Standard 28: Laboratory (Version 11)

Each instrument and measuring device is calibrated or verified at the set interval against a traceable reference, and its calibration status is current before any patient result is released.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

Calibration tells the laboratory that a device reads correctly against a known reference. A device that has drifted gives results that look normal and are wrong, so the laboratory must know, for every instrument and measuring device, when it was last calibrated or verified and when it is next due.

The calibration and maintenance register (LBT-REG-001) lists each device with its interval. The calibration certificate (LBT-FRM-006) should name the reference used, so that the result can be traced back to a recognised standard. Where a device has no traceable reference, the laboratory states how it has been verified instead.

When a calibration expires, the device is taken out of use until it is calibrated again. The out-of-calibration procedure (LBT-SOP-011) says who decides this and how patient results produced in the gap are reviewed. Results from the period are not released without that review.

What good looks like

• Each device has a calibration date, a due date and a named person responsible in the register.
• The calibration certificate names the reference standard used.
• Out-of-calibration devices are labelled and removed from use the same day.
• Results produced between the last good calibration and the failure are reviewed and recorded.

Common mistakes

• Calibration is recorded as done, but the certificate does not show traceability.
• A device stays in use after its due date because nobody checked the register.
• Repairs are made, but no calibration is done afterwards.
• Verification is accepted from a supplier without checking the reference used.

Questions the surveyor asks

• Is every instrument and measuring device calibrated or verified at its set interval? The surveyor checks the calibration and maintenance register (LBT-REG-001) for each device in the sample against its interval.
• Is each calibration traceable to a stated reference? The surveyor checks the calibration certificates for a traceability statement and the reference used (LBT-FRM-006).
• Is a device taken out of use as soon as its calibration expires? The surveyor checks the out-of-calibration log and the action recorded for each event (LBT-SOP-011).

How the surveyor verifies this criterion

Each new reagent lot is checked against the previous lot or the manufacturer's acceptance criteria before it is used for patient testing, and the check is recorded.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A new reagent lot can behave differently from the last one, even from the same manufacturer. Each new lot is therefore checked before it is used on patients, usually by running the new lot alongside the previous lot or against controls with known values.

The verification record (LBT-FRM-001) states the acceptance criteria, the results obtained and the decision. The criteria come from the previous lot or the manufacturer's acceptance limits, and they are written down before the test is run.

A lot that fails verification is quarantined and recorded in the lot register (LBT-REG-010). It is not used on patients until the failure has been investigated and the decision to release it is signed.

What good looks like

• Each new lot is compared with the previous lot before it is used on patients.
• The acceptance criteria are written before the test is run.
• A failed lot is labelled and stored separately, with the reason recorded.
• The lot number of every reagent is recorded against each patient result.

Common mistakes

• A new lot goes straight into use because the old one ran out.
• The lot check is done, but the criteria are changed after the result is known.
• Lot numbers are not recorded, so a problem cannot be traced.
• Control results are run only on the new lot, without a comparison.

Questions the surveyor asks

• Is each new reagent lot checked before it is used on patients? The surveyor checks the verification record (LBT-FRM-001) for each new lot in the sample.
• Are the acceptance criteria for a lot defined and used? The surveyor checks the lot verification procedure (LBT-SOP-012) and the results recorded against its criteria.
• Is a lot that fails verification kept out of use until it is resolved? The surveyor checks the lot register (LBT-REG-010) for rejected lots and the release decision recorded for each (LBT-POL-005).

How the surveyor verifies this criterion

Each test method is validated for its intended clinical use, covering precision, accuracy, reportable range and reference intervals, before it is used on patients.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A test must be shown to work for the purpose it is used for. Validation covers precision, accuracy, the reportable range, the reference interval and the limits of detection and interference, as far as they apply to the test.

The validation report (LBT-FRM-007) gives the acceptance limit for each parameter and the result obtained. The report is signed before the method is used for patient care, and the method is listed in the method validation register (LBT-REG-002).

A method is validated again when it changes significantly, for example a new reagent platform, a new software version or a change in sample type. The change control policy (LBT-POL-006) says which changes need revalidation.

What good looks like

• The validation plan is written before the study starts and states the acceptance limits.
• Each parameter has a result, a limit and a decision in the report.
• A method change triggers a documented review of whether revalidation is needed.
• Method validation is repeated with a new lot of critical reagents where the manufacturer advises it.

Common mistakes

• A method is used because the manufacturer says it is validated, without local data.
• The report gives a result for precision but not for the reportable range.
• The method is changed in the software but not in the validation file.
• Validation data are kept only in the instrument, not in the register.

Questions the surveyor asks

• Is each method validated for its intended clinical use before it is reported? The surveyor checks the method validation file (LBT-SOP-001) for each method in the sample.
• Does the validation report cover precision, accuracy and the reportable range? The surveyor checks the validation report (LBT-FRM-007) for each of these parameters and the acceptance limits used.
• Is a method revalidated after a significant change? The surveyor checks the change record for a method changed in the period and the revalidation done (LBT-POL-006, LBT-REG-002).

How the surveyor verifies this criterion

Internal quality control material is run at the set interval and with each analytical run, and results are reviewed against defined rules before patient results are released.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

Internal quality control checks that the method is working on the day it is used. Control material with known values is run at the set interval and with each analytical run, and the results are compared against defined limits before patient results are released.

The rules for accepting or rejecting a run are written in the quality control policy (LBT-POL-007) and applied the same way by every staff member. A failed control stops the run, and the cause is found and corrected before the run is repeated.

Each out-of-control event is recorded on the acceptance and corrective action form (LBT-FRM-008). The record states what was done, what results were held back, and whether any patient was affected.

What good looks like

• Control material is run at each level specified in the procedure, every day it is used.
• The quality control rules are written down and taught to every analyst.
• A failed control is investigated before the next patient sample is run.
• Quality control trends are reviewed at set intervals, not only when a run fails.

Common mistakes

• The control is run once a week but the results are reported daily.
• A failed control is repeated until it passes, with no record of the first failure.
• Control limits are changed without a reason recorded.
• Results from a failed run are released because the patient needed them urgently.

Questions the surveyor asks

• Is internal quality control run at the set interval and with each analytical run? The surveyor checks the internal quality control log (LBT-REG-003) against the schedule in LBT-SOP-002.
• Are control results reviewed against defined rules before patient results are released? The surveyor checks the documented rules (LBT-POL-007) and the review record for failed controls.
• Is each out-of-control event investigated and the corrective action recorded? The surveyor checks the QC acceptance and corrective action record (LBT-FRM-008) for each event in the sample.

How the surveyor verifies this criterion

The laboratory takes part in external quality assessment for each test it performs where a scheme exists, and acts on every unsatisfactory result.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

External quality assessment compares the laboratory's results with those of other laboratories using the same test, from a neutral provider. It shows whether results agree with the wider community, which internal control cannot show.

The laboratory enrols for each test where an EQA scheme is available, and records each result in the EQA register (LBT-REG-004). Where no scheme exists, the laboratory uses another method of comparison and records it.

An unsatisfactory result is investigated and the investigation recorded (LBT-FRM-009, LBT-SOP-013). Management reviews the participation policy (LBT-POL-002) at set intervals and records the decision.

What good looks like

• The laboratory joins an EQA scheme for each test where one exists, and keeps the enrolment record.
• Each EQA result is reviewed by a named person within the time the scheme requires.
• An unsatisfactory result leads to a documented root cause and corrective action.
• EQA results are reported to management with the other quality indicators.

Common mistakes

• EQA is joined for the easy tests only, and the difficult ones are left out.
• A result is marked satisfactory without comparing the value with the scheme's target.
• An unsatisfactory result is not investigated because the next round was good.
• The scheme provider is changed without a reason recorded.

Questions the surveyor asks

• Does the laboratory take part in external quality assessment for each test where a scheme exists? The surveyor checks the EQA results register (LBT-REG-004) against the list of tests and the schemes available.
• Is each unsatisfactory EQA result investigated and corrected? The surveyor checks the EQA result record (LBT-FRM-009) and the investigation (LBT-SOP-013) for each unsatisfactory result.
• Is EQA participation reviewed by management at set intervals? The surveyor checks the EQA participation policy (LBT-POL-002) and the management review minutes that refer to it.

How the surveyor verifies this criterion

Clinicians and patients receive information on the indications, limitations and required preparation for each test, in the test catalogue or on the request form.

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

Clinicians need to know what a test can tell them, what it cannot, and how the patient should prepare. Patients need the same, in plain language. A test used for the wrong reason, or with a sample taken at the wrong time, gives a result that misleads.

The test information (LBT-SOP-010) and patient preparation sheets (LBT-FRM-002) are kept for every test. The update log (LBT-REG-011) records each change and the date it was communicated to clinicians.

The test information policy (LBT-POL-008) states who approves a change and how it is released. A change that alters the preparation or the sample requirement is communicated before the next request is accepted.

What good looks like

• A one-page sheet for each test states the indication, the limit of the test and the preparation.
• The sheet is dated and approved before it is issued.
• Clinicians are told by a named route when a sheet changes.
• Patients get the preparation in writing and in their own language.

Common mistakes

• The test information is on a wall poster that nobody has updated for years.
• A change to fasting or sample time is made without telling the clinicians.
• The limits of a test are not mentioned, so results are over-read.
• Information is copied from a manufacturer leaflet without adapting it to the local method.

Questions the surveyor asks

• Are indications, limitations and preparation for each test available to clinicians and patients? The surveyor checks the test information (LBT-SOP-010) and the preparation sheets (LBT-FRM-002) for each test in the sample.
• Is the test information kept current, and are changes communicated? The surveyor checks the test information update log (LBT-REG-011) for changes in the period and the date each was communicated.
• Does the test information policy set who approves each change? The surveyor checks the test information policy (LBT-POL-008) and the approval recorded for each change.

How the surveyor verifies this criterion

Specimens are accepted, logged and rejected against defined acceptance criteria, and every rejection is recorded with its reason and the notice given to the requester.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A specimen that is damaged, mislabelled, unsuitable or past its stability limit gives an unreliable result. The laboratory defines the acceptance criteria for each specimen type and checks each specimen on receipt against them.

Each rejection is recorded in the rejection log (LBT-REG-005) with the reason. The requesting clinician is told, using the rejection notice (LBT-FRM-010), so that a new specimen can be taken where needed.

The acceptance procedure (LBT-SOP-003) and the acceptance policy (LBT-POL-009) apply equally to every specimen. A specimen is not accepted because it is urgent, unless the criteria have been met.

What good looks like

• The acceptance criteria are on the receiving bench, not only in a file.
• Every rejected specimen is recorded before the sample is discarded.
• The clinician receives a notice on the same day as the rejection.
• Rejection rates by ward or clinic are reviewed each quarter.

Common mistakes

• A damaged specimen is run anyway because the clinician is waiting.
• A rejection is recorded only verbally.
• Acceptance criteria are not defined for some specimen types.
• The rejection reason is 'unsuitable' with nothing more written.

Questions the surveyor asks

• Are specimens accepted or rejected against defined acceptance criteria? The surveyor checks the acceptance procedure (LBT-SOP-003) and the receipt log for a sample of specimens.
• Is each rejection recorded with the reason? The surveyor checks the rejection log (LBT-REG-005) for the reason recorded for each rejected specimen.
• Is the requesting clinician told when a specimen is rejected? The surveyor checks the rejection notice (LBT-FRM-010) sent for each rejection in the sample.

How the surveyor verifies this criterion

Specimens are transported in conditions that preserve their integrity, including packaging, temperature, time limits and labelling, and every deviation is recorded.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

Specimens change during transport. Temperature, time, light, shaking and packaging all affect them. The laboratory defines the conditions for each specimen type and makes sure the packaging and the courier keep the specimen within them.

The transport policy (LBT-POL-010) sets the packaging standard, including the packaging used for infectious substances under the WHO Laboratory Biosafety Manual. Each shipment is recorded on the transport record (LBT-FRM-003), with the temperature and time in transit kept in the courier log (LBT-REG-012).

A specimen that has been outside its limits in transit is rejected or flagged, and the decision is recorded. The laboratory tells the sender why, so that the cause can be corrected.

What good looks like

• The packaging meets the WHO Laboratory Biosafety Manual requirements for the specimen class.
• Each shipment has a temperature record that is checked on arrival.
• A courier is qualified before it is used, and the qualification is recorded.
• A specimen outside its limits in transit is flagged on the report.

Common mistakes

• Specimens are sent in a bag with ice that has melted.
• Temperature loggers are fitted but the data are never read.
• A courier is used without anyone checking how it carries specimens.
• The transit time is not recorded, so stability cannot be judged.

Questions the surveyor asks

• Are specimens packaged and transported to preserve their integrity? The surveyor checks the transport policy (LBT-POL-010) and the packaging used for a sample of shipments.
• Is temperature and time in transit recorded for each shipment? The surveyor checks the transport record (LBT-FRM-003) and the courier and temperature log (LBT-REG-012).
• Are specimens that exceed their stability limits in transit rejected? The surveyor checks the rejection decisions for shipments that were outside the limits recorded.

How the surveyor verifies this criterion

STAT specimens are identified and prioritised, and turnaround time for STAT and routine tests is monitored against defined targets.

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

Some results are needed within minutes to change a patient's care. The laboratory identifies STAT specimens on receipt, runs them first and tracks how long each test takes from receipt to result.

Turnaround time is recorded in the monitoring log (LBT-REG-006) for STAT and routine tests, against a target set in the priority and turnaround policy (LBT-POL-011). Targets are reviewed when they are repeatedly missed.

A STAT request is recorded on the request form (LBT-FRM-011) with the clinical reason and the requester. A request without a clinical reason is not automatically treated as STAT; the policy says how this is decided.

What good looks like

• STAT specimens are labelled with a distinct mark and placed at the front of the queue.
• Turnaround is measured from receipt to authorised result for each test.
• The target for each test is written in the priority policy.
• Missed targets are reviewed at the monthly quality meeting.

Common mistakes

• Every request is marked STAT, so the mark means nothing.
• The clock starts at result entry, so the delay before receipt is hidden.
• A STAT result is released without authorisation to meet the target.
• Targets are set once and never reviewed.

Questions the surveyor asks

• Are STAT specimens identified and prioritised on receipt? The surveyor checks the STAT request records (LBT-FRM-011) and the priority marking on the sampled specimens.
• Is turnaround time for STAT and routine tests monitored against the target? The surveyor checks the turnaround time monitoring log (LBT-REG-006) for the period.
• Is the priority policy followed and reviewed? The surveyor checks the priority and turnaround policy (LBT-POL-011) and the review record.

How the surveyor verifies this criterion

Forensic and legal specimens are handled under a documented chain of custody from collection to disposal, and every transfer is signed.

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A forensic or legal specimen may be used as evidence. The laboratory must show who had it, when, and what was done to it, at every step from collection to disposal. A gap in that record can make the result unusable.

The chain of custody procedure (LBT-SOP-006) sets out the steps. The form (LBT-FRM-004) records each transfer with the name, the time and the signature of the person receiving the specimen, and the register (LBT-REG-013) lists each case.

The policy for forensic and legal specimens (LBT-POL-012) states how the specimen is stored and when it is disposed of. The disposal is recorded in the register and signed.

What good looks like

• The custody form is started at the point of collection and travels with the specimen.
• Every signature includes a name, a role and the time.
• Storage locations are recorded for each specimen in the chain.
• Disposal is recorded and witnessed.

Common mistakes

• The custody form is filled in afterwards from memory.
• A specimen is left unattended on a bench between transfers.
• The name of the receiver is missing from a transfer.
• The case is closed without recording how the specimen was disposed of.

Questions the surveyor asks

• Is every forensic or legal specimen handled under a documented chain of custody? The surveyor checks the chain of custody procedure (LBT-SOP-006) for each forensic or legal case in the sample.
• Is each custody transfer recorded, with the name and time of each person? The surveyor checks the chain of custody form (LBT-FRM-004) for every transfer in the sample.
• Is the disposal of the specimen recorded? The surveyor checks the chain of custody register (LBT-REG-013) for the disposal entry of each closed case.

How the surveyor verifies this criterion

Critical values are communicated to a responsible clinician by a defined route within a defined time, and receipt is verified and recorded.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A critical value is a result so far outside the normal range that it needs immediate action. The laboratory defines which results are critical and makes sure a responsible clinician is told within the set time.

The critical value policy (LBT-POL-013) lists the values and the time limit. The communication procedure (LBT-SOP-007) sets the route, including what happens when the responsible clinician cannot be reached. The notification record (LBT-FRM-012) and the log (LBT-REG-007) show each call.

Receipt is acknowledged by the clinician, who gives their name and the time. The route should be written down and tested, as part of the patient safety approach set out in the WHO Global Patient Safety Action Plan 2021–2030.

What good looks like

• The list of critical values is posted at each bench and held in the information system.
• The communication time is recorded for each notification.
• A read-back of the value is required from the clinician.
• The route is tested at least once a year.

Common mistakes

• Critical values are passed on by a message left at the nurses' station.
• The time of notification is not recorded.
• No one checks whether the clinician received the call.
• The critical list was set years ago and has not been reviewed since.

Questions the surveyor asks

• Is a defined list of critical values in use? The surveyor checks the critical value policy (LBT-POL-013) against the list used in the laboratory information system.
• Is each critical value communicated to a responsible clinician within the defined time? The surveyor checks the communication procedure (LBT-SOP-007) and the notification times in the sample.
• Is receipt of each critical value acknowledged and recorded? The surveyor checks the critical value notification record (LBT-FRM-012) and the communication log (LBT-REG-007).

How the surveyor verifies this criterion

Each result is authorised for release by a qualified person before it leaves the laboratory, and the person authorising is recorded.

Rating: Minimum in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A result is only released after a qualified person has checked it against the quality control, the patient's history and the expected range. Authorisation is the last check before the result leaves the laboratory.

The authorisation procedure (LBT-SOP-014) and the policy (LBT-POL-003) state who may authorise each type of result. The authorisation record (LBT-FRM-005) and the authorised results register (LBT-REG-014) show who released each result and when.

A result that does not pass the check is held. It is not released until the cause has been found and the result has been checked again.

What good looks like

• The authoriser is named on the report, with their qualification and role.
• A result that falls outside the expected range is checked against the history before it is released.
• The authorisation is recorded before the report leaves the laboratory.
• A result that cannot be authorised is held and the reason recorded.

Common mistakes

• Results are released automatically without any human check, and nobody reviews the rules.
• The authoriser is also the person who ran the test, with no second check.
• A result is released by a person who is not qualified for that test.
• The authorisation is given verbally and not recorded.

Questions the surveyor asks

• Is each result authorised by a qualified person before release? The surveyor checks the authorisation record (LBT-FRM-005) for each result in the sample.
• Is the authorisation procedure defined and followed? The surveyor checks the result authorisation procedure (LBT-SOP-014) and the policy (LBT-POL-003).
• Does the authorised results register show who released each result, and when? The surveyor checks the authorised results register (LBT-REG-014) for each result in the sample.

How the surveyor verifies this criterion

Each report contains a defined minimum set of information, including identifiers, test name, result, units, reference interval and authoriser, and reaches the correct recipient.

Rating: Must in humanitarian settings; Must in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A report is the only part of the laboratory's work that most clinicians see. It must carry enough information to be read correctly: the patient identifier, the test name, the result, the units, the reference interval and the date and time of collection and reporting.

The report content procedure (LBT-SOP-008) defines the minimum set. The template checklist (LBT-FRM-013) is used whenever a template is changed. The release log (LBT-REG-015) records each release, and the report policy (LBT-POL-014) says how reports are delivered.

A report that is delivered in a different form, such as a fax or a message, carries the same information and is recorded in the same way.

What good looks like

• Every report carries the same minimum information, in the same order.
• The reference interval is printed next to each result, with its units.
• The report shows the date and time of collection and of release.
• Corrections are shown on the report, not hidden.

Common mistakes

• A report has no units, so a number cannot be read correctly.
• The reference interval is from an older method and is not updated.
• The report omits the requesting clinician's name.
• Reports are released in batches without a record.

Questions the surveyor asks

• Does each report contain the defined minimum set of information? The surveyor checks the report content procedure (LBT-SOP-008) and each sampled report against it.
• Is the report template checked before it is used? The surveyor checks the template checklist (LBT-FRM-013) for each template in use.
• Is each report release logged? The surveyor checks the report release log (LBT-REG-015) for each report in the sample against the report policy (LBT-POL-014).

How the surveyor verifies this criterion

Any change to a released result is recorded as an amendment, traceable to the original result, with the reason, the date and the person who made the change.

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

A result that is later found to be wrong must be corrected, but the original must remain visible. Any change to a released result is recorded as an amendment, so that a clinician can see what was reported first, what was changed and why.

The amendment procedure (LBT-SOP-009) and policy (LBT-POL-015) say who may authorise an amendment. The amendment form (LBT-FRM-014) states the reason and links the amended result to the original. The amendment log (LBT-REG-008) lists every change.

Where the amended result changes the clinical meaning, the clinician is told directly and the notification is recorded.

What good looks like

• An amendment shows the original result and the corrected result, with the reason.
• The amendment is signed by an authorised person other than the one who first released the result.
• The amendment is logged in the amendment register.
• The clinician is told when the change alters the clinical meaning.

Common mistakes

• The original result is overwritten, so the change cannot be seen.
• An amendment is made without a reason written down.
• The amendment is made by the person who first released the result, with no check.
• Amendments are made in the information system without a log.

Questions the surveyor asks

• Is each change to a released result recorded as an amendment? The surveyor checks the amendment log (LBT-REG-008) for each amendment in the period.
• Does the amendment link to the original result and give the reason for the change? The surveyor checks the amendment form (LBT-FRM-014) and the link to the original result for each sampled amendment.
• Is the amendment policy followed, including who may authorise an amendment? The surveyor checks the amendment policy (LBT-POL-015) and the authorisation recorded for each amendment in the sample (LBT-SOP-009).

How the surveyor verifies this criterion

Suppliers of reagents, consumables and equipment services are qualified before use and reviewed at set intervals against defined requirements.

Rating: Minimum in humanitarian settings; Medium in transition and fragile settings; Must in standard settings.

Not assessed (N/A) for: telemedicine, fitness and wellness.

Guidance

Reagents, consumables and equipment services affect every result. A supplier that delivers a faulty product or an unqualified service can compromise many tests before anyone notices. The laboratory qualifies each supplier before first use and reviews it at a set interval.

The supplier qualification register (LBT-REG-009) lists each supplier, the products or services supplied, the qualification decision and the review date. The qualification form (LBT-FRM-015) records the evidence used, such as certificates or performance data.

The qualification procedure (LBT-SOP-015) and policy (LBT-POL-004) apply to all new suppliers, including those offered at a lower price. A supplier that fails review is removed from the approved list.

What good looks like

• Each supplier is qualified on a defined set of evidence before its first order.
• Supplier performance is reviewed each year, with EQA results and complaints considered.
• A supplier that fails review is removed from the approved list.
• Equipment service engineers are qualified and their work is checked.

Common mistakes

• A new supplier is used because it is cheaper, without qualification.
• A supplier is never reviewed after the first order.
• A service engineer works on a device without a record of the work done.
• A product is replaced by a different brand without a new qualification.

Questions the surveyor asks

• Are reagent, consumable and service suppliers qualified before first use? The surveyor checks the supplier qualification register (LBT-REG-009) for each supplier in the sample.
• Is each supplier reviewed at a set interval? The surveyor checks the supplier qualification form (LBT-FRM-015) and the review date for each supplier in the sample.
• Is the qualification procedure followed for new suppliers? The surveyor checks the qualification procedure (LBT-SOP-015) and the policy (LBT-POL-004) against the suppliers added in the period.

How the surveyor verifies this criterion