Understanding ISO 9001: The Importance of Quality Management Systems

Mr. Christian Dispo, a quality and compliance officer with over six years of experience in quality, health, safety, and environment, is introduced as the presenter. He specializes in management systems, legal compliance, inspections, audits, training, and consultations. He holds a Bachelor of Science in Biology from the University of St. Louis, Baguio, and is pursuing a Master's in Environmental and Natural Resource Management from the University of the Philippines. He is a certified auditor for various management systems and has completed several international qualifications, including NEBOSH and OSHA certifications.

The training course focuses on ISO 9001, Quality Management System. Participants are requested to have a copy of the ISO 9001 standard, which is available for free download. The training aims to provide practical applications of the QMS rather than just theoretical awareness, building on a previous training conducted the prior year.

The objectives of the training include defining ISO and the Quality Management System, understanding its benefits and purpose, and exploring the PDCA (Plan, Do, Check, Act) cycle. Additionally, the training will cover the clauses of the standard, including context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.

ISO, established in the late 1940s to early 1950s in Geneva, Switzerland, arose from the need for international standards in response to quality complaints following World War II. The organization was officially founded in 1947, and the first standard, ISO 9001, was published in the 1990s. ISO is a non-governmental organization that has published over 19,500 standards applicable across various industries, including technology, manufacturing, and services.

Quality management is defined as ensuring that the products and services provided meet high standards of quality and service. This concept is central to the training and the implementation of ISO 9001.

The discussion emphasizes the importance of quality management processes and standard operating procedures in ensuring that company operations align with customer expectations and deliver high-quality products. The speaker highlights that these activities are essential for achieving customer satisfaction.

The speaker introduces the Annex SL structure, which serves as a foundational framework for all ISO standards. This structure includes the scope of the quality management system, normative references for standards, and definitions of key terms such as quality and non-conformity. It also addresses the context of the organization, identifying both external and internal issues that impact planning.

The context of the organization is crucial for identifying external requirements from regulatory bodies and customers, as well as internal issues from employees and management. This understanding is vital for effective planning and ensuring that the organization meets its quality objectives.

The discussion outlines the roles and responsibilities of senior management in quality management, emphasizing their leadership in guiding the organization towards achieving its goals and maintaining the scope of operations.

Planning is highlighted as a critical phase where the organization determines how to deliver products and services to customers. This includes assessing necessary resources, infrastructure, and competencies required to meet customer expectations effectively.

The speaker stresses the importance of performance evaluation in quality management, which involves establishing procedures to assess product quality and customer satisfaction. This includes conducting internal and external audits to ensure compliance and identify areas for improvement.

The discussion concludes with the need for continuous improvement based on performance evaluation outcomes. The organization must plan corrective actions for any identified issues and explore opportunities for enhancement to foster ongoing development.

The speaker outlines the primary purpose of the Quality Management System (QMS) as ensuring a consistent focus on customer needs and delivering high-quality products and services. This principle is fundamental to the effectiveness of the QMS.

The discussion emphasizes the importance of understanding customer expectations, which include receiving the ordered product and ensuring high quality and credibility of the product provided. This understanding is crucial for effective quality management.

Effective leadership is highlighted as a key principle in quality management. Without strong leadership, the success of quality management programs may be compromised, leading to inefficiencies.

Engaging employees is essential for enhancing their competencies and improving the quality of their work. This engagement not only boosts morale but also contributes to a more productive work environment.

The process approach is discussed as a fundamental principle of quality management, focusing on identifying and improving processes rather than blaming individuals for faults. This shift in focus allows for more effective corrective actions.

Continuous improvement is a core aspect of the management system, following the PDCA (Plan-Do-Check-Act) cycle. The results of this cycle are always aimed at enhancing processes and outcomes.

Evidence-based decision-making is crucial in quality management, relying on data, performance evaluations, and operational information to inform decisions. This approach is evident during internal audits and management reviews.

Maintaining strong relationships among all employees is vital for the success of the quality management system. This relational aspect significantly impacts organizational management.

The benefits of implementing a quality management system include delivering consistent quality products to customers and facilitating easier market entry. Companies often leverage ISO 9001 certification as a market strategy to enhance credibility.

A robust management system aids in identifying errors and inefficiencies within processes. It provides a structured approach to trace the source of complaints and issues, ensuring that procedures are in place to prevent recurrence.

Having a quality management system in place can ease the approval process for bank loans and business licenses. Companies seeking ISO certifications from reputable bodies like SGS or Bureau Veritas demonstrate a strong commitment from top management to quality management practices.

Kasi emphasizes that the recognition of certification bodies significantly enhances an organization's reputation, particularly when certified by international companies like SGS or Bureau Veritas. This recognition is crucial for improving customer satisfaction, internal effectiveness, and efficiency within the organization.

The discussion highlights that implementing quality management systems can lead to increased market share and profitability. By providing high-quality services and products, companies can expect a corresponding growth in their market presence.

Kasi introduces the Plan-Do-Check-Act (PDCA) cycle as a systematic approach to management. This cycle involves planning improvements, conducting actions, checking results, and making necessary adjustments. The analogy of preparing a dish, such as adobo, illustrates the importance of planning, executing, and evaluating processes in a restaurant setting.

In the context of an organization, external requirements such as permits and licenses are essential for establishing a restaurant. Customer requirements, like a specific dish (e.g., adobo), guide the planning process, which includes considering business permits, recipes, ingredient quantities, and necessary equipment.

Once the planning stage is complete, the 'Do' phase begins, where the actual cooking of adobo takes place according to the established procedures and recipes. This phase also includes ongoing checks to ensure the quality of ingredients and adherence to the planned process.

After delivering the dish to the customer, feedback is solicited to assess satisfaction. This feedback is crucial for recording, analyzing, and evaluating the organization's performance. The discussion emphasizes the importance of a bidirectional feedback loop in the quality management system, which informs future improvements and preventive actions.

Following customer feedback, an internal audit or management review is conducted to evaluate customer satisfaction records. This process involves assessing complaints and identifying potential improvements or preventive measures to enhance service quality and customer experience.

The discussion begins with the need for improvements and corrective actions, emphasizing the importance of planning based on observations and potential rectifications. It is highlighted that revisions and additions to procedures may be necessary, alongside regular checks for updates on external requirements, such as licenses mandated by regulatory bodies. Additionally, there is a focus on understanding customer preferences and expectations, particularly the management's need for profit, which drives the necessity for research and development to create products that use fewer materials while maintaining quality.

The speaker introduces ISO 9001 as the foundational standard among various ISO standards, including ISO 45001 and ISO 14001. They explain the PDCA (Plan-Do-Check-Act) cycle associated with each standard, noting differences in revision dates—ISO 45001 was revised in 2018, while ISO 9001 was revised in 2015. The speaker emphasizes that ISO 9001 encompasses comprehensive planning that integrates customer requirements and operational support, distinguishing it from other standards that may focus solely on specific aspects.

The speaker describes ISO 9001 as a comprehensive standard, likening it to a 'halo-halo' that includes various essential elements for organizational processes. They recommend starting with ISO 9001 due to its all-encompassing nature, which provides a solid foundation for addressing health and safety requirements as outlined in ISO 45001. The QMS (Quality Management System) is presented as a crucial resource for obtaining necessary documentation and procedures for conducting health and safety risk assessments, as well as for environmental management under ISO 14001.

The discussion transitions to the differences between single management systems and integrated management systems. A single management system focuses on a specific operational area within an organization, such as quality, environment, or health. The speaker notes that organizations with multiple certifications can still refer to their systems as single management systems if they maintain separate manuals for each area, highlighting the importance of clarity in management system structures.

The organization has separate manuals for Environmental Management System (ENS) and Occupational Health and Safety (OHS), indicating a structured approach to management. An integrated management system combines these manuals into one, allowing for a unified framework that includes standards for quality management, health and safety, and potentially security management.

An integrated management system enhances efficiency by aligning processes, procedures, and policies, thereby reducing duplication of efforts. This integration is beneficial for organizations aiming to streamline their operations and improve overall effectiveness.

Single management systems offer simplicity, making them easier to implement, maintain, and manage compared to integrated systems. The focus on a single standard allows for clearer guidelines, although it may limit the understanding of other standards if the management is not well-versed in them.

Single management systems allow organizations to specialize in specific operational areas, such as quality or health and safety. This specialization can prevent conflicts among auditors and enhance focus on particular standards, leading to improved resource allocation and operational efficiency.

Implementing a single management system is generally less expensive than an integrated system, requiring fewer resources and less time. The straightforward nature of a single system allows for easier implementation, while integrated systems necessitate highly competent auditors and more extensive training, which can increase costs.

An integrated management system increases efficiency by allowing multiple standards to follow the same structure. For instance, both Quality Management System (QMS) and Occupational Health Management System (OHMS) can share processes for controlling external providers, streamlining operations that would otherwise require separate forms and procedures in a single management system.

The discussion emphasizes the importance of an integrated management system that encompasses both quality and health and safety requirements. It highlights the need for safety plans to be in place before work commences on-site, suggesting that a single form for suppliers could streamline the process by combining quality and health and safety requirements, thus reducing duplication of effort and increasing efficiency.

The speaker notes potential disadvantages of an integrated management system, including its limited scope and the risk of bias if management is only committed to one aspect, such as quality or health and safety. This could lead to inefficiencies. Additionally, integrating more than three standards can complicate the system, requiring a complex structure and experienced auditors for effective implementation.

An example is provided regarding ISO documentation, where the speaker describes the necessity of maintaining various documents such as quality policies, manuals, procedures, and control reports. These documents serve as evidence of compliance during audits, forming a documentation pyramid that illustrates the planning and implementation processes necessary for a Quality Management System (QMS).

The speaker outlines a procurement process, illustrating how the operations department identifies the need for an ingredient, such as soy. They evaluate suppliers using a pre-qualification form to ensure that the suppliers have their own quality management systems in place. Following evaluation, negotiations occur, leading to an approved internal purchase negotiation and the issuance of a Local Purchase Order (LPO), which must be recorded for traceability as mandated by the QMS.

The discussion emphasizes the importance of a Quality Management System (QMS) in ensuring that all necessary documentation, such as quotations from suppliers, received invoices, and technical data sheets, are properly maintained. This systematic approach helps organizations avoid overlooking critical details during product receipt and quality checks, thereby enhancing operational efficiency.

In the planning stage of developing QMS documents, organizations must identify both internal and external issues. Internal issues may include manpower, resources, and process challenges, while external issues encompass political, economic, social, technological, legal, and environmental factors, collectively referred to as PESTEL. This comprehensive analysis is crucial for effective strategic planning.

The speaker highlights the use of SWOT analysis (Strengths, Weaknesses, Opportunities, Threats) as a tool for assessing internal issues within a company. It is essential for all departments and employees to participate in this analysis to ensure a holistic understanding of the organization's position and to identify areas for improvement and growth.

Understanding the needs and expectations of interested parties, such as customers, management, and regulatory authorities, is vital for meeting statutory and regulatory requirements. The speaker clarifies the distinction between statutory laws and regulatory requirements, emphasizing the importance of recognizing the diverse needs of stakeholders to enhance organizational performance.

The scope of the organization's Quality Management System must be documented and maintained, as specified in the standards. This includes trade licenses, ISO certificates, and other relevant permits. The speaker stresses the importance of identifying required inputs and expected outputs, linking this to the PDCA (Plan-Do-Check-Act) cycle to ensure that customer requirements are met effectively.

The discussion concludes with the necessity of establishing criteria and methods for monitoring and measuring processes. The speaker uses the example of preparing adobo to illustrate the importance of quality checks before delivering products to customers, reinforcing the need for consistent quality assurance practices within the organization.

The speaker humorously notes that adobo should not be blue, highlighting a potential inconsistency in food preparation or presentation.

The discussion shifts to the risks and opportunities within the company's processes, emphasizing the potential risk of reduced customer numbers against the opportunity for lower production costs while maintaining product quality.

The speaker reiterates the importance of establishing, implementing, maintaining, and continually improving a Quality Management System (QMS) as mandated by the standards, which includes maintaining necessary documentation and retaining essential records.

Leadership is identified as crucial for effective planning and operations within the QMS. The speaker stresses that without leadership involvement, the planning, operations, and overall performance of the company will falter.

The leadership is held accountable for the effectiveness of the QMS, with the speaker urging the need to inform top management about the implications of ISO standards and QMS, especially if they are unfamiliar with these concepts.

The establishment of policies and objectives is highlighted, with the speaker noting that these documents are often signed by top executives, such as the CEO, and serve as foundational elements in the documentation pyramid of the QMS.

Leaders are encouraged to promote a process approach and risk-based thinking, emphasizing that their involvement is essential for evaluating performance and customer satisfaction, which are critical for continual improvement in the management system.

The speaker discusses the importance of establishing a quality policy that outlines the company's purpose and context, with a focus on customer satisfaction and a commitment to continual improvement as key elements.

The necessity of communicating the quality policy to relevant parties is emphasized, with various methods suggested, such as sharing via email, posting on the company website, and regular communication with customers and suppliers.

The QMS is confirmed to comply with ISO 6000 standards, ensuring that it achieves deliberate and intended results, which is crucial for the company's operational integrity.

The discussion begins with a focus on reporting the Quality Management System (QMS) performance and identifying opportunities for improvement. Emphasis is placed on promoting customer focus and maintaining the integrity of the QMS during planned changes.

An organizational chart and job descriptions for all employees are established to clarify roles in the implementation of the QMS. This structure is essential for defining the organizational context and aligning products and services with customer requirements and expectations.

The planning phase involves identifying actions to address recent opportunities, setting quality objectives, and developing plans to achieve them. It is crucial to identify both external and internal issues, as well as potential risks, and to transform these risks into opportunities to enhance the effectiveness of the QMS.

Quality objectives must be specific, measurable, achievable, realistic, and time-bound (SMART). A common example is the objective of achieving an 85% customer satisfaction rate for the year, which will be measured through customer feedback surveys conducted annually, depending on the company's scope and top management's advice.

The training includes a customer feedback component to gather inputs for improvement. This feedback will help enhance the training provided to safety advocates and ensure that quality objectives are monitored, communicated, and updated appropriately. Documentation of quality objectives is mandatory to avoid non-compliance.

Plans to achieve the customer satisfaction objective include creating reports and designating responsible individuals for collecting customer survey feedback. The frequency of analysis can vary, being either annual or quarterly, based on specific requirements. Evaluation of customer satisfaction will involve analyzing feedback from a sample of customers to identify reasons for dissatisfaction.

Examples of quality objectives and their Key Performance Indicators (KPIs) include customer satisfaction rate, on-time delivery rate, employee engagement, internal process efficiency, compliance rate, and continual improvement rate. These metrics are essential for assessing the effectiveness of the QMS.

The speaker emphasizes the importance of checking for quality objectives within one's company, suggesting that they may align with common examples of quality objectives. This is a crucial step in ensuring that the organization adheres to quality standards.

The discussion transitions to the planning of changes, focusing on the purpose of change and its consequences. Key considerations include the integrity of Quality and Safety (Q&S), resource availability, and the allocation and reallocation of responsibilities and authorities.

The speaker outlines the necessary resources for operations as per ISO standards, highlighting the need for people, infrastructure (buildings and equipment), and the maintenance of these infrastructures to ensure conformity of products and services. The importance of preventive maintenance procedures is also noted, particularly in manufacturing contexts.

The environment for operational processes must be maintained, taking into account human and physical factors. The speaker stresses the need for procedures that ensure a conducive environment for operations, as mandated by the standards.

The speaker discusses the significance of organizational knowledge, which includes internal sources like intellectual property and lessons learned, as well as external sources such as standards, conferences, and customer feedback. This knowledge is essential for continuous improvement.

Monitoring and measurement resources are crucial for ensuring product quality. The speaker illustrates this with an example from cooking, where maintaining a specific temperature (90 degrees Celsius) is essential. The need for calibration certificates for equipment is highlighted to ensure accurate measurements.

Competence in the kitchen is discussed, emphasizing that while formal qualifications are not strictly required, individuals must possess the necessary experience and skills. Documentation of training and experience is essential to demonstrate competence.

The speaker stresses that awareness of quality policies should extend beyond customers and suppliers to all employees within the organization. Everyone must understand the quality policy, company objectives, and their roles in contributing to an effective Quality Management System (QMS).

Effective communication is vital, both internally within the organization and externally. The speaker notes that it is not sufficient to simply provide documents upon customer request; rather, there should be a comprehensive understanding and communication of policies, procedures, and records related to the QMS.

The speaker emphasizes the importance of confidentiality in sharing information, stating that it is not necessary to disclose all manual procedures as long as the organization can prove its certification from an ISO certifying body. If there are disagreements, a second-party audit can be conducted on-site.

The discussion shifts to the guidelines for creating and updating documented information, highlighting the need for identification and description. Essential elements include the title, date, author, signatories from top management, and a reference number, all of which are crucial for compliance with standards.

The speaker outlines the requirements for document control, stating that documents must be available and suitable for use when needed, adequately protected from loss of confidentiality or improper use, and that there should be a clear distribution and retrieval process. Document controllers should maintain a registry of all Quality Management System (QMS) documents and their distribution.

Records must be retained as evidence of conformity to guidelines, which will be necessary during audits to demonstrate compliance with QMS standards.

The speaker transitions to operational planning and control, stressing the need to plan and control processes to meet product and service requirements. The standard requires maintaining processes to meet customer and internal/external requirements, as well as retaining records for each process.

The discussion includes defining requirements for products and services, which encompass customer needs and legal requirements. The speaker notes the importance of reviewing these requirements before proceeding with production, as there may be instances where customer demands cannot be met.

The speaker addresses the complexities of clause 8.3 regarding the design and development of products and services, indicating that changes in procedures and standard operating activities will arise from research and development outputs. Planning is essential to determine stages, control tasks, and identify inputs, including functional performance and legal requirements.

The speaker highlights the management's goal of increasing profits through research and development, which may involve designing recipes that use fewer or alternative materials to reduce costs. It is crucial to maintain documented information on design and development processes and retain records of changes and reviews.

The discussion begins with the control of externally provided processes, products, and services, emphasizing the need to identify the type and extent of control over external providers, such as consultants, subcontractors, and contractors involved in infrastructure or chemical supply. It is crucial to evaluate these providers at least every one to two years based on the quality of their products and services, as documented information must be retained according to standards. This evaluation process is similar to the management of contractors in the Occupational Health and Safety (OHS) management system, which also requires assessment of health and safety practices.

The control of production and service provision necessitates established procedures for managing products and their delivery to customers. The standard mandates identification and traceability, requiring documented information such as batch numbers for products. For instance, when a paint product is delivered, it should include a batch number to facilitate traceability in case of complaints regarding product performance. Additionally, information about customer property from various providers must also be recorded.

Preservation of products is essential, particularly when complaints arise about product quality. For example, if a complaint is made about a paint's quality, the batch number must be checked, and a preserved sample of the chemical should be retained for future reference. This practice ensures that any issues can be traced back to the production batch, allowing for verification of potential defects or errors.

After delivery, it is important to have procedures in place for post-delivery activities, including the issuance of delivery notes and customer satisfaction surveys. These steps help in assessing customer satisfaction and ensuring that the delivery process meets established standards.

The standard requires retaining documented information that describes the results of any changes made to processes or products. Any changes must be recorded, especially if they occur unexpectedly, ensuring that there is a clear record of what modifications were made and their impact on the product.

Before releasing products and services, planned arrangements must be implemented to ensure compliance with acceptance criteria. This includes conducting physical, quality, and chemical checks to confirm conformity. Traceability is also vital, as it identifies who authorized the release, which is crucial for addressing any errors or faults that may occur during delivery. Recorded information, such as logs of released products or delivery notes, is essential for tracking these processes.

The discussion touches on the management of non-conforming outputs, indicating that when non-conformity occurs, there must be established procedures to address and rectify these issues effectively.

The correction process involves a formal procedure that specifies the corrections made, including segregation, containment, or return of suspension provisions. It is essential to inform the customer and obtain authorization for acceptance under concession, ensuring that all necessary documents are recorded and retained.

Performance evaluation encompasses monitoring, measurement, analysis, and evaluation, alongside internal audits and management reviews. It is crucial to monitor the proper implementation of planned procedures and the methods used during production. The common objective of Quality and Safety (Q&S) is to ensure customer satisfaction, which can be measured through surveys, feedback, and market share analysis. Appropriate documented information must be retained to support these evaluations.

Internal audits are typically conducted annually or semi-annually, depending on the company's established frequency. The standard mandates that an audit program must be planned, established, implemented, and maintained, detailing the frequency, methods, and responsible personnel. Records of the audits must be retained as documented evidence of implementation.

Management reviews focus on customer satisfaction and include updates on legal compliance, customer requirements, and analysis of complaints and delivery times. All relevant data must align with the company's policies and objectives, leading to observations for improvement and opportunities. Documented information from management reviews must be retained for accountability.

Improvement guidelines address non-conformities and corrective actions, particularly concerning major and minor non-conformance reports (NCRs). It is vital to document non-conformities and the actions taken to resolve them promptly. Corrective actions should aim to eliminate the root causes of non-conformities, with results also documented. Audits often yield observations for improvement, emphasizing the importance of continual improvement in organizational processes.