What is the definition of "Impartiality" in ISO 17025?
Clause 4.1 Impartiality means the presence of objectivity. It means that no conflict of interest exists, or any such conflict is resolved so as not to adversely influence the activities of the laboratory. The lab must show it is not under commercial, financial, or other pressures that compromise quality.
How often should we identify risks to impartiality?
Clause 4.1.4 The standard requires this to be done on an "on-going basis." This doesn't mean daily, but it does mean whenever a new relationship, contract, or personnel change occurs that could introduce bias. A formal review during the annual Management Review is the minimum.
Can a laboratory perform tests for its own parent company?
Clause 4.1 Yes, internal (captive) laboratories are allowed. However, you must demonstrate structural impartiality. The lab management must have the authority to report results without influence from production or marketing departments of the parent company.
What specific statement must be included in our reports regarding confidentiality?
Clause 4.2 While the standard doesn't dictate exact wording, you must inform the customer in advance if you intend to place their information in the public domain. Additionally, contracts usually include a confidentiality clause stating that all data generated belongs to the client.
Do we need a signed Code of Conduct from every employee?
Clause 4.1 It is a best practice and highly recommended to demonstrate evidence of commitment to impartiality. Auditors typically look for signed agreements covering confidentiality and freedom from undue pressure.
If a customer asks for a copy of another customer's report, can we give it?
Clause 4.2 No. Under Clause 4.2, all information is proprietary. You need written consent from the data owner.
What if the law requires us to release confidential info?
Clause 4.2.3 You must release it, but you must also notify the customer of the disclosure, unless prohibited by law.
Does "Impartiality" apply to purchasing?
Clause 4.1 Yes. You should not favor suppliers based on personal relationships (kickbacks/gifts).
Can sales staff manage the laboratory?
Clause 4.1 This is a high risk to impartiality. Sales targets conflict with quality rejection. Strong safeguards are needed.
How do we document impartiality risks?
Clause 8.5 A Risk Matrix specifically tagging "Impartiality Risks" is the standard approach.
Is the title "Quality Manager" mandatory?
Clause 5.6 No. The 2017 version removed the specific titles "Quality Manager" and "Technical Manager." However, the functions must still exist. You must identify who is responsible for the management system and who is responsible for technical operations.
What is meant by "range of laboratory activities"?
Clause 5.3 This is your Scope of Accreditation. You must clearly define what tests/calibrations you perform that conform to ISO 17025. You cannot claim ISO 17025 compliance for activities outside this scope.
Do we need a full organizational chart?
Clause 5.5 Yes. You must document the organization structure, its place in any parent organization, and relationships between management, technical operations, and support services.
Who are "specified personnel"?
Clause 5.6 These are staff members with specific authorities, such as authorizing results, developing methods, or training others. Their authority must be documented (e.g., in a Competency Matrix).
Can a one-person lab be accredited?
Clause 5.1 Yes, provided they meet all requirements, including impartiality (which is harder to prove for one person).
What is a "Legal Entity"?
Clause 5.1 The body legally responsible for the lab (e.g., a registered company, a government department). The lab itself might not be a separate legal entity.
Does the lab manager need to be technical?
Clause 5.2 Not necessarily, but they need access to technical expertise to make informed decisions.
What if we perform tests at a client site?
Clause 5.3 Your management system must cover on-site activities. This is often noted on your Scope of Accreditation.
How do we communicate the scope to customers?
Clause 5.4 Usually via your website, brochures, or by providing the official Accreditation Schedule.
Do we need job descriptions?
Clause 5.5 c Yes, you must define the responsibilities and authorities of all personnel.
Difference between Competence and Qualification?
Clause 6.2 Qualification refers to education (degrees, certificates). Competence is the demonstrated ability to apply knowledge and skills. A degree doesn't prove you can run a specific test; authorization does.
Do all equipment need calibration?
Clause 6.4.6 No. Only equipment that: 1) Has a significant effect on the accuracy or validity of the result, or 2) Requires calibration to establish metrological traceability.
Can we calibrate our own equipment?
Clause 6.5 Yes, but you essentially become a calibration lab for that specific parameter. You must have reference standards, a validated procedure, uncertainty budgets, and competent staff.
What is Metrological Traceability?
Clause 6.5 The unbroken chain of calibrations linking your measurement result to a primary standard (SI units), with defined uncertainty at each step.
How do we evaluate suppliers?
Clause 6.6 You must have a procedure. Common methods include: checking their accreditation (ISO 17025 for calibration), reviewing past performance, or testing a sample of their product.
Do we need to keep environmental records?
Clause 6.3 Yes, if environmental conditions affect the result (e.g., temp/humidity).
What if equipment leaves the lab?
Clause 6.4.9 It must be checked/calibrated upon return before being used again.
What are "Reference Materials"?
Clause 6.4 Materials with sufficiently homogeneous and stable properties (e.g., pH buffers).
Can we use non-accredited calibration labs?
Clause 6.5 Only if strictly unavoidable. You must then demonstrate their competence and traceability yourself (which is difficult).
Do we need to check consumables?
Clause 6.6.2 Yes, verified before use (e.g., checking new reagents against old ones).
Method Validation vs Method Verification?
Clause 7.2 Validation: Proving a non-standard method works from scratch. Verification: Proving your lab can correctly perform a standard method.
What is a Decision Rule?
Clause 7.1.3 It describes how Measurement Uncertainty is accounted for when stating Pass/Fail. For example, "We pass if the result is below the limit minus the uncertainty."
Do we need to calculate Uncertainty for every test?
Clause 7.6 Testing labs must evaluate uncertainty. If a rigorous calculation isn't possible, an estimation based on theoretical principles or performance data is sufficient.
What is Non-Conforming Work?
Clause 7.10 Any work that does not meet your own procedures or the customer's requirements (e.g., QC failure, equipment error). You must halt work and evaluate impact.
What needs to be in a Test Report?
Clause 7.8 Title, Lab Address, Customer Address, Unique ID, Method used, Results with units, Date, Signature, and Disclaimer.
Can we deviate from a standard method?
Clause 7.2.1.7 Only if documented, technically justified, authorized, and accepted by the customer.
What is a "Contract Review"?
Clause 7.1 Checking you have the resources and capability to do the job before accepting the sample.
Do we need a sampling plan?
Clause 7.3 Only if you are responsible for the sampling (collecting the sample).
How long do we keep retained samples?
Clause 7.4 As per your procedure. Usually long enough to allow for a re-test if contested.
Can we correct a mistake in a record?
Clause 7.5.2 Yes, cross it out (do not erase), write the correct value, and initial/date it.
What is Option A vs Option B?
Clause 8.1 Option A: Follow ISO 17025 direct requirements. Option B: Align with ISO 9001 if the lab is part of a certified org.
How often should Internal Audits be done?
Clause 8.8 "At planned intervals." Most Accreditation Bodies expect a full cycle annually.
Can I audit my own department?
Clause 8.8 Ideally, no. Auditors should be independent of the activity being audited.
Corrective Action vs Preventive Action?
Clause 8.7 / 8.5 ISO 17025:2017 replaced "Preventive Action" with "Risks and Opportunities." Corrective is reactive; Risk is proactive.
What are Management Review inputs?
Clause 8.9 Changes in issues, objectives, policies, audit results, corrective actions, feedback, workload, resources, and risks.
Do we need a Quality Manual?
Clause 8.2 Strictly speaking, no. But "Management System Documentation" is required. A manual is best practice.
How long do we keep documents?
Clause 8.4 Standard doesn't set a time. Check local laws or contracts (usually 3-5 years).
What is Root Cause Analysis?
Clause 8.7 Finding the underlying reason for a problem, not just fixing the symptom.
Do we need to document every risk?
Clause 8.5 No formal risk management methods are mandated, but you must show you considered risks.
What is "Document Control"?
Clause 8.3 Ensuring only approved, current versions of procedures are available to staff.