An Internationally Recognized Standard

ISO 9001 sets basic standards for what is actually a certified business system. Generally one can say that worldwide, your customers acknowledge and understand the value of a solidly developed quality / business system supporting their supply chain.

Core QMS Processes

This system provides for the existence and control of some very core processes which every business should have. In the case of an ISO certified business those processes are documented, followed by trained staff, controlled and updated as appropriate, and done in a repeatable fashion to assure a consistent output.

Catch Defects Before They Snowball

ISO generally guarantees more frequent review of process and operational or product discrepancies, those things that might cause customer dissatisfaction or escalate costs. Such review provides earlier or improved visibility into improvement opportunities, ensuring that the appropriate attention and resources are applied in a more timely fashion than might happen in many businesses that haven't been certified.

Market Entry

In some industries, ISO certification is essentially a barrier to entry if it is not obtained. Medical is a good example, in most cases requiring ISO 13485 (the equivalent of ISO 9001 for medical device manufacturing). ISO 9001 is also often required for doing business with companies located overseas, particularly in Europe.

Cost of Quality

In other cases, a company finds itself in a position where costs swing out of control due to operational, production or process control instability. The effect on the customer base with respect to trusting you as a reliable supplier and the internal cost of managing the defect situation are both painful and eventually result in lost customers.


Engineering efforts, manufacturability, and out-of-the-box profitability become more predictable and more capable of meeting time to market expectations when ISO certified business processes provide for a basic set of interface and review procedures across the organization. It has nothing to do with telling R&D how to do their job or engineering how to develop the product. It has much to do with assuring a process for requirements definition and review, phase reviews, documentation and sufficient cross-functional engagement for manufacturing transfer and release.

Pressure and Opportunity

The ISO decision is sometimes accompanied by competitive forces, a major production failure or customer loss. ISO has also been used to facilitate competitive differentiation, free up time for innovation by removing barriers, shorten cycle times and reduce the unplanned engineering and operations resource consumption that occurs from variation in output quality.

Management Support

Generally the executive team will be in agreement or perhaps simply be willing to investigate the benefits of a more developed business / quality system. But in all cases, securing executive support for the effort is a critical starting point.

Resistance to Change

In many cases there is disagreement as to the need to do anything further to enhance business processes and output. Some people resist change in general, particularly new controls. They view it as "more work" instead of an investment in reducing wasted effort. Furthermore, not everyone subscribes to the theory of minimizing variation to improve profits and customer satisfaction.

Softening the Resistance

While the drivers in each business may be slightly different, we recommend senior management rally behind the need to pursue ISO certification by tying it to part of your company's strategy and encouraging involvement. Cross-departmental barriers should be weakened, staff educated and goals shared. Ultimately, the team's effort will produce data that reinforces the ISO decision. But until then, management should continue emphasizing the benefits of tighter quality, such as:

  • Simplification of the business
  • Improvement in productivity
  • Customer satisfaction
  • Less volatility for shareholders
  • More predicatable time to market
A Note on Rewards

People need to be rewarded for productivity, meeting development and production schedules, and maintaining consistently high customer satisfaction ratings. Properly recognizing somebody's contribution, however, is challenging. Those employees who have built a well deserved reputation around firefighting the difficult problems that arise have indeed played a valuable role, but management should encourage them to adopt a "preventive approach" versus "reactive".


An inspection of an organization's documentation, facility and procedures to assess for conformance to ISO 9001.
The status of an organization that has met the requirements of ISO 9001.
The state of compliance with ISO 9001 requirements.
A philosophy or effort to make ongoing enhancements to manufacturing, design or management.
A process depicted using documentation and/or flow charts.
The difference between a desired value or state and what currently exists. For example, a gap analysis on documentation at the outset of an ISO 9001 program might compare the extent of a company's documentation to the requirements set by the ISO standard to identify areas of in need of elaboration.
An in-house inspection to identify areas where required documentation is missing, incomplete or not being followed.
The International Organization for Standardization (the world's largest developer and publisher of international standards).
A structured evaluation of an ISO 9001 project to discuss progress, review changes to the project plan, allocate budget, assign corrective actions for identified non-conformances and ensure that milestones will be met on time.
The discipline of confining the output of a process to values within an acceptable range of variation.
The collection of policies, procedures, resources and infrastructure used to systematically satisfy the wants and needs of the customer.
The offical set of documents that describes an organization's quality management system. It should include the Quality Policy, Quality Objectives, documented procedures, roles and responsibilities.
A goal aimed at meeting the requirements of ISO 9001.
A statement that expresses an organization's commitment to quality, including a definition of quality and the Quality Objectives.
An independent body that issues the final ISO 9001 certificate.
Provisions of the ISO 9001 standard that must be met to receive a certificate of conformance.
A commonly accepted manual of best practices that many companies choose to internalize and some governments even use as a basis for legislation given the credibility, objectivity and merit of an official standard.
A range of measurements that includes the expected value, or mean.

ISO Information Hub

More resources to acquaint you with ISO and the certification process.

ISO 9001 Tools

The following tools are designed for beginners to implement ISO 9001 on their own.

  • This guide offers high level instructions for becoming ISO 9001 certified. Request a free copy.
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