What is ISO 9001 and why is it so important for companies?

ISO 9001 is a generic standard, with terminology common to any type of context, scope, project and service: an aggregating standard.

When implemented well, certification can become the best way to begin institutionalizing integration and communication between areas and a culture of continuous improvement.

The latest revisions of the 2015 version have confirmed my opinion, making the standard more “integrable” with the numerous standards, reference models and frameworks available on the market.

I like this text from the standard that gives an idea of what is possible to achieve after good implementation: “An organization that adopts this approach generates confidence in the capability of its processes and the quality of its products, and provides a basis for continuous improvement.

This can lead to increased customer and other stakeholder satisfaction and also to the success of the organization.”

Speaking in more technical terms, what would the ISO series standards be then?

ISO 9000

– Quality Management Systems: Fundamentals and Vocabulary – “Essential principles and vocabulary.” The ISO 9000 standard describes the principles of a quality management system and defines the terminology.

ISO 9001

Quality Management Systems: Requirements – The ISO 9001 standard describes the requirements for a quality management system, whether for internal use, contractual use, or certification purposes. It is a set of obligations that the company must follow.

ISO 9004

Quality Management Systems: Guidance for Performance Improvement - This standard forms a consistent pair with ISO 9001, providing guidance beyond the requirements set out in ISO 9001.

It is based on the eight principles of quality management: Customer focus, Leadership, People involvement, Process approach, Systems approach to management, Continuous improvement, Factual approach to decision-making and Mutual benefits in relationships with suppliers.

ISO 10011:

This standard describes “Guidelines for auditing quality management and/or environmental management systems”.

ISO 31000

(Risk Management: Principles and Guidelines) – This may be a useful reference for organizations seeking a more formal enterprise-wide risk process, but is not mandatory.

This standard provides principles, a framework and a process for managing risk and can be used by any organization regardless of its size, activity or sector.

Why then is ISO 9001 so important?

The concept of Process Management introduced by the standard is essential for any type, size, and current situation of an organization.

Processes are important for a small company that is growing or a large company that needs to control its processes.

Continuous improvement allows the company to grow or maintain its size as effectively as possible.

The new version of the standard that establishes the need for the quality management system to support business objectives and formalize risk management in the organization brings these benefits.

The concept of processes should raise some good questions so that the organization can establish the concept of continuous improvement, such as:

• Is the process identified and appropriately defined?
• Are responsibilities assigned?
• Are procedures implemented and maintained?
• Is the process effective in achieving the required results?

In this sense, the processes identified by the organization must be at least:

• Technologically competitive;
• Adaptable and time-appropriate
• Capable of producing products that meet customer and business needs and;
• Suitable for organizational culture.

What each identified process should contain

• Purpose/Result: This type of definition is useful when you do not want to define the activities in detail, but you know the objective of the process (purpose) and the results it should produce;
• Activities: This is the most common approach, describing the activities and their interrelationships, as well as the sequence in which each activity is executed. The description should include:

• • • • Procedures and methods for carrying out activities
      • Tools that will support the execution of activities
      • The appropriate profile of who will perform the activities and what training is required
      • What process metrics will be used to assess process quality?

Another important concept that helps the company evolve and ensure that its processes support its business objectives is Continuous Improvement; the figure below represents the structure of Florac and Carleton, 1999.

Hence the importance of defining strategic objectives and, above all, how to obtain information from processes (indicators) capable of identifying how much of the strategic objectives are being met.

Processes must be built and measured according to the strategic alignment established and supported by Senior Management.

A key concept highlighted in this latest version of the standard is Strategic Planning, so where should one begin this strategic planning process?

• • Initial diagnosis of the business situation
  • Definition of the support structure
  • Defining authorities and responsibilities for prioritization
  • (Re)evaluation and (re)definition of organizational policies

Below is a diagram outlining the main steps for developing a Strategic Plan.

What then should we do in the Business Diagnosis:

• • Ensure that strategic and/or business objectives are clearly defined and available to stakeholders;
  • Perform benchmarking with the aim of analyzing an organization's maturity or the capabilities of its processes. We can consider several models for process evaluation, such as: ISO 9001, CMMi, MR MPS.BR, ISO 20k, ISO 29110.
  • Check if there are performance indicators
  • Check if there are critical success factors
  • Expected financial returns are based on models

What then should we do in Internal Diagnosis:

• Understand how the organization works
• Check if there are frameworks and/or processes implemented
• Verify whether favorable conditions exist for implementing what is necessary to achieve business objectives
• Check whether resources are available to conduct detailed internal diagnostics

What then should we do in the Operational Diagnosis:

• Perform a detailed GAP Analysis of each operation considering the Benchmarking taken into account in the Business Diagnosis.

I hope this has helped you understand what ISO is and how it can positively contribute to quality and process management in your organization.

If you would like to learn more about this standard and how to start the certification process, leave a comment below or contact ProMove!