Inspection Audit Checklist

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

Impartiality

• Are there any potential conflicts of interest?

  Yes

  No

• How are they managed?

• How does the laboratory protect itself from undue internal and external pressures?

Confidentiality

• How is client information protected to ensure confidentiality?

• Are there policies and procedures in place to handle confidential information?

  Yes

  No

Organization Structure

• Is the organizational structure clearly defined and documented?

  Yes

  No

• Are roles, responsibilities, and authorities of personnel clearly assigned?<br>

  Yes

  No

• Is the independence of the laboratory's personnel from commercial, financial, and other pressures ensured?<br>

  Yes

  No

Management and Personnel

• Are management and personnel competent for their roles?

  Yes

  No

• How is training and competence of personnel ensured and documented?

Personnel

• Are personnel qualifications, training, and experience documented and up-to-date?

  Yes

  No

• How does the laboratory ensure ongoing competence of its staff?

  Yes

  No

Facilities and Environmental Conditions

• Are the facilities suitable for the testing/calibration activities?

  Yes

  No

• How are environmental conditions monitored and controlled?

  Yes

  No

Equipment

• Is the laboratory's equipment appropriate for the testing/calibration activities?<br>

  Yes

  No

• Are equipment maintenance and calibration records up-to-date?

  Yes

  No

Metrological Traceability

• Are measurements traceable to national or international standards?

  Yes

  No

• How is metrological traceability ensured and documented?

  Yes

  No

Externally Provided Products and Services

• Are there procedures for selecting and evaluating suppliers of external products and services?

  Yes

  No

• How does the laboratory ensure the quality of externally provided products and services?

  Yes

  No

Review of Requests, Tenders, and Contracts

• Are client requests, tenders, and contracts reviewed for feasibility and clarity?

  Yes

  No

• How are changes to contracts handled and documented?

  Yes

  No

Selection, Verification, and Validation of Methods

• Are methods selected, verified, and validated appropriately?

  Yes

  No

• How are method validations documented?

  Yes

  No

Sampling

• Are sampling procedures defined and followed?

  Yes

  No

• How is the integrity of samples ensured?

  Yes

  No

Handling of Test and Calibration Items

• Are test and calibration items properly handled, stored, and tracked?

  Yes

  No

• Are there procedures for the management of test and calibration items?

  Yes

  No

Technical Records

• Are technical records maintained accurately and securely?

  Yes

  No

• How long are technical records retained, and are they readily retrievable?

  Yes

  No

Evaluation of Measurement Uncertainty

• How is measurement uncertainty evaluated and documented?

  Yes

  No

• Are uncertainty calculations regularly reviewed and updated?

  Yes

  No

Ensuring the Validity of Results

• What measures are in place to ensure the validity of test and calibration results?

  Yes

  No

• Are there regular quality control checks and proficiency testing?

  Yes

  No

Reporting Results

• Are results reported clearly, accurately, and objectively?

  Yes

  No

• Are test reports and calibration certificates in compliance with ISO 17025 requirements?

  Yes

  No

Complaints

• Is there a documented process for handling complaints?

  Yes

  No

• How are complaints recorded, investigated, and resolved?

  Yes

  No

Management of Nonconforming Work

• Are there procedures for identifying and managing nonconforming work?

  Yes

  No

• How is nonconforming work reviewed and corrected?

  Yes

  No

Control of Data and Information Management

• Are data and information management systems secure and reliable?

  Yes

  No

• How is the integrity and confidentiality of data ensured?

  Yes

  No

• Has the laboratory chosen between Option A (ISO 9001) and Option B (ISO 17025-specific requirements)?

  Yes

  No

• Is the chosen option implemented and documented properly?

  Yes

  No

Management System Documentation

• Is there a documented management system in place?

  Yes

  No

• Are all necessary documents controlled and up-to-date?

  Yes

  No

Control of Management System Documents

• Are procedures for controlling documents and records in place?

  Yes

  No

• How are changes to documents controlled?

  Yes

  No

Actions to Address Risks and Opportunities

• Are risks and opportunities identified and addressed?

  Yes

  No

• How are actions to address risks and opportunities documented and monitored?

  Yes

  No

Improvement

• Are processes for continuous improvement in place?

  Yes

  No

• How are improvement actions documented and implemented?

  Yes

  No

Corrective Actions

• Are corrective actions taken when nonconformities are identified?

  Yes

  No

• How are corrective actions tracked and verified?

  Yes

  No

Internal Audits

• Are internal audits conducted regularly?

  Yes

  No

• How are audit findings recorded, reported, and followed up?

  Yes

  No

Management Reviews

• Are management reviews conducted at planned intervals?

  Yes

  No

• What topics are covered in management reviews, and how are outcomes documented?

  Yes

  No