The secret of successfully implementing a quality management system is communication and interpretation. Cavendish Scott ISO consultants utilize their many years of experience to ensure that the processes developed exactly meet the needs of not just the standard but of the business where it is being applied. This can make the goal of certification less complicated, reaching the goal more quickly, and, in doing these keeping the costs low.
This is achieved by working closely with key personnel and process owners, understanding the need, then documenting those needs into formal procedures or process maps.
Our expertise extends across the full range of quality and environmental standards and across all industry sectors.
Give a call on (781) 592-2400, email at [email protected] or use our Contact Form for a free quote.
Sectors we work in:
ISO 9000 Series of Standards:
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).
This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Read more.
ISO 19011:2018 provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit program.
ISO 9004:2018 is a document that can accompany the ISO 9001 standard for implementing a quality management system. This document is designed to provide guidance to any organization on ways to make their quality management system more successful. ISO 9004 is not intended for certification, regulatory or contractual use. This means that you cannot certify your quality management system against ISO 9004. It also means that the use of ISO 9004 is not intended to be mandated as a legal or contract requirement. The standard is, however, a good reference to turn to for ideas on how to make your implementation of ISO 9001 more effective and successful.
ISO 14001 Series of Standards:
ISO 14001:2015 follows the same structure as ISO 9001:2015 and is based around the common structure that introduces a lot more processes to the mix. It requires integration of environmental management processes into strategic and business processes. Leadership involvement and engagement is now considered mandatory with the expectation that leadership will get significantly more audit time than they ever have, to talk about the process, their involvement and to these strategic elements. Risk, formal change management, knowledge, communication and other significant content are new to the standard and provide a solid set of requirements to establish an effective management system. Read More
ISO 19011:2018 is also a companion standard.
ISO 14004:2016 provides guidance for an organization on the establishment, implementation, maintenance and improvement of a robust, credible and reliable environmental management system. The guidance provided is intended for an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
This International Standard helps an organization achieve the intended outcomes of its environmental management system, which provides 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.
AS 9100 Series of Standards:
AS9100D Quality Management Systems – Requirements
for Aviation, Space and Defense Organizations. This
standard covers activities including, design, development
and manufacture. It can also cover repair but only of an
organization’s own product.
AS9110C Quality Management Systems – Requirements
for Aviation Maintenance Organizations. This covers MRO
activities of whole aircraft, components, and systems.
AS9120B Quality Management Systems – Requirements
for Aviation, Space and Defense Distributors. This has
been developed to apply to stockists and distributors of
aerospace and/or defense parts.
ISO 13485 Series of Standards:
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.