Why we need ISO 9001

Quality! Who does not want it. We read through hundreds and thousands of reviews each day just so we can buy a quality product or service. Even those searching for an ISO 9001 training are looking to identify a training provider that will provide a quality training. ISO 9001 is an international standard set by the International Organization for Standardization (ISO) that defines the framework for a quality management system. Organizations looking to deliver a quality product or service can use the framework to build a management system that helps them attain this goal.

So why do we need ISO 9001? Why not rely on this framework of reviews. After all many people have not even heard of ISO let alone ISO 9001. However, those who relied on reviews will find that they are not a sure-shot formula to guarantee success in decision making. ISO 9001 also need not necessarily guarantee this. However, ISO 9001 is not meant for the customer but for the organization implementing it. While it is centered around the customer requirements, with a focus on the customer, the benefit is to the organization implementing it. ISO 9001 training provides an in-depth overview of the standard and how it is to be implemented.

ISO 9001 has come to signify a global base minimum for a quality management system. Inherent in the certification that customers see is a commitment from the organization to continually improve, to identify and segregate non-conforming outputs and to design controls to ensure the process can deliver per requirements. An organization purchasing from another half way around the world has some level of confidence now. ISO 9001 training will demonstrate that ISO themselves say don’t just rely on certification. Determine the type and extent of control on the outsourced provider based on their impact to your processes.

ISO 9001 training can be tailored for all levels of the organization. For management who want to understand their role in the system as also why they should spend the money and invest in it. The workforce wants to understand how it benefits them and why they should adapt to the changes as they take place. Auditors need to understand the interpretation so they can assess if the system is being well run. So while an organization may not need ISO 9001 certification they can surely benefit from ISO 9001 and ISO 9001 training.

QMII provides ISO 9001 lead auditor training in a unique format that allows all levels of the organization to sit in on the same class and to leave as and when their relevant section is complete. Join us in a class and learn more about what ISO 9001 can do for you.

How is ISO 13485 different from ISO 9001

ISO 13485 released an updated version of the standard in 2016 but it broke ranks with ISO 9001. In the past the two standards were aligned with the ISO 13485 capturing the additional requirements for the medical device industry. An ISO 13485 overview would reveal that it has retained a lot of the documentation requirements and not left the standard as subjective as the revised ISO 9001:2015.
ISO 13485 provides the requirements for quality management systems for use by the medical device industry. While it still remains broadly based on the framework set by ISO 9001 compliance with the standard will not inherently mean compliance with ISO 9001. The standard is published by ISO, an international organization. It is assessed by certification bodies across the globe accredited by IAF.
ISO 13485 overview of the standard will show much more in-depth requirements for rick management. This essentially aligns with the US CGMP regulations as also regulations by international bodies. The standard for further assessing risk is ISO 14971 which specifically deals with risk within the medical device industry. In dues course the US CFRs will get aligned with ISO 13485 and plans are underway for the update.
As a part of risk management of the systems companies will now have to assess add address the risks from outsourced processes, Lack of competent personnel, lack of adequate number of personnel, loss of traceability, failure in testing of the products at relevant stages, Failure to timely address non-conformities, and the documentation of risk itself. Management need to keep an ISO 13485 overview of their system through the planned management reviews and periodic internal audits. To ensure audits add value these must be conducted by trained and competent personnel.
QMII’s ISO 13485 lead auditor training prepares your personnel to not only effectively audit the system but also implement it as needed. An ISO 13485 overview version of the course is also available for senior management, so they understand their roles and responsibilities with respect to the standard. Having discussed this the question often arises if ISO 13485 is mandatory. As with all other ISO standards it is not mandatory to implement ISO 13485 though it is mandatory to meet regulatory requirement such as CFRs and EU MDR. However, implement ISO 13485 provides confidence to customers that the organizations uses a process based approach to continual improvement.
ISO 13485 overview of the standard demonstrates that product quality cannot be guaranteed just from implementing the standard but that it must be vigorously used. The standard can also be applied to all sizes of organizations.

ISO 9001:2015 – Exclusions

Exclusions to what an organization does were integral to the ISO 9001 standard prior to the 2015 version update. After all an organization cannot do all the work. Clause 7.1.1 lays the foundation on this thought by accepting that an organization must determine and provide resources. In doing so it determines the constraints and capabilities of the existing resources and what needs to be obtained from external providers. As such in previous standards, the organization, when seeking certification, requested exclusion on those processes that it did not perform.

The drawback of this was a major flaw. Over the period of time, some of these organizations, sheltered under the exclusion provision even lost the ability to pick the correct outsourced party! For example, if the organization builds highways, but outsources bridges and tunnels, then it must have the ability to be able to pick the correct vendor/ contractor who will not let the customer down. The revised 2015 version of the standard therefore in the wisdom of TC-176, removed this exclusion provision. It does not imply now the organization cannot outsource what it does not do. All that it means that the organization can review the applicability of the requirements based on its size, complexity and decide on the activities it needs to outsource.

With the exclusion provision removed, the organization would need to do due diligence in appreciating the range of its activities and the risks and opportunities it encounters as also the effect if any of the outsourced vendors not performing to accepted requirements. The organization then remains accountable for the outcome of the outsourced processes and products and services externally obtained. To ensure their consistency and levels of acceptance, it would need to take measures as required by clauses 8.4.1, 8.4.2, and 8.4.3 of the ISO 9001 in enforcing monitoring and measuring to protect its customer and clients.

This assurance that an organization can not and will not outsource those activities which by its decision will not result in failure to achieve conformity of products and services. Clause 4.3 of ISO9001 in determining the scope of the quality management system clearly requires that conformity to the ISO 9001 can only be claimed if the requirements determined as not being applicable do not have an adverse impact on the promises made by the organization. The products it provides, based on externally obtained subproducts or services must not affect customer satisfaction.

In terms of auditing, it is incumbent upon auditors that they carefully seek conformity to this requirement when auditing. Internal audits to ISO 9001 must provide the objective inputs to top management to make better decisions and appreciate the risks of outsourcing to nonperforming and or underperforming outside organizations, remembering they remain accountable and answerable for the final product or service. Ensuring the organization’s accountability for the conforming products and services whether outsourced or not is the responsibility of the organization.

QMII’s ISO 9001 EG (Exemplar Global) certified lead auditor training designed carefully to meet the objectives as envisaged in the standard.


In the past year there has been a lot of activity in the development and revision of ISO standards. Highlighted below are a few key updates:

ISO 41001 – Facility Management

This new standard applies the concept of the Plan-Do-Check-Act cycle to the discipline of Facilities Management. This standard provides the requirements for a facility management system where an organization needs to demonstrate effective and efficient delivery of services. The standard is aligned with the High Level Structure adopted by ISO thus ensuring easier integration with other standards. Benefits of implementing this standard, per ISO, include improved productivity, communications, service consistency and costs benefits.

ISO 19011 – Guidelines for Auditing

ISO 19001 has become the primary guideline for all audits conducted globally. The FDIS was recently cleared and the updated revision is due to be published in July 2018. One of the main changes lies in the new auditing principle “Risk-based approach: an audit approach that considers risks and opportunities. The risk-based approach should substantively influence the planning, conducting, and reporting of audits in order to ensure that audits are focused on matters that are significant for the auditee and for achieving the audit program objectives.” This approach is evident in all the clauses of the standard which not follows the High level Structure. We will further update our readers as the standard is published.

ISO 9004 – Guidance to achieve sustained success

The standard has been updated to reflect the guidelines to achieve sustained success of and ISO 9001:2015 QMS. Per ISO, factors affecting an organization’s success continually emerge, evolve, increase or diminish over the years, and adapting to these changes is important for sustained success. The document addresses systematic improvement of overall performance and includes a self-assessment tool for reviewing the extent of conformity by the organization.