Quality Management System

Management system is a set of interrelated and interactive elements of an organization for establishing policies and objectives as well as processes for achieving those goals.

Quality is the degree to which a set of inherent characteristics of an object fulfills the requirements. The quality of products and/or services of an organization is determined by its ability to satisfy customers and the intended and unintended impact on relevant stakeholders. The quality of products and services includes not only their intended function and performance, but also their perceived value and benefit to the customer.

Quality management system is part of a management system related to quality. Quality management system covers activities by which organization identifies its goals and determines the processes and resources required to achieve the desired result. Quality management system enables top management to optimize the use of resources taking into account the long-term and short-term consequences of their decisions. Quality management system provides a means for identifying measures to deal with the intended and unintended consequences in the delivery of products and/or services.

BAS EN ISO 9000:2015 (ISO 9000: 2015, ISO 9000: 2015) provides the basic concepts, principles and glossary for quality management systems (QMS). This standard is intended to help the user in understanding the basic concepts, the seven basic principles and terms of quality management, in order to be able to effectively and efficiently apply a quality management system.

Basic principles of quality management are:

  • Customer focus;
  • Leadership;
  • Engagement of people;
  • Process approach;
  • Improvement;
  • Make decisions based on evidence;
  • Management of mutual relations;

BAS EN ISO 9000:2015 (ISO 9001: 2015, ISO 9001: 2015) is a basic standard that specifies requirements for a quality management system where an organization:

  • Needs to demonstrate its ability to consistently provide products and/or services that meet customer and applicable statutory and regulatory  requirements, and
  • Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and assurance of conformity to customer and applicable statutory and regulatory requirements.

Structure of the standard in the "Plan-Do-Check-Act" cycle

International document ISO/IEC Directives - Part 1, in Annex SL defined the unique structure of the standard management system. Annex SL enables organizations to more easily carry out the integration of different management systems. The structure of the standard EN ISO 9001: 2015 is in line with Annex SL.

Organizations can be certified in accordance with the requirements of EN ISO 9001: 2015 by accredited certification bodies, thus proving that they fulfill the requirements of the standard.

BAS EN ISO 9004:2011 (ISO 9004: 2009, ISO 9004: 2009) provides guidance to assist organizations in achieving sustainable success through a quality management approach. The standard is applicable to all organizations, regardless of size, type and activity, and it is not intended for certification, regulatory or contractual use.

BAS ISO 10001:2009 (ISO 10001: 2007), provides guidance to an organization in determining that its customer satisfaction provisions meet customer needs and expectations. Its use can enhance customer confidence in an organization and improve customer understanding of what to expect from an organization, thereby reducing the likelihood of misunderstandings and complaints.

BAS ISO 10002:2015 (ISO 10002: 2014) provides guidance on the process of handling complaints by recognizing and addressing the needs and expectations of complainants, and resolving any complaints received. The standard provides an open, effective and easy-to-use complaints process, including training of people.

BAS ISO 10003: 2009 (ISO 10003: 2007), provides guidance for effective and efficient external dispute resolution for product-related complaints. Dispute resolution gives an avenue of redress when organizations do not remedy a complaint internally. Most complaints can be resolved successfully within the organization, without adversarial procedures.

BAS ISO 10004: 2013 (ISO 10004: 2012), provides guidelines for actions to enhance customer satisfaction and to determine opportunities for improvement of products, processes and attributes that are valued by customers. Such actions can strengthen customer loyalty and help retain customers. 

BAS ISO 10005: 2012 (ISO 10005: 2005), provides guidance on establishing and using quality plans as a means of relating requirements of the process, product, project or contract, to work methods and practices that support product realization. Benefits of establishing a quality plan are increased confidence that requirements will be met, that processes are in control and the motivation that this can give to those involved.

BAS ISO 10006: 2004 (ISO 10006: 2003), is applicable to projects from the
small to large, from simple to complex, from an individual project to being part of a
portfolio of projects. The standard is to be used by personnel managing projects and who need to ensure that their organization is applying the practices contained in the ISO quality management system standards.

 BAS ISO 10007: 2012 (ISO 10007: 2003), is to assist organizations applying configuration management for the technical and administrative direction over the life cycle of a product. Configuration management can be used to meet the product identification and traceability requirements specified in this International Standard.

BAS ISO 10008: 2014 (ISO 10008: 2013), gives guidance on how organizations can
implement an effective and efficient business-to-consumer electronic commerce
transaction (B2C ECT) system, and thereby provide a basis for consumers to have
increased confidence in B2C ECTs, enhance the ability of organizations to satisfy
consumers and help reduce complaints and disputes.

BAS ISO 10012: 2004 (ISO 10012: 2003), provides guidance for the management of
measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. The standard provides quality management criteria for a measurement management system to ensure metrological requirements are met.

BAS ISO/TR 10013 provides guidelines for the development and maintenance of the documentation necessary for a quality management system. It can be used to document management systems other than those of the ISO quality management system standards, e.g. environmental management systems and safety management systems.

BAS ISO 10014: 2007 (ISO 10014: 2006), is addressed to top management. It provides guidelines for realizing financial and economic benefits through the application of quality management principles. It facilitates application of management principles and selection of methods and tools that enable the sustainable success of an organization.

BAS ISO 10015: 2001 (ISO 10015: 1999), provides guidelines to assist organizations in addressing issues related to training. The standard can be applied
whenever guidance is required to interpret references to “education” and “training” within the ISO quality management system standards. Any reference to “training”
includes all types of education and training.

BAS ISO 10018: 2013 (ISO 10018: 2012), provides guidelines which
influence people involvement and competence. A quality management system
depends on the involvement of competent people and the way that they are introduced and integrated into the organization. It is critical to determine, develop and evaluate the knowledge, skills, behaviour and work environment required

BAS ISO 10019: 2012 (ISO 10019: 2005), provides guidance for the selection of quality management system consultants and the use of their services. It gives guidance on the process for evaluating the competence of a quality management
system consultant and provides confidence that the organization's needs and
expectations for the consultant's services will be met.

BAS EN ISO 19011: 2015 (ISO 19011: 2011, ISO 19011: 2011), provides guidance on the management of an audit programme, on the planning and conducting of an audit of a management system, as well as on the competence and evaluation of an auditor and an audit team. ISO 19011 is intended to apply to auditors, organizations implementing management systems, and organizations needing to conduct audits of management systems.