ISO 9001:2015 Quality management systems

Rajesh Uppal April 8, 2023 Industry, Management, Manufacturing Comments Off on ISO 9001:2015 Quality management systems 906 Views

Within a global economy with enormous and fierce competition, the survival and development of a company depend on its ability to attract customers, make them loyal, and above all, constantly, exceed their expectationss and desires, in order to retain them.

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. Well-defined standards lead to less rework and schedule delays throughout your project. You will set quality standards with your team and your customer at the beginning of your project.

A quality management system (QMS) is a set of policies, processes, and procedures required for planning and delivering (production/development/service) in the core business area of an organization of any kind and size. QMS is 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.

International Organization for Standardization (ISO), is an independent, nongovernmental organization with a membership of 163 national standards bodies, that oversees the drafting of ISO 9001 and many other international standards. ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify. Above all, ISO 9001 is a management tool for improving customer satisfaction and for assisting organizations to be more efficient.

The 2000 version of the standard (ISO 9001:2000) sought to make a radical change in thinking. It placed the concept of process management at the heart of the standard, making it clear that the essential goals of the standard – which had always been about ‘a documented system’ not a ‘system of documents’ – were reinforced. The goal was always to have management system effectiveness via process performance measures.

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 9001:2015

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 revised version of ISO 9001:2015 Standard, is based on the following Seven principles of Quality management

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.

Rationale: “Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties on whom it depends. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization”. (ISO 9000: 2015)

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. It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value

Process Approach: A process is a set of interrelated activities that transform activity inputs into outputs. Quality management systems consist of interrelated processes. Knowing your inputs, actions and intended outputs makes day-to-day operations predictable and repeatable. Understanding how those results are produced by any of these systems enables an organization to optimize the specific system and its actual performance Effectively managing processes ensures resources are used efficiently and highlights areas for improvement.

The process approach is a management strategy that incorporates the plan-do-check-act cycle and risk-based thinking. It means that processes are managed and controlled. It also means that we not only understand what the core processes are, but we also consider how they fit together.

This means the organization needs to:1. Determine required process inputs and expected outputs,2. Assign responsibilities and authorities for processes,3. Identify risks and opportunities for processes, and plan to address them in an optimum way.

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. Organizational improvement is a prerequisite for any company or organization in order to operate as effectively as possible.

The organization should employ a consistent organization-wide approach to the improvement of the organization’s methods, tools, and metrics for improvement. The organization should provide people with the appropriate training in the methods and tools for improvement on an ongoing basis. The organization should, also, make improvements of products, processes, and services.

Evidence-based decision making – Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. It is important to understand cause-and-effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decision-making. Evidence includes any data or information that might be used to determine the truth of an assertion, and it could be quantitative or qualitative data.

The organization should base its decisions on process performance data generated by the management system, including audit data, customer complaints, and nonconformity data as inputs to decision-making. Effective decisions are based on the analysis of data and information. It means that managers make a decision on basis of various measurements, balanced with the experience and intuition within the management system.

The organizations need to build appropriate IT infrastructure to collect, analyze, present the data and consequently make the rightest decision. This includes (a) databases, data warehouses, data marts, etc. to store the data; (b) networks and connections to share the information and to make is accessible; and (c) the software to analyze and share the data.

Relationship Management: Today’s businesses and organizations do not work isolated. Identifying the important relationships you have with interested parties such as the customers and suppliers as well as any other stakeholder – and setting out a plan to interact effectively with them – will lead to sustainable development and ultimate success 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.

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.

Benefits

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.

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

Step 1 – Define the objectives of the organization. Why does the organization want to implement the standard? 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.

Step 2 – Make sure senior management is on board. It is crucial that everyone – from the top down – is supportive of the initiative and its objectives. If you are struggling with this, several accurate publications could help.

Step 3 – Identify your organization’s key processes for meeting your objectives as well as your customers’ needs. Within each of these processes, make sure you understand your customers’ requirements and can guarantee that these are met – each and every time. This will form the basis of your quality management system. 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

Step 4 – Buy the Standard and appoint a Quality Manager that will study the Standard and will act as an internal Ambassador in order to generate commitment and determination for adopting and implementing the QMS. Also, appoint the Quality team

Procedure for a Company to get ISO 9001 2015 Certified

For the company QMS to be certified, you need to finish the implementation first. After finishing all your documentation & implementing your processes, your company also needs to perform the following steps to ensure a successful certification:

Internal Audit: This is in place for you to check your QMS processes. The goal is to confirm that records are in place to confirm compliance with the processes & to find problems and weaknesses that would otherwise stay hidden.
Management Review: A review by your management to evaluate the facts regarding the management system processes in order to make appropriate decisions & assign resources.
Corrective Actions: After the internal audit & management review, you need to correct the root cause of any identified problems & document how they were resolved.

List of Vital Documents and Records Required by ISO 9001 2005

Following are some vital documents you need to produce if you want to be compliant with ISO 9001 2005:

Scope of the QMS;
Quality objectives;
Quality Policy;
Criteria for evaluation & selection of suppliers.

Following Are Some Mandatory Records:

Records of skills, experience, qualifications, and training;
Record of non-conforming outputs;
Product or service requirements review records;
Characteristics of product to be produced & services to be provided;
Records about customer property;
Internal audit program;
Results of the management review;
Results of corrective actions;
Monitoring & measurement review;
Results of the management review;
Record of conformity of product/service with acceptance criteria;
Production or service provision change control records;

The Company Certification Process Is Further Diving Into 2 Different Stages:

Stage 1 (Documentation Review): The auditors from your chosen certification body will check to confirm your documents meets the ISO 9001 2015 requirements.
Stage 2 (Main Audit): In this stage, the certification body auditors will check whether your activities comply with both ISO 9001 & your documentation by checking documents, company practices & records.

References and Resources also include:

https://www.researchgate.net/publication/342182999_Quality_Management_Systems_ISO_90012015

https://corpbiz.io/iso-9001-2015-certification-quality-management-systems