ISO 9001:2015 QUALITY MANAGEMENT SYSTEM CERTIFICATE
Ascent EMIRATES guide’s you through the latest version of ISO 9001:2015 with its 20 years’ experience in Training, Documentation and Audits by the team of Engineers, Auditors and experts in various fields. The ISO 9001:2015 is now more than ever a means for being strategically successful by addressing the needs and expectations of interested parties and by managing risk and opportunities.MR – ‘management representative’ in
ISO 9001 is the international standard which specifies requirements for quality management systems (QMS). Organizations implement requirements of the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard of the ISO 9000 series and the only standard in the series to which organizations can certify.
The new version of ISO 9001 was released in September 2015 and changes made in ISO 9001:2015 are more significant than those produced during the 2008 revision. On the first view are clearly seen changes in the structure of ISO 9001:2015, where the number of sections expanded from 8 to 10 but this paper explains the main changes in understanding quality which include the context of the organization, risk-based thinking, knowledge as resource and leadership
Ascent EMIRATES will help you identify the “context of the Organization” “
CONTEXT OF THE ORGANIZATION
The context of the Organization(or its business) refers to the combination of internal and external issues or factors that can influence Organization’s approach to its investments, services or products, and thus the implementation of QMS is influenced by its context.
The context of an Organization can or may include, for e
• Objective/s of the Organization,
• Needs and expectations of its ‘interested parties’ such as regulatory/statutory agencies, suppliers. customers and any other relevant entity.
• It’s products and services.
• It’s Size and Structure
• The Organization’s own way and uses the complexity of the processes to which they interact.
An Organization must identify those internal and external issues (both negative and positive) relevant to its ‘context’ and that can affect its ability to achieve the intended outcome/s of its Quality Management System.
The Organization must similarly continue to monitor and review those issues to check if any changes to them affect its Quality Management System, or its purpose.
Though many Organizations are already monitoring internal and external issues, in this standard it must be evidenced.
The Standard has no specific requirement that these internal and external issues, or their monitoring and review, must be documented by an Organization, so auditors cannot simply ask for a list of issues or records of reviews.
Never the less it is advantageous to have records, in many cases, this information could be available from several different sources. It can be a part of an Organization’s documented annual business plan or business strategy, for example, or be referenced on the Organization’s website, in its annual reports, or can be a part in the Management Review.
There may be cases where no such documentation is available. In such condition’s auditors cannot raise a finding unless they have clear evidence/s that a particular internal or external issue that is relevant to its ‘context’ has been identified.
ISO 9001:2015 incorporates term “Risk-based Thinking” in its requirements for the establishment, implementation, maintenance and continual improvement of the quality management system. This additional requirement in the new version of the standard is a logical requirement in a way of achieving preventive management system.
In ISO 9000:2015, the risk is defined as the “effect of uncertainty.” risk can be described as a “deviation from the expected,” either positive or negative. The term “uncertainty” is clarified as a lack of information or knowledge about an event that can be expressed in terms of consequences, the likelihood of occurrence. The risk is related to potential event/s, and that it’s expressed as a result of the likelihood and consequence of such an event.
KNOWLEDGE LIKE A RESOURCE
Knowledge has become a key element and crucial resource to successful projects and business development of ISO 9001:2015 and it considers knowledge like any other resource to be managed.
• It tells us to identify the knowledge necessary to carry out the activity in compliance with the Quality Management System and to attain the objectives,
• Knowledge protected and made available where necessary and maintained
This new requirement is very important and helps an Organization in maintaining Organizational knowledge and help the team to perform better in everyday operation.
ISO 9001:2015 takes leadership and management commitment to another level and places more emphasis on leadership unlike its predecessor/s, It requires greater involvement by business leaders and especially the top managers in controlling the quality management system.
ISO 9001:2015 is intended to reassure integration and harmonization with business processes and strategies. Now the top management must take more responsibilities for the effectiveness of the QMS.
Because ISO 9001:2015 pays more attention to risk management, interested parties and the context of the Organization, the quality management system also fits in better with the needs of the top management.
Benefits of the IS 9001:2015
The ISO 9001:2015 helps Organizations ensure that their customers regularly receive high-quality products and services, which in turns brings many benefits including satisfied customers, Employees, Management, ISO 9001:2015 specifies requirements for an effective QMS it helps to
• Organize the processes
• Improve its efficiency
• Achieve customers satisfaction
• Helps Identify & address organizational risk and opportunities
• Is more beneficial to services and knowledge-based organizations
• Puts greater emphasis on Leadership engagement
• Helps Identify & address the needs and expectations of interested parties
• Helps Identify & address internal and external issues.
All In all, the ISO 9001:2015 take’s account of societal changes and technologies. Information is no longer disseminated and accessed, organized, managed, maintained, or created, as it was 3 decades ago when the paper was the primary medium. This evolution allows for greater flexibility in Organizations. It is much easier to comply with the standard without risking managerial agility, as long as the essential principles are respected