ISO 9001:2015 was created as a High Level System (HLS). By virtue of being a HLS, the design of the new standard is for other standards to align themselves accordingly by integrating the elements and changes within the context of the principles required in the elements for 9001.
New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.
The 2015 revision of ISO 9001 has debuted with mixed reviews from smaller registrars and suppliers. The question arises: is there going to be any measureable benefit from these changes other than increased income for the ISO bureaucracy? One of the early reasons for change was to align ISO standards with Annex SL. Not sure all the interested parties are excited with this reason.
The long-awaited revision to ISO 9001 has arrived. The standard will be familiar to those in the quality industry: more than 1.1 million companies are certified to the standard as of 2014, and more than 33,000 certifications in the U.S. Whether you’re in the process of implementing the revision, just planning for it, or curious to see what’s new, here’s a look at the ISO 9001 revision.
Quality management professionals focused their eyes on the big update to ISO 9001 in September, and changes in the standard will require top leadership to do the same moving into the new year and beyond.
RISK IS GIVEN A FRONT-AND-CENTER PRESENCE IN SECTION 6 OF THE STANDARD.
October 2, 2015
Years in the making, the ISO 9001:2015 revision has been published. Prior to the release date, auditors, inspectors, quality managers, and many others studied the initial drafts in an attempt to understand the changes.
In early stages of industrialization, products were simpler, factories were smaller, most processes were manual, and process flows were shorter. Contact with customers was direct between production and customer.