Quality Management Systems

Abstract

Quality management systems (QMS) is a framework that helps companies of all sizes to improve their quality of products and services. QMS includes all aspects of a company and via collection of data such as internal performance indicators, training of employees, nonconformities and their root curse, well-argued management decisions based on these data can be made insuring a gradually increase of the quality. It focuses on create a closed loop in the organisation known as the Plan Do Check Act (PDCA) cycle, which is the basis for this gradually improvement of quality. The article will explain how a QMS is structured and how projects within an organisation with a certified QMS is performed. It will further more be discuss if the value produced from a product increases when performed within the framework of a QMS. DS/EN ISO 9001 outlays Plan Do Check Act (PDCA) as an eventual part of the QMS and by this reason ways of incorporating the PDCA in a project will be suggested. Further more it will be discussed why many organisations, regardless of its size, doing project could benefit from implementing a QMS system fitting their organisation. General principles of risk-based thinking will be explained and why it is especially important to include in a company’s Quality Management System and project management. Arguing that more organisations should implement a QMS in order to know their current level of quality throughout the organisation, projects and knowing their progress from investments and initiatives.

Quality Management Systems

A Quality Management System purpose is.... (genereal explanation of the purpose and function of a QMS, with references to 9000, 9001 and other guidance documents). - Systematical aproceh to gradually and continual increase the quality of products, processes or services in a organisation. - List all the aspects of a QMS with a short description - Handeling non non-conformities - CAPA (Part 820 Quality Systems Regulations)

- Ask the question in this section or the abstract: But how should a PM navigate in a QMS and what should the PM in particular be aware of? Why and how would the QMS come to the PM's advantage?

Plan Do Check Act

- insert homemade PDCA "wheel" - Explain the PDCA -

Project Management

Project mangement is the way of controlling and guiding a project and its stakeholders towards the project goal by use of methods, tools and expertise within the projects constraints. ref(ISO21500 and PRINCE2 2017 edition). A project is a contemporary constellation with a defined timeframe which create or add value in reference to the baseline.

- A project is a temporary constellation with a start and end date, which must fit into a QMS with the lifespan of the organisation. - Multiple factor from outside the organisations boundaries can effect the project and must therefor be encountered by the PM in order to reduce risks. These factors can be minimised by an efficient QMS where SOP's describe and standardise genereal methods and cosiderations which must be encountered when a project is carried out.

- Pre project and post projects is controlled and documented vie the QMS. The standardisation of the project eases post projects since the documentation and method use in the last project is well described. Revison and evaluation of the projects will gradually evaluate and improve the quality of the projet (and value. Likevise will a QMS also help to standardise and improve the programs and portefolie. - Important to mention that managenet standards can be used within the QMS, but the QMS help to custemise the way of performing project in the particular organisation. The QMS could also directly refer to a standard which must be used for execution projects. - The QMS will provide the PM with information of the personals competences e.g from a competence matrix. Easing the processes of creating teams with the necessary knowledge and experience. - The lifecycle of the project can be managed in the QMS and beyond. (Nok ikke nødvendigt and nævne)

General principles - Stakholders - Critical path - Preventive action

Project Management within a QMS

- What is difference of performing a project without a QMS from without - What to encounter as PM - SOP's

Value creating

- How a QMS captures value from the project and enables and ensures that the lessons learn will be accessible and reused. - Use of best practice -

Discussion

- Pros and Cons

Conclusion

[https://webshop.ds.dk/da-dk/standard/03-120-10-kvalitetsstyring/ds-en-iso-90012015 DS/EN ISO 9001