ISO 9001:2015 standard wants quality management systems to be strategically aligned with business objectives and intent. This has resulted in a very unique and important requirement called “Context of the organization” being added to the standard.
Before you do anything on ISO 9001 or QMS, standard says you understand your business environment. Understand what internal and external issues affect or may affect your organization. Identify who are your stakeholders or interested parties which are getting affected, has a potential to get affected or they perceive themselves to be affected. Each of the internal issues and external issues along with various interested parties if not addressed effectively, will pose a risk and will have an impact on how an organization achieves its intended output and strategic objectives.
QMS standard also talks about scope definition on the basis of context, interested parties, product/services etc . Any requirements of ISO 9001 : 2015 standard that cannot be applied due to nature of operations of an origination can be identified and documented under Scope.
Context of Organization module of Effivity ensures you meet all these requirements in an effective, efficient and simple manner. Below steps demonstrate capabilities of this module and how you can comply with requirements with respect to context of the organization clause
An intelligent module level home page welcomes user to the module with all compliance options available in the module on left side menu. This home page shows quality objectives for the department, available / recently changed documents, real time graphical analysis on the basis of data / information captured in the system, alerts for pending tasks, quick links for common / regular tasks etc. Module level help is also given at appropriate places.
1. Define the context of organization by establishing the aim of your organization, nature of business, and also identify strength, weakness, threat and opportunity of your business.
2. Define the different external issues that could arise due to competition, legal framework, culture and economy etc and how it affects your organization. Also list out the risks and opportunities associated with each external issues.
3. Define the different internal issues like lack of competence, low productivity, differing values etc and how it affects your organization. Also identify the risks and opportunities associated with each internal issues. These risks and opportunities can be analyzed in the risk and opportunity module of the software.
4. Define the stakeholders/interested parties (an individual/group of people/ organization) and identify their needs and expectations. How they impact your organization in case their needs and expectations are not effectively addressed and also list out risks associated with stakeholders/interested parties while keeping an eye on identification of any opportunity.
5. Risk associated and captured along with internal issues, external issues and interested parties are also available in risk and opportunity module where you can take action to manage the risks.
6. Define the boundaries of your QMS called as scope for which your organization is implementing and getting certified. Standard being generic, it may happen that not all the requirements will be applicable to your organization. In this case, you can identify requirements which can be not applied provided company’s capability to meet customer requirement and satisfaction is not impacted negatively.
7. Give justification for requirements from clauses which cannot applied.
8. Flowcharts, procedures and forms related to context can be captured in documented information module.
Comprehensive capabilities of this module enables all the requirements from context of the organization clause to be addressed in a quick and simplified manner while ensuring 100% compliance to ISO 9001:2015 standard. Contact us at info at effivity.com for further information or visit www.effivity.com to subscribe to our award winning and one of its kind of ISO 9001 compliance software.