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Difference Between Stage 1 & Stage 2 Audits - ISOUpdate.com

Small and large organizations recognize that the implementation of an ISO 9001 quality management system (QMS) in their processes gives them a competitive value. However, the task of implementing and successfully obtaining the certification requires time and money. Therefore, a popular question when deciding to implement is “What is the Cost to Implement ISO 9001?”

2 Costs of Implementing ISO 9001

There are 2 kinds of costs associated with the implementation of ISO 9001

These are:

  1. The costs for the implementation.
  2. The costs for the certification.



Costs of Implementing ISO 9001

In order to effectively estimate the cost for implementation, an organization will have to go through a gap analysis or assessment.

However, there are 3 main factors that an organization should take into account when estimating cost:

  1. The size and complexity of the organization. Is it a small single location organization? or is it a large company  with processes such as design, manufacture, installation, test, etc.?
  2. The type of quality system that is currently in use. Does it have a structured and disciplined system in place? Is the system documented, and how well?
  3. The time that staff and other members of the organization have to devote to the project. Will the organization create everything with its current members? Will it hire someone to guide them? Or, will it hire an ISO consultant to complete the entire process?

The major cost items that every organization needs to consider when implementing ISO 9001 are:

  • Training managers to get them to understand the requirements of ISO 9001
  • Assessment of current quality control practices and creating additional testing facilities routine if necessary
  • Renew the workspace, equipment, machines, public services, supporting facilities, etc, if necessary
  • Review and revamping arrangements for the handling and storage of raw materials, semi-finished and finished products, as appropriate necessary and safe
  • Review existing procedures / practices and listing of new procedures, checklists and records to be prepared
  • Development of QMS related documents
  • Conduct outreach activities of everyone who has roles and responsibilities for implementing the QMS
  • The various expenses such as word processing, stationery and other supplies necessary for the production of manuals, procedures and the like

Costs of ISO 9001 Certification

Regarding the cost of initial certification and costs associated with maintaining certification the main cost items are:

  • Registration and certification fee payable to the certification for a period of three years
  • Fees for the two-stage audit visit nominated by the certification body
  • Audit Committees regularly monitored by the certification agency nominated
  • Travel, accommodation and meals for auditor(s) of certification

The implementation and consequent maintenance of a QMS based on ISO 9001 is an investment of time and money for any organization. The success of the system will rely mainly in the commitment of all its members, especially on how senior management is committed to making ISO 9001 an effective tool to integrate their processes, continuously improve their QMS, and satisfy their customer’s expectations.



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Many small and medium sized organizations (SMOs) have decided to implement a quality management system (QMS) based on the well-known standard ISO 9001. After reviewing the costs and benefits associated with the implementation and certification process, it is essential to take a look at what are the costs involved with maintaining a successful QMS.

The main costs associated with maintaining a QMS after ISO 9001 certification are:

  • Periodically checking the condition of measuring instruments for their repair, maintenance and calibration.Here, the costs depends on the nature of the organization and in the complexity of its processes estblished with ISO 9001. In most SMOs, processes tend to be simpler with less specialized and sophisticated machines, which reduces the resources needed to keep their machines and instruments working in good conditions.
  • Performing periodic internal QMS audits.Effective internal audits need to be planned, executed and their results monitored by qualified and experienced auditors for ISO 9001. For many SMOs, it can be time consuming and costly to train existing workers to perform these audits, that’s why it is highly recommended for these organizations to consider contracting out their internal audits in order to reduce the overall cost associated with this process.
  • Training and raising awareness on matters related to the ISO 9001 QMS such as customer satisfaction, quality and improvement.These activities are easier and less expensive to do by SMOs than by large enterprises. It is far less expensive to train 100, 50 or less workers than attempting to train 500, 1000 or more.
  • Surveillance and re-certification audits.Organizations have to cover the fees for the periodic surveillance audits by the certification body, and every three years a re-certification audit must be performed in order to maintain certification. It is important to note that certification is not mandatory; many organizations decide to implement ISO 9001 without seeking certification by an independent third party audit.
  • Continuous improvement.This is one of the most important factors that will determine if a QMS will survive and thrive. A QMS must be used to continuously improve the efficiency of an organization’s processes, reduce waste and meet customer requirements on a continuous basis. Continuous improvement involves investing in correcting problems that may arise and eliminating their recurrence (associated with Corrective actions) and preventing problems from ever occurring (Preventive actions). The costs associated with this process varies with each organization. However, SMOs have an advantage because there is less bureaucracy and the decision makers are closer to the processes that need improvement, thus there is a greater probability that resources will be assigned exactly where and when they are needed.

Despite the resources needed, by maintaining a successful QMS, SMOs will benefit from lowering costs by reducing waste, improving the efficiency of their processes and having more satisfied customers who will come back for more products or services, which will contribute to the organization’s overall success.

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