Frequently Asked Questions About ISO 9001

At American Quality Management (AQM), we've been providing ISO 9001 consulting services for over 25 years. In that time, we've helped hundreds of organizations implement ISO 9001 quality management systems and achieve certification. We commonly receive many of the same questions from companies exploring ISO 9001. Below we've answered some of the most frequently asked questions regarding the ISO 9001 standard, certification process, implementation, and working with a consultant like AQM.

What is ISO 9001?

ISO 9001 is an internationally recognized standard that outlines the requirements for a quality management system (QMS). It provides organizations with a model for managing quality across people, processes, and systems to meet customer expectations consistently. Companies certified to ISO 9001 demonstrate that they follow rigorous quality practices.

When was ISO 9001 First Published? 

The first version of ISO 9001 was published in 1987 by the International Organization for Standardization (ISO). It was based on pre-existing national and industry-specific quality standards. ISO 9001 has been revised multiple times over the decades, most recently in 2015.

How Often is ISO 9001 Updated?

ISO 9001 is reviewed and revised approximately every 7 years to keep it current with the latest quality management trends and business landscape. The intent is to continuously evolve the standard while maintaining a stable framework organizations can build upon.

Who Publishes and Maintains ISO 9001?

ISO 9001 is published and maintained by the ISO organization itself. They engage experts from various industries worldwide to provide input on updates based on changing needs and expectations. National representatives also participate to build consensus.

What Industries Use ISO 9001?

ISO 9001 has broad applicability across industries including manufacturing, healthcare, technology, telecom, engineering, finance, transportation, and more. Over 1 million certifications have been issued across nearly every sector and company size.

What Does ISO 9001 Certification Mean?

ISO 9001 certification means an organization has implemented a quality management system that conforms to the ISO 9001 standard requirements. This certification is issued by an accredited third-party auditor after assessing the organization's ISO 9001 processes, documentation, and implementation.

What Are the Benefits of ISO 9001 Certification?

Benefits include improved quality, operational efficiency, cost reduction, customer satisfaction, profitability, sustainability, risk management and more. ISO 9001 provides globally recognized quality credentials that often provide access to new markets and customers.

What is Involved in the ISO 9001 Certification Process? 

Key steps include implementing an ISO 9001-compliant QMS, having it audited by an accredited certification body, remediating any issues, then receiving official certification once the organization demonstrates full conformance to ISO 9001. Ongoing surveillance audits are required to maintain certification.

How Long Does ISO 9001 Certification Take?

From project initiation through full certification typically takes 6-12 months depending on the complexity of current operations and maturity of existing quality practices. The more aligned an organization already is to ISO 9001, the quicker the certification process may be.

How Much Does ISO 9001 Certification Cost? 

Cost depends on company size and complexity. Typical costs range from $5,000-$15,000+ for external consulting help with implementation, plus $2,000-$5,000 for the certification audit itself. Ongoing maintenance adds $2,000-$5,000 annually for surveillance audits.

Who Can Get ISO 9001 Certified?

Any type of organization big or small, in any industry and sector can get ISO 9001 certified. Over 1 million certifications have been issued to public and private companies, government entities, and nonprofits worldwide. If your company is committed to quality management, ISO 9001 is attainable.

What is Involved in Maintaining ISO 9001?

After certification is achieved, organizations must maintain conformity through activities like internal audits, management reviews, ongoing training, document control, keeping the QMS current with any ISO 9001 revisions, and passing recertification audits every 3 years.

What Does ISO 9001 Implementation Involve?

Typical implementation steps include project planning, gap assessment, training, documenting processes and procedures, implementing controls and metrics, integrating the system into operations, audits and corrections, and management review. External consulting support can facilitate efficient implementation.

What Steps Are Needed to Implement ISO 9001?

High-level implementation stages include preparation, gap analysis, designing the quality management system, documentation development, training employees, piloting and integration, auditing, certification, and maintenance.

How Long Does ISO 9001 Implementation Take? 

Realistically, organizations should plan 6-12 months to fully implement ISO 9001. The timeframe depends on the complexity of current operations, existing quality practices in place, company size, and resources dedicated to the effort.

What Resources Are Required for ISO 9001 Implementation?

Successful implementation requires commitment from leadership and involvement across departments. Dedicated quality personnel to drive the effort is ideal. Many companies use ISO 9001 consultants to provide expertise and project management.

What Training is Needed for ISO 9001?

Training should cover ISO 9001 principles and requirements, internal auditor training for staff involved in QMS audits, and role-specific training to understand process documentation and quality responsibilities.

When Should a Consultant Be Used for ISO 9001?

Consultants provide valuable expertise and support throughout the ISO 9001 journey. Most companies find hiring a qualified consultant well worth the investment to guide implementation, achieve smooth certification, and optimize their quality management system.

How Can an ISO 9001 Consultant Help with Implementation?

Experienced consultants like AQM can help at every stage, from gap assessments and project planning to creating documentation, change management, internal auditor training, and ongoing optimization of the quality management system post-certification.

What Services Do ISO 9001 Consulting Firms Provide?

Typical services include gap assessments, internal auditor training, customized implementation roadmaps, document development, integration support, certification audit preparation, and post-certification maintenance support.

What Qualifications Should an ISO 9001 Consultant Have?

Look for consultants like AQM's experts who have decades focused exclusively on ISO 9001 implementation and auditing. Credentials like advanced ISO 9001 certifications and trainer qualifications are a plus.

How Do You Select the Right ISO 9001 Consultant? 

Consider consultants' ISO 9001 track record, experience aligning with your industry and needs, training and certification qualifications, customer reviews, personalized service approach, and expertise helping maximize ISO 9001 benefits for long-term success.

Approximately How Much Do ISO 9001 Consultant Services Cost?

Consulting costs vary based on scope of services, company size/complexity, project timeframes, and geographic location. Typical U.S. rates range from $150-$300 per hour. Fixed-fee project options are also available.

Ready to unlock the benefits ISO 9001 certification has to offer?