ISO 9001 Standard

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By Janardan Ghimire

If we are using the standard as a marketing gimmick or just because a customer requires it, then the standard will be a burden, not a benefit.

Why should we use the ISO 9001 Standard? An honest reply can say a lot about how effectively standardization can improve our business. If we are using the standard as a marketing gimmick (an advertisement on billboards, a plaque on the wall, a logo on a website), or just because a customer requires it, then the standard will be a burden, not a benefit. If the honest reason for implementing the standardization is improvement, then it can truly help your organization become better.

Improvement or Certification A certification is a lofty goal of course and it will be necessary to get the plaque and the logo or to meet a specific customer requirement. However, if certification is the only goal then you may gain certification but miss the benefit of the standardization. An organization can employ the standardization and benefit from it without ever seeking certification. In fact, a compelling argument could be that the best approach is to put a functioning ISO 9001 QMS in place for a period of time even before attempting to gain certification. Perhaps, it even employs external auditors to review the QMS with an outside perspective, mainly to identify system weaknesses and opportunities for improvement and not to gain a pass/fail grade for certification. The certification bodies available in the world are as per their own fame and reputation. While some have the psychology of increasing the clientele, some others are value added certification bodies. Therefore, the customer needs to identify their working style and study their own available team before approaching certification procedures.

We often perceive ISO standardization as a checklist item The real goal of ISO 9001, however, is continual improvement of the organization. Embracing the concepts of ISO 9001 can enhance an organization in several ways. ISO 9001 Documentation We have a misconception about documentation requirement for ISO 9001. The common belief seems to be that implementing ISO 9001 can create a bureaucratic documentation nightmare with volumes of complicated procedures that requires heavy oversight and workforce to create and maintain. That is not really the case. In fact, implementing ISO 9001 can actually streamline and simplify your documentation/record creation and management.

The key fact is that ISO 9001 can help to improve the documentation and records of the organization. First, the ISO 9001 does not have complex or complicated documentation requirements. In fact, they are quite simple. There are only six required procedures for the ISO 9001 QMS.

They are:

• Document Control (ISO 9001 clause 4.2.3)

• Record Control (ISO 9001 clause 4.2.4)

• Internal Audit (ISO 9001 clause 8.2.2)

• Control of Non-Conformities (ISO 9001 clause 8.3)

• Corrective Action (ISO 9001 clause 8.5.2)

• Preventive Action (ISO 9001 clause 8.5.3)

While it may be difficult for most organizations to get all six procedures, the fact is that these are the only required procedures to gain ISO 9001 certification. It should thereby send a message that ISO 9001 is not about tons of procedures. Besides the above-mentioned procedures, your organization must decide what are the required procedures based on issues related to compliance, importance, and performance.

An important concept to understand is that procedures are the only way to document processes, and the ISO standardization recognizes that. Processes can be documented by work instructions, visual aids, or training materials. The real requirement of the ISO is that key processes are understood and consistently carried out. The Importance of Records What receives more attention in the ISO 9001 standard are records. While there are only six required procedures, there are 21 required records. It is very likely that the organization is already keeping many of these records. The ultimate goal of ISO 9001 is improvement and one key towards improvement is record keeping that captures important data related to performance metrics.

Frequently, whether it relates to the production floor or finance operations, the key factor for auditors and regulators are concerns with process control or internal controls. Does the existence of procedures really prove control? Not actually. Control is truly demonstrated by defined goals and objectives along with clear and complete records that demonstrate how well processes are meeting these objectives. Records should also demonstrate what analysis and actions are taken to improve the process when objectives are not reachable. Using the ISO 9001 Standard can help organizations gain some perspective and reflection on how records are used, how they are controlled, and their role in gaining insight to your organization. In the proper perspective, ISO 9001 can help gain control of and assist with properly utilizing documents and records and prevents – additional record bureaucracy.

In fact, we could not get the result and benefit of ISO 9001 implementation especially in the service sector. It is a practice within the management of the organization without being management dependent.

If you are interested in effective implementation of the ISO 9001 Standardization QMS, then the consultants will help you to achieve this task. These professionals will study the gap analysis of your company and help to formulate the requirements to the companies, as well as consulting to put your system in place or make it more compliant and beneficial.

Improving Customer Satisfaction To implement ISO 9001, companies are choosing to get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their businesses. In addition, if an area of the company’s program appears to be too bureaucratic and non-value adding, then it might also be an area for continuous improvement efforts. Implementation of ISO 9001 will add value through cited procedures in order to fulfill the requirements and expectations of customers using different tools and techniques. . The tools and techniques are well defined in the procedure. Owners are responsible to act as per their roles and responsibility as mentioned in their job description and keep the records as per the standard operating system procedure.

Enhancing Company Performance Customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. Moreover, as a supplier becomes certified, the testing requirement is waived which saves the time and money of the company. The certification provides gaps of preference in the process by timeto- time evaluation process. Without evaluation, no one will get the result of a status where the findings are available by the evaluation or monitoring procedure. Live data helps in the decision-making process. Thus, the company can enhance the performance with the help of prescribed or established standardization in the process. Developing Best Practices Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” focusing continuous improvement cycle to achieve requirements. This process revolves around the eight quality management principles used by management experts as a guide towards improving performance and identifying the main elements needed in a good quality system:

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. Systems Approach to Management

6. Continual improvement

7. Factual Approach to Decision- Making

8. Mutually Beneficial Supplier Relationship

Building Stable Processes ISO 9001 policies, procedures and forms can provide employers, managers, and employees with a systematic and consistent approach in implementing policies, plans, procedures, and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help certification. In this case, you need to form a Steering and Task Team within the organization with a professional called consultant. It will not match your process if your people are not involved in formulating your system.

The readymade plans, policies, procedures, and forms cannot add value to companies. Most companies are likely to get the certificate as a fashion or for the completion of a task. Some organizations are using the ISO documents in a suitcase and provide manipulated document and data to the inspection body. This will not be useful as the company that exploits it will not comply with the system in the long run.

Auditing a Company System In the certification process, an independent registrar performs an on-site audit (1st and 2nd stage) of a company’s operations to verify that it complies with the ISO standardization. If the business complies, then that company is registered as ISO 9001 compliant.

After getting the certification, continual assessment of the company is possible only through the commitment of the top management level. Without top management commitment, regular assessment of an organization is not possible as it is a vital part of a certified organization.

Meeting Company and Customer Needs On the way to certification, a business can meet its ISO needs by: • Using well defined processes and procedures to build stable processes • Training in the audit and certification process • Continuously improving with ISO 9001 standards Noticing the Difference Complete procedure manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, as per the training procedure are established within the organization beforehand. Sometimes, the effort can be great but companies typically notice a remarkable difference in efficiency and effectiveness after the first year. It means that the difference in the whole process and organization will be international benchmarking by the third party or open door for the global market. Therefore, the organization needs to keep up with the civilization within an organization as required in the society. We have to maintain that “Quality is culture” that never ends.


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