It is always nice to start the year positively, this is a just a small share of a just-completed ISO 13485 Lead Auditor training class.
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It is always nice to start the year positively, this is a just a small share of a just-completed ISO 13485 Lead Auditor training class.
Top Management is very busy people and is responsible for the full remit of the enterprise's activity. Read More.
So what does this mean for your organization and how do you meet these requirements, given that, and I assume, you're not an attorney or legal expert?
As many are aware, ISO published an update to ISO 9001:2008 in September 2015. In fact, ISO 9001 is the most widely adopted ISO management system worldwide.
Mr. John Collins, Lead Instructor, Kelmac Group was delivering the training and was supported on the 2nd course by Dr. Farooq of QSCert Saudi.
The Kelmac Group® helped the Temetra increase the status and perception of the Information Security Management System within the organization.
The goal of an effective medical device quality management system(ISO 13485 Certification) is to ensure a safe and effective product and customer satisfaction.
ISO published ISO/IEC 27001 in 2005, since revised and updated in 2013 as the set of requirements for Information Security Management Systems (ISMS).
When a nonconformity occurred, there was always the escalation of the impact. In reality, a batch of product was directly impacted, and the value of trying to Sort/Rework was minimal.
Kelmac Group® has been in partnership with Quara Group S.A where together we have successfully run IRCA Certified Lead Auditor training throughout Latin America.
I mentioned in my last blog about having leadership written into the ISO 9001:2015 standard and how this has this specific word makes a difference.
This week Breda discusses the evaluation of process performance as per ISO 9001:2015. Read more here today!
As the world changes, so do the standards. So you can always be sure that your company is up to date with all the current standards to meet your customers' needs. If you're ready to get your company certified with ISO 9001, contact us today!
One of the clauses in the new ISO 9001:2015 standard refers to Risk Based Thinking. Risk Based thinking is now present in so many standards.
For ISO 9001:2015, the risk mind-set does not always come naturally to us. There are frequent occasions where management and staff of an organization are aware of potential risks but do consider that these risks will ever occur, they fail to consider these risks as real and actual threats, and are often surprised when the risks become a reality.
In ISO 9001:2015 Clause 10.3, looking at the specific actions required for Continual Improvement (CI), from now on the risk register is a key input to any preventive action.
For Continual Improvement, opportunities are lost when each of the lower risks items is not each considered. Very often other opportunities are also lost because the top management does not engage with the little issues that staff is having and the simple savings that can be made.
ISO 9001 is the world's most commonly used standard for implementing a systematic and effective approach to the quality management of products and services.
This standard is currently under review and will be available by the end of 2015 becoming ISO 9001:2015. There is a draft currently available for you to review should you require one in order to get a head start on the changes that are planned.
In this post, Brian discusses OHSAS 18001 – Occupational Health and Safety Management Systems and its purpose and benefits. What is it all about?
The Occupational Health and Safety Assessment Series Standard, OHSAS 18001 is the worldwide recognized system that a company can use to manage the safety, health and welfare of their employees and others who may be on their site or under their control from time to time such as contractors, in to complete some machine servicing, and visitors, calling in for a meeting or similar activity.