15 Most Valuable terms to understand ISO 9001:2015

Compliance with industrial standards, such as ISO 9001:2015, is a mandatory requirement for products, processes, and services. Various industries require ISO certification, including manufacturing, food, energy, medical, semiconductor, etc.  Even though ISO sounds simple, it has a vast vocabulary that consists of different concepts. 

This article will highlight a checklist of 15 terms and definitions used in ISO-certified organizations. 

A quick glance at ISO 9001:2015

ISO 9001:2015 is a technical standard for the quality management system (QMS) defined by the International organization for standardization (ISO). This standard contains seven principles for enhancing the performance of an organization including: 

  1. Process approach
  2. Customer focus
  3. Relationship management
  4. People engagement
  5. Leadership
  6. Improvement
  7. Decision-making

These elements determine the expertise as well as flaws in the entire system. The purpose is to meet customer and regulatory demands regarding products, individuals, services, testing, etc.  ISO certification is an assurance of getting high-quality products and services. Compliance with ISO helps businesses and companies develop 1000x faster.

ISO 9001:2015 aids in developing, executing, and improving the process approach to attain the ultimate goal of customer satisfaction. An understanding and management of cross-functional processes are essential to adopting this standard. PDCA (plan-do-check-act) and risk-based thinking are two popular methods to improve a firm’s productivity.

PDCA

This is the fundamental aspect of ISO 9001:2015. It is a four-step model to carry out the improvement. 

Plan: Recognize opportunities and make changes accordingly.

Do: Make the change and test it. Perform a small-scale analysis.

Check: Evaluate your test results, analyze the data, and identify what you learned.

Act: Use what you learned during the study step to take action. Retry the cycle if the change does not work. Apply the learnings from the test to wider changes if you were successful. Planning new improvements using what you learned is a good way to restart the cycle.

pdca-cycle.jpg
PDCA cycle

List of common terminology

ISO 9001:2015 uses the following terminology as a basis for its standardization.

Common terminology in ISO 9001:2015
Common terminology in ISO 9001:2015

Quality

Quality is the sum of all the attributes and elements of a product or service that specify its ability to fulfill the needs of its users.  It is the valuation related to the objective. It is the quality or lack of quality of any product, service, experience, or asset that determines its value. The concept of quality includes both definite properties such as characteristics and indefinite traits such as taste.

Basically, it is an assessment of a specific item’s quality. Technically speaking, it is conformance to requirements. For better understanding, consider a few examples such as product quality, service quality, or quality of life. 

Quality control (QC)

It is a part of QMS that refers to fulfilling the quality demands of a particular product. QC focuses on testing and inspection.

Quality assurance (QA)

It is also a part of QMS that gives assurance of meeting the quality requirements. QA is a tool that enhances quality processes to achieve intended results. It considers internal and external management including agencies, governments, third parties, etc. 

Quality management system

In any organization, a quality management system is a collection of policies, procedures, and processes that are used to plan and deliver (production/service/development) products and services. For ISO compliance, it is a must-have attribute.

Process

It is a task of transforming inputs into outputs by utilizing necessary resources. 

Sometimes, process and procedure might sound familiar. But there is a subtle difference between both the terms.  The process is an activity to convert raw material into finished goods, while the procedure is a set of instructions to carry out the process.

Scope

An area of application that describes the objectives and requirements of the process is known as a scope.  Each project or assignment revolves around its Scope. Usually, this is what your project is supposed to accomplish (deliverables). In terms of product scope, it is the core product or instrument to be created and delivered to the customer or end-user.

Inspection

It is a phenomenon that verifies compliance with specific requirements by checking, measuring, or testing the product or service features. Inspection exists primarily in three phases: Pre-process (raw material inspection), in-line, and Post-process. These phases can be divided into various stages according to the requirement analysis. 

The inspection involves using and handling various tools, instruments, and software. For instance, calipers, gauges, tapes, cameras, microscopes, etc. 

Vernier Caliper used in the inspection of ISO 9001
Vernier Caliper: An example of the inspection tool

Audit

Auditing is a method of assessing the effectiveness of the QMS for pinpointing risks and verifying adherence to requirements. The effectiveness of the audit depends on the collection of specific evidence. In the event of non-conformity, corrective and preventive action is taken. 

Generally, audits are conducted after particular planned intervals, also known as internal audits. This amazing approach to auditing allows you to document planning, execution, completion, NCs, etc. 

An illustration of an audit report

Conformity vs Non-conformity

Conformity is adherence to specific standards or rules, while non-conformity is a deviation from a specific norm. Simply put, non-conformity is a process that fails to accomplish the intended purpose. On the other hand, conformity brings out the expected result.

Defect

A defect is a type of imperfection or fault caused due to man, machine, material, and environment. Here are some important reasons:

  • Process disorder
  • Lack of proper planning, resources, or services
  • Inappropriate analysis of customer demands
  • Wrong setup/calibration/technology
  • Material shortage
  • Variation due to design or manufacturing errors
  • Miscommunication 
  • Absence of vision and mission
  • Humid factory settings

These are the few categories causing errors. 

Standards

A standard is a collection of practices, methods, systems, conditions, or specifications set by industry advisory groups that assist manufacturers in performing and sustaining product quality consistency.

Improvement

In an organization, quality improvement refers to unrelenting efforts put in by everyone to enhance every aspect of their work, especially the vital processes. It is an organized strategy of erasing or reducing rework, scrap, and defeats in production.

Continuous improvement in iso 9001:2015

Kaizen, or continuous improvement, refers to finding ways for streamlining work and reducing waste. Industries are implementing various tools such as PDCA, root cause analysis, lean methodology, and many others. Continuous improvements are made in the development of services, products related to services, and products under development. This also applies to the established and implemented processes.

Continual improvement

This approach is replicated and paused between repetitions to accomplish continuous improvement. In this system, improvements are made in phases, followed by a break to evaluate and analyze the results, then improvements are made again. 

Continual improvement aims to improve existing systems to get better results. Whereas continuous improvement is a chain link to continual that emphasizes short/little modifications within a system rather than huge advancements.

Compliance

It is an act of adhering or conforming to specified rules, regulations, or policies.

Efficiency vs effectiveness

Efficiency is a way to determine how well resources are used to acquire a particular outcome. In simple terms, it is the ratio of input to output.   

KPIs (key performance indicators) are defined to measure the success rate of any process. For efficiency, KPIs are:

  1. Productivity
  2. Energy expense per yield  
  3. Overall equipment effectiveness (OEE)

Effectiveness relates to the extent to which scheduled actions are completed, and intended outcomes are reached.

KPIs of effectiveness consist:

  1. Quality rating
  2. Occurrences of non-compliance per year
  3. On-time delivery
  4. High customer satisfaction index

Customer satisfaction

Customer satisfaction measures how many clients/customers are delighted with what a firm offers (products or services) while surpassing specified satisfaction objectives. It is crucial for maximizing customer lifetime value, stopping client churn, and assuring good brand orientation.

Corrective action

An appropriate corrective action plan (CAP), known as corrective action, involves taking steps to identify a problem’s root cause and creating a solution to prevent its recurrence by modifying it. The goal is to prevent problems from recurring within an organization by improving its processes. It not only mitigates damage caused by a failure but also corrects the problem permanently. 

Preventive action

As the name suggests, preventive action is a method of eliminating causes that could cause danger or undesirable situations. This enables you to fix a problem, risk, or flaw in a system.  The organization may also take measures to improve its roadmap or position. Also, a company should have controls to confirm preventive actions are in place and functioning.

Leadership in ISO 9001:2015

Typically, leadership is defined by characteristics, qualities, and conduct. The structure and direction of an organization and the behavior of leaders play a vital role in the effectiveness of a quality management process. Leaders entrust and help employees throughout the organization in their quest for excellence.

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