ISO 9001 Quality Management System

Millions of companies across the world have incorporated the ISO 9001 standard into their approach to achieving quality.

What is ISO 9001?

ISO 9001 addresses the aspects of quality management for organizations who want to ensure that their products and services consistently meet customer requirements, with an emphasis on continual improvement.

ISO 9001’s global popularity can be explained by a variety of reasons, including that it supports:

  • A framework for management to establish and measure common objectives.
  • Defining of an organization’s functional and operational capability.
  • Increased focus on Customer Satisfaction; and
  • Focus on Quality Assurance – establishing processes to proactively ensure quality requirements will be fulfilled through governance, structure, and audits
  • Establishing methods for Quality Control – focused on fulfilling quality requirements – this is more reactive and inspecting by measuring, examining, and testing

The intent of ISO 9001 is to address the basic principles of quality management:

  • customer focus
  • leadership
  • engagement of people
  • process approach
  • improvement
  • evidence-based decision making
  • relationship management

ISO 9001 simply establishes good business practices to deliver quality products or services. Many people think that ISO 9001 is all about documentation – which is not true, not anymore.

ISO 9001 is about achieving performance objectives to meet internal and external customer expectations. Forget checklist and manuals and think about value, performance, and process.

ISO 9001 Overview and Objectives

The objectives of ISO 9001:2015 is to provide a process approach on how an organization implements ISO 9001:2015 and operates a Quality Management System by applying the the Plan-Do-Check-Act cyle with a focus on risk based thinking.

The standard is written in a way that allows the principles to be applied to any organization, with attention to the development of strategic quality objectives, with attention to an organization’s operational and customer commitment.

What does a Process Approach mean?

A process approach is the identification, definition, and management of processes and their Interactions to achieve planned results aligned with the organization’s strategic direction.

What is the Plan-Do-Check-Act (PDCA) cycle

The Plan-Do-Check-Act (PDCA) Cycle provides a simple and effective approach for managing change and ensuring that ideas are appropriately tested before committing them to full implementation. The PDCA method can be outlined as follows:

  • Plan: Identify and analyze the work. Activities: define goals and objectives, identify requirements and risks, set a schedule with milestones, and document planned activities.
  • Do: Develop and test a potential solution. Activities: implement planned activities, train personnel, collect measures, and maintain relevant records.
  • Check: Measure how effective the test solution is and determine if the solution can be improved. Activities: conduct audits, assess performances, evaluate data, and analyze reports.
  • Act: Implement the improved solution. Activities: prevent and correct issues, modify processes, retrain staff, implement improvements, and verify effectiveness.

In addition to understanding the philosophy behind this approach to quality and process management, it is important to understand what is required to achieve certification.

An organization ultimately needs to understand the ISO 9001:2015 requirements and apply the principles to the way operations are performed.

What is risk-based thinking?

Risk-based thinking is a strategic and tactical focus on understanding both the risks and opportunities associated with plans, actions, objectives, and the associated activities and outcomes. Risks can be both positive and negative and each organization needs to understand the potential risks related to their QMS along with how to mitigate risks and exploit potential opportunities. Risk-based thinking is understanding how to manage uncertainty to achieve the most desirable outcome.  

ISO 9001:2015 Clauses

For an organization to successfully complete an ISO 9001 implementation, the organization must demonstrate adherence to the requirements of the ISO 9001:2015 Standard and its seven major clauses (Clause 4 through 10) (plus general introduction to the ISO 9001 Standard – Clauses 1 through 3)

Section 1-3 – ISO Scope, References, Terms

Expectations:

General introduction notes to the standard

Section 4 – Context of the Organization

In order to establish a Quality Management System (QMS) that can be ISO 9001 certified, the context of the organization needs to be defined.

 The intent of context of the organization is to understand the ISO 9001 scope by defining goals and the needs of customers, suppliers, and internal stakeholders to establish the organizational structure to meet customer requirements, deliver quality products and or services, meet any legal, contractual, or regulatory requirements without impacting the desired outcome. 

The value is that once the scope of the ISO 9001 QMS has been identified along with stakeholder expectations, the organization is able to identify a strategy for how quality is achieved and aligned to business goals.

What is expected for your organization is for you to develop a scope, define boundaries, outline a strategy to achieving the objectives of your quality management system to support business goals, and to identify the expectations and needs of relevant stakeholders.

Expectations:

Determining the scope of an organization’s Quality Management System (QMS) and understanding the strategy, interested parties, and needs.

Section 5 – Leadership Commitment in ISO 9001

The intent of this section is to ensure that the expectations for leadership are defined, roles are clearly defined, and that resources are provided. ISO 9001 requires top management to take appropriate steps to demonstrate leadership and accountability. A certified Quality Management System (QMS) considers interested parties, applicable legal and regulatory requirements, the organizations business strategy and identify quality objectives.

The value is that a governance structure provides accountability and ensures that resources are provided to personnel to ensure that the QMS is supported by leadership. Expectations should be understood and authority given to those with the responsibility to support ot maintain the QMS.

The expectation is to establish and communicate a Quality Policy to express leadership commitment to quality and customer satisfaction is a requirement for a certified QMS. Leadership must also ensure business processes are in place for the Quality Management System (QMS) and address roles, responsibility, and authority.

Expectations:

Leadership Commitment, Policy, Roles and Responsibilities

Section 6 – Planning a Quality Management System (QMS)

The intent of Section 6 is to focus on planning for the QMS to ensure that risks, opportunities, changes, and objectives are identified and managed effectively to ensure that performance is achieved, customer requirements are met, and issues are managed.

The value l is that the Quality Management System (QMS) can achieve intended results without introducing disruptive changes. Establishing Quality objectives are used to evaluate if intended results are achieved as well as the monitoring the health of the QMS.

Expectations

Promote a culture of risk-based thinking to address risks and opportunities, establish quality objectives and plan for changes. The measures to achieve the objectives are done at varies levels and functions relevant to the QMS to validate the performance and effectiveness of services, suppliers, and use of resources.

Using the measures, changes can be identified and carefully planned as to not disrupt ongoing tasks. A certified QMS will have a framework in place for changes and monitoring activities to determine change effectiveness to include identify any additional problems that it may cause.

Section 7 – Support of a QMS

The intent of  ISO 9001 Clause 7 Support, is to ensure that resources are provided, and infrastructure and tools are available. A certified Quality Management System (QMS) considers the there is a process for sharing organizational knowledge and establishing methods of communication. Each organization should have a method to evaluate competencies and skills and to provide training to address any gaps or new needs. A process to identify, manage, and control documents and records is required. As needed, define the methods to ensure measurement data is verified or calibrated.

The value is that the organization provides the support needed to establish and maintain the QMS. Resources (people, infrastructure, environment, etc.) is a particular area of focus since a successful QMS cannot be maintained and effect without proper resources. The focus on competency and awareness is key to ensuring training is provided. hCommunication and planning helps establish what is expected so that all parties understand what is required of tem. If information is controlled, it helps ensure that organizational knowledge remains protected, accessible, and correct.

Expectations:

Resources are provided, and that there is a process to manage competency, awareness, communication, and training along with evaluating the effectiveness. Each QMS should have a defined process for controlling documents and records. Additionally, there will need to be methods for verifying and calibrating measurement data.

Section 8 – Operation of a QMS

 The intent of this section is to ensure the effective product or service realization. This part of the standard is where the work is performed – this is what you do daily to deliver products or services to meet customer requirements. Organizations should define their processes, identify interrelationships, establish methods of control of inputs and outputs, manage suppliers and purchasing, and control nonconforming products or services.The value is establishing standard processes to manage the day-to-day operation of the QMS, there are processes that must be performed to ensure the continued health of the system. These processes need to be determined and documented in order to help ensure knowledge is retained and performed properly. A mandatory part of operations is the evaluating of the performance of processes and their outputs, the continued assessment of risks and the efforts to treat them, and controlling the release of nonconforming products or services to ensure customer specifications, requirements, and expectations are met to their satisfaction.

Expectations:

Establish processes for operational planning and control, define requirements for products and services, address input and output of design and development, control externally provided processes, products, and services, monitor the provisioning of production and services, monitor the release of products and services, and control nonconforming products or services.

Section 9 – Performance Evaluation

 The intent of this section is to use established methods to monitor and measure performance, review customer feedback, perform internal audits, and monitor external providers to evaluate the effectiveness of your QMS. The internal audits, metrics, feedback, and reviews help make decisions on what changes or improvements need to be addressed to manage risks or issues.

The value of is that with any system, there needs to be a way to validate performance and gauge the effectiveness of actions taken from the documented business activities. Taking trends from the process performance evaluation metrics can be vital information to the organization on areas that require attention. The organization adopts a proactive response to managing performance rather than reacting to issues.

The expectation is that by

Verify that you are achieving expected results as well as the ISO 9001 standard requirements by reviewing the results of monitoring activities, evaluating feedback from customers and other parties, analyzing performance metrics, and, performing internal audits.

Internal audits need to be conducted by someone who is objective and can remain unaffected by the outcome. Reviews of performance measures and internal audit should be held on a reoccurring basis. This team should have the ability and authority to analyze the information presented to them and make decisions that can affect the entire QMS.

Section 10 – Improvement of your QMS

 The intent of section 10 is to take the output of your evaluation of all of the work and performance monitoring to implement improvements and corrective actions to introduce positive changes that help the organization continually progress.The value is that there is an established methodology to effect a change of state. Whether to improve the QMS or to bring it back to center following a non-conformance with requirements, the organization is able to

implement  changes with a certain level of control. Providing a culture where continual improvements is the way of conducting business, an organization can yield a culture of learning and innovative thinking, which can drive higher customer satisfaction and growth

The expectation is that there are methods to identify and manage corrective actions, improvements, and lessons learned to prevent unintended changes and to promote the continual improvement of both processes and performance.

Why get an ISO 9001 Certification?

Unquestionably, multiple studies have shown that companies that have employed the services of an ISO 9001 Consultant, developed a Quality Management System (QMS), and get an ISO 9001 Certification tend to outperform similar organizations, which have not implemented an ISO 9001 based quality management system. Key performance differentiators are:

  • Reduced error rates in the delivery of goods or services,
  • Improved return on business assets,
  • Improved customer satisfaction, and
  • Increased marketability

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