A quality management system is make or break for any manufacturing company.

Your customers need to know that your organization’s products and services will consistently meet their specific requirements and needs. With this quality-oriented consciousness, a certified management system demonstrates your commitment to quality and customer satisfaction.  

Most, if not all, large clients will expect to examine your system, your documentation and your adherence to these standards, regardless of your certification status. 

Maintaining a quality system is an everyday task and Manex can often come in and assist in getting companies back on track.  

Manex has helped our clients prepare for certification in some of the most popular and widely adopted standards used in the manufacturing industry today, including:

• ISO 9001 Family – Quality Management Systems (QMS)
• ISO 45000 Family – Occupational Health and Safety Standards
• ISO 22000 – Food Safety Management
• ISO 31000 – Risk Management
• ISO 14001- Environmental Impact
• AS 9100 – QMS Specific to the Aerospace and Defense Industries
• TS 16949 – QMS Specific to the Automotive Industry 
• ISO 13485 – QMS for Manufacturers of Medical Devices 
• ISO 50001 – Standard for Energy Management

Although the ISO creates and defines international standards, they themselves do not certify that an organization has achieved certification. That duty falls to an independent certification body. Manex can thoroughly prepare your organization to pass the audit required to achieve ISO certification.   

A certification body is an independent third-party organization that is accredited by the ISO to judge an organization’s compliance with their standards.

Manex works with a number of independent certification bodies once our work is done. We can recommend one to you, or you can utilize one that you have worked with in the past.

The certification body’s audit will include a review of your organization’s documentation, as well as a physical on-site examination of the facilities. At Manex, our job is to consult and train your company to meet these standards.  

When an organization becomes certified in any of the ISO standards, it’s like receiving a stamp of approval that the company’s systems and processes meet the ISO’s rigorous standards. 

Achieving ISO certification is something your organization should be proud of. Many of our clients have placed the ISO Certification on their lobby walls and on their company website.  

Why ISO Certification Matters

Becoming ISO certified matters for any organization that wants to project trust and confidence to their partners. 

First and foremost, the biggest benefit of ISO certification is the impact that it can have on your organization’s efficiency and effectiveness. 

Some of the most adopted standards, including  ISO 9001  can help streamline your operations, reduce waste, facilitate a better trained workforce, and minimize incidents.

But beyond the internal positive impact on your own operations, ISO standards also enhance your brand reputation and credibility in the marketplace. 

Potential partners are more likely to work with organizations that have one or more ISO certifications. Some international markets may require industry-specific standards before you can even be considered for a contract. 

Ultimately, the benefits of ISO certification provide a significant competitive advantage by optimizing your internal performance, while also increasing your attractiveness to potential partners and consumers. 

ISO Standards Explained

So how exactly do ISO standards work? Let’s take a look at one of the most useful and commonly adopted standards as an example – ISO 9001. 

ISO 9001 provides a framework for establishing and maintaining a quality management system (QMS).

This ISO standard is not a specific set of rules to be applied – rather, it is a process-oriented framework that can be adopted by virtually any organization in any industry. In fact, many of the ISO standards are not industry-specific, giving them flexibility to be applied across many different industries. 

In the example of ISO 9001, the core principle is meeting the customer’s needs and keeping them satisfied. This is done by creating an environment of continuous improvement in the organization. 

The ISO 9001 standard helps organizations improve their efficiency by establishing clear processes and procedures, minimizing waste, and identifying and correcting errors quickly. 

ISO 9001 focuses on breaking down operations into their basic processes, documenting them so that they are consistent across the organization, and identifying risks and opportunities for improvement. 

ISO 9001 does this by establishing a framework for continuous improvement, known as PDCA – Plan, Do, Check, Act. 

Plan: Define objectives and establish a plan for improving an aspect of a process.

Do: Implement the plan.

Check: Gather and review data.

Act: If the change was successful, implement it across the organization. If it was not, return to the planning stage and try again.  

This framework establishes an approach to continuous improvement. It doesn’t tell an organization exactly what to do in each step – that is left up to the organization itself. But it does give them the tools to continually seek improvement in their operations. 

And that’s a competitive advantage in any industry. 

While the standards created by the ISO are entirely voluntary, ISO certification for businesses offers a significant advantage to organizations that adopt  

Action Items 

• Select a Standard – There are many types of ISO standards, and your organization can have more than one. But whatever standard you select, you need the complete backing of leadership. Carefully consider your organization’s goals before choosing a standard to implement.

• Consider a GAP Analysis – Before proceeding to the steps below, consider running a gap analysis to gauge your current performance vs the requirements of the ISO standard you seek. Manex is an expert in gap analysis, and can identify the areas that need the most improvement.  

• Form a Team – Manex will help assemble a team that is composed of representatives from across the organization’s different departments. They will be the ones responsible for preparing the organization for the ISO certification. 

• Develop/Document Your Management System –  Manex will train your team to thoroughly understand the requirements of the standard. Whether you’re starting from scratch, or adapting an existing system, you’ll need clear and concise documentation for each process. 

• Implement and Train – Manex will provide comprehensive training on the new systems. You’ll also need to conduct an internal audit and monitor your KPIs to review the effectiveness of your system before applying for certification. 

• Choose a Certification Body –  Although Manex can recommend one or more bodies, there are many certification bodies available. Prepare all your documentation ahead of time so you can easily provide it to the certifying body. 

• Prepare for the Audit – When it’s time for your audit, cooperate with auditors and provide them with any relevant information they request. Be confident in your preparation but be prepared to address any non-conformance promptly. 
• Seek Continuous Improvement – Passing the audit will award you with certification – but it’s not the end of the line. Maintaining compliance is key, and the best way to do that is to regularly self-audit and implement improvements. 

Following these tips will help you be prepared for a successful implementation of any of the ISO standards. 

Need Help with ISO Certification for Your Business?

Let Manex answer the call. As Northern California’s most recommended manufacturing consultant, we have developed a reputation for helping organizations prepare for ISO certification. 

Manex offers complete certification preparation programs designed to get you ready for a certification audit.

We work with your current systems to fit them to the desired standard you wish to achieve, minimizing disruptions to your existing workflow. We also provide industry leading training and documentation services, to ensure that your entire team is ready for the certification process.

Manex also conducts gap analysis to identify shortcomings against ISO standards, as well as identify opportunities to increase performance and improve your customer satisfaction. 

The result is an organization fully prepared for the rigorous audit of ISO certification bodies. Manex has a 100% success rate in preparing our clients for ISO certification. We have never had a client fail their ISO certification. 

Before you seek ISO certification, contact Manex for an initial consultation and let us show you how we can get your organization prepared for a successful implementation of any ISO standard. Call Manex today.