ISO/IEC 17025 clause 5.3: define and control the laboratory scope

What clause 5.3 requires in practice

Clause 5.3 asks the laboratory to write down, under control, the range of its own work for which it says it conforms to the standard. It then limits what the laboratory may claim: conformity can be stated only for that range. Laboratory activities supplied by outside parties on a continuing basis stay outside it.

Three ideas need to be kept apart. The range for which the laboratory itself claims conformity is a matter for the laboratory. The scope that an accreditation body grants follows that body's own process and rules. The services a business offers commercially may be broader than both.

The standard does not prescribe the form of the documented range. Methods, items tested, measurement ranges and locations are common ways of making it specific, but the accreditation body states how it wants scope expressed.

The output is a controlled description of the range, and a discipline that links quotations, websites and reports to it.

Describe work precisely enough to control it

Start with the laboratory activities actually performed. Consider methods, materials or items, relevant measurement ranges and locations when defining a usable scope. The exact form of an accreditation scope is subject to the accreditation body's arrangements, so confirm its application requirements rather than treating a generic scope sentence as sufficient.

Keep three records conceptually separate: the range for which the laboratory claims conformity, the scope granted by an accreditation body, and the services the business offers commercially. They may overlap, but they are not automatically identical. A company can arrange an externally provided service without claiming that it performs that activity within its own accredited scope.

Handle external provision transparently

The exclusion of ongoing externally provided laboratory activities from the claimed conformity range does not ban all external services. Clauses 6.6 and 7.1 address their suitability and the customer's approval where relevant. Reporting also needs to identify externally provided results appropriately.

Distinguish an unforeseen inability to perform work from a service that the laboratory routinely sources elsewhere. Do not use temporary language to disguise a permanent business model. Customers should understand who performs the work and what recognition applies to it before relying on the result.

Control changes before changing claims

When introducing a method, extending a range or opening a location, assess the necessary competence, verification or validation, equipment, conditions and reporting arrangements. Determine whether recognition needs to be extended or updated. Commercial readiness to accept an order is not evidence that a new activity is already accredited.

Coordinate the scope with quotations, website statements and report templates. Marketing staff need enough information to make accurate claims. A controlled scope with an owner and change route is a practical implementation method; clause 5.3 explicitly requires documentation but does not prescribe one universal table.

Why a controlled laboratory range matters to the business

Misstating scope is among the quickest ways to damage a laboratory's reputation. A customer who relies on a report believing it falls under accreditation, when it does not, may reject a product or lose a contract, and the laboratory is then answerable for the claim.

A clear range helps the business too. Sales teams know what they can promise, technical managers know what needs competence and equipment before an order is accepted, and management sees where investment would widen recognition. It also makes preparation for assessment far more focused.

How to implement clause 5.3

Begin with the facts of what is performed today and work outwards to what is planned. Keep the description as specific as the accreditation body expects.

1. List each activity with its method, the items or materials involved, the measurement ranges and the locations.
2. Check with the accreditation body how it wants the scope expressed and align your list to that format.
3. Mark activities supplied by outside parties on a continuing basis and keep them out of the range claimed.
4. Appoint an owner for the range and a route for changes covering new methods, wider ranges or new locations.
5. Before extending, assess competence, verification or validation, equipment, conditions and reporting, and find out what the accreditation body needs to be told.
6. Give marketing and sales the controlled range and ask them to check wording against it before publication.
7. Run a periodic comparison between the documented range, current quotations and published claims, and correct any difference without waiting for an outside party to point it out.

Evidence an assessor expects for clause 5.3

Evidence for clause 5.3 centres on whether the written range matches reality and public claims.

• The documented range, with an owner and a record of changes.
• Quotations, website text and report templates that match the range and describe external services accurately.
• Records of how a new method or location was assessed before being added.
• Interviews showing that sales, finance and technical staff all know where the boundary lies.
• Correspondence with the accreditation body when a scope change was considered, showing what was agreed or notified.

Two illustrative scope problems

Mistakes that create avoidable exposure