ISO 9001 - QMS

Quality Management System

What is ISO 9001?

ISO 9001 is one of the internationally recognized standards published by International Organization for Standardization (ISO) that has successfully taught the world a concrete framework and criteria about establishing a Quality Management System (QMS) for any organization regardless of how big or small the business is and what the business is about.

The most updated version of ISO 9001 is ISO 9001:2015 (the prior version was ISO 9001:2008) which has been applied to millions of organizations and still bearing fruits to real-time business results.

Why is ISO 9001 Important?

Since ISO 9001 is all about achieving Right Output First Time and with such a dynamic quality approach, business becomes customer focused enabling it to cater to every need and want of customers, going beyond the customers’ expectations ending up in overall better brand image and improved business credibility for future businesses. In such a competitive world, ISO 9001 is a tried and tested tool to win over competitors.

What are the benefits of ISO 9001?

A quality management system complying with ISO 9001 Standard would increase your company’s worth manifolds. The ISO 9001 implementation also takes out the unwanted cost of your business. It would further the organization’s objective and reduce shortcomings in operational processes and customer discontent. Some core benefits of being ISO 9001 certified are as follows:

  • Peerless consistent quality products and services will definitely give a boost in customers’ confidence level
  • Provision of an edge in competitive marketplace that will definitely result in increased profit margins,
  • Improved employees’ morale
  • Continuous improvement and
  • Efficient management of business resources

Adherence to appropriate quality management principles will aid the organization in achieving business objectives and goals, whereas poorly designed quality management system would result in huge overall deterioration of your company’s structure.

ISO, International Organization for Standardization released the framework for the Quality Management system that can be used by masses as ISO 9001:1987. ISO 9001 is applicable to various industries for product, service and processes. Since then every 7-8 years this standard is updated, and the current updated version is 2015 which was released on year 2015.ISO 9000 is a family of standards, of which only ISO 9001 is a certifiable standard.

After the initial certification award, regular surveillance audits are required and mandatory. Every 3 years recertification audits are conducted. The validity of the certificate is for 3 years based on the above-defined cycle. If any organization fails to comply with 3rd party registration requirements/certification body Audit program, there can be repercussions.

Stage 1:  Discovery

  • GAP Analysis to identify the gaps as compared to standard requirements
  • Awareness Training

 

Stage 2: Documentation & Implementation

  • Documentation

Documenting  Management System procedures, WI-based on document structure most suitable and value adds to the Organization.

  • Implementation

Once documents are drafted, reviewed, and approved, process owners, will implement the documented processes.

 

Stage 3: Audit (Internal and External)

  • Internal Audit of the implemented QMS and Management Review is a mandatory requirement. Internal Audit program with Internal Audit schedule and plan is required. Internal audit needs to be conducted by Trained Internal Auditors/External Contracted Auditors
  • After Internal Audit, External Audit can be scheduled and conducted.

 

This entire process can take up to 6-8 months depending on the number of locations, employees, scope, a number of processes, and resource commitment by organization.

If you are limited in internal resources or have time constraints or not familiar with ISO standard it is best to engage a consultant. Once the need for ISO certification is defined, it’s the right time to start identifying consultants. It is important to know that the consultant may not be local.

It will be critical to check if the consultant has relevant experience in a similar industry and can provide a customized solutions based on your unique requirements. Apart from mandatory requirements, the QMS for a Medium size company vs CNC Machine shop will be tailored to each organization requirement.

Please review the details for ISO Guideline for  Management Consultancy ( ISO 20700).

ISO standard can be purchased from ANSI stores, ISO website, and authorized vendors only. Printed/electronic copies are managed per the  Terms and Agreement as well as IEC and ISO copyright requirements.

While considering ISO certification it is very critical to understand the various costs incurred.

These include the cost for the first year :

  • Create and Charter ISO project (Quality Manager)
  • External Registrar Cost+ Logistic Cost
  • Consultant Support (if external consultant used)

     2nd-year cost: Surveillance Audit and Logistics cost

Soft Cost associated with Internal Audit, Reporting and Maintenance of the QMS

Recertification cost: External Audit and Logistics cost

Certification can be achieved by utilizing internal resources.  The best way is to have a person or team with ISO implementer training/previous relevant experience to charter the project.

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