Quality standards provide requirements, specifications, or guidelines that can be used to ensure that products, processes, or services are fit for achieving the desired outcome. These standards must be met in order for the product, process, or service to be considered successful by the organization and the customer. You will set quality standards with your team and your customer at the beginning of your project. Well-defined standards lead to less rework and schedule delays throughout your project.
A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. ISO 9001 helps organizations ensure their customers consistently receive high-quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.
ISO standards are subject to regular reviews; usually around every 5 years but the process of reviewing and updating can take a very long time. ISO 9001:2015, the most recent update to the ISO 9001 standard, is a company-level certification based on the standard published by the International Organization for Standardization titled “Quality management systems-Requirements”. ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.
This standard revises ISO 9001:2008 to include requirements for a new, higher-level structure as a common framework to all ISO management systems, risk-based thinking in quality system processes, fewer prescribed requirements with less emphasis on documentation, clear definition of quality management system boundaries, and increased leadership requirements.
The benefits of implementing a Quality Management System which is compliant with ISO 9001 can be far-reaching. Simply adopting a process approach to operations can immediately highlight areas for improvement. Documenting processes in a meaningful way can also help with communicating quality actions and strategies to people at all levels. Inductions and training are linked directly to business objectives and people within the organization are clear on their contribution to overall performance and success.
ISO 9001 as a Business Plan
ISO 9001:2015 is really more of a business infrastructure than a quality standard. As you look at the standard requirements, it is really the outline for a business plan:
- Understand the context of your organization and what interested parties expect.
- Leadership is responsible for the business.
- Decisions and activities are built on risk and planning.
- Determine what support is necessary for the business – infrastructure, competence, documentation, and resources.
- Define the key activities for actually producing a product or service, including the activities that you outsource to others.
- Measure the performance of your processes – how do you determine you are meeting intended results?
- Continuously improve your systems and processes. Identify non-conformances and address the root cause of issues to prevent a recurrence.
The main changes in ISO 9001:2015 were in the following areas: The switch from ‘preventive action’ to ‘risk-based thinking’. This is really the same thing but preventive action used to be considered as something to do after an unwanted outcome had occurred (to prevent it happening again!). Now, the focus is very much from the outset. Risk-based thinking encourages true preventive action and continuous improvement by putting it at the forefront of the process approach.
The leadership element requires top management to fully engage with the quality management system, not just delegate it to a Quality Manager or Quality Team. The Quality Management System should align with the overall organizational objectives. The emphasis on organizational context looks at quality management from a big-picture perspective. Understanding why the organization exists, who it interacts with and other constraints within which it must operate, such as legal and regulatory frameworks, helps to understand the resources, monitoring and measurement required from operational processes.
ISO 9000 describes the 7 quality management principles:
Customer Focus: this applies to both internal and external customers. Customer focus is the primary focus of quality management and seeks to meet customer needs and to strive to exceed their expectations. Customer focus aims to create value for the customer.
Leadership: Effective leadership creates a unity of purpose and direction. Strong direction ensures all activities within the organization are aligned to strategies, policies, and processes to collectively achieve planned objectives.
Engagement of people: Involving people means ensuring they are competent, empowered and engaged. Effective engagement of people gives the organization the tools to achieve its aims.
Process Approach: This has been a staple of quality management standards for many years. Knowing your inputs, actions and intended outputs makes day-to-day operations predictable and repeatable. Effectively managing processes ensures resources are used efficiently and highlights areas for improvement.
Improvement: Improvement is not about the admission of weakness or fault, but simply a desire to do better and keep doing better for the benefit of all involved.
Evidence-based decision making – how many of us have ever made an impulse purchase? Do we really believe that businesses don’t also make that same mistake sometimes? Of course they do! But, by applying evidence-based decision making, decisions can be based on known requirements and the planned outcomes, direction and purpose of the organization, having involved the customers and people and with improvement in mind.
Relationship Management: This applies to all relationships of the organization. Often it pays to know your competitors as closely as you know your customers. Building networks, engaging the general public, reaching your target audience, all of these things are essential to achieve the aims of a profitable enterprise.
It specifies the criteria to establish policies, processes and procedures required for the efficient planning and execution of the core business processes of an organization. The standard focuses on the context of the organization, leadership, planning, support, operation, performance evaluation and improvement. Benefits of being certified to ISO 9001:2015 include improvement in the quality of products produced, increased competitiveness, improved customer satisfaction and standardization of processes.
Implementing a QMS can also help you to be more efficient. Using resources, this includes people, materials, time, money and external partners and suppliers, as effectively and efficiently as possible has a direct positive impact on profitability. Consistent and predictable outcomes lead to greater understanding of capability and capacity. Understanding organizational capability and capacity can help you to manage growth and the associated risks.
Adopting a customer focus adds value for customers andis likely to enhance their satisfaction and loyalty. Repeat business is less costly to achieve than new business so it pays to keep your current customers happy
Focusing on root cause analysis when investigating problems ensures solutions are robust and improvements are effective. Ongoing monitoring and measuring provides evidence of the effectiveness of processes and can demonstrate the effectiveness of previous decisions and actions. (Remember the quality principle of evidence-based decision-making.) A QMS also helps you to manage your supply chain.
Encouraging strong, effective communication between parties ensures expectations and requirements are clear before everyone is committed. This leads to improvement opportunities for mutual benefit.
Military embracing ISO 9001
ISO standard is also being implemented by military. In 2018, Military Sealift Command’s Headquarters announced its attainment of the ISO 9001:2015 QMS certification by the International Organization for Standardization having successfully fulfilled all the requirements for a Quality Management System (QMS). “Being certified to ISO 9001:2015 QMS means that MSC has obtained an internationally recognized level of excellence with its business model,” said MSC’s Director, Corporate Governance (N92) Beth Zukovsky, the lead for the headquarters’ ISO 9001: 2015 certification effort. “This certification provides our partners assurance that when they work with MSC’s headquarters, they will receive high quality service.”
“We require our operating companies to maintain certification so we have reasonable assurance that they have processes in place for safe operations to protect life, platforms, and equipment; are hiring employees with the appropriate training, experience, and skillset; and have security measures that protect privileged and critical information related to national security,” said Zukovsky. “By obtaining the ISO 9001: 2015 QMS certification, our business partners will be confident that the MSC headquarters is managed at the same level of excellence that they are. We are ‘walking the walk’ so to speak in terms of requiring excellence and demonstrating a level of commitment to focus on our customers and continually improve the services we provide.” To earn the ISO 9001:2015 QMS certification, MSC was evaluated on seven key areas; context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.
Steps to Implementation
The first critical step to the successful implementation of an integrated system is the definition of the critical business plan or strategy. In other words, determine what the organization is trying to accomplish with the system, key elements to be addressed, and scope of the operations. You should also create a process map or interaction diagram of the key processes.
The next key step is to identify a process owner/driver for each of the key processes. Ownership includes the definition of responsibility and accountability to ensure the processes achieve the intended goals. Rather than set the various standards and processes to compete with each other, identify opportunities to leverage the activities and eliminate or reduce redundancies. This synergy will also eliminate unnecessary complexity and costs from the overall business plan.
Once you have identified the key processes and activities, you can begin the process to select the appropriate tools to support the system. A requirements document is the best way to organize the organization’s needs and expectations for tools. There is no need to have separate tools for each standard or regulation. There are many good tools on the market for managing and controlling the documentation and data from the system. It is important to know what you want the tool to do before you complete a selection. A best practice is to select a tool that can be configured to support your business needs and will provide additional ad hoc reporting without complication. Most of the tools allow you to attach attributes to a document or record that facilitates the data analysis and/or generation. Matching your needs to the business expectation and requirements to the tool(s) can ensure a successful implementation. Never, ever, ever, ever automate a broken process