ISO 9001:2015 - Frequently Asked Questions
We're constantly getting questions about all things ISO 9001, and ISO 9001-related. We've decided to share some of the best questions we've been asked on our blog.
What is ISO 9001?
ISO 9001 is an international standard developed by the International Organization for Standardization for Quality Management Systems. "ISO" is not an acronym as would be expected; it is from the Ancient Greek isos, or "equal". The "9001" refers to the standard (Quality Management Systems), with "2015" referring to the year published.
Why do I need ISO 9001?
When talking about the "need" for ISO 9001, a true need would typically result from the requirements of a customer or other interested party, or as the result of a compliance obligation. However, many organizations do aspire to be ISO compliant, due to the potential benefits of improved performance, standardization, market recognition, etc.
What's the difference between being ISO 9001 compliant and ISO 9001 certified?
Compliance is a matter of meeting specified requirements. Certification refers to a written confirmation that specified requirements have been met, through a process of review by an external party. To be ISO 9001 certified therefore, it can be assumed that you've been audited by a third party and found compliant, with a written statement to that effect issued. With regards to ISO 9001, this written testimony is usually issued by an ISO Certifying Body or Registrar, which is accredited for such purpose.
What’s the difference between ISO 9001:2008 and ISO 9001:2015?
Any technical differences aside, ISO 9001:2015 is the replacement standard for ISO 9001:2008. It was issued in September of 2015, with a three year implementation window; as a result, ISO 9001:2008 will no longer be valid after September 2018.
ISO 9001 has a reputation for requiring a lot of documents. Do we still need to "document everything that we do"?
ISO 9001:2015 makes only a few references to documented information that must be "maintained" by an organization's Quality Management System; however, the new ISO 9001 standard does require that the organization ensure the effective operation and control of its processes. There is no longer a requirement for a quality manual, and there is no minimum number of procedures.
The minimum requirement for documented information that must be maintained includes: the Scope of the Quality Management System (4.4), Quality Policy (5.2) and Quality Objectives (6.2).
I plan to upgrade from ISO 9001:2008 to ISO 9001:2015. Can I keep my existing work instructions?
From our experience, aside from some reorganization, there's little changed between ISO 9001:2008 (7.0, Product Realization) and its replacement, ISO 9001:2015 (8.0, Operation). Assuming that day-to-day work operations are not impacted by the ISO 9001 upgrade, there shouldn't be any affect on existing work instructions.
Do I need to hire an ISO consultant to get ISO 9001 certified?
There's no ISO 9001 requirement for a consultant to be involved with your ISO 9001 certification efforts. You should consider a consultant if either your organization does not have sufficient resources or capacity to handle this task themselves, or alternatively, your organization lacks the technical skill and/or experience.
How long should ISO 9001 certification take?
How long it takes for a company to become compliant is an internal issue, which must take into account the number of employees, the complexity of the work performed, the stability and control of existing work processes, and the resources which will be allocated to support compliance efforts. Assuming no consultant involvement and limited experience, 1-2 years is not an unreasonable amount of time. Hiring a good consultant may be able to reduce this duration to a few months.
The amount of time to complete the actual process of certification would be in addition to any time spent on initial compliance efforts. Once the certification process is initiated with the Certifying Body, it is typically completed within 90-120 days.
How much should an ISO 9001 consultant cost?
This is the magic question asked by almost every organization. Pricing varies due to a range of factors, including company size, range of products, geographic location, etc., as well as the expertise, experience and reputation of the consultant themselves. We always recommend getting multiple quotes prior to making a decision.
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Information, thoughts and periodic updates from MAS Solutions' QMS Consulting Group.
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