ISO 9001 Certification Quality Management System – Quality Management is nothing but the management of the organization’s business practices such as processes, activities, resources, infrastructures, equipment, raw material, supplier, subcontractor, outsourced processes, Man, materials, machinery, etc. When the organization manages the entire organization’s activities and resources effectively to enhance the overall productivity of the organization is said to be the organization’s Quality Management System is effectively implemented.
So now it has been clarified that Quality Management System -ISO 9001 is effective management of resources of the organization to enhance the productivity of the organization and keep the customer focus on priority.
What is ISO 9001 Certification- Quality Management System
ISO 9001 Quality Management System Standard is a systematic approach to the management of resources in the organization, the management of business practices Quality of the organization to optimize the productivity organization.
Requirements of ISO 9001 -Quality Management System are very common business practices of the organization, where most of the organization as a business to manage the resources of the organization most of the time, every time they do exercise to optimize the resources utilization in an effective way to enhance the profitability of the organization. The only difference of ISO 9001 Certification is that – the organization has to implement the ISO 9001 requirement in a systematic way as said in Quality Management System Standard-ISO 9001 and maintain compliance.
The requirements of ISO 9001 Quality Management System are provided in QMS Standard from Clause #1 to Clause # 10. But for the Implementation of QMS in the organization, the organization has to look at the requirement given in Clause 4 to Clause- 10 only.
If you Look into the ISO 9001:2015 Standard, you find that some of the requirements are very generic to Business Management practices and some are very much specific to process.
So, in this blog, we will try to focus on the specific requirements of the ISO 9001 Quality Management System Standard. But some of Generic Business Management practices will also be covered in this blog, for more clarification and understating.
So, I will subdivide the QMS Requirements into two groups
The requirement in ISO 9001 Certification- Quality Management System
-Context of the Organization
-Leadership
-Planning
– Support
– Operation
– Performance Evaluation
– Improvement
So above two groups of requirements of ISO 9001 -Quality Management System – Cover all the requirements of QMS from Clause # 4 to Clause # 10.
Now, we will try to cover and explain the process-based QMS requirements for understanding to users, so that they can apply to the organization for implementation of QMS requirements to get ISO 9001 Certification.
Operation
In the requirement of this clause, the organization has to look into the following for the Implementation
- Operational Planning and controls – Look into all resources that 5M+1E- are available at the planning of operations. for Example- availability of Manpower, Infrastructure, Machinery, Monitoring, and measuring equipment, Technical specifications (if any), Raw Materials, etc.
- Requirements for products and services- This includes the customer requirements and any specification / regulatory requirement that may be related to products and services. Also, include the review of requirements – whether they can be met or not. So, all possible aspects related to customer requirements, and delivery of products including other aspects related to products and services have to be considered.
- Design and development of products and services- If the organization does the designing and development of products, then look in the Requirements
- Control of externally provided processes, products, and services- In the requirement where supplier approval, Supplier rating, Control of Bought our products, and control on the supplier, including inspection / Testing of product – which received from the Supplier are covered.
- Production and service provision- As per the requirements the organization has to look into all possible aspects of Production and service provision to meet the customer requirements.
So, these are the summarized requirements of ISO 9001 Quality Management System for the clause – Operations.
The rest of the other requirements, we will try to cover in our next blog.
Best Practices of ISO 9001 Certification -Quality Management System
Before Going for ISO 9001 Certification to any organization, first must think about the purpose behind getting ISO 9001 Certification. Generally, the organization goes for ISO 9001 Certification for enhancement of overall productivity of the organization and Enhancement of Customer Satisfaction.
With this objective, the organization can adopt the Best Practices of ISO 9001 Certification as given below are
- Gap Analysis
- Training & Awareness
- Implementation of QMS and address the Gap
- Monitor the Process and overall QMS performance
- Timely review of implementation system (Which may include Internal Audit & Management Review meeting)
- Improvements
ISO 9001 Certification Process
The ISO 9001 Certification process are
- Implement the ISO 9001:2015 in the organization
- Develop and implement the required documents to Demonstrate Compliance
- Do a Timely Review of Implemented System
- Apply to ISO Certification Body
- Get ISO 9001 Certification.
To Know more about ISO 9001 Certification -QMS Certification and How to get ISO 9001 Certification, Watch the Video, given below