ISO 9001:2015 – Quality Management System - TMSAcademy

1 T V S DDemonstrating strategic commitment to continuous improvementISO 9001: 2015 Quality Management SystemWhite paperAbstractISO 9001 is the world s most widely adopted Quality Management System (QMS) standard. It is also the only standard in the 9000 family of standards, published by the International Organization for Standardization (ISO), which can be used for the purpose of conformity assessment. iso 9001 also serves as the basis for many other sector-specific standards, including ISO 13485 (medical devices), ISO/TS 16949 (automotive) and AS/EN 9100 (aerospace), as well as widely used Management System standards such as OHSAS 18001 and ISO ensure that they remain relevant and reflect the changing needs of the global marketplace, ISO standards are reviewed every five years.

2 The ISO therefore published a major revision of iso 9001 on 15th September 2015 . This whitepaper outlines the key updates, giving an overview of the various changes that will impact an organisation s Quality Management approach, as well as the additional organisational benefits it GatzProduct Compliance Manager iso 9001 , T V S D Management ServiceAs Product Compliance Manager for iso 9001 , Sami Gatz is responsible for assuring that the standard s requirements are understood and complied with. Prior to joining T V S D, he worked in various organisations, including NGOs, across diverse industries, covering automotive, elevators, furniture, and insurance.

3 Trained as an auditor, he has conducted Management System audits for a broad range of companies, and as a recognised industry expert he has also been actively involved in the creation and establishment of a certification body. His auditing experience with iso 9001 was complemented by the Management of both internal and supplier audits for automotive OEMs. He obtained his work experience while living and studying in different countries, including Germany, Mexico and the iso 9001 : 2015 | T V S DContents1 INTRODUCTION 32 OVERVIEW OF iso 9001 : 2015 33 MEETING iso 9001 : 2015 REQUIREMENTS 54 WORKING WITH T V S D 65 BENEFITS TO YOUR BUSINESS 76 CONCLUSION 77 APPENDIX 8 About the T V S D expert3T V S D | Navigating iso 9001 .

4 2015 IntroductionISO 9001 was first introduced in 1987 and is the world s most popular Quality improvement standard, with over one million1 certified organisations in 180 countries. The origins of iso 9001 are embedded in the global defence industry s need for standards that govern Quality assurance, and it is based upon two military standards: the UK s BS 5750 series of standards, driven by the Ministry of Defence; and the MIL-Q-9858, the US Military manufacturing first edition of iso 9001 introduced three QMS models, with several variants of each QMS making an allowance for the working practices of different industry sectors.

5 The first was concerned with Quality assurance in design, development, production, installation and service for manufacturing new products. The second model covered production, installation and service, while the third focused on final inspection and testing. The second edition ( iso 9001 :1994) emphasised product assurance using preventive actions, instead of solely checking the final product. Focusing on managing Quality by control, rather than assurance, the standard required organisations to comply with documented introduction of iso 9001 :2000 presented a radical change, by placing Quality and process Management at its core.

6 Focusing on Quality Management instead of Quality control, the standard first analysed the organisation s requirements before designing processes to deliver them. This third edition also focused on the continuous improvement of processes and the importance of tracking customer satisfaction. In 2008, updates to iso 9001 clarified the specifications of the 2000 edition, making it more consistent with ISO 14001:2004, the environmental Management System is iso 9001 important?To ensure success, businesses must offer products and services that surpass customer expectations, while meeting ongoing competitive pressures to increase efficiency and cut costs.

7 The iso 9001 QMS was developed as a way for all organisations, regardless of size, industry or location, to take a structured and comprehensive approach to Quality Management , which resolves the joint challenges of improved Quality , increased efficiency and lower of iso 9001 :2015A major revision of the iso 9001 standard was published on September 15, 2015 , the final result of a multi-year process involving representatives from ISO member countries and stakeholders from around the world. The new version is now more applicable to service, as well as manufacturing industries, as the term product has been replaced with product and services throughout the main changes since the 2008 fourth edition include:Revised structureOne of the key changes to the new iso 9001 standard is the adoption of the High-Level Structure, common to many other standards such as ISO 14001 and ISO 45001, making it easy to integrate into any existing ISO Management System .

8 This means that in the future, ISO member countries and stakeholders, who are responsible for the development of Management System standards, will use a consistent structure that shares the same common section headings and core approachAnother major modification to iso 9001 is the new emphasis on risk-based thinking. This helps you to examine the context of your organisation and to choose the most appropriate risk Management technique. This systematic approach to risk-based thinking can save significant amounts of Management time, and must be embedded within the organisation as a continuously evolving process that optimises knowledge development and preparedness.

9 4 Navigating iso 9001 : 2015 | T V S DA risk-based approach requires an understanding of risk assessment, which can be found in Section Quality Management System and its processes ; as well as the leadership issues outlined in Section ; a separate sub-clause in Section Actions to Address Risks and Opportunities ; and risk-based approaches, which can be found in Chapters Operational Planning and Control and Management Review .While organisations are required to identify and act on these risks, there is no statement within the standard which outlines how the risk Management should be conducted.

10 In addition, there is no clause containing specific requirements for preventive measures in the High-Level Structure or core texts. This is because it is already considered one of the main purposes of contextThe standard assumes that long-term business success is most likely when stakeholder requirements are considered. It therefore adopts a stakeholder approach to Quality Management and focuses on Stakeholder Relationship Management (SRM), which goes much further than the Customer Relationship Management (CRM) approach outlined in previous editions of iso 9001 .