The Quality Manual is a direct translation of the ISO9001:2000 Standard. This is the most efficient and accurate method of producing a fully compliant ISO Quality Manual. Top management enjoys it because it is brief, only about 15 to 16 pages. It indicates “Your Company Does”, where the Standard requires “The Organization Shall”. The formal approval and issuance of this document constitutes your company’s Top Management commitment to fully institute and support the ISO9001:2000 Quality Management System. As such, the Quality Manual is created by your Quality Assurance Manager or designee, checked by another cognizant employee, and then approved by all of your company’s Top and Senior Management.
This Quality Manual contains the additional feature of an Index of the supporting documents and departmental responsibilities which serves as your company’s Quality Assurance Program Plan (QAPP). In regard to ISO requirements, it provides the details that describe the responsibilities and interactions within the Quality Management System (QMS), and it is “Auditor Friendly”.
The Quality Manual is written to support the entire ISO9001:2000 requirements, which include all of Design, Development and Manufacturing.
ABOUT THE AUTHOR:
This manual was developed by Bernd R Guggolz, a certified Internal Auditor with over 23 years of technical management experience. Bernd’s experience includes:
• Developing, implementing, and maintaining ISO9001, military & space level Quality Management Systems
• Selecting registrars, attaining ISO Registration and upgrades without findings, and working with DSCC, government auditors and source inspectors.
If you have any questions on these instructions or any questions on the Quality Manual itself, please call Bernd directly at (508) 757-1227 or email him at firstname.lastname@example.org
Software Intructions Notes For the Quality Systems Manual:
The Quality Manual is written to support the entire ISO9001:2000 requirements, which include all of Design, Development and Manufacturing. If your company does not perform the design or manufacturing functions, or parts thereof as described in section 7, then exclusions may legitimately be made of pertinent section 7 details. An exact decision of needed exclusions must be made and justified. These exclusions and justifications must be written into section 3, the Related References exclusion statements of this Quality Manual, and are limited to section 7 only.
Example: Your company performs all of section 7 (Product Realization) except it does not service its products (within section 7.5.1 and 7.5.2), and it does not obtain or maintain customer property (section 7.5.4). It is your company’s responsibility to plainly claim these exclusions and provide a simple justification statement in section 3 of the Quality Manual. After the successful registration audit, your company’s Registration Certificate will also contain such exclusions.
Before the body of the Quality Manual, three additional items are addressed.
1- A statement of Your Company’s mission. Who are you, what do you do, and what is your mission. This is not an ISO requirement, but rather helps to support the Scope Statement in section 2. Furthermore, it provides auditors and customers, who will request the Quality Manual, with a uniform, well thought through statement of Your Company’s scope of business and product line(s). Here, an affirmation of commitment to Customer Satisfaction and Continuous Improvement would be of value as well. The Marketing and Sales department is a likely candidate for developing the Mission Statement. Perhaps it has already been developed, and may simply be copied into the Quality Manual. This may also be a good time to re-evaluate the existing verbiage.
2- A Quality Policy Statement. A member of Senior Management, usually the Management Representative develops this policy statement. Per ISO section 5.3, “Top Management shall ensure that the quality policy:
1. is appropriate to the purpose of the organization
2. includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system
3. provides a framework for establishing and reviewing quality objectives
4. is communicated and understood within the organization, and
5. is reviewed for continuing suitability.”
After this Quality Policy has been drafted and approved, place the finished statement into the Quality Manual and also make it available for all to see. This could be a plaque, or a framed sheet, placed on all computers desktops and so forth. After the Quality Manual is fully approved, everyone in Your Company must become familiar with the statements and be able to verbalize their contribution to the Quality Policy. Verbatim knowledge is not necessary. However, auditor(s) will ask employees if they know it. It is useful to have the Quality Policy available at many locations so that employees can point to it and explain their contributions as they apply to their work.
3. Quality Objectives. It is best not to physically locate these into the Quality Manual, but rather to place them in appropriate locations that are readily accessible by personnel. Since Quality Objectives are fluid, and often proprietary (yield goals, and device attributes for example), they are best not published in issued documents. In the space allocated for Quality Objectives, prepare a simple statement of their general location in Your Company’s Quality Management System. Section 5.4.1 explains the detailed requirements of the Quality Objectives.
In Section 3, Related References, the second bullet mentions in which Top Level document the organizational chart is located. Again, it is best not to provide it in the Quality Manual because this too may be fluid.
This is a good time to begin considering the documentation identification formats. A suggested format for a document hierarchical system is as follows:
Two or three letters that are a synonym of your company name
Q for Quality Management System documentation, followed by either:
100x for Top / Senior Management level documents or
10x for Quality Direct documents (Incoming Inspection, ECO System, Calibration etc. or
000x a sequential number up to 999 for operational documents (Clean Room Maintenance, Review of customer requirements, Design and Development etc.).
The Quality Manual would be XYZQ1000 - Top Management
Documentation and Change Control would be XYZQ0100 - Quality Direct
Design and Development would be XYZQ0016 - Operational
The Quality Manual in its raw form contains numerous references to “your company” in red font and yellow highlights, YOURCOMPANY or YC for example. These are included for visibility, and need to be changed to your company’s name in black font, and with the highlights removed. Red text is instructional and may be eliminated after the instructions have been considered. The red text of document names in the Index / QAPP are the minimum required documents needed to be ISO compliant. These will need to be developed and formally instituted.
Whenever the Quality Manual references records, these must be created as part of your company’s documented system.
Although the Standard requires only a few documents, you are strongly urged to create supporting documents for all facets of your operations. (See above) The auditor(s) will ask “where is it written - - “. Formally issued documents for quality and operations provide a uniform work environment, the required training, and personnel fully capable of working within and supporting your company’s ISO environment. Records are best placed into the documents that require them as part of its operations.
As these documents are named and developed, write their numbers, titles and responsible personnel’s titles into the Index to complete the Quality Assurance Program Plan.
Remove the hidden text in the headers.
The Quality Manual is now ready for review and acceptance.
Additional insights are available in the ISO QMS Development Roadmap.