The ISO (International Organization for Standardization) is an independent, non-governmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. As technology continues to rapidly develop, new standards are drafted and implemented by people at all levels within the global industry going through standardization. The ISO 9000 family of standards pertains to quality management systems in any industry; read on to learn more about the ISO 9004 measure, and how it can benefit your manufacturing organization!

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What is the ISO 9004 Standard?

The ISO 9004:2018 gives guidelines for enhancing an organization's ability to achieve sustained success, which is consistent with the quality management principles given in the family of ISO 9000:2015. This particular standard provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document. Also, ISO 9004:2018 is applicable to any organization, regardless of its size, type, and activity.

What is the Difference Between ISO 9004 and ISO 9001?

Both ISO 9004 and ISO 9001 are singular measures within the general body of the ISO 9000 standards. Each specifies requirements for a quality management system (QMS) when an organization needs to demonstrate its ability to consistently provide products and services that meet customer expectations in addition to applicable statutory or regulatory requirements. ISO 9001 improves manufacturing quality management systems by requiring detailed processes and implementing gap analysis and internal audits, whereas ISO 9004 entails a self-assessment component.

A Breakdown of ISO 9004

There are seven major themes presented in this standard. Each theme is composed of particular qualities and questions by which to evaluate your manufacturing organization in alignment with this ISO standard.

Assessing and Sustaining the Quality of An Organization

An effective quality management system creates value rather than simply just enforcing compliance means you’ll have fewer repeat problems and provide an exceptional customer experience. 

Managers should work based on similar objectives that communicate your organization’s vision and values. Employees in leadership positions should work to empower their staff to "take and own the action" so they can help workers overcome an "It's not my job" mentality, which shifts the blame and results in lowered engagement. When problems arise, managers should aim to address the root causes rather than the symptoms by bringing the pertinent people together to resolve them.

Quality Management Control

Use the following QMS Self-Assessment Range to get an idea of where your manufacturing operation currently stands:

  • Low ranking: The work environment is addressed casually
  • High ranking: The company manages its infrastructure and work environment to achieve its desired (high-performing) results

Leadership’s Role

There is a distinction to be made between managers and leaders; while managers control a group to accomplish a goal and are concerned with an organization's efficiency, leaders influence a group's behavior to empower them towards a goal.

Top management, through its leadership, should:

  1. Convey their mission, vision, and culture so that it is easy to understand
  2. Create an environment where people feel committed to achieving their objectives
  3. Encourage supervision that promotes one purpose
  4. Promote a culture of trust, integrity, teamwork and quality leadership

Overall, continual, small, incremental progress is the goal. By improving your manufacturing organization, your company becomes more attractive to customers and workers, and further builds a competitive edge!

Traits of Quality Leadership include the ability to:

  • Learn from past problems
  • Commit to meeting all requirements
  • Select suppliers based on several criteria, not just on price alone
  • Train others to think through problems rather than how to perform a specific task (in other words, teach them to fish for a lifetime)
  • Show appreciation for those that use and improve the system as opposed to those pursuing "lone hero praise"

Use the following QMS Self-Assessment Range to get an idea of where your manufacturing operation currently stands:

  • Low ranking: The organization reviews its KPIs only intermittently
  • High ranking: All KPIs are understood and maintained to properly communicate the company’s guiding principles and strategies

Process Management

You must proactively manage your processes. For each procedure, you should appoint an "owner" - this person will have the responsibility and authority to maintain that process and address any audits or performance gaps. Once more, this theme of empowering your employees to boost their performance and engagement plays a crucial role in the success of your manufacturing organization.

Use the following QMS Self-Assessment Range to get an idea of where your manufacturing operation currently stands:

  • Low ranking: Responsibilities for processes are only casually defined
  • High ranking: Processes are clear and are audited and improved regularly

Resources Management

Your manufacturing organization must ensure there are proper resources in place to control each process. In addition to allocating enough time and money, resources also consist of:

  • Enough people
  • Effective technology
  • Appropriate work environment
  • Proper information
  • Infrastructure; equipment, space, and utilities

Use the following QMS Self-Assessment Range to get an idea of where your manufacturing operation currently stands:

  • Low ranking: No formal process to manage the equipment, machines, and facilities exist
  • High ranking: The company works with its suppliers to identify and make improvements to its products so all can benefit

Evaluation of An Organization's Performance

Competent, empowered and motivated people are the key resources of your manufacturing organization. Your management should be able to attract and retain people with the competencies needed and who can contribute to your growth. When the degree of performance does not meet expectations, you should review your training strategy.

Use the following QMS Self-Assessment Range to get an idea of where your manufacturing operation currently stands:

  • Low ranking: Development of people is ad-hoc, and only if needed
  • High ranking: Great results from engaged and motivated employees; the company frequently promotes best practices and excellence

Improvement, Learning, and Innovation

Empowering your employees enhances the motivation of people to take responsibility for their work and its results. As such, managers should discuss the significance of the worker's responsibilities and ability to create value in your manufacturing organization!

Your job as a leader is to create more leaders, not more followers. Ask yourself, what type of coaching are you providing to your department's emerging leaders? How are you laying the foundation for success in the future?

Use the following QMS Self-Assessment Range to get an idea of where your manufacturing operation currently stands:

  • Low range: Improvement projects are conducted spur of the moment without much planning or forethought
  • High range: The company can achieve long-term results routinely in every department on a regular basis; this happens organically

ISO 9004 quality control

Establishing the Context and Identity of an Organization

The context and identity of your manufacturing business involve many moving parts, both internal and external. Any combination of these facets can have a significant impact on your organization’s success, reputation, and future. It’s important to understand each of these factors in order to evaluate their influence on your company’s short- and long-term plans and performance.

Internal issues include aspects within the organization that can jeopardize your success, such as:

  • Size of your business
  • The complexity of your products
  • Quantity of your products
  • Your organization’s performance
  • Seeking innovation
  • Competence and maturity

External Issues, on the other hand, include factors that influence your ability to continue success. These might include:

  • Competition
  • Globalization
  • Statutory and regulatory requirements
  • Other factors such as Social, Economic
  • Political and Cultural; Natural Environment
  • Innovation and Technology

CMTC is Here to Help!

By using the ISO 9004 guidance to achieve sustained success, you can construct a strategic quality plan to fill those gaps and improve the performance of your operations. To help your manufacturing business understand the standards you need to thrive in the face of advancing technologies and increasingly complex supply chains, CMTC has created an ISO Tip Sheet to break down the details of the standard. Download it for free or reach out to our manufacturing experts today for more information!

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About the Author

Eliot Dratch

Eliot Dratch is a quality, lean and safety consultant who understands that U.S. manufacturing has been the economic engine that raised the living standards and built economic equity for the last 6 generations of Americans. Eliot’s work with manufacturers for his entire 30+ year career from different manufacturing sectors allows him to leverage a unique blend of experience for his clients. His goal is always to measurably improve a CMTC client’s productivity, safety and profitability.

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