The Impact of ISO 9001

Simple frameworks can make a big difference. ISO 9001 Quality Management System standard is a perfect example of this, creating a foundation for multiple industries to deliver consistent, safe, and effective products and services that meet customer and regulatory expectations.

Over 2 million companies and organizations, representing over 183 countries internationally, are ISO 9001 certified. They run the gamut from hospitals to factory floors to service fields like education and hospitality. The standard official was initially published in 1987, influenced by the development of military quality management demands in the post-World War II period. In the past 35 years, it has been incrementally enhanced as an industry-agnostic framework for QMS. 

Examples from Everyday Life

Examples of ISO 9001 can be found everywhere in the products and services of everyday life. Let’s start with a simple one, like baking a cake. Previously, regional bakeries lacked standardized specifications for ingredients, recipes, and employee training. This meant there were often no protocols for cleaning, cooking, and food storage. Without clear, documented processes, it was often impossible to trace contamination for allergens, microbial growth, and foodborne illness.

The CDC records hundreds of outbreaks in the 1980s from bakery-related pathogens that could’ve been prevented through ISO 9001 quality controls. More recently, USDA studies have shown a clear reduction in foodborne sickness after the widespread adoption of QMS certifications, though this correlation is surely only one of many factors.

The Road to Certification

Achieving ISO 9001 certification requires adopting QMS standards that meet specific international criteria for quality encompassing planning, processes, resources, and documented information to achieve intended objectives. Certification represents a formal recognition that is granted following a multi-stage audit by an independent ISO 9001 Certification Body or Registrar:

• Preparation and gap analysis

• Documentation and policy/procedure drafting

• Organization-wide implementation

• Generation of documented objective evidence

• Internal auditing for self-assessment and continual improvements

• Independent, staged external audit for certification

Certification is not a one-time project but an ongoing commitment to structured improvement and documented evidence.

Practical steps for an organization to get started include the following:

1. Engage top management. Ensure incentivization and alignment.

2. Consider relevant interested parties, including customers, employees, suppliers, and regulators requirements for your organization’s products and services.

3. Identify key processes and the interaction of processes for your business.

4. Assess internal and external context affecting your QMS

5. Review QMS requirements. Analyze existing practices and identify gaps based on the latest version of ISO 9001 Standard from 2015. Consider whether to update current systems or implement new ones.

6. Build your ISO 9001-based quality management system.

7. Seek certification or self-declare conformity.

A Japanese fish market highlights its ISO 9001 credentials.

The average timeframe for an organization to become ISO 9001 certified depends on several factors, including the size of the organization, current process maturity, resource allocation, and the scope of certification. Smaller businesses with fewer than 50 employees can often achieve certification in 3-6 months, where there is strong commitment and limited gaps to address. Larger companies in highly regulated industries, especially where significant gaps exist, may require a year or more.  Establishing written procedures for your organization’s processes is an important first step.  Even more importantly, organization’s must demonstrate through documented information (i.e., objective evidence) that these are ‘living’ processes with a spirit of striving for increased customer satisfaction and continual process improvements.

Benefits of implementing ISO 9001-compliant business operations and QMS include:

1) Consistently providing goods and services that meet (or exceed) customer and regulatory requirements,

2) Facilitating customer and relevant interested party satisfaction,

3) Providing systematic framework for addressing risks and opportunities, and

4) Demonstrating conformity to specified QMS requirements. 

For companies in a broad range manufacturing and service providers of industries, ISO 9001 offers a well-defined path to improved maturity and expanded opportunities with customers, partners, and regulatory agencies. From baking cakes to flying cars, society will continue to innovate to serve core human needs. ISO 9001 is an example of how simple, unglamorous processes can make a world of difference.

Landrich Group certified and trained lead auditors have supported entrepreneurs in a wide range of industries in planning and implementing ISO 9001:2015 (and ISO 13485:2016) in ways that enhance the efficiency and effectiveness of their business operations leading to sustainable change and improvements. Contact us today for a free assessment of your potential to benefit from ISO 9001 certification.