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ISO Consulting Article2: ISO 9001:2015 Quality Management System

ISO 9001 , ISO 9001:2015

ISO 9001:2015 – Magnus Management Consulting LLC

ISO 9001:2015 sets out the criteria for a quality management system and is based on several quality management principles including a strong customer focus, the motivation and implication of top management, the process approach, and continual improvement. Using ISO 9001:2015 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits. For more information, please visit www.iso.org.

 

ISO 9001:2015 Quality management systems — Requirements

What is Quality Management System (QMS)?

The quality management system is defined as a set of interrelated or interacting elements to establish policies, objectives, and processes to achieve those objectives about quality.

QMS is part of the overall management system, based on a business risk approach, to establish, implement, operate, monitor, review, maintain and improve quality.

ISO 9001:2015 specifies requirements to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system used to manage quality. The requirements set in ISO 9001:2015 are generic, flexible, and useful to all types of organizations. Thus, this ISO Management System Standard can be aligned and integrated with other Management Systems such as Energy Management, Business Continuity Management, and other management systems, due to their similar structure.

Quality management standardization evolves with ISO 9001:2015 by adding:

  • Greater emphasis on process approach, risk management, monitoring performance and metrics.
  • Better focus on interested parties.
  • More careful analysis of the organization’s context is needed to ensure quality improvement.

ISO 9001 applies to all types and sizes of organizations that wish to:

  1. establish, implement, maintain, and improve a QMS.
  2. assure conformity with the organization’s stated quality policy.
  3. demonstrate conformity to others.
  4. seek certification/registration of its QMS by an accredited third-party certification body; or
  5. make a self-determination and self-declaration of conformity with this International Standard

Key clauses of ISO 9001:2015

Following the new structure of the Annex SL, ISO 9001 is organized into the following main clauses:

 

Clause 1: Scope

Clause 2: Normative references

Clause 3: Terms and definitions

Clause 4: Context of the organization

Clause 5: Leadership

Clause 6: Planning for the quality management system

Clause 7: Support

Clause 8: Operation

Clause 9: Performance evaluation Clause

Clause 10: Improvement

 

Clause 4: Context of the organization

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its QMS such as:

  • issues arising from the technological, competitive, market, cultural, social, and economic environments.
  • issues related to values, culture, knowledge, and performance of the organization.
  • the identified needs and expectations of relevant interested parties.
  • applicable legal, regulatory, and other requirements to which the organization subscribes.

Defining the scope of the QMS, taking into account the organization’s strategic objectives, key products and services, risk tolerance, and any regulatory, contractual, or stakeholder obligations is also part of this clause.

Clause 5: Leadership

Top management shall demonstrate leadership and commitment concerning the quality management system by:

  • Taking accountability for the effectiveness of the quality management system.
  • Ensuring that the quality policy and quality objectives are compatible with the strategic direction and the context of the organization.
  • Ensuring that the quality policy is communicated, understood, and applied within the organization.
  • Ensuring the integration of the QMS requirements into the organization’s business processes.
  • Promoting awareness of the process approach.
  • Ensuring that the resources needed for the QMS are available.
  • Ensuring that the QMS achieves its intended results.
  • Engaging, directing, and supporting persons to contribute to the effectiveness of the QMS.
  • Promoting continual improvement.
  • Ensuring that customer requirements and applicable statutory and regulatory requirements are deterred- mined and met.
  • Ensuring that the risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed.
  • Establishing, reviewing, and maintaining the quality policy.
  • Ensuring that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.

Clause 6: Planning for the quality management system

This is a critical stage as it relates to establishing strategic objectives and guiding principles for the QMS as a whole. The intent of the organization to treat the risks identified and/or to comply with the QMS requirements can be expressed through the QMS objectives. The quality objectives shall:

  • be consistent with the quality policy.
  • be measurable.
  • consider applicable requirements.
  • be relevant to the conformity of products and services and the enhancement of customer satisfaction.
  • be monitored, communicated, and updated as appropriate.

 

An organization wishing to comply with ISO 9001 shall at least:

  • Select and define a risk assessment methodology.
  • Demonstrate that the selected methodology will provide comparable and reproducible results
  • Define criteria for accepting risks and identify acceptable levels of risk.

Clause 7: Support

The day-to-day management of an effective quality management system relies heavily on using the appropriate resources for each task. These include having competent staff with relevant (and demonstrable) training and supporting services, awareness, and communication. This must be supported by properly managed documented information.

Both internal and external communications of the organization must be considered in this area, including the format, the content, and the proper timing of such communications.

The requirements for the creation, update, and control of documented information are also specified in this clause.

Clause 8: Operation

After planning the QMS, an organization must put it into operation. This clause includes:

 

Operational planning and control: This activity includes the implementation of plans and processes that lead the organization toward meeting the quality management system requirements. Additionally, this clause requires organizations to establish controls that help in preventing any deviation from the quality policy, objectives, and legal requirements.

 

After the requirements have been established, the organization should control the planned changes and review the unintended changes to mitigate any adverse effects. All the processes within the organization, including outsourced processes, should be controlled.

 

Determination of requirements for products and services: The organization shall determine all the requirements related to products and services, such as customer requirements, organizational, statutory, and regulatory, and ISO 9001:2015 requirements. The organization shall establish an effective customer communication process. After all the requirements have been determined, they must be reviewed to ensure contract or order requirements differing from those previously defined are resolved.

 

Design and development of products and services: This activity requires that organizations establish, implement and maintain a design and development process.

 

Control of externally provided products and services: The organization shall ensure that externally provided processes, procedures, and services conform to specified requirements. This clause applies to both physical products and consumed services related to the end product of the organization. An organization will need to apply a risk-based approach and determine the type and extent of controls necessary.

 

Production and service provision: Businesses should control delivery and post-delivery activities to ensure that the product and service provision is implemented under controlled conditions. This requirement expects organizations to have a traceability mechanism to identify process outputs, protect and safeguard the property belonging to customers or external providers, and preserve the products and services.

 

Release of products and services: Organization should verify conformance to acceptance criteria when re-leasing the products and services. Acceptance criteria are the criteria set by the organization specifying certain indicators or measures employed in assessing the ability of a component, structure, or system to perform its intended function. Setting the criteria before initiating the project makes its development much easier. Each organization should define its criteria to ensure a higher level of customer satisfaction.

 

Control of nonconforming process outputs, products, and services: This activity involves the identification of control of products and services to ensure that they comply with the stated requirements. Nonconforming processes, products, and services have to be corrected, segregated, or returned. Additionally, the standard requires that organizations inform the customers of the nonconforming products to prevent customer dissatisfaction.

Once the QMS is implemented, ISO 9001 requires permanent monitoring of the system as well as periodic reviews to:

 

  • demonstrate the conformity of products and services to requirements;
  • assess and enhance customer satisfaction.
  • ensure conformity and effectiveness of the quality management system;
  • demonstrate that planning has been successfully implemented;
  • assess the performance of processes.
  • assess the performance of external providers.
  • determine the need or opportunities for improvements within the quality management system.

Clause 10: Improvement

Continual improvement can be defined as all the actions taken throughout the organization to increase effectiveness (reaching objectives) and efficiency (an optimal cost/benefit ratio) of processes and controls to bring increased benefits to the organization and its stakeholders. An organization can continually improve the effectiveness of its management system through the use of quality policy, objectives, audit results, analysis of monitored events, indicators, risk analysis, corrective actions, and management review.

 

Quality Management – the business benefits

Today, effective quality management ISO 9001:2015 is not about being forced into taking action to address external pressures, but its importance relies on recognizing the positive value of quality good practice being embedded throughout your organization.

The adoption of an effective quality management process within an organization will have benefits in several areas, examples of which include:

 

  1. Improved organizational effectiveness and efficiency.
  2. Improved understanding of the business as gained through risk identification and analysis.
  3. Operational resilience which results from implementing risk reduction
  4. Downtime reduction due to the identification of alternative processes and workarounds
  5. Protection of stakeholder value
  6. Increase customer and employee satisfaction.
  7. Increased market share and profit.
  8. Improved organizational culture.
  9. Enhanced continuous improvement.
  10. Process improvement; and
  11. Avoidance of liability actions.

Quality management principles

ISO 9001:2015 is based on seven quality management principles that can be used by top management to lead the organization toward improved performance.

  • Customer focus: Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
  • Leadership: Leaders establish the unity of purpose and direction of the organization. They should create and maintain an internal environment in which people can become fully involved in achieving the organization’s objectives.
  • Engagement of People: People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
  • Process approach: A desired result is achieved more efficiently when activities and related resources are managed as a process.
  • Improvement: Improvement of the organization’s overall performance should be a permanent objective of the organization.
  • Evidence-based Decision Making: Effective decisions are based on the analysis of data and information.
  • Relationship Management: An organization and its interested parties are interdependent and a mutually beneficial relationship enhances their ability to create value.

Why Might You need our consultancy services?

There are many reasons why you may require our consultancy services.  It could be because:

  • You want to improve your current systems.
  • You no longer have the skills in-house to effectively run a system.
  • You need help auditing your system.
  • You need to upgrade from a standard to an updated version.

 

Our highly experienced team of ISO consultants has years of expertise in this field, assisting a diverse range of clients in the implementation and efficient use of effective management systems. Our approach to ISO consultancy is no different from the one we adopt when implementing ISO Management Standards.  Ultimately, we believe in adopting a collaborative, supportive approach where our clients can receive as much assistance as they require. We simplify the entire process, ensuring it remains straightforward and stress-free for you throughout.

ISO Consulting Services from Magnus Management Consulting LLC are considered to be the best in terms of service delivery, consulting approach, timely project completion, and effectiveness of implementation. Reliable & Quick ISO Implementation in Doha Qatar.List of ISO Certification consultants in Qatar. Reliable ISO Certification Consultant in Doha Qatar ISO Consulting in Doha Qatar ISO Consultants in Doha Qatar. Best ISO Consultation in Doha Qatar.

Our ISO consulting services cover training, gap analysis, documentation, implementation assistance, internal audit, and pre-assessment audit.

You get a management system with us that helps your organization achieve its true potential by improving processes and performance.

Magnus Management Consulting LLC, Provides consulting services for ISO 9001, ISO 14001, OHSAS 18001, ISO 45001, ISO 22000, HACCP, ISO 27001, ISO 20000, and SA 8000 standards.

Magnus Management Consulting LLC, provides training, documentation, implementation, internal auditing, and pre-assessment auditing for ISO 9001, ISO 14001, OHSAS 18001, ISO 27001, HACCP, ISO 22000, ISO 450001, ISO 20000, and other ISO standards in UAE, Saudi Arabia, Canada, Oman, Bahrain, Qatar & Kuwait.

Inquire our ISO 9001:2015 Consultation at: https://www.mmcc.qa/service/iso-9001-2015-quality-management-system/

Also you can read:  https://www.mmcc.qa/2023/01/16/magnus-iso-consulting-services/

1.resources : ISO – ISO 9001:2015 – Quality management systems — Requirements

 

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