches suitable for each test

• Review results/performances

• Poor performances investigated, corrected +data generated to

show resolved

• Keep good records

• Look for trends/bias

Assuring Quality of Results

EXAMPLES

External Proficiency Schemes

Internal Ongoing Method Verification/Lab

Competence

• Duplicate analyses (repeatability/reproducibility data)

• Spiked Samples/Reference Materials (recovery data, detection

limits, ability to recover target organism from sample types)

Assuring Quality of Results

Media QC: Sterility, pH, growth, volume

Confirmation tests: Positive/negative controls

Commercial Kits: Positive controls, kit controls

Daily Controls: Sterility and positive controls

Control of Equipment • Suitability (accuracy, resolution, stability, capacity etc)

• Commissioning (before enter use)

• Service/maintenance (scheduled and/or as required)

• Calibration (NPL traceable, certified reference materials/standards,

technically valid approaches, criteria to appraise results).

• Calibration Procedures (equipment; parameter to calibrate/check;

frequency; acceptable tolerances/limits for deviation; procedure).

• Calibration Results (appraise impact on use, conduct of tests and

reliability of results, policies on applying offsets/adjustments/ correction

factors).

Control of Records

All data/information relevant to tests and

supporting activities to be held

• Traceability (throughout system; work can be repeated under conditions

close to original; sources of error/corrective actions taken to be identified)

• Maintenance (legible, in indelible ink; Mistakes neatly cross out + correct

entry made along side + initialled).

• Storage/Retention (protect from damage, loss, misuse; Maintain

confidentiality; retention times)

• Electronic Data (access control; loss of data minimised; amendments

verified/traced; protect from unauthorised changes)

Non Conforming Work

Definition

“Any aspect of laboratory operations or testing

activities that do not conform to defined/prescribed

parameters”

Examples Out of spec equipment

Poor EQA performance

Failure to follow methods

Poor GLP/bench practice

Media QC failures

Failure to maintain operations

Managing Non Conforming Work

• PRESENT – problem has been identified

– Investigation to establish cause

• FUTURE: – Corrective action

– Verification of effectiveness

• PAST: – Impact on work, results

Managing Non-Conforming Work

• Responsibility

• Investigation (prompt)

• Corrective Action (timely, appropriate, address cause not

symptom)

• Appraise significance/impact (on tests, client requirements ,

reliability of results -must include halting work if necessary until

problem fixed and informing clients).

• Records

Corrective Action Loop (Continuous Improvement)

? ? NCN

Quick

Fix

Establish

CauseIdentify Solution/

preventive action

Implementsolution

Check effect

AnalyseEvidence

Solution

Effective YES NO

Corrective Action Should:

•Address cause, not

symptom

(often only quick fix

taken)

•Strengthen/improve

systems

•Prevent re-occurrence

•Be timely

Monitoring for Improvement

• Proactively examine systems for potential

weaknesses, drifts or trends in stability and make

improvements to strengthen operations.

• Common Approaches

– management reviews

– internal audits

– trends in proficiency performances

– risk analysis

– complaints analysis

Internal Audits

• Planning (responsibility, schedule, all areas once per year, including

witness of tests).

• Auditors (trained/qualified in principles of audits; independent).

• Conduct (depth to give confidence in effectiveness/maintenance of

systems; examine on going activities + historical records) .

• Identification of NCW/Improvements

• Corrective actions (Actions, Responsibility, Time-scales)

• Appraisal of Findings (impact on testing activities, previously issued

results)

• Verification (completion of corrective actions/audit sign off)

• Records

How to Make Audits Effective ?

• Provide adequate resource

• Understand principles of, and reason + benefits for audits

• Understand your quality system!

• Operate a defined procedure for managing + conducting audits

• Schedule audits according to risk/stability of operations

• Train auditors + ensure audits thorough

• Keep audits independent, objective + challenge system

How to Make Audits Effective ?

• Identify true NC’s + proactively look for beneficial

improvement

• Draw clear conclusion on status of area

• Take “timely” corrective/improvement action

• Verify actions are taken + are effective

• Maintain good records

• Ensure findings are formerly reviewed/appraised

Management Review

• Frequency (at least annually).

• Attendees (Senior Company Management and appropriate

lab personnel)

• Agenda (DEFINED)

• Records (minutes, action points, responsibilities, timescales)

Ensure Appropriate data/information is extracted from quality

system and presented to give management full and

accurate picture of the true status of operations – including

any weaknesses

Complaints

• Responsibility

• Investigations (prompt, thorough, impartial)

• Outcome (inform complainant and management)

• Corrective Action (if complaint justified; if casts doubt on

results clients affected must be informed).

• Feedback (complaint, any clients whose work affected)

• Records.

Sub-Contracting

• Selection (accredited subcontract lab; or if not possible

appraise suitability of lab)

• Verification (evidence of accreditation status or result of

assessment/appraisal; approve methods)

• Notify Clients

• Reporting Results (subcontract work to be identified and

reported as such).