QMS

QMS

ISO 9001:2015 specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

 

ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

ISO 14001:2015 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. Consistent with the organization's environmental policy, the intended outcomes of an environmental management system include:

  • enhancement of environmental performance;
  • fulfilment of compliance obligations;
  • achievement of environmental objectives.

ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective. ISO 14001:2015 does not state specific environmental performance criteria.

ISO 14001:2015 can be used in whole or in part to systematically improve environmental management. Claims of conformity to ISO 14001:2015, however, are not acceptable unless all its requirements are incorporated into an organization's environmental management system and fulfilled without exclusion.

ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.

ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.

ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization's OH&S policy, the intended outcomes of an OH&S management system include:

a) continual improvement of OH&S performance;

b) fulfilment of legal requirements and other requirements;

c) achievement of OH&S objectives.

ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.

ISO 45001:2018 does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system.

ISO 45001:2018 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing.

ISO 45001:2018 does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.

ISO 45001:2018 can be used in whole or in part to systematically improve occupational health and safety management. However, claims of conformity to this document are not acceptable unless all its requirements are incorporated into an organization's OH&S management system and fulfilled without exclusion.

This document gives guidelines for the process of complaints handling related to products and services within an organization, including planning, design, development, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.

NOTE Throughout this document, the terms "product" and "service" refer to the outputs of an organization that are intended for, or required by, a customer.

This document is intended for use by any organization regardless of its type or size, or the products and services it provides. It is also intended for use by organizations in all sectors. Annex B provides guidance specifically for small businesses.

This document addresses the following aspects of complaints handling:

a) enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its products and services, including customer service;

b) top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training;

c) recognizing and addressing the needs and expectations of complainants;

d) providing complainants with an open, effective and easy-to-use complaints process;

e) analysing and evaluating complaints in order to improve the quality of products and services, including customer service;

f) auditing of the complaints-handling process;

g) reviewing the effectiveness and efficiency of the complaints-handling process.

This document does not apply to disputes referred for resolution outside the organization or for employment-related disputes.

This document gives guidelines for defining and implementing processes to monitor and measure customer satisfaction.

This document is intended for use by any organization regardless of its type or size, or the products and services it provides. The focus of this document is on customers external to the organization.

NOTE Throughout this document, the terms "product" and "service" refer to the outputs of an organization that are intended for, or required by, a customer.

 

We are proud to announce that we have received accreditation from the National Aerospace and Defense Contractors Accreditation Program (Nadcap) for Heat Treatment and Aerospace Quality System (AC7004) in September 2018. Being Nadcap accredited means that we are compliant with and have been audited to the most stringent quality standards in our industry and are capable of processing aerospace quality components.

ISO 31000, Risk management – Guidelines, provides principles, a framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector.

Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment.

However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or external audit programmes. Organizations using it can compare their risk management practices with an internationally recognized benchmark, providing sound principles for effective management and corporate governance.

ISO/IEC 27001 is widely known, providing requirements for an information security management system (ISMS), though there are more than a dozen standards in the ISO/IEC 27000 family. Using them enables organizations of any kind to manage the security of assets such as financial information, intellectual property, employee details or information entrusted by third parties.

The IATF is an “ad hoc” group of automotive manufacturers and their respective National Automotive Industry Associations, formed to provide improved quality products to automotive customers worldwide. Specifically, the purposes for which the IATF was established are:

  1. To develop a consensus regarding international fundamental quality system requirements, primarily for the participating companies’ direct suppliers of production materials, product or service parts or finishing services (e.g. heat treating, painting and plating). These requirements will also be available for other interested parties in the automotive industry.
  2. To develop policies and procedures for the common IATF third party registration scheme to ensure consistency worldwide.
  3. To provide appropriate training to support IATF 16949 requirements and the IATF registration scheme.
  4. To establish formal liaisons with appropriate bodies to support IATF objectives.

5S is often summarized by the philosophy “a place for everything and everything in its place.”

You may have heard of “KonMari,” a home organization system propagated by Marie Kondo. The KonMari method transforms cluttered homes into tidy and simplified living spaces. The 5S principles are similar to KonMari. However, saying that 5S is just about tidying is like saying yoga is just about stretching. In other words, there is much more depth. So, let’s explore the true intent and meaning of 5S.

5S originated as 5 Japanese words: Seiri, Seiton, Seisou, Seiketsu, and Shitsuke. In English these have come to be known as:

  • Sort: Eliminate that which is not needed.
  • Straighten: Organize what remains after sorting.
  • Shine: Clean and inspect the work area.
  • Standardize: Write standards for 5S.
  • Sustain: Consistently apply the 5S standards.

Lean approaches are beneficial for the development and maintenance of management systems compliant with ISO 9001, ISO 13485, ISO 14001 ISO 45001 standards and 21 CFR 820 FDA regulation. An excessive number of documents, over-detailed and over-decorated “Standard Operating Procedures” (SOPs) are ineffective and costly. On the other hand, well-written and organized procedures can lead an organization to a more efficient Lean management system. The article offers an effective tool to document and monitor the progress in the transition to a Lean ISO management system, and will be helpful to those organizations that struggle with over-documented management systems and those that are searching for assistance in optimizing their ISO procedures.