ISO Certification Help for Small Businesses

ISO 9001 Certification in Four Months

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What is the ISO 9000 Family of Standards?

ISO 9000 is a group of quality management standards including ISO 9000, ISO 9001, ISO 9002, and ISO 9004.  ISO 9001 is the only standard within the ISO 9000 family that is certified.  The other 3 standards support ISO 9001 certification.  For example, ISO 9002 gives guidance on the purpose of the requirements contained in ISO 9001:2015, including examples of potential steps a company can take to meet the requirements and to help you get more familiar with the requirements. ISO 9000 is a standard within the family of standards and can help you become more familiar with the basic concepts, principles, and vocabulary of a quality management system.

ISO 9004 contains 7 practices to help you improve your quality management system and include the following:

1.  Customer Focus

2.  Leadership

3.  Engagement

4.  Process

5.  Continuous Improvement

6.  Evidenced Based Decision Making

7.  Relationship Management

Although ISO 9004 is not meant for certification, it can help organizations gauge the level of maturity when it comes to these seven practices. The ISO 9004 standard can help organizations gauge the needs and expectations of their customers and offers guidance on how to balance those needs and the needs and expectations of other interested parties.

What are the ISO 9001:2015 Requirements?

The ISO 9001:2015

First published by the International Organization for Standardization (ISO) in 1987, the ISO 9001:2015 Standard is the only standard in the ISO 9000 family of standards that is certification.  ISO 9001 outlines the requirements for certification and if used in conjunction with the support and guidance of the other ISO 9000 standards, a high-level Quality Management System can be achieved and maintained.

This is a Brief Overview of the ISO 9001:2015 Clauses:

Clause 1, Clause 2, and Clause 3 are more introductory while the remaining 7 clauses are comprised of the requirements for a quality management system needed to achieve certification.

It is also about discovering who the stakeholders in your business are, like suppliers, staff, and other interested parties.  Finally, clause 4 is about understanding your customer’s needs and expectations.

Clause 5: Leadership

Having your leadership team take responsibility for your Quality Management System is an important part of having a successful and sustainable QMS. Clause 5 requires that your leadership team take responsibility for establishing the quality policies and goals and communicating these policies and objectives to employees who are responsible for any part of the QMS.  This clause encourages the leadership team, in effect, to establish the policies and goals of the QMS.  This clause also requests the leadership team manage the annual reviews.

Clause 6: Planning

Risked-based thinking and considering potential desirable opportunities are essential when building a sustainable QMS policy. Clause 6 is about top management putting together a plan to prevent or reduce undesired effects and at the same time, create plans to improve the possibility of positive effects. Clause 6 also requires documentation of potential risks including the chance of risks happening and potential severity.

Clause 8: Operation

Clause 8, operation, requirements of ISO 9001:2015 guide you to define the quality objectives when it comes to creating and delivering goods or services to your customers.  These quality objectives are focused on the process guides, documents, and resources your employees need to create products or services with quality, and rules controlling the creation and storage of your records. There will also be a process to outline and maintain monitoring, inspection, or testing methods to confirm the quality of your products or services.

Clause 9: Performance Evaluation

Clause 9 outlines the importance of demonstrating that all aspects of your QMS adhere to the ISO 9001:2015 requirements and continue to improve quality management in all areas of your business.  Clause 9 involves expectations for measuring, documenting, and recording your processes, evaluating customer satisfaction, internal auditing, and ongoing leadership review of the QMS.

How to get ISO 9001 Certification

Now that we have covered the family of ISO 9000 standards and outlined a brief overview of the ISO 9001:2015 requirements, we will now cover how ISO 9001 certification is accomplished.

First and foremost, you need to get a copy of the official ISO 9001 requirements and get to know them. Also, download copies of the other Standards in the ISO 9000 family.  All will help reach the goal of ISO 9001 certification.

Next, you need to set up your company with a Quality Management System aligned with and meeting all of the ISO 9001 requirements.  After this is accomplished then you should do and pass an internal audit. Once this is accomplished then you bring in the official certification body or ISO 9001 registrar to audit your company to confirm all of the requirements are met.

Certification lasts for 3 years.  Then you need to get re-certified.

How Does ISO 9001 Certification Benefit Employees?

Higher Job Satisfaction

With the implementation of a quality management system, employee’s roles are more clearly defined.  Employees report a higher level of job satisfaction when roles are defined. Thus, employee potential is expanded.

Higher Job Security

Once a solid quality management system is in place the organization will typically produce higher quality products and services meeting customer’s needs and expectations. This creates job security for employees of the company.

Employee Engagement and increased Morale

With a QMS in place, employees tend to feel like they are part of something bigger than themselves and feel more responsible for the part of the process they are involved in.

Better Company Culture

Any company that has continuous quality improvement at their goal raises the way people feel about working for the company.  Acquiring and maintaining ISO 9001 can move the company culture in a positive direction.

The Risk of Negative Events is Reduced

One of the pillars of a successful quality management system requires you to assess possible internal and external negative events and establish a plan to address negative events if they happen.  Just having a QMS in place should reduce risk significantly.

Improves Business Image and Branding

When you get ISO 9001 certified, you are telling the world that your company can be trusted to have all your ducks in a row.  This is a big benefit because it increases your image and Branding and helps you to stand out from your competition.  People will think better of your company with an ISO 9001 certification under your belt.

Makes Decision Making Easier

The requirements of ISO 9001 involve a lot of information documentation that can be used to make decisions about the future of the company going forward.

Higher Efficiency

Usually, a successful QMS will lead to process automation which means more effective and efficient processes for products and services.

Opens Doors to New Opportunities

New companies who only want to or can only work with organizations that have ISO 9001 certification will now take notice of you.

Improves Revenue and Market Share

Naturally, if you get ISO 9001 Certification, more doors open, and you will make more money because you will be working with more customers. Isn’t that the bottom line?

Makes Customers feel more Secure

When you go through the process of acquiring ISO 9001 certifications and adhering to all of the requirements, customers know they are getting a higher quality of products and services. It makes customers feel more comfortable about doing business with you.

Customers get Better Quality Products and Services

When you improve your processes, customers will get higher quality products that may have better longevity than other products.

Meets Customers’ Needs and Expectations

The ISO 9001 requirements expect you to discover what your customers’ needs are and encourage you to try to meet those expectations.  There is a higher chance of meeting more customer needs and expectations with a solid QMS in place.

Other ISO Certifications

We offer ISO Certification Consulting for ISO 9001 and these other related ISO Certifications:

What is ISO 9001:14001?

ISO 14001 Meaning

“ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.”

From: https://www.iso.org/standard/60857.html

ISO 14001 is a part of the ISO 14000 family and applies to the environmental aspects of an organization’s activities, products, and services.  ISO 14001 is the only standard in the ISO 14000 family that can be certified and applies to any size company, no matter the type or nature of the organization. ISO 14001 is designed to provide a structure for the management of environmental compliance in whole or in part to systematically and gradually improve environmental management.

Moving beyond just complying with regulatory requirements, going through the process of certifying to EMS ISO 14001 is about developing processes and procedures to get ahead of the possibility of violations happening before they occur.

This certification is not used to certify products.  It is used to monitor, maintain, and control your processes so that your medical devices can meet the expectations and requirements of your customers and applicable regulatory requirements.  ISO 13485 must be re-certified every 3 years. 

What is ISO 45001 Certification?

In short, ISO 45001:2016 stipulates requirements for an organization’s occupational health and safety (OH&S) management system so that they can proactively get ahead of potential work-related injury and ill health in the workplace. ISO 45001 applies, to any organization of any size that wants to establish, implement, and maintain an OH&S management system.  The intention is to eliminate hazards and minimize risks under the organization’s control and to take advantage of opportunities for improvement when it comes to OH&S.

ISO 27001 is the international standard that specifies best practices for establishing, implementing, monitoring, maintaining, and improving an organization’s controls for an Information security management system. Controls can be human, technical, organizational, legal, or physical.

It is correctly named ISO/IEC 27001 because there are two international organizations involved in determining best practices for security systems and IT processes.  ISO 27001 certification verifies that the organization’s security systems and IT processes follow current best practices.

What is ISO 20000-1?

ISO/IEC 20000-1:2018 Has to do specifically with IT Services and sets out guidelines to establish, implement, maintain, and continually improve a service management system (SMS).

Producing documents and records for all processes related to ISO 20000 SMS compliance is a requirement of this standard.  The number of records you will need to complete is directly related to the size of your company.

American Made

We’re an American business helping American small businesses. We started out with two brothers in a basement, an entrepreneurial spirit, and a desire to help. Today, we help hundreds of American businesses achieve certification and improve their processes every year. We want to help you meet and exceed customer expectations.