Process Requirements


7.1 Review of Requests, Tenders and Contracts

Review includes requirements are adequately defined, documented and understood, whether the lab can do the work, the final contract is equally acceptable in the previous points, the appropriate method is selected, any subcontracting.
Records must include any changes.
Customers are notified when deviations from the contract occur.
Contract amendments undergo the same review.

7.2 Selection, Verification and Validation of Methods
Test methods must be validated.
Any method deviation must be documented.
Selected methods must meet client needs.
Reference methods are preferred.
Lab is to inform client if client-specified method is not appropriate.
Non-standard methods must be validated and approved by customer.
Validation requirements must be listed.
Data must be controlled through calculations and data transfers as well as computers and automated equipment.

7.3 Sampling
Ensure sampling plan and method are available. The plan is to include valid statistical features where applicable.
Deviations from the plan are to be recorded.

Ensure that data recording includes sampler identification, location, date, conditions, statistical basis (i.e., traceability).

7.4 Handling of Test or Calibration Items
Document procedures for sample handling such as receipt, storage, labeling, disposal.
Ensure test samples are uniquely identified.
Establish acceptance criteria.
Ensure deficiencies are recorded and client informed.
Ensure lab can provide for sample integrity.
Ensure required environmental conditions are maintained.

7.5 Technical Records
Technical records are retained and contain sufficient information to establish an audit trail.
Observations, data and calculations are recorded at the time they are made.
Mistakes crossed out, corrected and initialed/signed.
Keep records for measurements, observations and customer information.
Use a pen.
Initial the records so that they are traceable.
Include the date.

7.6 Evaluation of Measurement Uncertainty
All significant contributions to measurement uncertainty are taken into account when evaluating. Appropriate methods of analysis are utilized depending on the laboratory.

7.7 Ensuring the Validity of Results
Ensure use of Certified Reference Materials and internal reference materials.
Ensure participation in Proficiency Testing programs.
Ensure insertions of replicates and retesting of retained samples.
Ensure correlation of sample characteristics.
Ensure documentation and charting of controls and statistical analysis of data.

7.8 Reporting of Results
Specifies what test reports should contain including title, method, result units, signing authority, unique sample identifier, etc.
Provides for interpretations with basis of such documented - compliance, sampling information, variance, test conditions, etc.
Subcontracted work to be identified.
Reporting amendments identified as "supplemental" and references original.
Quality is signing your name to the results!

7.9 Complaints
Procedures for resolution of complaints.
Maintain records of complaints and corrective actions.

7.10 Nonconforming Work
Procedures for handling nonconforming testing or calibration work.
Evaluate the significance of nonconforming work.
Correct the nonconforming work.
Customer is notified and work recalled if necessary.
Potential recurrence leads to Corrective Action (8.7).

7.11 Control of Data and Information Management

ISO 17025 Quality Manual Template