ISO 9001 Quality Management Systems – Revision
All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. ISO 9001:2015 is designed to respond to the latest trends and be compatible with other management systems such as ISO 14001.
At the outset, each ISO deliverable is assigned to a standards development track. This track determines the timeframe of the project as it passes through the various stages to publication. Whichever track is chosen, the development process for ISO standards follows defined stages as follow:
The development process for ISO standards
This first step is to confirm that a new International Standard in the subject area is really needed.
This stage can be skipped for revisions and amendments to ISO standards that are already published (as long as the scope does not change).
Usually a working group (WG) is set up by the parent committee to prepare the working draft (WD). The WG is made up of experts and a Convenor (usually the Project leader).
During this stage the draft from the working group is shared with the members of the parent committee.
This stage is optional.
The Draft International Standard (DIS) is submitted to ISO Central Secretariat by the committee secretary. It is then circulated to all ISO members who then have 12 weeks to vote and comment on it. (The submission interface should be used to submit the draft).
This stage will be automatically skipped if the DIS has been approved and no technical changes are introduced
If this stage is used, the Final Draft International Standard (FDIS) is submitted to ISO/Central Secretariat (ISO/CS) by the committee secretary. The FDIS is then circulated to all ISO member for an 8 week vote (The Submission Interface should be used when sending the draft to ISO/CS).
At this stage the secretary submits the final document for publication through the Submission Interface. But if the standard has passed through the Approval stage, the secretary may submit the project leader’s responses to member body comments on the FDIS.
What’s different from ISO 9001: 2015?
ISO 9001: 2015 underwent significant changes over previous versions. The following are major changes to ISO 9001: 2015:
Starting from chapters and sub-chapters, and the order of clauses is really structured and well grouped. This neat clause is intended to enable companies to incorporate other relevant ISO standard components, such as ISO 14001:2015, ISO 55001, and ISO 45001. Not only that, the number of clauses in ISO 9001:2015 has increased from 8 clauses in ISO 9001:2008 to 10 clauses in ISO 9001:2015.
Risk is considered as a unity that can not be separated from the system. Therefore, with a risk-based thinking approach, the company is expected to be more proactive in preventing and reducing unwanted effects and continually improving its system management. When risk management is applied seriously, automatic precautions will be taken.
However, there is one thing that is different from ISO 9001: 2015. This standard does not require the existence of a management representative who must be appointed officially. Every person, especially the person in charge of each division/department of company has the same duty and responsibility in applying ISO quality management system ISO 9001:2015.
The existence of a quality manual in ISO 9001:2015 is not mandatory, as many people who feel the quality manual is just a formality document and do not provide any additional benefits to the company.
Clause 4 ISO 9001:2015 discusses the organizational context. This latest standard introduces requirements relating to the organizational context:
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectation of interested parties
Both of these points require the company to understand the context of its organization and recognize the risks that may impact the planning of the quality management system and recognize opportunities that can be used to improve or develop a quality management system.
The organizational context clause also explains that while ISO 9001:2015 states that all clauses in this standard can be applied to all types of organizations without exception, clause 4.3 ISO 9001:2015 still permits exceptions as long as there is justification received.
The term “product” in ISO 9001:2015 changes to “goods” and “services” to avoid confusion. Because, most users of ISO 9001 often misunderstand “product” as a physical goods only, but the product also includes services.
“Work Environment” is replaced by “Environment for the Operation of the Process”
“Supplier” replaced with “External Provider”
“Purchased Product” is replaced by “Externally Provided Products and Services”
The change of the term applies not only to goods, but also to services. If your company has applied the old term to ISO 9001:2008, the term can still be used as needed.