HLS, an acronym you should be familiar with when dealing with Quality Management Systems (QMS). Read here all about the HLS.
What HLS means
High-Level Structure (HLS) is a structure to be applied to all Quality Management System (QMS) standards under the ISO organization. The HLS structures the many different QMS into the same high-level chapters for better and easier alignment and understanding.
Why hls is needed
The HLS allows the direct comparison of chapter and clauses of the many different QMS under ISO. With this, the differences between the different QMS can be easily seen and evaluated. With this, updating an organization from ISO 9001 to ISO 14001 can be done by an assessment of the different clauses in a very effective way.
The HLS makes use of the underpinning Plan-Do-Check-Act (PDCA)-cycle, which is true for every QMS. Along the PDCA-cycle, chapters of the QMS under the HLS are assigned. With that, any QMS, following the HLS has the following chapters, according to ISO Directive Part 1.
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Which standards follow HLS?
Currently, only ISO 9001, ISO 14001, ISO 45001 and ISO 50001 follow the HLS. Whatsoever, every new standard dealing with QMS will have to follow the HLS.
… and yes, ISO 13485:2016 does not yet follow the HLS structure. So, it can be expected that with the next update, the ISO 13485 might have to be adjusted to the HLS as well.
How Avanti Europe can help
Avanti Europe’s Experts have a decade-long track record and expertise in consulting and hands-on working with different eQMS and eDMS in the Pharmaceutical, Cosmetical, and Medical Device industry. Our experts support your company with hands-on workforce and support in risk-based process design, documentation, and training for the company staff. Visit our online shop for checklists and other services.
