management requirements l.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Management requirements : PowerPoint Presentation
Download Presentation
Management requirements :

Loading in 2 Seconds...

play fullscreen
1 / 20

Management requirements : - PowerPoint PPT Presentation


  • 127 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Management requirements :' - malia


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
management requirements
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
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
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
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
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
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
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
Suppliers - 3 (ISO 17025: 2005, 4.6)
  • Criteria for evaluation of suppliers
  • Documentation of evalution
  • Preventive action in case of poor performance
complaints
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
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
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
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
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
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
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
Audits in general
  • Horizontal audits 1 subject example personnel and competence
  • Vertical audits following a process through an organization
management reviews iso 17025 2005 4 15
Management reviews (ISO 17025: 2005, 4.15)

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

pitfalls
Pitfalls
  • Managerial system
  • Bureaucratic
  • Static system
  • Not flexible
slide19

management

license

samples

registration

Analytical

methods

law

Document control

accommodation

reference standards

calibration

validation

permits

equipment

Profiency testing

personnel

environment

storage

(local) government

Building a Quality System

final remark
Final Remark
  • Laboratory Accreditation is a tool to demonstrate the true underlying quality of the analytical testing program

!