A Guide to Incorporate ISO 9001 in Existing Business Process

Go through this article to explore an effective guide to implement a Quality Management System within the business structure of a small and mid-level enterprise.

With rapidly increasing demands of quality, implementation of ISO 9001 has emerged as an effective weapon for instilling confidence in the customers through a certified Quality Management System or QMS. Small businesses might believe it to be a daunting task. However, it is not that difficult, even for the SMEs (small and mid-level enterprises). Often business owners think that they need to discard their current system and implement a brand new one to implement the QMS. However, it is not true. The Quality Management System should always be aligned with the operations and functions of the existing business processes. In this article, we are going to discuss how a QMS that is certified to ISO 9001 Standard should be incorporated into a small or micro business structure.

Before diving into the deeper discussion, let’s have a look at the basic structure of the ISO Quality Management Standard.

Structure of a Certified QMS

This Standard contains ten clauses or sections- Scope, Normative References, Terms, and Definitions, Context of the Organization, Leadership, Planning, Support, Operation, Performance Measurement, and Improvement.

Scope

Scope clearly describes the purpose and main aims of the Quality Management Standard, such as-

• Formalizing the QMS to demonstrate the dedication of the company to maintain the quality consistently
• Regularly reviewing the system
• Introducing a policy statement of the business approach

Normative References

The section “Normative References” suggests the fundamentals and vocabulary relevant to this standard. It has listed all the technical definitions of terms used in ISO 9001. Moreover, it is important to ensure that the words have been used the way the standard directs you to do.

Terms and Definitions

This section explains the meaning of the technical terms used in ISO 9001:2015. This section helps to understand the definition of several regulations associated with ISO 9001:2015.

Context of the Organization

This clause, the context of the organization makes it mandatory to identify the external and internal issues that have an impact on business operations. However, this clause contains both positive and negative factors and conditions.

Leadership

ISO 9001:2015 requires the active participation of the senior management. The management is expected to conduct an assessment on a regular basis. The close involvement of the senior management will assure the effectiveness of the QMS in meeting the business goals.

Planning

The main aim of this clause is to make the requirements meant for the existing business management system clear. First, the risks and the opportunities should be identified. The clause is designed for enhancing the desirable outcomes.

Support

This section “support” makes sure that a business has considered everything that is required for operating the business in the best possible way.

Operation

Operation describes several functionalities that a QMS requires. It is important to align these functionalities suggested by the ISO with the unique requirements of a business.

Performance Measurement

This clause explains the necessity of regular monitoring. It also suggests how an organization should measure the performance of the QMS on a regular basis.

Improvement

ISO 9001:2015 has attached great importance to continuous improvement. This clause describes the importance of continuous improvement and how a company should maintain it.

How can Small Businesses Incorporate it into the Existing Business System?

A business needs to go through several steps to incorporate an ISO 9001 certified Quality Management System into the existing business structure. These steps are-

1. You need to understand the system before placing it into the business structure. It is also important to aware all of your employees from the very beginning so that they can operate the system properly after the implementation.
2. The documents for the system can be either handwritten or computerized
3. You should use your existing operating system as the base of the formalized system.
4. It is important to understand each of the processes carefully. There should not be any error within the Quality Management System.
5. Map out a simple end-to-end flowchart for figuring out the business operations and their branches off.
6. While hiring ISO consultants for integrating the QMS in your BMS, it is important to ensure that the consultants provide a web-based management system that is able to reduce waste of time, money, and requirement of human resources.

By following these simple guidelines, you can easily incorporate the QMS within your existing business structure.