ISO 9001 and Quality Management System Frequently Asked Questions

Q: What is ISO 9001?

ISO 9001 is an international standard that specifies the minimum requirements of a quality management system.  The intention of the standard is to help companies increase customer satisfaction and to address the needs and expectations of all interested parties.

Q: What does it mean to be ISO 9001 certified?

An ISO 9001 certification is an international business certification to the ISO 9001 quality management standard.  To become certified, a company must pass an audit by a third-party registrar and must comply with the requirements of the ISO 9001 standard.  

Q: Why do companies pursue ISO 9001 certification?

Many companies pursue ISO 9001 certification because it is a requirement of their customers and can be a great marketing tool.  Companies with successful quality management systems also enjoy a structured approach for achieving higher customer satisfaction, continual improvement, higher product and service quality, and increased business efficiency.

Q: Can ISO 9001 be applied to companies of all sizes?

The ISO 9001 standard and its principals are applicable for companies of all sizes.  However, it is usually best for micro-companies to consider adopting parts of the ISO 9001 standard as they grow and mature their management system.  Seeking an ISO 9001 certification is ultimately a strategic decision for every company and should be fully understood before starting any implementation.

Q: How much paperwork is required by ISO 9001?

In the 2015 release of the ISO 9001 standard, there are no longer requirements for written procedures or a quality manual; the only required paperwork is that which is flagged by the phrases “maintain documentation” and “retain documentation.”  The standard does very little to prescribe just how much documentation is required and leaves it up to the organization to prove that there is enough documentation to properly support its processes and to have confidence the processes run as planned.s.

Q: How should leadership get involved in ISO 9001?

While the direct requirements for leadership are in Clause 5 of the ISO 9001 standard, leadership must support every aspect of the quality management system for it to be successful.  Before starting any ISO 9001 quality management implementation, leadership should focus on the principals, understand the major concepts, explore best practices, and decide what they want to get out of their quality management system.  

Q: What are the minimum requirements for ISO 9001?

The requirements of the ISO 9001 standard are indicated by the word shall.  There are 131 shalls, indicating that there are 131 requirements for the organization.  The standard does not dictate exactly how each shall is to be achieved or how much work is required.   It is ultimately up to the organization to prove that its methods for achieving the requirement are implemented and effective.  When starting any ISO 9001 implementation, it is important for companies to recognize the requirements already achieved by their current day to day and business activities.

Q: Why use a consultant to help implement ISO 9001?

The ISO 9001 standard is written more like a legal document rather than a “how-to” manual.  A good consultant can help you interpret the standard and figure out how the apply its requirements to your organization in a manner that is efficient, effective, practical, and in line with your strategic direction for your organization. Additionally, good consultants can bring industry-proven practices and ideas to the table saving your organization tremendous time, money, and wasted effort.

Q: How often should I perform an internal audit or management review?

ISO 9001 does not dictate a specific frequency for internal audits or management reviews but does require that they are performed at defined intervals. The generally accepted minimum occurrence for each is once a year, but this is often the least effective method for operating an effective quality management system. Simplicit recommends a minimum frequency of 3-4 times a year to gain traction and increased effectiveness. An organization may consider breaking up the management review and internal audits into partial reviews or audits spaced at frequencies that work best for the content covered.



Q: Do I need a quality manual?

The ISO 9001 standard no longer requires a quality manual; however, many organizations choose to keep them for the internal benefit or at the request of their customers. The decision to use a quality manual should always be up to the organization.  If you choose to keep a quality manual, Simplicit Engineering recommends streamlining it as much as possible for effectiveness and usefulness within the organization.

Q: How long does the ISO 9001 certification process take?

The ISO 9001 certification process is highly dependent on your company’s readiness and capacity when starting the implementation process. For companies new to the ISO 9001 standard and its requirements, Simplicit Engineering recommends a minimum of 9-12 months for the implementation of a minimally compliant system, but some can take much longer. Companies can achieve implementation in a much faster fashion, but it takes a considered effort and focus from the organization. The absolute minimum time frame is typically 3-4 months. Keep in mind that the ISO 9001 process is one of continual improvement and should not stop at certification.

Q: How many internal auditors should I have at my company?

There are two benefits to training employees to be internal auditors. One is to have multiple auditors to spread the auditor load, and the other is to help your company understand and adopt the ISO 9001 quality management system. Simplicit Engineering recommends a minimum of 3 trained auditors for any company with 20 employees or less and an additional auditor for every additional 15 employees up to 100 employees. For larger companies with more complex systems and full-time quality professionals, more consideration is needed to determine the appropriate number of internal auditors.

Q: How do I select my 3rd party registrar?

Your registrar body should be accredited by a member of the International Accreditation Forum (IAF). Although they are heavily regulated, Simplicit Engineering recommends getting quotes from at least three registration bodies to guarantee a good fit for your organization and a competitive cost.

Q: Is ISO 9001 for service-based companies?

The short answer is YES!  ISO 9001 was specifically revised in 2015 to cater more to service-based industries.  The key to successfully applying the requirements of ISO 9001 to a service-based organization is your interpretation of the standard.  The terminology may not always be the same, but the principals, requirements, and functions apply to all industries and organizations.

Q: Are vendor audits required by ISO 9001?

ISO 9001 requires that a method for evaluating and re-evaluating your vendors is setup, but ISO 9001 does not specifically dictate which method you use.  Vendor evaluations should always be set up in a way that they are effective for your organization and helps to ensure the quality of your organization's products and services.  Vendor audits and surveys should only be used when they are seen as the most effective method for evaluating your vendor's performance.

Q: Do I need to evaluate vendors for items such as office furniture?

ISO 9001 does not require it.  Vendors required for evaluation are those detailed by clause 8.4.1 of the ISO 9001 standard.  The vendor categories include those whose products and services are incorporated into your products and services, those who supply products and services directly to your customer, and those who perform part of your process.

Q: What is the "Context of the organization?"

“Context of the Organization” is a new phrase introduce in Clause 4 of ISO 9001.  The context of the organization addresses the current organization issues, interested parties, the scope of the organization's quality management system, and its processes.  The context of the organization adds a more holistic view of the organization, which helps to identify why the quality management system is set up, what it is based around, the requirements placed on it, and the key processes involved.

Q: How many interested parties should I have?

ISO 9001 brings up the concept of interested parties in Clause 4.2 of the standard.  It is up to leadership to determine which interested parties and requirements are monitored and reviewed.  To determine which parties are considered, leadership teams should focus on the phrase “parties (or requirements) that are relevant to the quality management system.”  If a party and its requirements can affect, be affected by, or be perceived to be affected by the quality management system, then they should be considered.

Q: What makes for good quality objectives?

The best quality objectives are those fully supported by management and are seen as part of a scoreboard for the organization.  Perhaps the most important requirements for quality objectives are that they must be measurable, monitored, and communicated!  Simplicit Engineering recommends starting with a minimum number of highly impactful objectives that leadership feels compelled to communicate and report.  Over time companies should add, modify, and change objectives at different levels within the organization to be more meaningful and impactful.   Simplicit Engineering recommends the use of SMART goal principals when developing your quality objectives. (SMART = Specific, Measurable, Achievable, Relevant, Time-Bound)