Last Updated on August 20, 2026 by Hafsa J.

ISO/IEC 17065 Evaluation, Review and the Certification Decision: The Segregation Rule (Clauses 7.4-7.7)

Here is the rule that fails more ISO/IEC 17065 files than any other single clause: the person who makes the certification decision (clause 7.6) must not be a person who carried out the evaluation (clause 7.4). Sitting between them, the review (clause 7.5) must also be done by one or more persons who did not perform that evaluation. Evaluator is not reviewer. Reviewer is not necessarily the decision-maker, but the decision-maker can never be the evaluator. That is the segregation rule, and an assessor checks it against your role-assignment records, not your good intentions.

If you run a certification body (CB), this is the part of Clause 7 that turns an abstract impartiality principle into a daily staffing problem. You have a file. You have three or four competent people. The standard tells you who is allowed to touch each stage of that file, and it does so in language that is easy to misread when you are short-staffed. The wrong reading produces a non-conformity that calls your whole decision into question, because if the decision-maker also evaluated, every certificate that came out of that arrangement is suspect.

This article operationalizes 7.5 and 7.6 for a working CB. You will get a who-can-and-cannot-decide matrix, the same-person-different-application rule (you may evaluate file A and review file B), the evaluation-versus-review boundary at the corrective-action edge (where verifying corrective actions counts as evaluation and quietly disqualifies you from reviewing that file), the contractual test for who may legally make a decision, the competence requirement for the decision-maker, separation tactics that survive an assessment when you have only a handful of staff, and the exact records that prove your independence. We walk the chain in order, then show how the complaints and appeals rule in 7.13 mirrors the same principle.

The Decision-Rights Matrix: Who Can and Cannot Decide

Read this matrix per file, not per person. The same individual can legitimately hold different roles on different applications. What the standard forbids is one person holding two incompatible roles on the same application. The constraints below come straight from clauses 7.4.2, 7.5.1, 7.6.1 and 7.6.2, plus the outsourcing limit in 6.2.2.3.

Two reads of this matrix matter most. First, reviewing and deciding can be performed by the same person on the same file, as long as that person did not evaluate it and satisfies the decision-maker tests in 7.6.1 and 7.6.2. Second, the certification decision is the one stage you can never hand to an outside contractor, no matter how competent or independent they are. Evaluation can be outsourced; the decision stays inside the CB. The sections that follow show how each row is built and what evidence ties a name to a role.

Walking the Chain: Application Review to Documentation

The segregation rule only makes sense once you see where it sits in the process. ISO/IEC 17065 builds the certification of a product, process or service as a chain of distinct stages, each producing an output the next stage depends on. The independence requirements attach to specific links in that chain, so you have to know the links before you can defend the separation.

7.3 Application review

Before any evaluation begins, 7.3.1 requires the CB to confirm that the application information is sufficient and understood, that any differences of understanding are resolved, that the CB actually has the competence and capability to certify the requested scope, and that scope, sites, time and other points are defined. If the request cannot be handled, 7.3.2 requires you to give reasons and keep a record. Application review is not subject to the segregation rule, but it is the point where you decide which scheme drives the file and therefore what evaluation will involve.

7.4 Evaluation

Evaluation is the technical work. The CB produces an evaluation plan (7.4.1), assigns competent and independent evaluation personnel (7.4.2), and carries out the evaluation per the scheme through the appropriate mix of tests, inspections, audits and document review (7.4.3). The output is an evaluation report listing conformities and non-conformities (7.4.4). Non-conformities are communicated to the client with a chance to correct them before the decision (7.4.5), and the CB evaluates the corrective actions (7.4.6). Traceability runs both ways, requirements to methods to results (7.4.7), including outsourced contributions (7.4.8), and evaluators keep confidentiality, especially against other clients (7.4.9). Everyone who touches this stage on a given file is an evaluator for that file, and that label follows them into the segregation rule.

7.5 Review

Review is the first checkpoint of independence. Under 7.5.1, the evaluation results are reviewed by one or more persons who did not carry out the evaluation. The reviewer is not redoing the technical work; they are confirming that the evaluation supports a sound conclusion. The output is a documented review recommendation (7.5.2) to grant, maintain, extend, suspend or withdraw. That recommendation feeds the decision but does not replace it.

7.6 Certification decision

The decision is the second and harder checkpoint. Under 7.6.1, the decision is made by one or more persons employed by, or under a legally enforceable arrangement with, the CB, who did not take part in the evaluation. Those persons must have the competence to evaluate the certification processes and requirements (7.6.2). If certification is refused, the applicant is told the reasons and the route to appeal (7.6.3). This is where evaluator and decision-maker must part company, and where most files come undone.

7.7 Certification documentation

Only after a positive decision does the certificate issue. Under 7.7.1, it must show the holder name and address with a grant date no earlier than the decision date, an unambiguous identification of the certified product, process or service, the scheme and version of requirements used, the CB identity with the accreditation mark where applicable, and the validity or duration with any conditions or limitations. It is signed by authorised person(s) (7.7.2). The grant-date rule is a quiet trap: a certificate dated before its decision is dated proves the paperwork ran ahead of the decision, and an assessor reads that as a broken chain.

The Evaluation-Versus-Review Boundary (Where Files Break)

The segregation rule is simple to state and easy to break, because two facts about it are routinely missed. The first is that it is a per-file rule, not a per-person rule. The second is that the line between evaluation and review can move depending on what you actually do with a non-conformity. Get either wrong and the same person ends up evaluating and reviewing the same file without realising it.

The same-person-different-application rule

The standard never says a given individual may only ever evaluate, or only ever review. It says the reviewer of a file must not have carried out the evaluation of that file (7.5.1) and the decision-maker must not have taken part in the evaluation of that file (7.6.1). So one competent person can evaluate file A on Monday and review file B on Tuesday, provided they did not evaluate file B. The constraint binds to the pairing of person and file, not to the person alone. This is what makes a small CB viable: you do not need separate evaluation and review departments, you need a clean way to ensure no name appears twice on the same application in incompatible roles.

The corrective-action edge

This is the boundary that catches careful CBs off guard. Clause 7.4.6 makes evaluating corrective actions part of evaluation. So if you take the client’s corrective action, examine the new evidence and confirm the non-conformity is genuinely closed, you have performed evaluation on that file. You are now an evaluator for that file and cannot review or decide it.

Contrast that with a different act. If a minor non-conformity is handled by accepting the client’s corrective-action plan, on its merits, without verifying that the action has been carried out, you have not evaluated anything technical. Accepting a plan is not the same as verifying its result. A reviewer can accept a minor-non-conformity plan as part of forming the review recommendation and remain a reviewer. The verification, if and when it happens, is the evaluation act, and whoever performs it becomes an evaluator for that file.

Why does this matter so much in practice? Because the closure of non-conformities is where roles blur in real workflows. The reviewer, wanting to move a file along, picks up the client’s evidence and checks it themselves. The moment they do, they have stepped into 7.4.6, become an evaluator, and invalidated their own review. The discipline is to route every act of verifying corrective-action results back to evaluation personnel, and keep the reviewer reviewing.

Who May Make the Decision, and With What Competence

Clause 7.6.1 sets two tests for the decision-maker, and both have to be satisfied at once. They are easy to read past, so take them one at a time.

The contractual test (7.6.1)

First, the decision-maker must be employed by the CB, or be under a legally enforceable arrangement with the CB. A volunteer, an unaffiliated expert, or a friendly contact who never signed anything cannot make a certification decision, however qualified they are. Second, that person must not have taken part in the evaluation of the file they are deciding. The contractual link and the non-involvement in evaluation are separate gates; passing one does not excuse the other. This is also why the decision can never be outsourced (6.2.2.3): you can buy in evaluation capacity, but the decision must rest with a person bound to the CB.

The practical consequence for a small CB is that you can engage an external specialist under a legally enforceable arrangement to make decisions on files outside their other involvements, as long as the contract is real and they did not evaluate those files. The arrangement, not the payroll status, is what 7.6.1 cares about.

The competence test (7.6.2)

Independence alone is not enough. Under 7.6.2, the decision-maker must have the competence to evaluate the certification processes and requirements, which means they must be able to judge whether the evaluation and review genuinely support the conclusion. A decision-maker who is independent but cannot read the technical file is a rubber stamp, and an assessor will treat the decision as unsupported. The competence requirement for the decision-maker is set per scheme, the same way you set evaluator competence under 6.1.2, and it has to be recorded.

Separation tactics when staff are limited

Most CBs do not have a large bench, and the segregation rule is built to work without one. The following tactics keep you compliant on a thin roster:

• Rotate roles by file, not by person. Maintain a roster so that for any application, the evaluator, the reviewer and the decision-maker are three different names, even if those same individuals swap roles on the next file.
• Combine review and decision in one independent person. The standard allows the reviewer to also decide, so a CB with three competent people can run evaluator plus reviewer-decision-maker plus a spare for the next file.
• Engage a contracted decision-maker. A legally enforceable arrangement with an external specialist satisfies 7.6.1 and gives you a clean decision-maker for files where every internal person evaluated.
• Quarantine corrective-action verification. Decide in advance who verifies closed non-conformities (an evaluation act under 7.4.6) so the reviewer and decision-maker never accidentally step into evaluation.
• Keep remuneration neutral. Under 6.1.4, no one in the chain may be paid by the number or outcome of evaluations, which removes the pressure that makes role-blurring tempting in the first place.

None of these tactics requires more people than a lean CB already has. What they require is a deliberate assignment of roles to each file and the records to prove it, which is the subject of the next section.

The Records That Prove Independence

An assessor does not take your word that the evaluator, reviewer and decision-maker were three different people. Clause 7.12.1 requires records demonstrating that every process requirement was met for each client, and the segregation rule is one of those requirements. If your records cannot tie a named person to a single role on a given file, the assessor cannot confirm independence, and you will carry a non-conformity even if your process was actually clean. The records do the proving. The table below maps each clause in the chain to the record that demonstrates it.

The single most useful artefact here is the per-application role-assignment record. One line per file that names the evaluator, the reviewer and the decision-maker lets an assessor confirm in seconds that no name appears twice in incompatible roles. Without it, you are asking the assessor to reconstruct independence from scattered signatures, and reconstruction invites doubt. For the build mechanics behind these records, see our walkthrough of the key requirements of ISO/IEC 17065, and for ready-made templates the ISO/IEC 17065 documentation kit includes the role-assignment, review and decision records described above.

The Same Principle in Complaints and Appeals (7.13)

The segregation logic does not stop at the certification decision. Clause 7.13 applies the same separation to complaints and appeals. Under 7.13.3, the persons who decide a complaint or appeal must be different from those who carried out the evaluation and the decision being contested. The reasoning is identical: a person cannot impartially judge the soundness of their own work. If an appeal challenges a certification decision, the people who evaluated or decided that file are out, exactly as an evaluator is out of the review.

The procedure around it follows the same record discipline. Clause 7.13.1 requires a documented procedure for receipt, evaluation and decision of complaints and appeals; 7.13.2 requires you to acknowledge receipt and report progress and outcome; 7.13.4 requires the formal decision to be communicated with reasons; and 7.13.5 requires you to keep the records. The same-person-different-matter logic that lets a CB run evaluation and review with a lean team also lets it staff appeals: a competent person who had no role in the contested file may decide the appeal, and the record proves it.

Running the Chain Without Tripping the Rule

Once you stop reading the segregation rule as a staffing burden and start reading it as a per-file assignment problem, the whole of clauses 7.4 to 7.7 becomes manageable on a small team. The evaluator does the technical work. A different person reviews it. A person who did not evaluate, bound to the CB and competent to judge the file, decides it. Corrective-action verification stays with evaluation, never the reviewer. And every one of those choices is captured on a per-application record that an assessor can read in seconds. The rule is not asking you to be large; it is asking you to be deliberate about who touches what, and to keep proof.

If you are still building the body itself, the role separation described here is the backbone of the work, and our guide answering the most common questions about ISO/IEC 17065 certification sets it in the wider accreditation picture. For the authoritative wording of every clause cited above, consult the standard itself on the ISO catalogue page for ISO/IEC 17065:2012. The clauses are short. The discipline of assigning roles per file, and recording them, is what turns those few sentences into a chain an assessor will trust.