ISO/IEC 17025 Accreditation Checklist Template

Start about seven months before the assessment visit. The first task names the lab, the accreditation body, the five people, the type of assessment and whether the lab tests, calibrates or both; each answer adds the tasks or notes it needs. Every due date counts back from the first day of the visit in working days.

• Set up the accreditation project — the lab and its legal entity, the accreditation body, whether this is a first assessment or a reassessment, whether the lab tests, calibrates or both, the first day of the assessment visit (which every due date counts from) and the five people; later tasks are assigned from these fields
• Read the accreditation body’s requirements — the standard, the body’s own requirement documents and policies (traceability, proficiency testing, use of its symbol), its application and assessment steps, and its customer agreement
• Define the scope of accreditation — each test or calibration, the method, the range or matrix, the site, and whether any of the work includes sampling; only what is on the scope is covered by the accreditation
• Run a gap analysis against the standard — every clause from 4 to 8 and the body’s own requirements, what the lab already has, what is missing, an owner and a date for each gap, and which management system option the lab will use
• Enrol in proficiency testing for the scope — the schemes or interlaboratory comparisons available for each test or calibration on the scope, the first rounds booked, and where none exists, the alternative the lab will use

Clauses 4 and 5 come first in the standard: the lab acts impartially, keeps customer information confidential, is a legal entity that is responsible for its work, and has a defined structure with people who have the authority to run it.

• Identify the risks to impartiality — management’s commitment to impartiality, then each risk from the lab’s activities, its relationships and its people, and how each is eliminated or minimised (clauses 4.1.1 to 4.1.5)
• Set up confidentiality arrangements — legally enforceable commitments to keep customer information confidential, telling customers in advance what the lab will make public, what happens when the law requires release, information from other sources, and commitments from staff, committee members and contractors (clause 4.2)
• Confirm the legal entity and who is responsible — the legal entity (or defined part of one) that is legally responsible for the lab’s activities, and the management with overall responsibility for the lab (clauses 5.1 and 5.2)
• Define the range of activities, the structure and the authorities — the range of activities the lab claims conform to the standard (clause 5.3), the organisation and management structure, responsibilities and relationships (5.5), people with the authority and resources to run the management system and act on deviations (5.6), and management’s communication about the system and its integrity through changes (5.7)

Clause 6 covers the resources behind every result: competent and authorised people, suitable facilities and environmental conditions, equipment that is calibrated and controlled, and externally provided products and services that are checked before use.

• Set competence requirements for each role — the education, qualification, training, technical knowledge, skills and experience for each function that affects the results (clause 6.2.2)
• Train, supervise and authorise the staff — the procedure and records for selection, training, supervision, authorisation and monitoring of competence (clause 6.2.5), and who is authorised to develop, verify or validate methods, analyse results, and report, review and authorise them (6.2.6)
• Check facilities and environmental conditions — the conditions each method or specification needs, how they are monitored, controlled and recorded, access to areas, prevention of contamination and separation of incompatible work (clause 6.3)
• Bring the equipment records and the calibration programme up to date — every item that can affect results, including software, standards and reference materials; calibration where accuracy or uncertainty affects validity or traceability, the programme reviewed and adjusted, status labels, intermediate checks and equipment taken out of service (clause 6.4)
• Control externally provided products and services — requirements for suppliers, calibration providers, proficiency testing providers and any subcontracted lab work, how they are evaluated, selected, monitored and re-evaluated, and checks before use (clause 6.6)

Results must be traceable through an unbroken chain of calibrations, and every result needs an uncertainty that has been evaluated. The tasks on a calibration lab’s own uncertainty and CMC appear for calibration labs, the testing task for testing labs, and both for labs that do both.

• Map the traceability chain for each measurement — for each measurement on the scope, who calibrates the equipment and reference standards, and whether each provider gives traceability by a route the accreditation body accepts (clause 6.5)
• Check calibration certificates and reference materials — each certificate covers the right range and gives results with their uncertainty, and each certified reference material comes from a source with established traceability
• Evaluate measurement uncertainty for each method — the contributions that are significant, including those from sampling where the lab samples, the method used to combine them, using the verification and validation data, and where each evaluation is recorded (clause 7.6.1)
• Estimate uncertainty where a test method does not allow a rigorous evaluation — an estimate based on the theoretical principles of the method or practical experience of its performance (clause 7.6.3), and when uncertainty is reported on a test report
• Evaluate uncertainty for every calibration and set the CMC — the uncertainty of every calibration, including calibrations of the lab’s own equipment (clause 7.6.2), and the calibration and measurement capability (CMC) for each calibration on the scope

Clause 7 covers each job from the customer’s request to the report: the contract review, methods that are verified or validated, sampling and item handling, records that let the work be repeated, quality control and proficiency testing, and reports and certificates.

• Review requests, tenders and contracts — the customer’s requirements, the method, the lab’s capability, any external provider, and the decision rule agreed with the customer where they ask for a statement of conformity (clauses 7.1.1 to 7.1.3)
• Select and verify methods — the latest valid version of each standard method unless it is not appropriate, and evidence that the lab can perform each one properly before it is introduced (clause 7.2.1)
• Validate non-standard and lab-developed methods — methods the lab developed, non-standard methods, and standard methods used outside their intended scope or modified, with the procedure, the performance characteristics and a statement on validity (clause 7.2.2)
• Write the sampling plan and method — the sampling plan and method for each place the lab samples, the factors that must be controlled, and the records of each sampling (clause 7.3)
• Set up the handling of test or calibration items — transport, receipt, handling, protection, storage, retention and disposal or return of items, a unique identification for each item, and how problems on receipt are recorded (clause 7.4)
• Check technical records and data control — records that let each test or calibration be repeated, who did and checked each step, original observations recorded at the time and amendments traceable (clause 7.5), and data and information management, including validation of any LIMS before use (clause 7.11)
• Plan internal quality control — how the validity of each method’s results is monitored, such as reference materials, replicate tests, retesting retained items, check standards and control charts, with the data recorded so trends can be seen (clause 7.7.1)
• Review quality control and proficiency testing results — results analysed against the criteria set, used to control and improve the work, and action taken when a result is outside them (clauses 7.7.2 and 7.7.3)
• Check test reports carry what the standard requires — the general report contents (clause 7.8.2), and for test reports the test conditions, statements of conformity with the decision rule, uncertainty where it is relevant, and opinions and interpretations by authorised people (7.8.3, 7.8.6 and 7.8.7)
• Check calibration certificates carry what the standard requires — the general report contents (clause 7.8.2), and for certificates the measurement uncertainty, the conditions, how the results are traceable, results before and after any adjustment where available, no recommended calibration interval unless agreed with the customer (7.8.4), and statements of conformity with the decision rule and opinions where relevant (7.8.6 and 7.8.7)

The lab handles complaints and nonconforming work, takes corrective action, and runs a management system to option A or option B. The option chosen in the gap analysis adds its own tasks.

• Set up the complaints process — how complaints are received, evaluated and decided, a description of the process available to any interested party on request, and outcomes made or reviewed by someone not involved in the original work (clause 7.9)
• Control nonconforming work — who is responsible, actions based on risk, the impact on earlier results, when customers are told and work recalled, who authorises the work to resume, and records (clause 7.10)
• Set up corrective action — react to the nonconformity, find its cause, act, review whether the action worked, and update risks and the management system where needed (clause 8.7)
• Document the management system and control documents and records — policies and objectives covering competence, impartiality and consistent operation, top management’s commitment, control of documents, and control and retention of records (clauses 8.2 to 8.4)
• Check the ISO 9001 system supports clauses 4 to 7 — the ISO 9001 system, and its certificate and scope where it is certified, and evidence that the system supports and shows the lab meets clauses 4 to 7, so that it meets at least the intent of 8.2 to 8.9 (clause 8.1.3 asks for a system in line with ISO 9001, not a certified one)
• Address risks and opportunities, and improvement — the risks and opportunities to the lab’s work and the actions planned for them, and improvement, including feedback from customers (clauses 8.5 and 8.6)

An internal audit and a management review scoped to ISO/IEC 17025 (clauses 8.8 and 8.9) before the visit. This template’s choice is a full round of both; A2LA says it does not require a complete one before accreditation, but looks at the programme and records. For the audit and review method in general, see the ISO 9001 and ISO management review templates.

• Plan the internal audit — an audit programme covering every clause and every test or calibration on the scope, with its frequency, methods, responsibilities, criteria and scope (clause 8.8.2); this template’s choice is auditors who do not audit their own work, as ISO 19011’s guidance on objectivity suggests
• Carry out the internal audit — the management system clauses, a vertical audit of each test or calibration from request to report, witnessed work, and findings recorded against the clause
• Correct the internal audit findings — correction and corrective action for each finding without undue delay, with evidence that each action worked (clauses 8.8.2 and 8.7)
• Hold the management review — the inputs clause 8.9.2 lists, including internal audit results, corrective actions, external assessments, complaints, quality control and proficiency testing outcomes, risks and resources, and the outputs in 8.9.3: effectiveness, improvement, resources and changes

A first assessment adds the application, the optional pre-assessment and acting on it; a reassessment adds a review of the last cycle and a check of scope changes. The phase ends with the laboratory director’s decision that the lab is ready for the visit, and nothing after it can be completed until it is made.

• Submit the application — the body’s application form, the proposed scope, the key policy and procedure documents it asks for, proof of legal status, and the signed customer agreement; record the body’s reference
• Review the last cycle’s reports — the last assessment and surveillance reports, findings and their closure, any changes since, and anything the body asked the lab to show at reassessment
• Confirm scope changes and the visit with the body — tests or calibrations to add, change or withdraw, new sites or key staff, and the visit dates and plan the body proposes
• Decide on and hold a pre-assessment — whether to have the optional pre-assessment, and if so its date, the areas covered and the report
• Act on the pre-assessment — each issue raised, what was changed and the evidence; where no pre-assessment was held, record the lab’s own readiness check
• Confirm the visit plan and the assessment team — the visit confirmation and plan, the assessors and any conflict of interest, the activities to be witnessed, the staff and records needed each day, and the rooms
• Approve the lab as ready for the assessment — the laboratory director’s decision, from the internal audit, the management review, open actions and the visit plan, that the lab is ready; Ready with conditions or Not ready adds the next step
• Agree a new assessment date with the body — the reasons the lab is not ready, a new date agreed with the accreditation body, the date changed on the first task, then the director un-completes the readiness decision, changes the Decision when the lab is ready, and completes it again
• Close the conditions before the visit — each condition the director set, closed with evidence before the first day of the visit

The assessment visit, the findings raised at the closing meeting, the evidence that clears them, and the accreditation body’s decision. Findings add the corrective action tasks, and the decision adds the tasks that follow it.

• Host the assessment — the opening meeting, records ready, staff available for interviews, and the tests or calibrations the assessors witness
• Record the findings at the closing meeting — each finding with its clause and grade, the team’s recommendation, and the deadline agreed for the evidence
• Find the cause of each finding and act — the root cause of each finding, the correction, the corrective action and the review of whether it worked (clause 8.7)
• Send the evidence to the body — evidence for each finding sent by the deadline agreed with the body, and any questions from the assessors answered
• Record the accreditation body’s decision — the decision and its date, the scope granted or continued, and any part of the scope not granted
• Check the schedule and use the symbol as the body allows — the published schedule against the scope applied for, and the body’s rules for its symbol and any reference to accreditation on reports, certificates and marketing
• Decide the next step with the body — the reasons given, whether to appeal under the body’s process, reapply, or narrow the scope, and the director’s decision
• Plan the next cycle — the surveillance visits and the reassessment date the body sets, the next internal audit and management review, and the proficiency testing plan for the cycle