Quality Management Systems

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Contents

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 essential 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.

-Why is project management a good idea to do within a QMS. Defined method customised for the specific organisation, defined output which can be used as concrete experience and input for the next project. The QMS will control the input, processes and output.


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) - Mandatory training of employees is required in order to fulfil the requirements of the DS/EN ISO 9001 which guarantee a default of knowledge of important procedures used in the organisation.

- 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) - The QMS could include SOP describing general templates of what should as minimum be included in a project plan and project management plan. Template describing what to be included in a baseline. - Defined change control system that formalises the acceptances from both the client and contractor before actions upon this is made.



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 - DS ISO 21500 2012 speaks of inputs into new project plan, such as the business case, lessons learned from the last project, approved changes etc. In relation to the QMS the input of lessons learn from the previous project is of particular importance in order to make improvements upon the last project.The PDCA method also describes this continues processes of improvement. I order to ensure the inputs is at an acceptable level of quality some standardisation of what these inputs should include must be defined. An example of this could be a template for a project evaluation with specific topics that must be evaluated both internally in the project group but also an evaluation from the clients.

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 - Suggestions in the DS ISO 21500 2012 mention that lessons learned during the project should be noted and accumulated in a report when the project is finalised. General inputs for this report is suggested but only with general terms. These should be specified in order to obtain consistent performance indicaters, best practices and what to avoid in subsequent projects and included as a SOP for PM in the QMS.

Discussion

- Pros and Cons

Conclusion

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

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