ISO 9001 Beginner's Guide

ISO 9001 guide 2021年08月02日

If you are new to the ISO 9001 world, it is not the easiest subject to master. To this end, we have developed the ISO 9001 Basic Guide-an overview of every step of becoming an ISO 9001 certified organization.

The most recognized business improvement standard in the world


ISO 9001 is a standard issued by the International Organization for Standardization (usually referred to as ISO). Although ISO 9001 is related to quality management, ISO is also responsible for nearly 20,000 other standards related to all aspects of our lives. The standards formed and reviewed through global consensus aim to make cross-border transactions easier and establish global best practices in terms of quality, safety and efficiency. Whether it's related to receiving treatment in a hospital or using credit cards to purchase items, ISO standards often play a role in our lives, and we don't even realize it.


ISO 9001 is described as a quality management standard, but for most small businesses, it is also an effective standard for running a business. The standard defines the requirements for creating a quality management system (QMS) so that organizations can create a documented plan to provide service or product consistency.


This standard can be traced back to the late 1980s, when it was heavily oriented towards manufacturing. Revisions over the years have seen it become more versatile and therefore more relevant to more organizations of all types and sizes. Therefore, many organizations' first experience with the standard is as a bidding requirement. Especially in the supply chain bidding, it is stipulated to filter wheat from friction to ensure the continuity of quality from the main contractor to each subcontractor. This reduces reputation risk and maximizes the consistency of delivery.


The structure that allows your organization to thrive


If you read this article because ISO 9001 is a customer requirement, you may feel compelled, but you may be a little reluctant. However, it is worth remembering that implementing ISO 9001 also has real internal benefits. Knowing that your employees are all on the same page should not be underestimated (we will cover this in detail later in the next section).


For an organization to grow, its leaders need to have a strategic vision. This only happens when management is able to engage in business rather than continue to engage in business. Especially for smaller organizations, ISO 9001—through the creation of a quality management system—is a tool that helps define who does what, when, why, and how. This means that work can be delegated with confidence because the right people are doing the right work, freeing up time for leaders to focus on key strategic issues.


ISO 9001 requires you to ensure that employees are adequately trained in their roles and encourage interaction with your employees to identify opportunities for improvement. Using the plan, execute, check, act (PDCA) model, continuous improvement is the cornerstone of the standard. With this, the problem of inefficiency should be resolved quickly—as evidenced by the Harvard Business School and Dun & Bradstreet's research—customers benefit because you provide a consistently high level of service. In addition, if there is a problem, you can trace and solve the problem, whether it is a process problem or a personnel problem. It is fair to say that any well-run business is more efficient. By helping to better establish roles and responsibilities through ISO 9001, your employees will feel more motivated and capable when they leave. Therefore, standard certification not only helps to sign the latest potential contracts, but may be the difference between winning and retaining future business.


Getting employees to join is the key to the success of ISO 9001


Hopefully, by the time you read this article, you have realized that obtaining ISO 9001 is not as daunting as you initially thought. Although we would never think this is easy—the initial implementation will require you to rethink the way you manage your business—but it is simple. But like most things in life, the more you invest, the more you get. Therefore, if you want to benefit from the standards, interacting with your employees is very important. Your employees must agree with the reasons for implementing ISO 9001 and understand the benefits to them, your customers, and the entire organization. Their continuous investment and participation is crucial, so they will not lose motivation and commitment; we often see the responsibility on a person's shoulders, leading to stress and disappointment. To help the acceptance process and motivational speeches, we also provide training courses-internal and regional public courses. This type of training includes the first step to familiarize yourself with the standards and implement them through internal auditor training.


You can take ownership or use consultants to prepare for ISO 9001


Starting with a topic that may be a little confusing at first, a Google search sometimes adds to the puzzling world of ISO 9001! The search results will show certification agencies, consulting companies, and companies that provide software or templates that compete with Google’s real estate. Where would you start?


Choose a consultant

  • Do they have relevant qualifications?

  • Do they have reliable references?

  • Do they have industry experience?

  • How will the cost be calculated?

  • Are they financially stable?

  • Do they have insurance?


The answer depends on your motivation; do you want to be certified immediately due to pressure from existing or potential customers? Or do you have a more comprehensive view and hope to move forward as a more efficient and profitable organization? If time is tight, there are consultants who can help you complete the creation of the quality management system, which will largely relieve you of your responsibilities and required resources. This means you can continue what you have been doing. However, the disadvantage is that you may learn very little from experience and cannot benefit from internal improvements. However, if certification allows you to obtain short-term benefits from winning the contract, it is your decision. Hiring consultants will significantly increase project costs. However, in order to let you understand the problem you are facing, an experienced ISO consultant should be able to quote the package fee. We are happy to ask you to contact a local consultant to discuss this issue with you.


Do you need a consultant?


Larger organizations may want to use consultants for different reasons; to help you gain employee approval, and to assist in unavoidable internal audits to ensure that everything is going well. In addition, a good consultant will add value by using their experience to help overcome any problems or doubts. Of course, no one forces you to take a black and white approach. You can get certified quickly, and then take the time to take proactive actions after the certificate helps you win important contracts. Many of our customers have encountered this situation, and they immediately seek our help after obtaining certification to provide training for their employees to ensure that best practices are passed.


Certification shows the world that you are trustworthy


Anyone can say that they run a customer-centric and efficient business, but it is another matter to prove this. Obtaining certification by a certification body indicates that you have accepted a third-party independent evaluation; confirming that you meet all the requirements of ISO 9001. As with any supplier, the certification body you choose should be a perfect fit for your organization and priorities. This may be from showing your industry knowledge to being able to meet your schedule. We strive to make the customer experience simple and easy. For example, we always provide a fixed fee, and there are no hidden additional fees, such as annual registration or travel, others may hide these in small print.


Also, unusually, we will not try to sign a long-term contract with you. We strive to provide the best service, and finally feel that whether you choose us to move forward should be based on want, rather than must!


Once you have selected a certification body, the first step is to make a preliminary visit to determine where you are now and what you need to do to meet the requirements of ISO 9001. Many organizations worry that they will have nothing, but there are indeed many processes-even if it is currently in people's minds-they may only need to make some adjustments to help build a strong ISO 9001-compliant quality management system. Although your quality management system keeps records of key document processes, the execution of these processes is what really matters!

Case study: see how our customers are successful!


To ensure that you act according to your wishes, an internal audit must be conducted. Once you are sure that everything is in place, you can arrange for a formal conformity assessment.


Buyer beware


The financial industry has FCA, and the holiday company has ABTA, but unfortunately, the certification industry is not well regulated. As a result, there is no protection for those who choose the wrong path by mistake. Therefore, it is important to make the right choice before signing on the dotted line. In Europe, certification bodies (often called conformity assessment bodies) have clear ways to prove their competence and credibility. This is certified by the respective national certification bodies. In the UK, this role is performed by the UK Certification Service (UKAS).


However, unlike regulatory agencies (such as FCA), this is not mandatory, nor is it a legal requirement. UKAS is licensed by the government to perform its duties and is supervised by the Department of Business Innovation and Skills (BIS). The following is the government policy statement on their website:


Where to get certification in the UK


"The British government hopes that the UK's conformity assessment bodies will comply with European legislation and seek the accreditation of UKAS (British Accreditation Service), which is designated by BIS as the British National Accreditation Body. BIS encourages and recommends that UK companies, governments and local governments require third-party conformity assessment Service is an authority that provides such services from a conformity assessment body recognized by a national accreditation body (if any)." – Source: www.gov.uk, January 29, 2015


The popularity of ISO 9001 in the United Kingdom (it is the fifth largest adopter of the standard in the world) is driven by many government contracts that require standard certification as a qualification requirement in the procurement process. The huge motivation for companies to obtain ISO 9001 certification in order to obtain work qualifications has resulted in certification bodies that are not accredited by UKAS for issuing certificates. This practice is not illegal, but it will make the water turbid and may result in the rejection of such certificates.


Most non-accredited certification bodies can be identified by providing low-cost transactions and certification in a short period of time. This is of course a "buyer beware" issue, like most things, you get what you pay for. Sadly, there are thousands of organizations in the UK that are far from finding that their certificates will be rejected only once. For example, procurement departments in multiple industries (public and private sectors) use a publicly available specification called PAS 91. This document was created to ensure consistency in the requirements set for potential suppliers. Among them, the certification accredited by UKAS is the only form of accreditation. As an added benefit, those who are certified will also find that they can skip lengthy questions in the Prequalification Questionnaire (PQQ).


Understand the importance of UKAS: not all ISO certificates are created equal


In the UK, the government hopes that certification bodies will seek UKAS certification. The accreditation process (processed in accordance with the ISO 17021 standard) is used to verify the competence and impartiality of the certification body. This process involves a rigorous review of management, policies and procedures by the headquarters. The certification body must also pass its proficiency test through a witness assessment conducted by UKAS; their auditors will follow up with our auditors to ensure that we meet the expected level. Once approved, all content will be re-checked after 6 months and every year thereafter. In order to prove the importance of "ability", UKAS certification is filtered to the industry level. For example, whether it is a construction company, a warehouse distribution center or a cleaning company, we can only be approved to work in these fields after we have obtained the qualifications for the audit. The benefit to you (the client) is that your auditors have demonstrated that they understand your business and the challenges involved in achieving ISO 9001 certification.


Finally, like any provider, you should also review capabilities, resources, customer reviews, contract terms, and ongoing costs before submitting; there should be no difference when choosing a certification body. You can also check whether they are accredited by UKAS by checking their website.



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