ISO 9001 Certification-Quality Management System

ISO 9001 Certification-Quality Management System

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 process, Man, material, machinery etc . When the organization manage the entire organization activities and resources effectively to enhance the overall productivity of the organization is said to be that organization Quality Management System is effectively implemented.

So now it has been clarified that Quality Management System -ISO 9001 is effectively 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 of management of resources of the organization, the management business practices Quality of the organization’s to optimize the productivity of the organization.

Requirements of ISO 9001 -Quality Management System are very common business practices of the organization, where most of the organization as business do manage the resources of the organization most of the time, every time they do exercise to optimize the resources utilization in effective way to enhance the profitability of the organization. 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 the compliances.

The requirements of ISO 9001 Quality Management System are provided in QMS Standard are from Clause # 1to Clause # 10. But for Implementation of QMS in the organization, there organization has to looks 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 specific requirement of 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 sub-divide the QMS Requirements in two groups

The requirement in ISO 9001- Quality Management System

-Context of the organization

-Leadership

-Planning

– Support

– Operation

– Performance evaluation

– Improvement

So above two group of requirements of ISO 9001 -Quality Management System – Covers 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 user, so that they can apply to organization for implementation of QMS requirement to get ISO 9001 Certification.

Operation

In the requirement of this clause, the organization has to looks in to followings for implementation

Operational Planning and controls – Look in to all resources that 5M+1E- availability at the planning of operations. for Examples- availability of Manpower, Infrastructure, Machinery, Monitoring and measuring equipment’s, Technical Specification (if any), Raw Material etc.
Requirements for products and services- Which includes the customer requirements and any specification / regulatory requirement may be related to products and services. Also include the review of requirement – weather it can be to meets or not. So, all possible aspects related to customer requirement, delivery of products including other aspects related to products and services has to be considered.
Design and development of products and services- If the organization do the designing and development of products, then looks in the requirements
Control of externally provided processes, products and services- In the requirement where supplier approval, Supplier rating, Control of Bought out products and control on supplier, including inspection / Testing of product – which received from Supplier are covered.
Production and service provision- As per the requirements the organization has to look in to the all-possible aspects Production and service provision to meets the customer requirements.

So, these are the summarized requirements of ISO 9001 Quality Management System for the clause – Operations.

The rest of the other requirement, 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 thing the purpose behind getting ISO 9001 Certification. Generally, the organization go 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 implement system (Which may include Internal Audit & Management Review meeting)
Improvements

ISO 9001 Certification Process

The ISO 9001 Certification process are