Procurement specifications often require certification as a condition to supply, so certification and verification opens doors. Show
ISO 9001 is the international standard for a quality management system (“QMS”). In order to be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.
There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification. Typically, an entire organization will seek certification, but the scope of the QMS can be tailored to improve performance at a particular facility or department. The current version is ISO 9001:2015, which was published in September of 2015 (thus the: 2015).
A great way to understand how ISO 9001 works is to apply it to an example. Here is an easy example of ISO 9001 applied to making cookies.
“ISO 9001 Certified” means an organization has met the requirements in ISO 9001, which defines an ISO 9001 Quality Management System (QMS). ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while forcing you to identify and implement improvements. Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results (reduced scrap and increased efficiency).
As with most business processes, the more you do yourself, the less the cost, but the more time it may require. No matter how many external resources are utilized, there will need to be involvement by your employees and staff to varying degree. While there is no total “do it yourself” solution, you can go a long way on ISO 9001’s basic requirements by using pre-formatted materials for documentation and training. (Check out our materials here!) While the procedures and methods in these must be tailored to your situation, they are typically created with the goal of minimizing the changes required and maximizing the ability for others to use and comprehend them. The goal of any quality management system should not be to add unnecessary paperwork, but to make all references clear and highly usable.
ISO 9001:2008 was published on November 14, 2008, replacing ISO 9001:2000. The 2008 version became obsolete effective September of 2018 and was replaced by ISO 9001:2015. Click here to compare ISO 9001:2000 to ISO 9001:2008. List of significant changes the 2008 version brought to ISO 9001 (from the 2000 version):Clause 0.2 (Process approach):
Clause 1.1 (Scope)
Clause 4.1 (General requirements)
Clause 4.2.1 (Documentation)
Clause 4.2.3 (Document control)
Clause 4.2.4 (Records control):
Clause 5.5.2 (Management rep)
Clause 6.2.1 (Human resources)
Clause 6.3 (Infrastructure):
Clause 6.4 (Work environment)
Clause 7.2.1 (Customer related processes)
Clause 7.3.1 (Design & development planning)
Clause 7.3.3(Design & development outputs):
Clause 7.5.4 (Customer property):
Clause 7.6 (Now retitled Control of Monitoring and Measuringequipment)
Clause 8.2.1 (Customer satisfaction)
Clause 8.2.3 (Monitoring / Measurement of process)
ISO Organization’s Introduction and support package(© 2008 ISO)In conjunction with the publication of ISO 9001:2008, Quality management systems – Requirements, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommittee SC 2, Quality systems, has published a number of guidance modules:
ISO Management Systems articles
ISO 9001:2000 was a major overhaul of ISO 9001:1994 and replaced three standards:
The ISO 9001:2000 revision allowed exceptions to design and development procedures if a company did in fact NOT engage in the creation of new products, as well as introduced a few concepts: Changes from 1994 to 2000The text has been reworded for easier adaptation to a wider range of organizations. Some definitions have been changed. The standard has a process-oriented structure. It includes a process model based on the Plan-Do-Check-Act cycle, which outlines the product and/or service cycle and the management control cycle. The 20-point format was replaced. The text of the standard is now organized into four major processes:
Documentation requirements are less-prescriptive, and allow greater flexibility.
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of final product inspection, requiring evidence of compliance with documented procedures. This version also included ISO 9002 and ISO 9003 as in the 1997 versions.
ISO 9001:1987 was based on BS 5750, with three quality management systems depending on the activities of the organization:
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