Management requirements:

Contracts Subcontracting

Suppliers
Complaints Corrective

and preventive actions (CAPA) Internal audits Management reviews

Review of request tenders and contracts -1 (ISO 17025: 2005, 4.4)

Policy

and procedures required Differences between request and the contract shall be resolved before work starts Relevant discussions with a customer are registrated

Review of request tenders and contracts - 2 (ISO 17025: 2005, 4.4)

Contract has to be acceptable for customer and laboratory

In contract procedure:

Requirements including the method are adequately defined, documented and understood Capacity ad resources of laboratory are assured How to act in case of deviations

Review of request tenders and contracts - 3 (ISO 17025:2005, 4.4)

A

contract can be a written or oral agreement Review of compatibility by earlier work or proven skills to perform

Subcontracting tests
(ISO 17025; 2005, 4.5)

Documented policy and procedure available including review of subcontractors (ISO 17025 accreditation preferred) Contracts with subcontractors are documented in a register Laboratory is also responsible for subcontracted tests Gain approval of customer for subcontracting

Suppliers -1 (ISO 17025: 2005, 4.6)

Policy

and procedure for selection and use of supplies and services Procedures for inspection, acceptance and storage of supplies

Suppliers -2 (ISO 17025: 2005, 4.6)

Evaluation of suppliers critical for the quality of test results Services Subcontracting Equipment Reference substances Reagents Critical consumables

Suppliers - 3 (ISO 17025: 2005, 4.6)

Criteria

for evaluation of suppliers Documentation of evalution Preventive action in case of poor performance

Complaints

The laboratory shall have a policy and procedure for the resolution of complaints (ISO 17025:2005, 4.8)

Control of nonconforming testing work (ISO 17025; 2005, 4.9)

Policy

and procedure required for nonconforming work and registration Evalution of the significance is made Correction is taken immediately When necessary customer is notified and work recalled Authorization of resumption of work is defined

Corrective Actions -1
(ISO 17025; 2005, 4.11)

The

laboratory shall establish a policy and procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the quality system or technical operations have been identified.

Corrective actions -2
Analyse

cause, select and implement corrective actions (if necessary audit related activities) Document changes resulting form corrective actions

Preventive actions (ISO 17025; 2005, 4.12)

Needed

improvements and potential sources of nonconformities shall be identified Pro-active process: elements can be risk analysis, possibility for quality improvement

Internal audits -1 (ISO 17025: 2005, 4.12)

Verify

that laboratory operations continue to comply the requirements of the management system and ISO 17025:2005

Internal audits - 2 (ISO 17025: 2005, 4.12)

All elements of the management system have to be audited periodically Audit programme made by Quality manager Carried out by trained and qualified independent personnel (if allowed by resources) If audit findings results in doubts about effectiveness of results/processes timely corrective actions are taken Follow up audit activities shall verify undertaken actions

Audits in general
Horizontal

audits 1 subject example personnel and competence audits following a process through an organization

Vertical

Management reviews
(ISO 17025: 2005, 4.15)

The laboratorys executive management shall periodically conduct a review of the laboratory's management system

Pitfalls
Managerial

system

Bureaucratic Static Not

system

flexible

Building a Quality System

law
management

license

permits

Analytical methods

environment (local) government

storage

Final Remark
Laboratory

Accreditation is a tool to demonstrate the true underlying quality of the analytical testing program