Fast ISO 9001 Implementation
Are you implementing a quality program at your organization? What will be your first step? How will you get started? We have heard from several customers about the need for implementing ISO in their unique organizational settings. If you are asking ‘How do I get started?’ or ‘How do I roll out ISO in my company?’ Then you have come to the right place.
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What is ISO 9000?
ISO 9000 refers to a set of three Quality Management System (QMS) documents: ISO 9000, ISO 9001, and ISO 9004, produced by the International Organization for Standardization.
- ISO 9000 contains the definitions and terminology used by the ISO 9001 standard.
- ISO 9001 contains the actual QMS requirements used for certification or registration audits.
- ISO 9004 is a set of guidelines that can be used to develop a quality management systems.
Although, the three documents make up the ISO 9000 set, the main one that everyone concerns themselves with is the ISO 9001 standard itself. About every seven years a new ISO 9000 set is released. The release date is then added to each set to complete the naming convention. So, ISO 9001:2008 is the full name of the standard and the current release used for ISO registration.
We no longer use ISO 9002 or ISO 9003. These names were used in the older ISO 9000:1994 standard that was obsoleted by the ISO 9000:2000 version, which in turn, was deprecated by the latest ISO 9001:2008 version. This may sound confusing but ISO rules require the standards to be reviewed and updated periodically to stay current with technological and market developments. We don’t expect the next update until ISO 9001:2015.
Creating a Quality Management System (QMS) that fulfills the ISO 9001:2008 Standard requirements can seem daunting, but it doesn’t have to be. At Bizmanualz, we have helped small and medium sized businesses become ISO 9001 certified in three to six months. A project typically includes establishing all the required elements of the ISO Quality Management System and assisting them in getting it off ground.
ISO has helped Bizmanualz cultivate the belief and practice of continuous improvement. By using the “Plan – Do – Check – Act” methods on which most quality systems are built, we have focused on improving underlying processes and avoiding problems in the future. Our process orientation reinforces teamwork: we’re all in this together to improve the process that will create ever-better, sustainable results. We aim to help other organizations implement quality systems with training materials, consulting, or this set of ISO 9001 MS-Word document templates.
What is Your Goal: Improvement or Certification?
Why should your organization use the ISO 9001 Standard? An honest reply can say a lot about how effectively the standard can improve your business. If you are using the standard as a marketing gimmick (a plaque on the wall; a logo on a website), or just because a customer requires it, then the standard will be a burden, not a benefit. If the honest reason for implementing the standard is improvement, then it can truly help your organization become better.
Did you notice in the above paragraph that I didn’t mention becoming ISO 9001 Certified? Of course, certification is a lofty goal and it will be necessary to get the plaque and the logo or to meet a specific customer requirement. But, again, if certification is the only goal then you may gain certification but miss the benefit of the standard. An organization can employ the standard, and benefit from it, without ever seeking certification.
In fact, a compelling argument could be made that the best approach is to put a functioning ISO 9001 QMS in place for a period of time before even attempting to gain certification. Perhaps even employing external auditors to review the QMS with an outside perspective – mainly to identify system weaknesses and opportunities for improvement – not to gain a pass/fail grade for certification.
Implementing the ISO 9001 Quality Management System (QMS) can serve as a business improvement tool. Frequently the ISO standard is perceived as a checklist item; Get ISO 9001 Certified;Done. The real goal of ISO 9001, however, is continual improvement of the organization. Embracing the concepts of ISO 9001 can enhance an organization in several ways, which we will cover in upcoming articles.
Is ISO 9001 About Documentation?
Let’s address what we feel is a real misconception about ISO 9001; the documentation requirements. ISO 9001 can help you simplify and improve your documentation and records. First; the ISO 9001 standard does not have complex or complicated documentation requirements. In fact, they are quite simple; there are only six required procedures for the ISO 9001 QMS. They are:
- Document Control (per ISO 9001 clause 4.2.3)
- Record Control (per ISO 9001 clause 4.2.4)
- Internal Audit (per ISO 9001 clause 8.2.2)
- Control of Non-Conformities (per ISO 9001 clause 8.3)
- Corrective Action (per ISO 9001 clause 8.5.2)
- Preventive Action (per ISO 9001 clause 8.5.3)
While it may difficult for most organizations to get by with these six procedures alone, the fact that these are the only required standard operating procedures should send a message that, despite the perception of the opposite, ISO 9001 is not about a lot of procedures, besides the required procedures above, your organization must decide what procedures are needed based on issues related to compliance, importance, and performance.
An important concept to understand is that procedures are only one way to document processes, and the ISO standard recognizes that. Processes can be documented by Work Instructions, Visuals Aids, or training materials. The real requirement by ISO is that key processes are understood and consistently carried out.
The Importance of Record Control
What receives more attention in the ISO 9001 standard are records. While there are only six required procedures, there are 21 required records. It is very likely that your organization is already keeping many of these records; but what do you do with them? The ultimate goal of ISO 9001 is improvement (as we will discuss in later articles), and one key to improvement is record keeping that captures important data related to performance metrics.
Frequently, whether it relates to the production floor or finance operations, the key factor for auditors and regulators are concerns with process control or internal controls. Does the existence of procedures really prove control? Not actually. Control is truly demonstrated by defined goals and objectives along with clear and complete records that demonstrate how well processes are meeting these objectives. Records should also demonstrate what analysis and actions are taken to improve the process when objectives are not being reached.
Using the ISO 9001 Standard can help organizations gain some perspective and reflection on how records are used, how they are controlled, and their role in gaining insight to your organization. In the proper perspective, ISO 9001 can help gain control of and assist with properly utilizing documents and records – not add additional record bureaucracy.
I recommend our ISO 9001 QMS Manual. While it is written from a manufacturing perspective, the principles, as well as many of the specific policies, procedures and forms, can be generalized for a service business. And it has been recently updated to conform to the ISO 9001:2008 standard.
ISO 9001 Quality Policy and Procedures Template
Prewritten QMS policies and procedures make it easy for you to write quality procedures that help you comply with the ISO 9001 quality standard. With the purchase of this ISO 9001 Policies & Procedures Manual, you get 23 policies and procedures, 48 quality forms and records, background on ISO 9001, a sample Quality Manual, and guidelines to help you develop an effective quality management system (QMS) of policies and procedures.
Fast Quality Procedures for ISO 9001 Implementation
The Bizmanualz ISO 9001 QMS Policies, Procedures, and Forms Manual comes with over 400 pages of practical documentation, designed to help you comply with the latest version of the ISO 9001 standard. All policies and procedures contained in the ISO 9001 manual are modeled on the Deming (or “Plan-Do-Check-Act“) Cycle.
You also get a detailed explanation of the ISO 9000 series of standards, as well as helpful information and guidance to help you produce your company’s QMS manual. The accompanying CD contains all content, including policies, procedures and forms, in editable MS Word files.
View sections of the ISO 9001 QMS Policies and Procedures Manual
Take advantage of this comprehensive ISO 9001 Quality Policies and Procedures Manual. Get your ISO 9001 certification journey started the right way — use the ISO 9001 QMS manual to simplify the process of developing, implementing, and managing your quality management system effectively! Download Free sample ISO 9001 procedure templates.