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WHY YOU NEED PROCEDURES
ISO 9001 Quality Manual and Procedures
Create an ISO 9001:2015 Quality Procedures Manual fast. Save time writing out quality procedures. Our Quality Management System (QMS) comes with the basic components to get your started. You will receive Quality Manual, 24 procedures, 57 forms, and 25 job descriptions pre-written in Microsoft Word for easy editing.
Putting Together an ISO Quality Management System
We have put together what you will need to build a Quality Management System. It starts with a situational analysis to determine your interested parties, their wants and needs. What are Interested Parties?
They are stakeholders in your organization. Customers, owners, suppliers, employees, the community and others that have a stake in the ongoing success of your organization. Top Management should use the results of the situational analysis in the development of the Company’s QMS Scope, Quality Policy, Quality Objectives, and QMS processes.
QMS Scope, consists of defining the requirements of relevant interested parties, the types of products and services covered by the QMS, and provide justification for any exclusions to requirements of ISO 9001 that the organization determines is not applicable to the scope of its quality management system. Note: Exclusions to ISO 9001 may only be claimed if they do not affect the organizations ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
Quality Policy, must be appropriate to the purpose and context of the company. It ties in with and provides a framework for the Quality Objectives, includes a commitment to satisfy requirements, and a commitment to continual improvement of the QMS.
Quality Objectives, are derived from the Quality Policy, are measurable, and communicate to interested parties the effectiveness of the QMS. As objectives, they provide a basis for planning that at a minimum includes: Who, will do What, by When, requiring What resources, and How will results be evaluated.
QMS processes are those necessary for the QMS. Each QMS process shall list:
- the inputs and outputs expected,
- the sequence and interaction of these processes with each other,
- measurable process criteria (or control method),
- resources required by the process,
- responsibility for the process,
- process risks,
- how the process will be evaluated, and
- opportunities for improvement.
Are you implementing an ISO quality program at your organization? What will be your first step? How will you get started? The ISO 9001 Quality Manual and Procedures will answer many of these questions.
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.
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.
contains the definitions and terminology used by the ISO 9001 standard.
contains the actual QMS requirements used for certification or registration audits.
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.
Your Goal: Process Improvement or ISO 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 ISO 9001 Certification wasn’t mentioned? 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.
ISO Quality Manual
We provide two versions of the Quality Manual Corporate Stocks. A shorter “lean” version and a longer version. The short version of the Quality Manual reflects lean thinking most of all. Rather than borrow the text of the standard verbatim, we stripped the Quality Manual to the bare essentials. It’s not going to be for everyone – some will, no doubt, still insist that their ISO Quality Manuals parrot the text of the ISO 9001 standard, so that they’re sure their Quality Management System documentation covers every aspect of ISO 9001.
Putting in a lot of verbiage that’s not required by the standard, however, can make your Quality Manual less user-friendly, less useful, and less likely to be improved. Just in case this is your approach, we also provide a long version of the quality manual that covers all of the text of the ISO 9001 standard — all 136 shall statements.
There are fewer procedures in the new and improved ISO 9001 procedure template manual. Quality procedures that are included are ones that many organizations consider important or critical (e.g., Internal Auditing, Corrective Action). Those procedures are modeled on the Deming Cycle — they have a Plan, Do, Check, and Act phase. Some procedures that aren’t typically high priority and/or that didn’t amount to much more than simple work instructions (e.g., Serial Number Designation) have been omitted.
View Free Sample Procedure Templates
Throughout the updated manual, we refer to ISO 9001 requirements. The six required procedures are highlighted in the Quality Manual; they’re also the first six of the twenty-three procedures we provide. We’ve done something new with the “Forms and Records” section at the end of each procedure. We’re still providing sample forms for you to use, but now they’re categorized as “required” or “other” and we tell you which ISO 9001 clause requires the record. For example, in the Internal Audits procedure, there’s a form for audit reports; the Forms/Records table tells you the report requirement is in clause 8.2.2.
We think this is a much improved product, one that will smooth the bumps in your organization’s road to ISO 9001 compliance and certification. Download Free Sample ISO Procedure Templates to see how easy it is to edit MS Word Templates to build your own policy and procedure quality management system.
ISO 9001 Documentation (clause 4.2)
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.
Required ISO 9001 Procedures
- 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 ISO 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 business processes are understood and consistently carried out.
Fast ISO 9001 Procedures Manual
The ISO 9001 Procedure Template Manual is written from a manufacturing perspective, yet the quality policies and procedures can be generalized for any business.
An ISO 9001 Procedures Manual template simplifies the task of complying with the ISO 9001 standard. With the purchase of this ISO 9001 Procedure Template Manual, you get 23 ISO procedures, 48 quality forms/records, background on ISO 9000, a sample ISO Quality Manual, and guidelines to help you develop an effective quality management system (QMS).
Fast ISO 9001 Procedures
The ISO 9001 Procedures Manual comes with over 400 pages of quality documentation (download only). All policies and procedures contained in the ISO 9001 manual are modeled on “Plan-Do-Check-Act” or PDCA Cycle.
You also get an explanation of the ISO 9000 series of standards and helpful guidance to help you produce your company’s ISO 9001 manual.
ISO 9001 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.