Everything You Need to Know About ISO 9001 Quality Management System

What is ISO 9001?

ISO 9001 is a global industry standard that specifies requirements and best practices for a quality management system (QMS). Implementing ISO 9001 in business operations ensures that products and services are quality and according to standards. The current ISO 9001 standard is ISO 9001:2015. It’s used by over a million organizations worldwide across all industries and sizes.

What is a Quality Management System?

A QMS is the documentation of an organization’s processes and plans for achieving quality objectives. It should be tailored to the organization and to the needs of its customers. An effective quality management system enables organizations to consistently deliver high-quality products, resulting in happier customers and better business overall.

Elements of a Quality Management System

Quality management systems have these nine elements:

Quality Policy and Quality Objectives

A quality policy is an official statement of the organization’s commitment to quality and its strategy for promoting, maintaining, and improving quality. To ensure alignment with quality policies, organizations set specific business goals or quality objectives. Both quality policies and quality objectives are standard requirements of ISO 9001.

An example:Quality Policy – Guarantee client’s satisfactionQuality Objective – Maintain at least 95% client satisfaction

Quality Manual

A quality manual is a document containing the rationale for implementing a quality management system and an overview of the organization’s quality procedures.

Organizational Structure and Responsibilities

For upper-level management, allocating a quality-focused responsibility to each member of the organization helps facilitate a smoother and more well-rounded QMS implementation. A simple Roles and Responsibilities (RACI) Matrix Template can help align each team member with their specific duties.

Data Management

Data management entails defining data sources, collecting data from these sources, organizing data collected, storing organized data for easy access, and analyzing them to find the insights needed for improvement.

Processes

Any process affecting the quality of products and services has to be monitored and assessed through the quality management system using tools like Turtle Diagrams.

Customer Satisfaction with Product Quality

To provide proof of customer satisfaction with product quality and demonstrate the organization’s ability to meet and exceed customer needs, it’s first necessary to figure out exactly how to measure customer satisfaction.

Continuous Improvement

One of the topics covered in ISO 9001’s approach is a requirement to drive improvement. In simple terms, organizations planning on getting ISO 9001 certified have to take concrete action toward improving quality.

Quality Instruments

A quality instrument is any machine or equipment built for testing products or aspects of its production against specific criteria. In the food industry, a temperature sensor can be considered a quality instrument since food often has to be stored at a certain temperature for its quality to be preserved.

Document Control

Though document control and data management are closely related, what makes document control different is that there is a greater focus on recordkeeping.

7 Quality Management Principles of ISO 9001

According to the ISO, implementing a quality management system will be much easier if the organization follows the 7 quality management principles. These 7 principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision-making, and relationship management. Know more about each below:

1. Customer focus – attracting and retaining customers by meeting, exceeding, and adapting to their needs

2. Leadership – unified direction and purpose across the organization, from high-level management to employees, a culture of internal collaboration

3. Engagement of people – staff should have sufficient training, support, and resources to do their job well.

4. Process approach – seeing activities as processes that connect and function within a system, ensuring that everyone is familiar with the organization’s processes and how it all works together to drive business

5. Improvement – sustaining an ongoing focus on improvement even as time goes on, being proactive when it comes to building innovation, and reacting to internal and external changes as they evolve and manifest in different ways

6. Evidence-based decision-making – establishing, measuring, and acting on quality metrics for greater ROI and efficiency

7. Relationship management – identifying and effectively managing key stakeholder and supplier relationships through an established plan

Quality Management Methods

TQM is a quality management method focused on combining the processes, systems, and strategies of an organization with customer-based definitions of quality through strong internal collaboration. Other well-known quality management methods are PDCA and 5 Whys for Lean, DMAIC and DMADV for Six Sigma, Kaizen, and Gamba Walk.

Types of QMS Standards

QMS standards can be divided into two types:

1. ISO 9000 series:

• • ISO 9001 – the main standard

  • ISO 9004 – for sustaining the ISO 9001 certified QMS

  • ISO 19011 – for auditing guidelines

2. Industry-specific standards:

• • ISO 13485 – For medical device manufacturing, distribution, servicing, and disposal. ISO 13485 certification is also a prerequisite for manufacturers that want to get certified for the Medical Device Single Audit Program (MDSAP).

  • IATF 16949 – Developed by the International Automotive Task Force (IATF) for the automotive industry. Members of IATF require their suppliers to be IATF 16949 certified.

Importance of ISO 9001 Certification

Here are the 5 benefits of having an ISO 9001-certified QMS:

Improve the Quality of Products and Services

As ISO 9001 certification requires an independent third-party audit, your processes will be well-scrutinized. Recommendations on how to further develop the quality management system of your organization will also be provided.

Meet the Requirements of Potential Business Partners

By meeting ISO 9001 requirements and getting certified, you can attract more business partners that are likely ISO 9001 certified themselves and expand into new markets.

Drive Customer Satisfaction

High-quality products and services delivered consistently bring customer satisfaction and loyalty to the forefront, creating a ripple effect that results in the business acquiring other clients and partnerships.

Leadership Engagement

By providing opportunities for leaders to identify gaps in performance and spearhead new initiatives to address them, ISO 9001 increases the organization’s overall efficiency.

Improve Company Culture

With roles, expectations, and company direction clearly defined, employees will perform better and be more professional at work. Getting ISO 9001 certified may also boost company morale as it is a worthwhile achievement and recognition of their efforts.

How to Get ISO 9001 Certification: A Step-by-Step Guide

To specifically get ISO 9001 certification, here are 6 steps to help you get ISO 9001 certified:

Step 1: Get Buy-in

Gather and agree on implementing a QMS at both management and staff levels. Clearly communicate the objective and purpose to staff (e.g. whether to improve overall efficiency, customer satisfaction, bid for new work, etc.)

Step 2: Gap Analysis

Conduct a gap analysis in order to find out to what extent your company is already meeting ISO 9001 requirements and where the emphasis of your implementation efforts should be.

Step 3: Planning

Once you have identified the gaps, sketch out and implement a project plan with key timelines, parties, deliverables and responsibilities. Draft your quality policy and align it with ISO 9001 standards.

Step 4: Implementation

Implement your ISO-aligned QMS in your organization. Make sure that all employees are aware of why the QMS is being implemented. An efficient QMS helps employees increase their productivity by allowing them to focus on the metrics that matter. Management should regularly review the business as a whole to ensure continual improvement.

Step 5: Internal Audit

Conduct internal audits to assess and sustain compliance with the implemented QMS. Use an internal audit checklist to gather information to determine if your QMS is effective and achieving quality objectives.

Step 6: Get Certified

Find a reputable independent certification body that will visit and perform site audits to determine if your company can be ISO 9001 certified. Check if the certification body uses the relevant CASCO standard.