ISO 17025

Presentation On Management: Subcontracting of tests & calibration; Purchasing of services and supplies; Service to customer
PRESENTED BY: Sanju Maharjan M.Pharm 1st sem.

Subcontracting of tests &calibration

This topic describes how to ensure that tests and calibrations subcontracted to third parties are performed according to the same quality standards as if they were done in the subcontracting laboratory.

Key points:
The competence of the subcontracted party should be ensured, through a documented quality system, such as ISO/IEC 17025. The subcontracting laboratory is responsible to the customer for the subcontractors work, except in the case where the customer or the regulatory body specifies which subcontractor should be used.

Subcontracting of tests &calibration

When a laboratory subcontracts work, whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) of on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question. The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.

Subcontracting of tests &calibration

The laboratory is responsible to the customer for the subcontractors work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used. The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question.

Subcontracting of tests &calibration

The laboratory must keep a list of approved sub-contractors, normally compiled by the quality manager. Laboratories which operate a quality system in compliance with ISO 17025 are automatically eligible to appear on this list. In the case of non-accredited laboratories, an appraisal is required, which include a visit to the sub-contractor to carry out an audit. The key issues would be to ensure that the laboratory is suitably equipped, has training procedures and records, calibrates its instruments traceably and has appropriate internal and external quality control procedures, including participation in relevant interlaboratory proficiency exercises.

Purchasing of services and supplies

This topic describes how to ensure that services and supplies delivered by third parties do not adversely impact the quality and effectiveness of laboratory operations.

Key points:
Suppliers should be selected and formally evaluated to ensure that services and supplies are of adequate quality. Records of the selection and evaluation process should be maintained. The quality of incoming material should be verified against predefined specifications.

Purchasing of services and supplies

The Laboratory shall have a policy and procedures for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations. Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations. The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. These services and supplies used shall comply with specified requirements. Records of actions taken to check compliance shall be maintained.

Purchasing of services and supplies

Purchasing documents for items affecting the quality of laboratory output shall contain data describing the services and supplies ordered. These purchasing documents shall be reviewed and approved for technical content prior to release. The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration, and shall maintain records of these evaluations and list those approved.

Service to customer
This chapter describes how to ensure that the laboratory continually meets customer requirements. Key points: The laboratory should communicate with customers to clarify requests and get customer input. The laboratory should have a formal program to collect feedback from customers on an ongoing basis. The laboratory should allow customers to audit the laboratory.

Service to customer
The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customers request and in monitoring the laboratorys performance in relation to work performed, provided that the laboratory ensures confidentiality to other customers. providing the customer or the customers representative reasonable access to relevant areas of the laboratory for thewitnessing of tests and/or calibrations performed for the customer. Preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes. The laboratory shall seek feedback, both positive and negative, from its customers. the feedback shall be used and analyzed to improve the management system, testing and calibration activities and customer service.

Self-examination for compliance with ISO 17025

These questions go through the key requirements of ISO 17025; they are the kind of questions which a laboratory should be asking own self, to decide where it is ISO 17025 compliant.

Subcontracting of tests and calibrations

Do you have a list of approved subcontractors? Do you have a record of the accreditations of the subcontractors?

Where subcontractors are not accredited do you have other evidence

that they are competent?

Purchasing services and supplies Do you have a list of approved suppliers and a policy for inclusion of a supplier on the list? Does this policy ensure that purchased materials and services will be good enough to ensure that the quality of your data is not threatened? Service to clients and complaints Do clients know how to contact you and who to speak to about the progress of their work? Do you follow up complaints from clients and learn from them so that you can take steps to ensure that the problem does not happen again?

References
ISO 17025:2005(E) General requirements for the competence of testing and calibration laboratories Complying with ISO 17025 A practical guidebook.pdf

THANK YOU