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The ISO 9001:2015 is a global standard that describes what a Quality Management System (QMS) should look like. It serves as a guide to help organisations provide quality products and services constantly and meet customer’s needs, while increasing the efficiency of their operations.
In turn, implementing ISO 9001:2015 has many advantages such as improved performance, customer confidence and competitive edge. In doing so organisations can regulate processes, manage risks systematically and show commitment to quality thus resulting in more business achievement and improved brand loyalty.
This blog post seeks to delve into the details of ISO 9001:2015 by outlining its merits as well as fundamental elements that should be taken into account when applying for certification.
Ready to transform your business through ISO 9001:2015?
Download our free guide “3 Key-Steps To Implementing An Iso 9001:2015 Quality Management System” for an outlined approach to implementation.
Understanding ISO 9001:2015
The ISO 9001:2015 standard is designed to be universally applicable. This means it can be implemented by any organisation, regardless of its size, industry, products or services offered. The standard provides a framework for establishing and maintaining a Quality Management System (QMS) that focuses on:
- Consistent product or service delivery: Ensuring that products or services meet customer and regulatory requirements.
- Enhanced customer satisfaction: Implementing processes to understand and meet customer needs.
- Continual improvement: Fostering a culture of ongoing improvement within the organisation.
When organisations are implementing ISO 9001, they have to define, in line with the standard, where their QMS starts and stops. They will have to spell out which products, services and processes that are covered by this system.
There must be a detailed description of the scope of the QMS. This document lays down the perimeter for the Quality Management System, hence it is vital to have it written down as per ISO 9001:2015 requirements.
If some part of this norm is not applicable to entities, then this should be outlined in the QMS scope statement so that it could explain why some clauses or parts do not apply. On the other hand if there is any possibility of applying a clause then it becomes necessary that such a clause should be applied. Besides, when an intentional omission leads to reducing customer satisfaction or risking legality compliance then such a clause cannot be excluded.
Key considerations when determining the scope of your QMS:
- Products and services: Clearly outline the specific products or services within the scope of the QMS.
- Geographical locations: Specify the locations covered by the QMS.
- Exclusions: Justify any processes or activities that are excluded from the QMS.
- Customer and regulatory requirements: Ensure the QMS addresses relevant customer and regulatory expectations.
The boundary/scope may be defined in terms of organisational structure.
For example, the organisation may decide to install a QMS into a single department, or a business unit.
Its description may explain which part of the management structure has accountability, authority and responsibility over the selected QMS by defining the part of the organisation chart that is included.
The boundary/scope may be defined in terms of geographic boundary.
For example, the organisation may choose to install a QMS on a particular site, or in a specific factory.
The scope description may therefore be by way of a site plan.
The boundary/scope may be defined in terms of business processes.
For example, the organisation may:
- abstract raw material,
- beneficiate the material to produce products,
- distribute and store its products, and
- sell them through a retail network.
The scope of the system may define the boundary to only include the processes within the benefaction key process.
The boundary/scope may be defined in terms of products.
For example, the organisation may produce several ranges of products but choose to control the production of a subset of these many ranges.
This definition within the scope is mandatory.
By carefully defining the scope, organisations can effectively tailor ISO 9001 to their specific context and achieve the desired benefits.
The History of ISO 9001
In the 1980s, ISO 9001 was established as a way of standardising quality management systems worldwide. It has gone through several revisions to keep pace with changes in the business environment. The 2015 is a major update from the previous ones and emphasises more on leadership, risk and customer satisfaction. Afterwards, there were some minor updates in 2018 and its next review is expected sometime around 2025 to include emerging issues such as sustainability and digital transformation.
Read more: Navigating Quality Management: The ABCs of ISO 9001:2015
Benefits of having an ISO 9001:2015 Management System
Enhanced customer satisfaction
By focusing on understanding and meeting customer needs, businesses can deliver superior products and services. This leads to increased loyalty, a positive reputation, and long-term business success.
Improved operational efficiency
Through a QMS, organisations can identify inefficiencies, reduce waste, and boost productivity. Continual improvement is encouraged, leading to better products, services, and overall performance.
Increased market opportunities
Having an ISO Certification is usually necessary to conduct business in markets or, with clients particularly in cases where quality and compliance are crucial. It demonstrates a company’s dedication to excellence and alignment with standards. This paves the way for exploring market prospects and drawing in clientele. Moreover, obtaining ISO certification bolsters the organisation’s standing and trustworthiness making it more attractive to investors thereby gaining a competitive edge.
Better risk management
The ISO 9001:2015 standard focuses on the importance of considering risks urging companies to recognize, evaluate and address risks and opportunities that affect their Quality Management System (QMS) and overall business performance. This proactive approach to risk assessment helps in predicting issues and proactively taking actions reducing disruptions. It enables organisations to be prepared for opportunities by anticipating their occurrence in advance. By managing risks companies ensure operations safeguard their interests and instil trust, among customers and stakeholders.
Ready to transform your business through ISO 9001:2015?
Download our free guide “3 Key-Steps To Implementing An Iso 9001:2015 Quality Management System” for an outlined approach to implementation.
Key Terminologies in ISO 9001:2015
Quality Management System (QMS)
A Quality Management System (QMS) is a structured framework of policies, procedures, and processes. Businesses implement these to ensure consistent delivery of products or services that meet customer and regulatory requirements. It’s a systematic approach to managing and improving quality throughout the organisation.
Risk-Based Thinking
Risk-based thinking involves identifying, assessing, and managing potential risks and opportunities that can impact the QMS. It requires proactive consideration of potential negative and positive outcomes, and taking steps to mitigate risks and capitalise on opportunities.
Continual Improvement
Continual improvement is a fundamental principle of ISO 9001. It refers to the ongoing process of enhancing organisational performance through systematic identification and implementation of improvements. It involves setting improvement goals, measuring performance, analysing results, and implementing corrective actions.
Core Elements of ISO 9001:2015
Context of the organisation
To understand the context of the organisation, it’s important to identify both internal and external factors that can affect the Quality Management System (QMS). This involves understanding the needs and expectations of interested parties, like customers, suppliers, and regulators. By assessing these factors, businesses can align their quality management efforts with their strategic goals, ensuring that their QMS stays relevant and effective.
Leadership
The Clause on Leadership, in ISO 9001:2015, emphasises the need for leadership and commitment of top management. This plays a pivotal role in driving and supporting the QMS. Top Management are responsible for establishing the quality policy, setting quality objectives, and ensuring that the QMS is integrated into the business’s overall strategy. Effective leadership also involves fostering a culture of quality, providing necessary resources, and engaging employees in quality management practices.
Planning
Planning involves defining how the QMS will achieve its objectives and addressing potential risks and opportunities. This includes setting quality objectives, planning actions to address risks and opportunities, and determining the resources needed to implement and maintain the QMS. Effective planning ensures that the QMS is proactive and capable of meeting both current and future challenges.
Support
Clause 7 looks at Support and covers the need for resources, infrastructure, and training required to implement and maintain the QMS. This includes providing adequate human resources, ensuring the availability of necessary equipment and communication opportunities, and managing documented information. Support also involves a culture of competence and awareness, ensuring employees have the knowledge and skills to contribute effectively to the QMS.
Operation
The clause on Operation focuses on the management and execution of processes that produce products or deliver services. This element involves planning, controlling, and monitoring operational processes to ensure they meet quality requirements and achieve desired outcomes. Effective operation management ensures that products and services consistently meet customer and regulatory requirements.
Performance Evaluation
A key clause of the standard is on Performance Evaluation. This involves monitoring, measuring, analysing, and evaluating the effectiveness of the QMS. It emphasises the need for conducting internal audits, assessing customer satisfaction, and analysing performance data to identify areas for improvement. Performance evaluation provides insights into the QMS’s effectiveness and helps ensure that it is functioning as intended.
Improvement
The requirement for Improvement is a continual process aimed at enhancing the QMS and its performance. This involves identifying opportunities for improvement, addressing non-conformities, and implementing corrective and preventive actions. A focus on continual improvement helps organisations adapt to changing conditions, enhance customer satisfaction, and achieve better overall performance.
Context of the organisation in ISO 9001:2015
Understanding your organisation and its context
Analyse your internal operations, culture, and external factors like the market, economy, and regulations to identify potential opportunities and challenges.
Understanding the needs of your Interested Parties
Identify the needs and expectations of your stakeholders, including customers, employees, suppliers, and regulators.
Establishing the Scope of Your QMS
Define the boundaries of your QMS by specifying products, services, locations, and exclusions while considering customer requirements.
Leadership and commitment in ISO 9001:2015
Role of top management
Top management must demonstrate commitment by setting quality policies, allocating resources, and promoting a customer-focused culture.
Leadership principles
Successful leadership in a QMS emphasises customer focus, employee engagement, continual improvement, risk management, and data-driven decision-making.
Roles and responsibilities
Clear roles and responsibilities must be defined by top management, outlining quality management teams, process owners, employees, and internal auditors to ensure the effectiveness of QMS.
Planning in ISO 9001:2015
Addressing risks and opportunities
Organisations must identify, assess, and address potential risks and opportunities that could impact the QMS and its ability to achieve its intended outcomes.
Setting quality objectives
Setting clear, measurable, and achievable quality objectives aligns the business’s efforts with its overall goals and achieving customer satisfaction.
Support in ISO 9001:2015
The Support clause of ISO 9001:2015 outlines the essential elements for operating an effective QMS. Resource management ensures the availability of necessary resources such as personnel, facilities, equipment, and information.
This clause emphasises the need for competence and awareness. This focus ensures that employees have the skills and knowledge to perform their roles effectively. It also emphasises the need for communication and sharing of information across the organisation.
Lastly, documented information provides the foundation for the QMS, outlining processes, procedures, and records. These elements collectively support the overall effectiveness of the QMS.
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Operations in ISO 9001:2015
The Operations clause outlines how an organisation delivers its products or services. Operational planning and control ensure processes are managed effectively to meet requirements.
Requirements for products and services specify customer and regulatory needs. Design and development focus on creating products and services that meet these requirements.
Finally, control of externally provided processes ensures that outsourced activities comply with the QMS.
Performance Evaluation in ISO 9001:2015
Performance evaluation ensures the QMS is operating effectively. Organisations must monitor, measure, and analyse data to understand system performance. Internal audits assess conformance to the standard and identify improvement areas.
A management review evaluates the QMS’s overall effectiveness, sets objectives, and makes necessary changes. This cyclical process drives continual improvement.
Improvement in ISO 9001:2015
The improvement clause focuses on enhancing the QMS. The clause contains detail on nonconformity and corrective action activities. These apply for instances where the QMS (or a part thereof) doesn’t meet requirements, ensuring corrective actions are implemented to prevent recurrence.
Continual improvement is the ongoing process of enhancing organisational performance through systematic identification and implementation of improvements. This includes setting improvement goals, measuring performance, analysing results, and taking corrective actions.
Implementing ISO 9001:2015 in Your Organisation
- Gap analysis: Assess your business’s current practices against ISO 9001 requirements.
- Scope: Define the scope of your quality management system.
- Process mapping: Identify and document core processes.
- Documentation: Develop necessary policies, procedures, and work instructions. Ensure you implement a method for document control.
- Training: Educate employees on ISO 9001 principles and their roles in the management system.
- Internal auditing: Conduct regular internal audits to assess conformance.
- Management review: Evaluate the QMS’s performance and effectiveness.
| Resistance to change | Address through effective communication and employee involvement. |
| Time and resource constraints | Prioritise tasks, allocate resources efficiently, and consider external support. |
| Documentation burden | Identify what is needed. Use document management tools and templates. |
| Balancing compliance with business needs | Align the QMS with organisational goals. |
Certification process
ISO 9001:2015 Certification
Certification of your ISO 9001:2015 Quality Management System brings many benefits including: increased credibility and recognition, access to new markets and increased efficiency and competitiveness. ISO Certification demonstrates a commitment to quality and customer satisfaction, thereby potential increases in revenue and continual improvement on processes can be achieved.
To achieve system certification, an organisation needs to implement a robust QMS and have a verification assessment carried out by an accredited Certification Body, such as our sister company Wynleigh International. Technically, a Certification Body is called a Conformity Assessment Body.
ISO Certification is for three years and comprises complete Audits. There are specific rules which an accredited Certification Body has to follow, ISO 17021-1 is one such rule, as per which stage1 & stage2 audits are to be done for getting certification.
Stage 1 audit, to verify the organisation’s readiness and confirm the accuracy of information that was planned by the CB and will receive a report to guide them in their readiness.The Certification Body conducts the stage 2 audit to confirm the conformity of the management system under the chosen standard. Upon closure of major nonconformities, the system is considered conforming, and a certificate of conformance is issued, valid for 3 years.
After certification, periodic surveillance audits are conducted to ensure ongoing conformity of the management system, with a report provided for each audit. A recertification audit takes place before the certificate’s expiry date to confirm the organisation’s continued certification status.
Each subsequent three-year cycle follows the same process.
Choosing a certification body
Selecting the right certification body is crucial for successful ISO 9001:2015 certification. Although price and BBBEE may play a role, selecting a Certification Body should focus on the full value proposition. Key considerations for choosing a certification body include:
Accreditation
Choose a Certification Body accredited by an IAF member for the most credible ISO Certification results. Not all Certification Bodies are accredited, which might leave your Certification outcome wanting more. This also limits the recognition of your certification.
Auditor competence and credentials
It is critical that the correct auditors are used and can demonstrate relevant competence. By selecting a Certification Body with independently certified auditors, you are offered an additional layer of assurance that the certification process is credible.
Reputation and customer feedback
Research the Certification Body’s reputation and read client testimonials. Seek references from a third party. Start by considering who the key stakeholders may be concerning your chosen ISO Management System Standard.
Remember, while cost is a factor, it shouldn’t be the sole determining factor. A reputable certification body can provide valuable guidance and support throughout the process.
Maintaining certification
Preserving your ISO 9001:2015 certification demands ongoing commitment to your Quality Management System. Regular surveillance audits by the certification body are essential to verify continued compliance.
Internal audits, corrective action implementation, and management reviews are critical for identifying and addressing potential issues. Keeping documentation updated and employees trained is also vital.
A proactive approach to improvement, including setting clear objectives and measuring performance, is key to demonstrating ongoing commitment to quality. By consistently upholding these practices, organisations can sustain their certification and reap its benefits.
Ready to transform your business through ISO 9001:2015?
Download our free guide “3 Key-Steps To Implementing An Iso 9001:2015 Quality Management System” for an outlined approach to implementation.
If you are looking to dive further into the world of ISO 9001:2015, contact Risk ZA. We have a myriad of services that can assist you with achieving your Quality Management System goals. Call us at +27 (0) 31 569 5900 or +44 (0) 203 728 6179, or send an email to enquiries@riskza.com
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