envelope  Contact us

phone1-301-495-0477

ISO 9001

Since its first publication in 1987, ISO 9001 has been revised several times to remain relevant and in line with the market needs of businesses. A new revision of the standard was launched in September 2015; replacing the latest version published in 2008. With over 1.2 million companies certified around the world, ISO 9001:2015 introduced several changes; some of those are significant as they impact key areas of the companies’ Quality Management System.

 

Objectives of the revision

The revision of the standard was undertaken to reflect several aspects. One of them was to allow for a better structuring of the standard and facilitate its future evolutions. Through language and definitions, and a consistent approach to quality management, the goal was to develop a more stable framework and environment focusing on key principles to allow for a smoother transition in the eyes of future evolutions.

 

High Level Structure (HLS)

The first main modification of the revised version of the ISO 9001 standard resides in its structure. The 2015 version follows a format commonly known as the “High Level Structure” or “HLS”. The High Level Structure (HLS) is a standardized way of drafting ISO management system standards. This structure is universal and includes 10 articles (8 for the ISO 9001:2008 version) as well as joint requirements. It has been defined to allow a better integration with other management system standards.

Some other standards such as the ISO 14001:2015 standard for the Environmental Management Systems as well as the ISO 27001:2013 standard on Information technology, have already been published following the same structure and more are expected to follow down the same path (the ISO 45001 Standard for Occupational Health and Safety Management Systems, the ISO 50001 standard for the Energy management etc.)
The new ISO 9001 standard is based on the “Deming Cycle” revolving around the following principles:
Plan”; “Do”; “Check” and “Act

In the figure below, the common requirements of the HLS structure are identified in bold:

ISO 9001 ACT PLAN CHECK DO

The Scope and Principles of ISO 9001:2015

The scope of the standard remains unchanged; it is still “applicable where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction”.
As for the principles, they are evolving but without major modifications: they go from 8 to 7 and we can note the introduction of a new terminology including the wordings “Leadership”, “Evidence based-decision” and “Interested parties. To this, 8 new definitions have been added and several others modified compare to the previous version.

The Requirements Evolution

The following table summarizes the new additions and removals of the requirements between the 2008 and the 2015 revision of the ISO 9001 standard:

 

 

Standard section

Added

Removed

PLAN

4. Context of the organization

5. Leadership

6. Planning

 

Integration of the understanding of the context and interested parties

Reinforcement of the requirements related to the processes.

Management responsibility accentuated.

Preventive actions replaced and extended to actions taken to address risks and opportunities.

Reinforcement of the requirements on planning of changes.

 

Suppression of the requirement related to the management representative.

DO

7. Support

8. Operations

 

Integration of organizational knowledge.
Reinforcement of requirements related to awareness and communication.
Reinforcement of the requirements related to the control of operational activities (external providers, post-delivery activities, modifications…).

Reduction of the documentation (absence of requirement related to quality manual and mandatory procedures).

CHECK

9. Performance Evaluation

 Reinforcement of the  requirements related to monitoring, measurement, analysis and evaluation.  
 ACT

10. Improvement

 Improvement not limited to continuous improvement  Removal of the words « preventive actions ». Those actions are considered in the actions to face risks identified in chapter 6.

 

This  brief summary shows that some substantial changes have been introduced  and those will have a significant impact on the companies’ Quality Management System.

 

Transition: Moving from ISO 9001:2008 to ISO 9001:2015

In order to allow for a smooth transition between the two versions of the ISO 9001 standard, a 3 year transition period has been defined.

Below is the one proposed by LNE/G-MED:

ISO 9001 Transition Period

 

LNE DOWNLOAD PDF  Download this newsletter in pdf format here.

MDSAP Prepare the transition, worldwide market access

Combo Training ISO13485 MDSAP

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

lne gmed arrow Submit a request

clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

Click here to Register