Wednesday, 9 November 2016

UPGRADE TO THE NEW ISO 9001:2015

UPGRADE TO THE NEW ISO 9001:2015
ISO 9001, the world's leading quality management standard, is revised in 2015. Each major revision of the standard introduces a concept that allows certified companies to reach a new level of maturity.


ISO 9001:2015 – Risks & Opportunities

Risk Management Approach (risk identification, qualification and management) has become fundamental in the revised standard. Quality results from proper management of associated risks, which go beyond the strict scope of the product or service delivered. Quality cannot exist unless the organization can provide its client a conforming product or service over the long term.

Risk has its counterpart: opportunity. The ISO 9001:2015 standard also embraces this concept of positive uncertainty. Of course, risk is an additional concept that in no way supersedes the concept already present in the standard. Risk is incorporated into the fundamentals and rounds out these notions. As such, the process approach and PDCA remain two essential pillars.

Managing risk also means working towards continuous improvement. Corrective action corresponds to an unidentified, wrongly qualified or mismanaged risk; preventive action addresses a risk of possible but un-occurred noncompliance.

The commitment to quality through strong and visible leadership is strengthened: The idea of a “management representative” disappears completely. The quality policy and stated goals must be deeply in keeping with the strategic orientations. QMS requirements must be merged into business processes.

The purpose of the standard is to take account of technological and societal changes. Information is no longer created, organized, managed, maintained, disseminated and accessed as it was 20 years ago when paper was the primary medium. This change also allows for greater flexibility in companies’ organization. It is now possible to comply with the standard without jeopardizing managerial agility, as long as the fundamental principles are respected.

Be the first in your sector to gain the ISO 9001:2015 certification

Contact us today to find out how you can upgrade your existing quality management system.


OM CONSULTING SERVICES

Mob: +91-9416180188; 7206730080

Thursday, 27 October 2016

ICMED Scheme is the first Indian certification scheme for the medical devices. The Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) started voluntary quality certification scheme for medical device manufacturers. ICMED scheme is started with intend to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. This scheme will help to the medical device industry in India to showcase its strength in terms of meeting the highest international standard.

Under ICMED certification scheme OMCS providing consulting services against the Criteria of following scheme:

·         ICMED 9000, An ISO 9001: 2008 requirements Plus additional requirements
·         ICMED 13485, An ISO 13485: 2012 requirements Plus additional requirements

OM CONSULTING SERVICES is a reputed professionally managed organization offering a range of International Trade services related to Quality; having Head Quarters in India & providing services globally. These include various Third party Certification services and Product Certification consulting services.

For detail information you can visit following link:


If you are interested in any of our services, then kindly contact us we look forward for an active participation in continual improvement of your organization and assure you of our value added services at all times.

OM CONSULTING SERVICES

Mob: +91-9416180188; 7206730080

Tuesday, 25 October 2016

The Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) is rolling out a voluntary quality certification scheme for medical devices which will help to grow medical device industry.

Posted by:

Gaurav Suden
Email: omcshim@gmail.com
Mob: 9416180188