ISO 9001:2015 specifies requirements for a quality management system when an organization a) needs to demonstrate its ability to consistently provide products and services that meet customer requirements and applicable legal and regulatory requirements, and b) seeks to increase customer satisfaction through effective application of the system, including processes for improving the system and ensuring compliance with customer requirements and applicable legal and regulatory requirements. All requirements set forth in this International Standard are general in nature and apply to any organization, regardless of its nature or size or the nature of the products and services it provides. (Source)
Implementation in process4.biz
This international standard was mapped into the process4.biz modeling tool and serves as a starting template for the implementation and certification of this standard.
First, the seven main chapters and their 27 sub-chapters were mapped in process4.biz. Furthermore, the overview diagram of the ISO standard was created.
The PDCA cycle is a model for implementing changes. It is an integral part of the lean manufacturing philosophy and an important prerequisite for the continuous improvement of people and processes. The Plan-Do-Check-Act cycle has been added to the main chapter and sub-chapters.
A second view on the ISO main chapters is quality management.
Quality management describes all organizational measures that serve to improve process quality. The advantage of process4.biz is that the ISO main chapters are created only once in the process4.biz database and therefore these objects can be reused on many diagrams. If you change the name of the object, it will be updated automatically on all diagrams.
Next step of the ISO standard implementation was the import of the 22 question groups and their 284 assigned questions. They existed in an Excel file, which was imported with the process4.biz extension Import Export Manager with a wizard.
Each ISO chapter consists of several sub-chapters, which in turn are assigned to question groups, whereby the question groups have additional questions.
These dependencies were then displayed graphically in process4.biz to make the dependencies easier to understand.
All objects (ISO main chapters, subchapters, question groups, questions) are linked in the process4.biz database and can then be queried with the process4.biz extension Query Builder to create a report.
Advantages of ISO 9001:2015 documentation with process4.biz
process4.biz offers decisive advantages with regard to the structured documentation of standards such as ISO 9001:2015. Some of these advantages are summarized here:
Database support & capable multi-user solution
process4.biz is based on a database, all structures, templates, contents & diagrams, documents are stored in this database. The tool is multi-client capable and ideally suited for multi-user operation.
Answers to the 284 ISO questions
These can be entered directly in the tool or with an Excel export they can also be entered in Excel and then imported into the ISO model with the process4.biz extension ImportExportManager. There is also integration with Microsoft SharePoint, where the contents can be maintained web-based.
Version management is available in process4.biz both with and without Microsoft SharePoint and is ideally used on the basis of approval management.
process4.biz is multilingual by default and allows modeling and execution of all reports in any display language supported by Windows.
process4.biz contains a native workflow for configurable multi-level approval management, which can also be set up on the basis of Microsoft SharePoint and extended by workflows there if required.
process4.biz enables redundancy-free modeling of all content, i.e. effectively “inheritable” changes. These changes are made once centrally and are then available throughout the entire data model.
- Publication of selected descriptive data and graphical diagrams in static web pages
- Extensive navigation options as well as filter and search functions
- Possible display of the approval status of the diagrams or publication of only approved diagrams
- Publication of descriptive data and diagrams from a process4.biz database into any Microsoft Word template
- Creation of a table of contents and keywords for each document
- Publication of specific contents from the database (according to query results from the process4.biz Query Builder, with variable object values, diagrams) to Microsoft Word
- Freely definable structure of a publication document for automatic creation of ISO manuals
- Sort and filter function of all model data according to self-defined criteria and parameters Export of these data in their respective dependency on each other as a result to Microsoft Excel
- Basis for building flexible documents with the process4.biz Document Composer
- Query results can be used as a basis for further queries
As an example in process4.biz we have created an ISO 9001:2015 query in the pocess4.biz Query Builder:
(Main chapter / subchapter / question group / question)
We hope that this article could give you some ideas and impulses regarding the possibilities of implementing ISO 9001:2015 (or other standards) in process4.biz models.
Please feel free to contact us if you have any questions, suggestions or feedback, or if you would like to see a live demonstration of the described demo content in our tool. We also offer consulting services for a concrete implementation in your process4.biz solution. Simply contact us here or via email.
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