Consultant | Konsultan ISO 9001, ISO 14001, ISO/TS 16949, ISO 22000, ISO 17025, ISO/OHSAS 18001, SA 8000, ISO SYSTEM CERTIFICATIONS.

We are Consultant firm have extensive experience in implementing ISO 9001, ISO 14001, ISO/TS 16949, ISO 22000, ISO 17025, OHSAS 18001, SA 8000, ISO SYSTEM for various types of industries. The methodology adopted has been fine tuned with experience in order to deliver the maximum benefits to our customers.

The Scope of Our Work could include the following :

• Study of the present systems in the organizations
• Identifying the relevant systems and processes that could form part of the ISO system
• Determining the gaps and lacunae in the present system with reference to the requirements of the ISO standards
• Drawing up time-bound plans to bridge the gaps
• Training a group of team leaders in the organisation on the ISO methodology
• Preparation of all required documentation to suit the Standards
• Arranging and coordinating with reputed accredited certification bodies for systems audit and certification

Our Experience in ISO 9001, ISO 14001, ISO/TS 16949, ISO 22000, ISO 17025, ISO/OHSAS 18001, SA 8000 and ISO SYSTEM

Please Contact SIEN Consultant to get information our services Consultancy / Consultant ISO 9001 , ISO 14001 , ISO 22000 , ISO/TS 16949 , ISO 17025 , SA 8000 , etc

http://digg.com/gaming_news/Consultant_Konsultan_ISO_9001_ISO_14001_ISO_TS_16949

http://digg.com/gaming_news/Consultant_iso

______________________________

New Articels :

• Apakah  akan berhasil menjalankan sebuah Sistem Tanpa Tujuan Visi – Misi?
• Bagaimana Menjalankan SMM tanpa membangun Budaya Mutu ?
• Tujuan Audit Mutu Internal – IQA
• Sertifikasi ISO9001
• Download ISO
• Public Training – Inhouse Training – Workshop ISO System
• Jasa Konsultan ISO System
• ISO Consulting & Training
• Home

ISO Series :

• ISO Standard
• ISO9001 – Quality Management System
• ISO14001 – Environment Management System
• OHSAS 18001
• ISO17025 – Laboratories Management System
• ISO22000 – Food Safety
• GMP – Good Manufacturing Practice
• 5 S
• SA8000 – Social Accountability
• ISO/TS16949 – Automotive Management System
• ISO13485 – Medical Device
• ISO 27002 – Information Security Management
• Six Sigma
• Home

Call Us for more information :

Ph: +62-21-3398 0073

or email to : info@sienconsultant.com

Bookmark It

Hide Sites

Medical Devices :

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system.

Source : http://www.iso.org/iso/home.htm

http://digg.com/business_finance/ISO_13485_2003_for_Medical_Devices

_________________________

New Articels :

• Apakah  akan berhasil menjalankan sebuah Sistem Tanpa Tujuan Visi – Misi?
• Bagaimana Menjalankan SMM tanpa membangun Budaya Mutu ?
• Tujuan Audit Mutu Internal – IQA
• Sertifikasi ISO9001
• Download ISO
• Public Training – Inhouse Training – Workshop ISO System
• Jasa Konsultan ISO System
• ISO Consulting & Training
• Home

ISO Series :

• ISO Standard
• ISO9001 – Quality Management System
• ISO14001 – Environment Management System
• OHSAS 18001
• ISO17025 – Laboratories Management System
• ISO22000 – Food Safety
• GMP – Good Manufacturing Practice
• 5 S
• SA8000 – Social Accountability
• ISO/TS16949 – Automotive Management System
• ISO13485 – Medical Device
• ISO 27002 – Information Security Management
• Six Sigma
• Home

Call Us for more information :

Ph: +62-21-3398 0073

or email to : info@sienconsultant.com

Bookmark It

Hide Sites

Information Security Management in an Organization :

ISO/IEC 27002:2005 comprises ISO/IEC 17799:2005 and ISO/IEC 17799:2005/Cor.1:2007. Its technical content is identical to that of ISO/IEC 17799:2005. ISO/IEC 17799:2005/Cor.1:2007 changes the reference number of the standard from 17799 to 27002.

ISO/IEC 27002:2005 establishes guidelines and general principles for initiating, implementing, maintaining, and improving information security management in an organization. Continue Reading »

Bookmark It

Hide Sites