ISO 9001:2015 Subject: Quality Management System Clause 4 - Context of the organization 03.03.2016. 1 1

Many are stubborn in pursuit of the path they have chosen, few in pursuit of the goal. Friedrich Nietzsche (German Philosopher, 1844 - 1900)

Objectives OF ISO 9001:2015 Quality Management System 3 3

Products and services in conformity to requirements! ? Quality Costs Time

Objectives of a Quality Management System Examples Consistently meeting customer requirements & ensuring “legal compliance” Increasing customer satisfaction & fulfilling the owners’ awaiting Acting proactively Modelling capable processes Ability to demonstrate conformity

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Benefits of Quality Management Systems Internal advantages Better process control Process improve-ment Improved product or service quality Increased producti-vity Increased legal certainty Simplified tracea- bility of processes Easier initiation: employe-es Reduced costs Increased customer satisfacti-on Secured corporate know-how Support for strategy deployme-nt Strengthe-ned competiti-veness 7

Benefits of Quality Management Systems External advantages Access to new markets. Sectors expecting or explicitly requiring certification of the management system Increase in the market share. Improvement of customer satisfaction, product quality, delivery performance 8

ISO 9000 Family ISO 9000 family of standards was developed to help organizations of every: type (profit-making organizations, non-profit organizations, manufacturing companies, service providers etc.) and size (micro-enterprises, small and medium-sized enterprises and large companies) to implement a quality management system.

ISO 9000 Family The quality management system is the part of an organization's management system that is aimed at helping to achieve the quality objectives.

ISO 9000 Family Furthermore, the quality management system tries to meet the requirements of relevant interested parties.

ISO 9000 Family environment financing occupational health and safety The quality objectives supplement other objectives of the organization environment financing occupational health and safety growth profitability …

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Design of the quality management system It is determined by many influencing factors: context of the organization customer requirements organization’s objectives and SIZE products provided corporate culture 14

E D I ISO 9000 Establishes the fundamentals of quality management. Defines the relevant terms for quality management. I Important basis of quality management is formed by the 7 principles of quality management.

ISO 9000 customer focus leadership engagement of people process approach improvement evidence based decision making relationship management The seven principles 16

establishes minimum requirements for a quality management system! ISO 9001 establishes minimum requirements for a quality management system! “The organization shall …” ISO 9001 promotes the process approach and risk-based thinking! This should help to increase customer satisfaction by meeting the customer expectations.

Visualization of the process approach

Visualization of the structure of ISO 9001 GOAL

ISO 9004 provides top management of an organization with guidance on how sustained success can be achieved in a complex, demanding and ever-changing business environment by using a quality management approach. Sustained success of an organization is achieved by the organization’s ability to meet the requirements (needs and expectations) of its customers and other interested parties in the long run.

Suppliers and partners Interested parties Needs and expectations Customers Owners/ shareholders employees Suppliers and partners Society Quality, price, delivery performance Profitability, increase of shareholder value, legal security, transparency Good working conditions, job security, recognition, payment Mutual benefits, continuity, fair treatment Compliance with legal and statutory requirements, ethical behavior (moral behavior), environmental protection

ISO 9001:2015 Quality management systems - Requirements 22 22

Contents Clause 5 Clause 4 Clause 7 Clause 6 Clause 8 Clause 9 ISO 9001:2015 clauses Clause 4 Context of the organization Clause 7 Support Clause 8 Operation Clause 9 Performance evaluation Clause 6 Planning Clause 5 Leadership Clause 10 Improvement

CLAUSE 4 - Context of the organization Topics 4.1 4.2 4.3 4.4 Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the quality management system Quality management system and its processes

Scope of the quality management system organization shall consider: the relevant external and internal issues the requirements of relevant interested parties the products and services of the organization

Context of the organization External and internal issues Relevant to its purpose and strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

Context of the organization External issues Legal Technological Competitive Market Cultural Social Economical environment

Context of the organization Internal issues Values Culture Knowledge Performance of the organization

Context of the organization Interested parties (stakeholders) Customers Proprietors Employees Suppliers Banks Authorities Unions Partners Society

Quality management system and its processes The organization shall 1 Determine the inputs required and the outputs expected from these processes. 2 Determine the sequence and interaction of these processes. 3 Determine and apply the criteria and methods needed to ensure the effective operation and control of these processes. 30

Quality management system and its processes The organization shall 4 Determine the resources needed for these processes and ensure their availability. 5 Assign the responsibilities and authorities for these processes. 6 Address the identified risks and opportunities. 31

Quality management system and its processes The organization shall 7 Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results. 8 Improve the processes and the quality management system. 9 Maintain and retain documented information to support the operation of its processes. 32

Project Work - instructions Quality Manual Select group members Get a group number Choose the group leader Choose the example organizati-on Follow instructi-ons based on ISO 9001 Translate project template on Serbian lang. Prepare section by section Finalize Quality Manual Prepare prsentati-on for the exam Pass the exam  33

A Goal is a dream with a deadline. Napoleon Hill (American author, 1883-1970)