Biosecurity and Quality Control

Name: Martha Galarraga Date: April 12, 2019

What are the similarities and the differences between Certification (ISO 9001) and Accreditation (ISO
17025)

CERTIFICATION (ISO 9001) ACCREDITATION (ISO 17025)

APPLICABILITY It is applicable to all types of companies in Only applicable to calibration

OF STANDARDS all industries laboratories I any industry

Same minimum requirements: Improvement, management reviews, management

REQUIREMENTS system control requirements, documentation of management system, corrective
actions, handling risks and opportunities, records control, internal audits.
It means accordance with standard
It means the recognition of
assessed by management system,
CONCEPT competence of specific technical
certificated by any independent body that
competence.
is internationally agreed.

Identification of internal and external

ORGANIZATION Not discuss the problems
problems

Benefits of implementing ISO 9001

- A certified ISO 9001 quality management system increase the quality of the services.
- Gives a positive company image.
- Greater profit potential.
- Better resource management by a better resource gestion.
- Good relationship between customers and suppliers.
- Identification and faster resolution of problems, in many cases without the presence of the supplier.
- Greater job security for the staff through better commercial performance.
 - Employee morale is increased and motivation is increased through better training capabilities.

Benefits of implementing ISO / IEC 17025

- Achieve international recognition of its technical competence gain the confidence of customers and
interested parties, as well as open doors to new market both locally and international.

- Greater quality awareness amongst employees and reduced defects, scraps, rework failures and service
recovery.

- Potential increase in business due to enhanced customer confidence and satisfaction.

- Savings in terms of time and money due to reduction or elimination of the need for re-testing of
products.

- Control laboratory methods variation.

- Increase of confidence in Testing / Calibration data and personnel performing work.

- Validity and appropriateness of test methods.

Benefits of implementing ISO 15189

- Promotes development of an international reputable image for your organization through Quality
Assurance and Management Systems.
- Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both
from an international and national perspective.
- Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service
delivery.
- The certification program also has been very critical in promoting modern laboratory practices that
include professionalism and expertise in conduction of medical activities in the labs.
- Ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory
testing

Reference
Honsa, J. D., & McIntyre, D. A. (2003). ISO 17025: Practical benefits of implementing a quality
system. Journal of AOAC International, 86(5), 1038-1044.

Gašparec-Skočić, L., Kubanović, V., & Kaštelanac, D. (2003, January). The adventages of being an
accredited laboratory. In Savjetovanje Hrvatska normizacija i srodne djelatnosti-Tehničko usklađivanje na
putu prema Europskoj uniji.

Khodabocus, F., & Balgobin, K. (2011). Implementation and practical benefits of ISO/IEC 17025: 2005 in
a testing laboratory. University of Mauritius Research Journal, 17(1), 27-60.

Santos, G., & Millan, A. L. (2013). MOTIVATION AND BENEFITS OF IMPLEMENTATION AND
CERTIFICATION ACCORDING ISO 9001--THE PORTUGUESE EXPERIENCE. International Journal for
Quality Research, 7(1).