ISO 9001 Quality Management is sometimes looked at as ‘something’ we need to have, a badge – Often companies don’t realize the positive impact it can have if the management system written actually matches what the organization actually does, but more importantly it is simple enough to keep a track of so you are always ready for audit and not having to get ready by back tracking just to ‘be compliant’. To be compliant for audit does not mean the management system is working for your organization – it just means you are in shape for an audit.
ISO 9001 has gained global credibility and acceptance among organizations in various industries. Today ISO 9001 is recognized as an international standard and provides a clear and time tested framework for quality management.
Why should you by ISO 9001:2015 compliant? A good quality system will ensure a high quality of products and customer satisfaction with the added value of:
- Staying competitive
- Driving business growth
- Exceeding customer expectations
- Surviving in the market
- Motivating employees and improving productivity
- Reducing risks and unnecessary costs
There are basic requirements for an ISO 9001 Quality Management System (QMS) that an organization must fulfill in order to demonstrate its ability to consistently provide Products and Services to achieve customer satisfaction and meet regulatory requirements.
The basic requirements of the ISO 9001 are quite straight forward and things your organization will be striving to do anyway – these include
- Maintaining of procedures and policies that cover the core business and its processes
- Regular process reviewing, monitoring and analysis
- Keeping documents and records up to date
- Optimization of resource allocation and management
- Driving continuous improvement throughout the organization
The quality management principles take a process-oriented approach to continual improvement based around these requirements.
In order to achieve the standard the organization must be able to meet these requirements, the organization must ensure its quality system is prepared for effective documentation and process management.
The problem with trying to remain compliant and also benefit from the data produced with a paper based system is time consuming and very labor intensive. The organization sometimes cannot justify the administration and therefore only gets behind the standard at time for audit.
Paper-based quality systems are cumbersome and do not sufficiently meet these specifications, thus the need for automated solutions that achieve and maintain compliance with comparable ease.
How do automated quality systems makes ISO 9001 compliance easier:
Simple and Visual
The automated quality system needs to be simple to use and visually easy on the eye, the more complex the harder it is to train and the less people want to use it. The system needs to standardize and improve process visibility, enable automatic notifications and escalations for pending tasks, providing the complete picture to the management through real-time reporting and analysis. You need your system to make document search and retrieval easy. The functionality to track actions and documents in real time so you are always ready for audits and not having to get ready last minute. These functions all simplify maintaining conformance to the requirements of ISO 9001. With an electronic document control system, the organization can easily update documents, procedures and communicate these changes to all members of an organization.
Ensures closed loop processes
One of the most effective ways of achieving ISO compliance is through closed loop processes. ISO 9001 requires every organization demonstrate that all issues raised are visible and that required corrective, preventive or improvement actions are done on time. Automation enables integration of document control, CAPA, audits and customer complaints to ensure that monitoring, analysis and resolution of issues are handled effectively and timely.
Training integrated in the quality system for continuous improvement
Quality management systems like ISO 9001 are there to improve staff performance through training and therefore giving customers a better level of service and/or production a better visibility to continually improve the product or services. Automated quality systems support the training requirements through easy planning, monitoring, and analysis of personnel training needs. Some of the features of an electronic system for training may include -
- Easy creation of training plans
- Ensuring that personnel competencies match the job requirements
- Automatically raising training events based on job skills
- Regular review of personnel appraisals
- Quick access to personnel certificates
- Attaching and regularly updating the training documents to personnel
If you feel that an automated system is for you contact us via our website www.compliancecube.com