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The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.
ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system.
Regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects.
Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out a product that satisfies customers' expectations.
The requirements for a quality system have been standardized but many organizations like to think of themselves as unique. So how does ISO 9001:2008 allow for the diversity of different enterprises and companies?
The answer is that ISO 9001:2008 lays down the requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively or, to put it another way, to check that it is fully in control of its activities.
In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.
Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.
The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context.
BTS Consulting provides guidance for the transition from ISO 9001:2008 to ISO 9001:2015 and provides advice to interested parties on transition arrangements, templates, training and implementation support to be considered before implementing ISO 9001:2015. ISO 9001:2015 revision official since September of 2015 introduces significant changes. The standard is based on Annex SL of the ISO Directives, a high-level structure (HLS) which standardizes sub-clause titles, core text, common terms and core definitions to enhance compatibility and alignment with other ISO management system standards such as ISO 14001 and ISO 45001. The main changes in the new version of ISO 9001:2015 are:
• The adoption of the HLS as set out in Annex SL of ISO Directives Part 1.
• An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach.
• Fewer prescribed requirements.
• Less emphasis on documents.
• Improved applicability for services.
• A requirement to define the boundaries of the QMS.
• Increased emphasis on organizational context.
• Increased leadership requirements.
• Greater emphasis on achieving desired outcomes to improve customer satisfaction.
ISO 9001:2008 certifications will not be valid after three years from publication of ISO 9001:2015 (September of 2015). The expiry date of certifications to ISO 9001:2008 issued during the transition period needs to correspond to the end of the three-year transition period.
For any organization the degree of change necessary will be dependent upon the maturity and effectiveness of the current management system, organizational structure and practices, therefore an impact analysis/gap assessment is strongly recommended in order to identify realistic resource and time implications.
Organizations using ISO 9001:2008 Organizations using ISO 9001:2008 are recommended to take the following actions:
a) Identify organizational gaps, which need to be addressed to meet new requirements.
b) Develop an implementation plan.
c) Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organization.
d) Update the existing quality management system (QMS) to meet the revised requirements and provide verification of effectiveness.
e) Where applicable, liaise with their Certification Body for transition arrangements.