This should be supported by continual assessments of risks and opportunities and planning of strategies to excel the needs of all interested parties and not just those of customers. Therefore, the adoption of a quality management system should be a strategic decision of an organisation rather than just a tool to win tenders. Now the new ISO Mantra becomes, Say what you do and justify what you do!!
In 1987, the International Organization for Standardization (ISO) published a series of International Standards, the ISO 9000 family based on BS 5750. It had three "models" for quality management systems, the selection of which was based on the scope of the activities of the organisation, namely ISO 9001, ISO 9002, and ISO 9003. The emphasis tended to be placed on conformance with procedures rather than the overall process of management.
ISO 9000:1994 emphasised the prevention of nonconformities through quality assurance while achieving customer satisfaction. Bureaucratic documented procedures hindered improvement efforts.
ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. The title of the standard no longer included the term Quality Assurance. For the first time, emphasis was placed on the Process management concept, while meeting statutory and regulatory requirements related to products and enhancing customer satisfaction.
Only minor clarifications to the requirements of ISO 9001:2000 were introduced in the 2008 revision. The fifth edition of ISO 9001 was issued in September, 2015.
The new revision of the standard is based on Annex SL template, which consists of a high-level structure that standardises sub-clause titles, core text, common terms and core definitions in order to enhance compatibility and alignment with other ISO management system standards.
Impose new responsibilities on the top management that demands their active involvement and accountability while integrating quality management into business processes. A management representative is no longer being explicitly requested, but adequate responsibilities and authorities must be ensured within the organisation
Re-emphasise Process Approach while managing the organisations processes and their interaction aiming at value creation, based on Plan-Do-Check-Act cycle of improvement.
More explicitly stated, Risk-based thinking to identify, address risks and proactively look for opportunities in order to achieve improved results and preventing negative effects.
Added context of the organisation to determine expectations of interested parties that impact planning and development of management system as well as its intended outcome. Organisaitons need to scan their situation, i.e. context such that they are ready to react to the crisis immediately without compromising on adverse effects on product and service quality.
Both documents and records are now referred to as documented information, which are less prescriptive compared to the previous edition. This will allow organisations to explore alternative methods for the effective implementation of the quality management system.
Products are now termed as "products and services" whereas supplier as external provider.
Continual improvement: Previous edition was referring to continual improvement as improvement of organisations ability to fulfil requirements. Now it means enhancing performance, which is an important shift.
Organisational Knowledge: Organisations are now required to determine, acquire, and share the knowledge that personnel need for the operations of their processes and to achieve the conformity of products and services.
Product realisation concept is now replaced under a section called Operations.
The third revision of this Environmental Management System standard has also been issued in September 2015 to follow the high-level structure mentioned above. Amongst other key changes mentioned under ISO 9001, this revision also requires operational planning and controls to take into account both positive and negative environmental impacts of activities, products and services more comprehensively from a life-cycle perspective as well as control over outsourced processes.
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