ISO:9001 is a globally recognized international standard that defines requirements for how an organization establishes and maintains an effective Quality Management System.
ISO 9001 serves as a framework for businesses of all sizes and industries to enhance customer satisfaction, improve operational efficiency, and achieve continual improvement.
In this article, we will introduce ISO 9001, its origins, what it is (and what it’s not), and what certification means.
In this article we’ll be covering:
- What is ISO 9001
- What are the characteristics of ISO 9001
- What ISO 9001 isn’t
- How is ISO 9001 structured?
- Why get an ISO 9001 certification?
- How ISO 9001 underpins your business
- ISO 9001 and the customer
- Benefits of ISO 9001 Certification
- How to get ISO 9001 Certified
- Common Pitfalls and Challenges in ISO 9001 Implementation
What is ISO 9001
For those of us who have been in and around industry, we’re likely to have some acquaintance with 9001.
For starters, ISO 9001 is everywhere. There are around 2,000,000 organizations around the world that are ISO:9001 certified, and in some cases, it has become necessary within some industries (and by some industry partners if you want to trade with them).
The standard has been updated a few times, and you’ll often see 9001 referred to as ISO 9001:2015, with 2015 representing the last update of the standard.
How is ISO 9001 structured?
ISO has several sections:
- Scope: This defines the applicability of ISO 9001 requirements.
- Normative References: Mandatory external documents for ISO 9001 compliance.
- Terms & Definitions: Clause 3 covers terminology and how it relates to the standard.
- Organizational Context: Clause 4 covers the context of the organization, such as processes, work instructions and related documents.
- Leadership: Clause 5 covers leadership responsibilities.
- Planning: Clause 6 covers your Organizational Quality Management System and how it addresses things like risks, opportunities, changes and objectives
- Support – Clause 7 addresses resources for documented information
- Operation – Clause 8 refers to planning and control of product and service needs from design, production, and release
- Performance Evaluation – Clause 9 refers to monitoring, measuring and evaluating your quality management system
- Improvement – Clause 10 focuses on continual improvement. Identify opportunities, address nonconformities, and enhance quality management system.
These clauses have sub-elements that reference specific aspects of your business management system.
For example, clause 8.2 references your customers and interactions there.
Leadership also plays a crucial role in ISO 9001.
Leadership must endorse and actively participate in quality management, ensuring resources are allocated for implementation and maintenance. Leadership establishes policies and objectives reflecting commitment to customer requirements and continual improvement. They foster a culture of quality, encouraging communication, employee involvement, and recognition of contributions to quality improvement. Regular monitoring and review of the Quality Management System (QMS) are essential for effectiveness and improvement. Leadership’s commitment and support are vital for the successful implementation and maintenance of the QMS, driving continual improvement and enhancing customer satisfaction.
What are the characteristics of ISO 9001?
ISO:9001 has several key characteristics:
- International Standard: ISO 9001 is developed and published by the International Organization for Standardization (ISO), an independent, non-governmental organization based in Geneva, Switzerland.
- It focuses on Quality Management: ISO 9001 specifies requirements for a quality management system (QMS) that organizations can utilize to establish their ability to repeatedly supply products and services that meet customer and regulatory requirements.
- It is applicable across industries: ISO 9001 is applicable to organizations of all sizes and industries, including manufacturing, services, healthcare, education, and more.
- It has a keen interest in continuous improvement: The standard emphasizes the importance of continual improvement, encouraging organizations to regularly assess and improve their processes and procedures to enhance efficiency and customer satisfaction.
- It has a strong Customer Focus: ISO 9001 places a strong emphasis on customer satisfaction by requiring organizations to understand and meet customer requirements and strive to exceed customer expectations.
- It is part of a Certification Process: Organisations can voluntarily seek ISO 9001 certification by undergoing an audit conducted by an accredited certification body. Achieving certification demonstrates an organization’s commitment to quality management.
- It includes Risk-Based Thinking: The latest version of ISO 9001, revised in 2015, introduced a risk-based approach to quality management, encouraging organizations to identify and address risks and opportunities that could affect the achievement of quality objectives.
- It requires Leadership Involvement: ISO 9001 emphasizes the importance of leadership involvement and commitment to quality management, requiring top management to demonstrate leadership and actively promote a culture of quality within the organization.
- It needs Documented Information: While the standard is flexible and does not prescribe specific documentation requirements, it does emphasize the importance of maintaining documented information necessary for the effectiveness of the QMS.
- It has a Global Adoption: ISO 9001 is one of the most widely adopted ISO standards globally, with millions of organizations certified across numerous countries showcasing its significance in enhancing organizational performance and customer satisfaction.
What ISO 9001 isn’t
Many people starting out on the ISO 9001 road sometimes get confused that 9001 is something that it’s not.
ISO isn’t:
- A product or service that can be bought or sold.
- It is not a specific set of procedures or instructions dictating how to achieve quality.
- It’s not a guarantee of product or service excellence, nor does it eliminate the possibility of errors or defects.
- It isn’t a one-time achievement; it requires an ongoing commitment to continual improvement and compliance with its principles.
- It’s not exclusive to certain industries or sectors; it can be applied to any organization seeking to enhance its quality management processes.
Why get an ISO 9001 certification?
Organizations (including many different types of businesses from manufacturing, service, and public sector) seek ISO 9001 certification in order to demonstrate excellence in quality management, credibility, efficiency, cost savings, international trade opportunities, and continuous improvement demonstration.
Fundamentally, having ISO 9001 certification demonstrates to a potential customer that the organization has strong internal processes and controls in order to deliver a premium service to its customers.
It demonstrates that
- The company has a joined-up approach throughout its business
- Focuses on customer requirements
- Adheres to regulatory standards,
- Delivers products and services that either meet or exceed expectations.
- Consistently apply continuous improvement practices to their business.
How ISO 9001 underpins your business
One way to consider the concept of ISO 9001 is that of your business support structure.
I’ve heard the analogy before of ISO being like the pillars that support a bridge. Each pillar represents aspects such as:
- Planning
- Leadership
- Processes
- Control of activities
- Improvement
These pillars underpin the bridge, keeping it stable. Ignore a pillar, and the bridge becomes weaker.
Like a bridge, ISO needs to be maintained; all areas need to be looked after in order for the business to be maintained, protecting the organization’s performance and reputation.
I think this is a super analogy and one I often use with clients when talking about how ISO can be applied.
ISO 9001 and the customer
A further aspect of ISO 9001 is that it is inherently customer-centric.
ISO focuses on some key areas:
- Customer input: Quality Management Systems (QMS) often incorporate mechanisms for gathering and analyzing customer feedback, ensuring that products and services align with customer needs and expectations.
- Customer focus in processes: QMS frameworks prioritize customer satisfaction throughout various processes, from design and development to delivery and support, ensuring that customer needs are considered at every stage.
- Continuous improvement: QMS emphasizes a culture of continuous improvement, where customer feedback and satisfaction metrics are used to drive enhancements to processes, products, and services.
Benefits of ISO 9001 Certification
I’ve often been asked, “What’s in it for me?” when talking to leadership around 9001. Many unfortunately see it as an unnecessary burden or a cost of doing business without actually properly understanding the many benefits that it offers, including:
- Enhanced credibility and trust: ISO 9001 certification boosts credibility and trust among stakeholders, nurturing better relationships with customers and partners.
- Improved operational efficiency: Certification drives operational efficiency through process streamlining and waste reduction, resulting in significant cost savings.
- Expanded business opportunities: ISO 9001 opens doors to new business prospects, especially in global markets where certification is often mandatory.
- Cultivation of continuous improvement: Certification promotes a culture of continuous improvement, enabling organizations to adapt and thrive in evolving business landscapes.
- Commitment to quality excellence: Ultimately, ISO 9001 certification demonstrates a dedication to quality excellence, bolstering competitiveness and positioning organizations for long-term success.
How to get ISO 9001 Certified
The primary focus for most when looking at 9001 is how do I get my company certified?
The first key thing which I can’t stress enough is to get appropriate help.
Find a competent organization that can help you through the process, someone with experience and a proven track record who not only understands the certification process but how ISO can add value to your organization.
That latter part is crucial; lots of people can get you certified, but few will understand how to apply it and improve your business.
ISO 9001 is not merely a box-ticking exercise.
Some thoughts here:
- Assess a number of partners
- Get references
- Talk about your business with them before hiring them – talk about your objectives
- Choose someone that gets your vision,
- Choose someone who understands your industry
Of course, you can do it yourself, but if you lack experience, you might miss something crucial and fail your certification audit. The result is likely to cost you time and money.
Obtaining certification can be broken down into a series of steps:
- Gap Analysis: Assess your current processes, procedures, and documentation against the requirements of ISO 9001 to identify gaps that need to be addressed.
- Develop Quality Management System (QMS): Establish or update your QMS to meet the requirements of ISO 9001. This includes defining quality policies, objectives, processes, and documented procedures.
- Training and Awareness: Provide training to employees on the requirements of ISO 9001 and their roles within the QMS to ensure understanding and compliance.
- Implementation: Implement the QMS throughout the organization, ensuring that processes are followed consistently and documented information is maintained as required.
- Internal Audit: Conduct internal audits to assess the effectiveness of the QMS and identify areas for improvement.
- Management Review: Hold management reviews to evaluate the performance of the QMS, review audit results, and make decisions regarding improvements and resource allocation.
- Corrective Actions: Address any non-conformities identified during internal audits or management reviews through corrective actions to prevent recurrence.
- Pre-certification Audit (Optional): Some organizations choose to conduct a pre-certification audit to assess readiness before undergoing the formal certification audit.
- Certification Audit: Engage an accredited certification body to conduct a formal certification audit of your QMS to determine compliance with ISO 9001 requirements.
- Certification Decision: Based on the results of the certification audit, the certification body will decide whether to grant ISO 9001 certification.
- Maintain Certification: Once certified, maintain compliance with ISO 9001 requirements through regular internal audits, management reviews, and continual improvement activities.
Common Pitfalls and Challenges in ISO 9001 Implementation
As I’ve alluded to already – implementing 9001 isn’t without its challenges, some of which include:
- Resistance to change, as the business may be reluctant to adopt new processes or procedures.
- Inadequate leadership support and commitment
- Resource constraints, such as insufficient training or staffing, may impede progress.
- Focusing solely on documentation rather than practical application.
- Misalignment between ISO 9001 requirements and organizational goals or culture.
- Maintaining momentum and enthusiasm for continuous improvement beyond the initial implementation phase.
Summary
ISO 9001 is a globally recognized standard.
It embodies a systematic approach to quality management, providing a framework for organizations to enhance customer satisfaction, streamline processes, and drive continual improvement.
At its heart lies a customer-centric ethos, where meeting and exceeding customer expectations are paramount.
By adhering to ISO 9001 standards, businesses not only bolster credibility but also cultivate a culture of excellence and efficiency.
Through structured processes, risk-based thinking, and leadership commitment, ISO 9001 fosters resilience and adaptability in today’s dynamic business landscape.