When customers engage with your business, they expect to see consistent quality in the products they purchase. As such, companies must strive to produce goods that meet these expectations. To maintain consistent quality standards around the globe, businesses often look to the International Organization for Standards to provide an independent set of criteria and best practices they can reference.

The International Organization for Standards (ISO) is responsible for creating a global set of standards across various fields to provide a set of guidelines for different businesses to integrate quality, safety, and efficiency across their operations.

For manufacturers, ISO has outlined a set of quality management standards known as ISO 9001. These standards govern how a business should ideally make decisions and address the various aspects of its quality management processes.

Businesses will often advertise their ISO certification or compliance as proof to customers and partners that they meet the global standards. It’s worth noting that being ISO compliant does not necessarily mean the manufacturer is ISO certified.

Types of ISO standards

As an organization, ISO has ratified more than 22,000 standards across different fields. However, a few of these standards have garnered global adoption because of the domains over which they preside.

These include:

ISO 9001: This set of standards deals with the quality management system employed in a company’s operations. It focuses on customer experience and satisfaction as well as the quality of the company’s processes and continuous improvement. Additionally, ISO 9001 sets standards for an organization’s executive management.

ISO 14001: These standards outline a framework that companies can use to be environmentally friendly. Many manufacturing operations have a significant impact on their surroundings. ISO 14001 caters to their environmental management system, allowing the organizations to assess their process and limit the consequent environmental impact.

ISO 45001: This family of standards covers employee health and safety from workplace hazards. This ISO standard is of particular importance in a manufacturing environment because of the machine-rich work environment in which human personnel operates.

ISO/IEC 27001: These standards are concerned with information management and security systems. They cover information relating to employees, finances and intellectual property, among others. These standards are of even more importance in modern manufacturing owing to the widespread adoption of the data-intensive Industry 4.0.

ISO 22301: Businesses refer to these standards when crafting a business continuity management system. In other words, this is a risk assessment and management standard that allows companies to prepare for business-hostile scenarios adequately.

Quality management in pharmaceutical manufacturing environment

ISO 9001 compliance in manufacturing

First, let’s dive deeper into ISO 9001, a set of quality management standards outlined for manufacturers. According to the International Organization for Standards:

ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

In the case of ISO 9001, businesses must meet several quality management standards as set out by the organization.

Getting formally certified for meeting these standards is a lengthy and costly process. As a result, some manufacturers find it more prudent to adhere to the standards but not get certified. Such companies are considered ISO compliant instead of ISO certified.

How to get ISO 9001 certification

ISO 9001 is technically the only standard that a business can be certified to. The first step to becoming ISO certified is building and implementing a Quality Management System in an organization. While it is recommended that businesses perform an internal review of their system on a regular basis, becoming officially certified requires that manufacturers are audited by an independent, external entity known as a Certification Body. Steps to becoming certified include:

1. Conduct an internal audit of your QMS to ensure that the systems and processes adhere to the current ISO 9001 standards and best practices.

2. Begin evaluating a number of different certification bodies to ensure they are accredited and use the relevant CASCO standard.

3. Once your QMS has been prepped, an internal audit has been done, and you’ve selected an independent certification body to verify that your systems adhere to the relevant standards, it’s time to begin the certification process. Certification typically occurs in multiple stages. In Stage 1, the auditor will check your documentation to ensure ISO 9001 requirements are met and match what is actually being done across the business. This stage of the audit will uncover any areas of deficiency as well as opportunities for improvement. Once required changes have been made and requirements are met, Stage 2 includes a final verification that ISO compliant systems are actually being utilized.

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What are the benefits of maintaining ISO standards in manufacturing?

In many areas, ISO certification isn’t a requirement for running a manufacturing operation. However, manufacturers generally will benefit when they incorporate ISO standards across quality management, occupational safety, and information security processes.

Some of the benefits of ISO compliance that manufacturers can expect include:

Improved production quality

Maintaining standards such as ISO 9001 allows manufacturers to sow quality management best practices into their processes. As such, companies can improve quality throughout the organization, stemming from development and material sourcing all the way to product delivery and customer interaction. Additionally, this set of standards provides for continuous quality management, allowing manufacturers to reduce defects and efficiently ship quality products.

Customer trust and brand loyalty

Another reason it’s important for manufacturers to implement and adhere to ISO standards is that it shows current and prospective customers that the operation believes in its products. In other words, ISO compliance or certification shows customers and distributors that they can expect products that meet the global standard. And when customers consistently expect and receive quality products, the brand’s reputation grows to rival and even exceed the competition.

Improved productivity through better worker conditions

Manufacturers benefit from having a healthy and motivated workforce. This is often where ISO 45001 standards come in. This set of standards provides manufacturers with a framework to mitigate work-related hazards. Additionally, specifics under ISO 45001 also provide for workers’ mental health. As such, supervisors will comply with these standards to ensure that all aspects of the employees’ well-being are catered for. And with a healthy workforce, a business’ productivity increases significantly.

Ensured business continuity

Local or global events affecting various or specific industries can negatively affect a business’ operations, and consequently, its revenue stream. For instance, the current COVID-19 pandemic upended several industries, halting their progress or putting brands out of business. However, the ISO has standards that show companies how to proceed with operations in case of catastrophic events. In other words, manufacturers that comply with ISO 22301 have an out when it comes to making sense of unfavorable business conditions.

Improved cybersecurity

As earlier stated, manufacturing businesses in the Industry 4.0 era are often IT-centric. In other words, they depend on their information technology to remain operational. However, this increased device connectivity provides several points of potential data breaches. As such, companies require a standard way of safeguarding invaluable information like employee particulars and financial data. ISO/IEC 27001 provides for optimal digital risk management and security. The framework detailed in this standard is central to a manufacturer’s information security management system.

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