Quality Management Systems ISO 9001

The quality management systems differ from one another in each sector of activity key aspects related to the nature of the activities or specific processes, as well as the applicable regulations. However in all of them, the quality concepts remain in a global way and specifically, the coordination, its standarisation and process systematization and the presence of control systems to get, principally, an organisation that applies contnuous improvement to effectiveness and efficiency to achieve the customer satisfaction.

Plan de Transición ISO 9001:2015

The adoption of the ISO 9001:2015 in September 2015, has brought major changes, summarized as follows

 

 

The addition of Annex SL, with a high-level structure which becomes common to both the standard and the ISO 14001, with the aim of unifying the structures of management systems, and thus facilitate the integration of these systems and others.

 

The need of the approach to risks, thinking based on risk, to support and improve the actual application of the approach and process management, as this process management has not finished being implemented in a real way in many cases, even under certificates ISO 9001: 2008.

 

Reducing the number of requirements.

 

Less emphasis on documentation. This does not mean you should not have this or that manual or procedure, since the rule emphasizes several points, there must be documented support on the activity, etc, but gives greater flexibility to the company in the selection or definition what should be this documentation, and how to structure and manage it.

 

The standard is best suited for businesses to provide services, or that part of the activity.

 

The definition of the context of the organization becomes a basic requirement, together with the definition of the perimeter of the quality management system, from which the activities, organization and processes are identified, and the scope of influence and influenced by second and third parties.

 

Leadership requirements increase as the system itself and objective management system and how management develops.

 

Customer satisfaction as a result of achieving better conditions in achieving the product or service is strengthened.

Companies or organizations that need a transition to ISO 9001:2015, can use the following list as a guide where to focus:

Identify the absence of management and organization, to be addressed to meet the requirements of the standard.
Provide adequate training and awareness, to any person or organziación that has an impact on the effectiveness of the organization.
Updating the Quality Management System to suit the new requirements.
Study and itemize the context of business activities.
Define how the organization will move to the approach to risks, activities & interfaces in order to support process management and continuous improvement.
Review and adapt the document structure, and its requirements, to improve flexibility.
Develop an implementation plan.

 

The reasons advising to evolve from a quality control towards to a process quality management, integrated or not with other systems are very clear:

  • To establish a direction and achive the compliance our customers expectations
  • Improve the control process
  • Reduce rejects and waste
  • Reduce costs
  • Increase the market share
  • Facilitate training
  • Involve employees
  • keep morale high

Curiously, the companies having such systems recognize and understand that it helps the compiance of objectives, however, a lot of them do not measure it. PDCA is a necesary process, W.E. Deming probably was the most responsible person in current revolution in quality.

The most extended standards are:

  • ISO 9000 - Quality Management Systems - Fundamentals and vocabulary
  • ISO 9001 - Quality Management Systems - Requisites
  • ISO 9004 - Continuous Improvement Guides

ATEC+ID implements certifiable quality management systems, under diferent norms, specially ISO 9001:2008, as a baseline for other systems, we integrate them with the environment management system ISO 14001, Health and Safety Risk OHSAS 18001 or R&D&Innovation UNE 166002 (Spanish standard) if wanted, as well as EFQM systems.

Maintenance of Management Systems

The quality systems require a certain annual maintenance, in several relevant fields:

  • Calculation and revision of risks and related processes efficiency
  • Customer satisfaction assessement and improvement
  • CAPA control, followed actions and responsables
  • Identification of the improvement lines to be initiated and planned
  • Update production or department process changes in the procedures and documentation

 Moreover ATEC+ID advises to include specific tasks in:

  • Requisites update
  • Adaptation to Norm changes, of processes, structure
  • Cálculation of objetives
  • Statistical Analysis
  • Update of specificplanning and resources programming
  • Revision and assessement of the evolution of SWOT and context of the organization

For computerized systems, in the updating of tables, database, access to documents, sites access and permisions.

Moreover, ATEC+ID collaborates in performing the internal audits.

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