Eliot Dratch
Published: Wednesday, September 22, 2021 - 11:02 The International Organization for Standardization (ISO) is an independent, nongovernmental, 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 global industries. The ISO 9000 family of standards pertains to quality management systems in any industry; read on to learn more about ISO 9004 and how it can benefit your manufacturing organization. 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 standards included in ISO 9000:2015. ISO 9004 provides a self-assessment tool to review the extent to which the organization has adopted the concepts within the ISO 9000 group. Also, ISO 9004:2018 is applicable to any organization, regardless of its size, type, and activity. Both ISO 9004 and ISO 9001 are standalone standards within the family of 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. There are seven major themes presented in ISO 9004. Each theme is composed of particular qualities and questions by which to evaluate your manufacturing organization in alignment with the ISO 9000 series. Assessing and sustaining the quality of an organization An effective quality management system (QMS) creates value rather than simply enforcing compliance. This means you’ll have fewer repeat problems and can provide an exceptional customer experience. Managers should work based on organizationwide objectives that communicate your company’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. Use the following QMS self-assessment range to get an idea of where your manufacturing operation currently stands: Leadership’s role A distinction must 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 toward a goal. Top management, through its leadership, should: Overall, continual 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: Use the following QMS self-assessment range to get an idea of where your manufacturing operation currently stands: 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: 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: Use the following QMS self-assessment range to get an idea of where your manufacturing operation currently stands: Evaluating 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: 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 workers’ 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: Establishing an organization’s context and identity 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 effect on your organization’s success, reputation, and future. It’s important to understand each of these factors 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: External issues, on the other hand, include factors that influence your ability to continue success. These might include: Tapping the CMTC to gain deeper insight By using the ISO 9004 guidance to achieve sustained success, you can construct a strategic quality plan to fill performance gaps and improve 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, California Manufacturing Technology Consulting (CMTC) has created an ISO 9000 tip sheet to break down the details of this important standard. First published Aug. 11, 2021, on the CMTC blog. 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.
Management How to Use ISO 9004 to Improve Your Manufacturing Operation
Responding to the organization in the mirror
What is the ISO 9004 standard?
What is the difference between ISO 9004 and ISO 9001?
A breakdown of ISO 9004
• 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.
• Convey the organization’s mission, vision, and culture so that it is easy to understand.
• Create an environment where people feel committed to achieving company objectives.
• Encourage supervision that promotes one purpose.
• Promote a culture of trust, integrity, teamwork, and quality leadership.
• 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.
• Show appreciation for those who use and improve the system as opposed to those pursuing “lone hero praise.”
• Low ranking: The organization reviews its key performance indicators (KPIs) only intermittently.
• High ranking: All KPIs are understood and maintained to properly communicate the company’s guiding principles and strategies.
• Low ranking: Responsibilities for processes are only casually defined.
• High ranking: Processes are clear and are audited and improved regularly.
• Enough people
• Effective technology
• Appropriate work environment
• Proper information
• Infrastructure such as equipment, space, and utilities
• Low ranking: No formal process to manage the equipment, machines, and facilities exists.
• High ranking: The company works with its suppliers to identify and make improvements to its products so all can benefit.
• 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
• 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
• Size of your business
• The complexity of your products
• Quantity of your products
• Your organization’s performance
• Ability to seek innovation
• Competence and maturity
• Competition
• Globalization
• Statutory and regulatory requirements
• Other factors such as social and economic
• Political and cultural factors; natural environment
• Innovation and technology
About The Author
Eliot Dratch
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Comments
As co-convenor of the
As co-convenor of the ISO/TC176 Working Group that prepared the current version of ISO 9004, published in April 2018, I was initially happy to read Mr. Eliot Dratch’s paper “How to Use ISO 9004 to Improve Your Manufacturing Operation”, published in QD on 22nd Sep. 2021. The use of ISO 9004 in any type of organization is very welcome.
Having said that, I can’t leave this paper without comments as there are profound concerns that it is misleading the readers in their understanding of ISO 9004 and how it differs from ISO 9001.
In particular, I need to correct the gross misconception expressed in the paper related to the scopes of ISO 9001 and ISO 9004, where it is stated that “Each standard 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.”
This is correct for ISO 9001 as it copies clause 1 a) of ISO 9001 scope, but it is definitely not the scope of ISO 9004 which (according to its clause 1) is to provide “guidelines for enhancing an organization’s ability to achieve sustained success”.
This difference in scope is key to understanding the respective focus of the two standards:
1. Although most organizations derive significant benefits by implementing an ISO 9001-based system (in terms of productivity, communications, breaking down interdepartmental barriers etc), the core objective of ISO 9001 is (and always has been) to provide confidence in the organization’s products and services.
2. The focus of ISO 9004 is to provide confidence in the organization itself, and its ability to be successful in the long term. This involves many factors other than just “providing conforming products and services”! This is emphasized in clause 4 of ISO 9004, which clearly states that: “The organization should go beyond the quality of its products and services and the needs and expectations of its customers. To achieve sustained success, the organization should focus on anticipating and meeting the needs and expectations of its interested parties with the intent of enhancing their satisfaction and overall experience”. (Examples of various interested parties and their needs and expectations are presented in Figure 2 of ISO 9004).
This conceptual difference between ‘Product/Service Quality’ and ‘Quality of an Organization’ is also illustrated by the difference in the inputs and outputs of ISO 9001 Figure 2 and ISO 9004 Figure 1 that represent the structure of each document respectively.
Last but not least, the tailorable 5-level Process Maturity self-assessment annex in ISO 9004 is aimed at helping organizations to diagnose their strengths and weaknesses, to be used as a basis for improvement activities.
Because ISO 9004 is a guideline (not a requirements) standard, “yes/no” conformity assessment such as that applied for ISO 9001 is not appropriate. To paraphrase Deming “you don’t have to do any of this – Survival is not compulsory!”.
Dr. Isaac Sheps
Chairman Central committee for MSS, The Standards Institution of Israel