Trial
Posted on April 22nd, 2009 by Plato
What Is The Transition Time Frame To Comply With This Revision And Whether Your Organization Requires Full Re-Assessment For ISO Certification?
Posted on March 26th, 2009 by Plato
Certification to ISO 9001:2008 is not considered an “upgrade”. The rules for transition are as follows:
1. The new edition will not require any specific reassessment for certification. Certification Bodies will evaluate conformity to the new ISO 9001:2008 standard during regular surveillance visits and full reassessment will only take place once your current certificate expires.
2. ISO and the IAF have agreed that all certificates to ISO 9001:2000 should be transitioned to ISO 9001:2008 within 2 years of publication date, (i.e., before November 14, 2010). Your organization can request your Certification Body to asses your QMS to ISO 9001:2008 at your next Surveillance audit.
3. One year after publication of ISO 9001:2008 (i.e., before November 14, 2009), all certifications issued (new certifications and re-certifications) must be to ISO 9001:2008.
4. Two years after publication of ISO 9001:2008 (i.e., before November 14, 2010), existing ISO 9001:2000 certifications will not be valid.
Preclinical Development Planning for Emerging Pharma and Biotech Firms
Posted on March 24th, 2009 by Plato
This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies.
Does ISO 9001:2008 has Additional Requirements Beyond ISO 9001:2000?
Posted on March 22nd, 2009 by Plato
This latest (4th) edition of ISO 9001 contains no new requirements compared to the (3rd) year 2000 edition, which it replaces. What it does is provide clarification to the existing requirements of ISO 9001:2000 based on eight years’ experience of worldwide implementing of the standard and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.
The clarifications and changes in ISO 9001:2008 represent fine-tuning, rather than a thorough overhaul. It focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. The changes address such issues as the need to clarify, provide greater consistency, resolve perceived ambiguities, and improve compatibility with ISO 14001.
ISO has organized the changes incorporated in this ISO 9001:2008 edition into the following categories:
- Minimum changes on user documents, including records
- Minimum changes to existing QMS processes
- Minimal training required
- No effects on current certifications
ISO 9001:2008 Implementation Plan
Posted on March 21st, 2009 by Plato
Validity of certifications to ISO 9001:2000: One year after the publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.
What are the main changes in ISO 9001:2008?
Posted on March 20th, 2009 by Plato
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008
All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO 9001:2008.
Generic Drug Approval Process - FDA
Posted on March 18th, 2009 by Plato
Slides from the FDA site at http://www.fda.gov/cder/consumerinfo/generic_all_resources.htm#presentation
Translator
By N2H