ISO 9001 QMS
ISO 9001:2015 identifies requirements for a quality management system where an organization requirements to demonstrate its ability to consistently offer product that meets customer and applicable statutory and regulatory requirements, and aims to increase customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to client and applicable statutory and regulatory necessities. All requirements of ISO 9001:2015 are generic and are intended to be applicable to all organizations, regardless of type, size and product providing.
We have now gone a step further, and ISO 9001:2015 is even less prescriptive than its predecessor, focusing instead on performance. We have achieved this by combining the procedure approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
All ISO standards are reviewed every five years to confirm that they remain relevant to the market environment. ISO 9001:2015 is the final result of a multi-year procedure involving representatives from ISO member countries and stakeholders from around the world.
ISO 9001 2008 had five main sections (4 to 8) and ISO 9001 2015 now has seven (4 to 10). This is because the new edition uses the new Annex SL template. According to ISO, all future management system standards (MSSs) will use this new layout and share the same basic needs. As a result, all new MSSs will have the same basic look and feel.
Section 4.3 of ISO 9001 2015 says “The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system”. So once you’ve determined the scope of your QMS, ISO 9001 2015 says that every necessity must be applied within the boundaries defined by your statement of scope if it applies in your case.