[Reading Record -123] A Textbook That Thoroughly Explains ISO 9001 Standards and Audits in One Volume

A practical manual that systematically explains the essence of ISO 9001 and audit countermeasures

When aiming for certification or operation of ISO 9001 (the international standard for quality management), many managers find themselves troubled by the complex text.

This book, "A Textbook That Thoroughly Explains ISO 9001 Standards and Audits in One Volume", is a practical introductory guide that explains the complex standard requirements and audit mechanisms in a way that even beginners can understand. By opening this book, you will understand that the essence of ISO 9001 is not "mere rule compliance" but rather "a mechanism (QMS: Quality Management System) to achieve organizational improvement and increased customer satisfaction", and you will gain insights into how to apply this mechanism to your daily operations.

I intend to write this article from the perspective of "how management can utilize ISO 9001 for governance", rather than for those in charge of ISO 9001 implementation. If you are going to go through the trouble of obtaining certification, it is definitely better to elevate it to that level.

The author of this book, Yoshiharu Fukunishi, is a person who, after many years of working in quality assurance and factory health and safety at a chemical manufacturer, has supported many companies in obtaining and maintaining certification at Techno Soft Co., Ltd.

Chapter 1: The "Basics" of ISO 9001 - The Mindset Management Should Have as Governance

When introducing ISO 9001, the most important foundation is "management's awareness and attitude toward governance (steering the company)".

As indicated in "Clause 5: Leadership" of the standard, "ISO is not just an activity for the front lines, but something that management leads in order to determine and control the correct direction the company should take".

The steps for the basic mindset that management should have are as follows.

Step 1: Position ISO as the core of the management governance system

Management needs to view ISO 9001 not as mere "on-site procedures" but as "a mechanism for soundly steering the company".

Based on "Clause 4: Context of the Organization", establish a system to "clarify external and internal issues and the needs of interested parties, and control the company from a macro perspective". Responding to "climate change," which has recently become mandatory, is also part of major policy decision-making that affects corporate sustainability, and top management is required to steer the company while covering these aspects.

Step 2: Clarify the quality policy and standards that serve as organizational norms

Management must "establish a 'Quality Policy' and communicate it to the entire organization in their own words" as a standard for steering the company in the right direction.

Top management must take the lead in demonstrating involvement and responsibility so that all employees can have the "awareness (Clause 7.3)" of "what policy the company is operating under" and "how their own work contributes to the governance of the entire company".

Step 3: Ensure reliable steering through risk management

The "Actions to address risks and opportunities" in "Clause 6: Planning" is "the very essence of decision-making in governance".

It involves "proactively predicting the company's uncertainty (deviation in a favorable or unfavorable direction = risk)" and "appropriately allocating resources (people, goods, equipment, organizational knowledge, etc.) to manage it" (Clause 7: Support). And "placing that (risk) under the control of top management" is, it is no exaggeration to say, governance = steering the company.

Chapter 2: "Audit Countermeasures" to Prevent Formalism - Procedures to Achieve Organizational Improvement and Customer Satisfaction

If your only goal is to pass the audit, you will only end up with more paperwork that is just for show, leading to the formalization of on-site operations. The correct audit countermeasure is to notice your company's weaknesses and build a mechanism to achieve organizational improvement and increased customer satisfaction.

I will explain the specific practical procedures that should be carried out for that purpose.

Step 1: Correctly measure customer satisfaction and evaluate the results

After providing products or services in "Clause 8: Operation," move on to the procedure of collecting and analyzing data on how customers feel about the company's response based on "Clause 9.1.2: Customer Satisfaction."

This is not simply about "conducting a survey." It is about
reflecting the voice of the customer in management governance (steering) and reliably feeding it back into daily processes (a series of activities that transform input information into intended results). By doing so, you can naturally raise the quality of your products or services (QMS: Quality Management System).

Step 2: Establish an internal audit mechanism to enhance self-cleansing capabilities

Before being pointed out by external auditors, it is necessary to build a system that strictly checks for any slack in the company's governance.

When conducting internal audits, to ensure objectivity and fairness, you should enforce the rule that auditors "must not audit their own assigned duties (based on ISO 19011)". This is because unless you eliminate leniency among insiders, you cannot discover inconsistencies in rules yourself. And that leads to the cultivation of an organization's "self-cleansing nature."

Step 3: Establish a "corrective action" process and cut off the causes of problems

When nonconformity (things not going according to rules) occurs during work, you must not end it with just "stopgap corrective measures".

Based on "Clause 10.2: Nonconformity and Corrective Action," thoroughly investigate the "root cause" of the problem that occurred and execute "corrective action" to remove the cause itself. This process of preventing recurrence, and leaving the demonstration of the effectiveness of that process as "documented information", will lead to future organizational improvement. At the same time, it will be highly evaluated in external audits, which is the best audit preparation.

Step 4: Make management review functional and level up governance

Now, once you have done this much, it is time for "Clause 9.3: Management Review."

Management review must be carried out by management with their own responsibility. Based on the results of internal audits raised from the field, you yourself must review (evaluate, critique, and re-examine) whether the QMS (Quality Management System) is functioning appropriately and is consistent with the strategic direction of the organization. You must not leave that to someone else.

In conclusion, in the implementation of ISO 9001, it can be rephrased that what management needs to do is "review whether PDCA is rotating correctly". It is easy to understand if you divide it into "input" and "output" broadly.

Input:
Corresponds to the "Do (Implementation)" → "Check (Evaluation)" part of the PDCA cycle.

First, management must instruct the person in charge of the field to build a mechanism that can record the activity results of the "Do" process. And they must establish a routine to have it reported (input) periodically (weekly, monthly, etc.). If this wavers, you will not be able to conduct a correct review.

Items required for reporting (input) will be as follows.

Output:
Corresponds to the "Act (Improvement)" → "Plan (Next Plan)" part of the PDCA cycle.

Management must analyze and evaluate the reported (input) information and instruct (output) the next actions for continuous improvement of the QMS. And, including the following decisions and actions in the output is required by "Clause 9.3.3," and reflecting that in the "Plan" of the next cycle is what it means to "rotate the PDCA cycle".

To connect to the 'Plan' phase of the next cycle, the points that management must decide upon based on reports (outputs) can likely be narrowed down to the following three.

Of course, putting the processes written in this book into practice one by one will surely lead to receiving ISO 9001 certification.

However, a 'QMS: Quality Management System' that is truly useful for your company will likely come down to management itself grasping the overall picture of ISO 9001 and 'reviewing whether the PDCA cycle is functioning correctly' from a macro perspective.

Reference Links

・JISC Japanese Industrial Standards Committee

・JAB Japan Accreditation Board

・Techno Soft Co., Ltd. (Author's affiliated organization)

・Amazon 'A Textbook to Thoroughly Understand ISO 9001 Standards and Audits in One Book' Product Page