Small Business Solutions for ISO 9001 Requirements

WHAT ARE ACCUFAST CONSULTING’S “Do-It-Yourself” PRODUCTS?"

When I started AccuFast Consulting 11 years ago, my previous 30 years experiences in manufacturing and quality (primarily in high-tech semiconductors and electronics, aerospace, and med-device business sectors, and in small and large organizations), assured me that there cannot be a truly ‘turnkey’ solution for ISO compliance (9001 or the other spin-offs such as AS9100 and ISO 13485) that will meet all the needs of all businesses. One size simply cannot fit all! Now after using my strategies and ‘boilerplate docs’ in numerous ISO implementations with our AFC consulting customers over the last 11 years, I have seen that my ‘set of boilerplates’, and overall approach to all the requirements of ISO 9001 are about 90% ready for use! (Darn close to turnkey!) The last 10% is adapting to the customer’s business, and then deploying or re-deploying individual processes or the entire quality system. Often this is a simple as reviewing processes, ‘finishing the AFC boilerplate’, implementing the changes, and doing the training. We have enjoyed and will continue to do the hands-on consulting, but these products are now being offered to the benefit of organizations beyond our reach! All AFC do-it-yourself products come with tips regarding process review, implementation, finishing the docs, and training; so our product customers can now enjoy the benefits of proven boilerplates and self-implementation at a fraction of the cost of our hands-on consulting services!"
Bob Dodge – President/Consultant

IMPORTANT NOTE REGARDING THESE PRODUCTS

MUST HAVE MS Office and Adobe Reader! All documents are presented in MS Office Word, Excel, PowerPoint, or in a pdf format where no editing is required by our customer.

DISCLAIMER: As with any ‘do-it-yourself kit’, a successful end result is very dependent on the customer’s diligence to follow the instructions and tenacity to finish the project!

WHY CHOOSE ACCUFAST CONSULTING’S “Do-It-Yourself” PRODUCTS?

1. AccuFast Consulting’s “Do-It-Yourself” PRODUCTS ARE THOROUGH, EFFECTIVE, AND PROVEN SOLUTIONS! (Not just a pile of forms and documents…and a “Good Luck!”)
THOROUGH and COMPLETE PROCESS/SYSTEM!AccuFast products include (see individual products below):

· All Required and recommended documentation

· Implementation and training guidance

PROVEN SOLUTIONS! Our products have been developed, tested, and continually improved upon over a long period of time, in a wide range of organizations, small to large, and with or without previous quality systems.

2. AccuFast Consulting’s “Do-It-Yourself” PRODUCTS ARE FULLY ISO COMPLIANT SOLUTIONS!

ISO COMPLIANCE! All of our products have been evaluated by as many as 4 ISO 9001 registrars, during numerous initial and surveillance audits, and not one of our customers ever received any findings that the ‘strategy taken’ or documentation was not compliant with all the ISO requirements!

3. there are BIG BENEFITS in a “Do-It-Yourself” implementation strategy!

BIG BENEFITS!

þ The organization gets an implementation project WIN! (Sense of accomplishment!)

þ The organization now has an internally ‘owned’ and self-managed process!

þ New or improved process is ours!

4. AccuFast Consulting’s “Do-It-Yourself” PRODUCTS ARE VERY COST EFFECTIVE SOLUTIONS!

Strategies for Creating New or Improving Old QMS Processes or Quality Mgmt Systems	Outside Consulting Support COST	Process Review & Development COST	Process Strategy & Documentation Development COST	Training/ Re-Training Materials COST	Staff Support COST	Total Overall Cost
Strategy 1: Task the internal staff	(None)	Can be HIGH if done by inexperienced staff	Can be HIGH if done by inexperienced staff	Can be HIGH if done by inexperienced staff	HIGHEST of these 4 strategies	Typically HIGH (Due to high number of staff hours, and possibly hit-miss results)
Strategy 2: Buy a ‘turnkey’ software, and then implement it internally	MEDIUM? (Typically some s/w consulting is needed.)	MEDIUM (Software may only cover part of a process or ISO reqmt)	MEDIUM to HIGH (Depends on how much internal docs need to be edited to accommodate software)	MEDIUM (Depends on system selected)	MEDIUM (Depends on system. Often high IT hours and always staff training hours)	Typically MEDIUM to HIGH
Strategy 3: Bring in a consultant	HIGH (Support is at $100+ per hour)	MEDIUM to HIGH (Depends on staff ability and participation)	HIGH (Typically created at $100+/hr rate.)	MEDIUM to HIGH (Depends on staff ability and participation)	LOW to MEDIUM (Staff always involved in and trained on the process!)	MEDIUM to HIGH (Depends on capabilities and participation of the staff)
Strategy 4: Buy AFC’s Do-It-Yourself system!	(None)	None to LOW (Staff always needs to review existing processes)	LOW (Docs in products are typically 90% completed, so just need edits.)	LOW (Products contain training materials or tips.)	MEDIUM (Staff needs to own and manage process)	LOWEST! (Cost of package, plus staff support, mgmt, &training only!)

ACCUFAST CONSULTING PRODUCTS LIST

Simple Quality Management System ISO-Compliant Solutions!

(MS Office - Excel, Word & PowerPoint & Adobe Reader - Required)

PRODUCT Rebates: AccuFast Consulting offers a Rebate on every product we sell, BECAUSE WE WANT CUSTOMER FEEDBACK! To receive the product Rebate simply click Customer Feedback Rebate on our Contact us page, fill in your customer contact information and the product number, fill in the short survey, and click Submit. We will send the Rebated amount promptly!

IMPORTANT NoteS regarding PRODUCT Rebates:

1. PLEASE COMPLETE PRODUCT IMPLEMENTATION BEFORE APPLYING FOR THE REBATE! This allows for more thorough feedback regarding our overall product and its ability to meet your needs!

2. AFC doubles the advertised Rebate for the first 10 customer satisfaction feedback inputs received for each new product, so please forward your inputs as soon as you have completed implementation or used your product!

Product Code:	AFC-01	ISO 9001 INTERNAL AUDIT PROGRAM/SYSTEM		Available:	Now!
Scope:	Complete program for conducting internal audits of ISO 9001-based quality management systems.
ISO Addressed:	ISO 9001:2008 – Section 8.2.2 (all)
Contents:	· System “Owner’s Manual”, which contains all the plans, recommendations, and tips necessary for effective internal audit program implementation, management, and continual improvement, · Boilerplate (ISO required) documented procedure defining internal audit process, · Detailed auditor training instruction and test, and templates for (ISO required) auditor training and competence records, · Boilerplate internal audits scheduling and status template, · 12 boilerplate internal audit forms (each includes audit prep, audit tips, audit questions, and [SO required] audit summary template), covering all ISO 9001 requirements.
Price:	$995 USD
Rebate::	$50 USD		Rebate applies after receipt of customer satisfaction feedback.

Product Code:	AS9100C INTERNAL AUDIT PROGRAM/SYSTEM	Available:	Now!
Scope:	Complete program for establishing a comprehensive internal audit program, conducting internal audits, and maintaining records. THIS SYSTEM IS “PROCESS-BASED” (PLAN-DO-CHECK-ACT!) AS REQUIRED BY THE LATEST AS9100C STANDARDS, AND THE ISO 19011 AUDITING GUIDANCE.
ISO Addressed:	AS9100C – Section 8.2.2 (all), and the ISO 19011 guidance for auditing
Contents:	· Internal Audit program/system “Owner’s Manual”, which contains all the plans, recommendations, and tips necessary for the implementation, management, and continual improvement of an effective internal audit process. · Boilerplate (AS9100-required) documented procedure defining the internal audit process. · Detailed internal auditor training instruction and test, and templates for (AS9100- required) auditor training and competence records. · Internal audits scheduling and status template. · 12 individual boilerplate internal audit forms (each includes audit preparation, audit tips for that audit scope, the AS9100 requirements within the scope of the individual audit, appropriate interviewing questions, and a template for summarizing audit conclusions and findings). This set of 12 audits covers 100% of the AS9100 requirements!
Price:	$995 USD Click here to see demo.
Rebate::	$50 USD Rebate applies after receipt of customer satisfaction feedback.

Product Code:	AFC-02	ISO 9001 CORRECTIVE AND PREVENTIVE ACTIONS PROGRAM		Available:	August 2011
Scope:	Complete program for the taking and recording of formal corrective and preventive actions
ISO Addressed:	ISO 9001:2008 – Sections 8.5.2 & 8.5.3 (all)
Contents:	· Boilerplate (ISO required) documented procedure defining corrective and preventive actions processes, · Boilerplate CAPA log template (ISO required record), · Boilerplate CAPA (processing) form template (ISO required record), · Process “Owner’s Manual”, which contains recommendations and tips for effective program/ process implementation, management, and continual improvement,
(Est.) Price:	$500 USD
(Est.) Rebate::	$30 USD		Rebate applies after receipt of customer satisfaction feedback.

Product Code:	AFC-03	ISO 9001 CONTROL OF NONCONFORMING PRODUCT PROCESS		Available:	Sept 2011
Scope:	Complete process for the identification, segregation, processing, and recordkeeping on product that ‘does not meet requirements’
ISO Addressed:	ISO 9001:2008 – Section 8.3 (all)
Contents:	· Boilerplate (ISO required) documented procedure defining this process, · Boilerplate NC tag template (ISO required record), · Boilerplate NC tracking log, · Process “Owner’s Manual”, which contains recommendations and tips for effective process implementation, management, and continual improvement,
(Est.) Price:	$250 USD
(Est.) Rebate::	$20 USD		Rebate applies after receipt of customer satisfaction feedback.

Product Code:	ISO 9001 CONTROL OF MONITORING & MEASURING EQUIPMENT & CALIBRATIONS PROGRAM	Available: Now
Scope:	Complete system for establishing the controls of monitoring and measurement tools/devices/equipment, and managing calibrations on equipment requiring calibration.
ISO Addressed:	ISO 9001, AS9100 and ISO 13485 – Section 7.6 (all)
Contents:	Documentation provided: · Boilerplate documented procedure for establishing the requirements for and fundamental controls of monitoring and measurement equipment, to define calibration requirements for the organization, and to establish the responsibilities and link with the record keeping database provided. · Boilerplate/sample instruction for the internal calibration of calipers. · Boilerplate/sample instruction for the internal calibration of OD micrometers. · Boilerplate/sample internal calibration instruction template. Calibration Database provided has provisions for: · Defines measurement equipment by tool types, calibration strategies and requirements. Establishes internal calibration requirements, and links to specific calibration instruction, tool pictures. · Manages records of external and internal calibrations, i.e. history, results, and actions taken. Records out-of-tolerance incidents and closure before re-use. · Provides for automatic Email notifications and visible Alerts for expired tools. · Quickly search and view histories and certs (paperless calibration records!) · Industry-standard database reports include Tool List, Individual Tool History, and ‘What’s due next?’
(Est.) Price:	$499 USD User Guide Access 2003 Demo Access 2007/2010 Demo Demo (Access Not Required)
(Est.) Rebate::	$50 USD Rebate applies after receipt of customer satisfaction feedback.

Product Code:	AFC-05	ISO 9001 MANAGEMENT REVIEW PROCESS		Available:	Dec 2011
Scope:	Complete process for the planning, executing, and recordkeeping of ISO required management reviews of the quality management system
ISO Addressed:	ISO 9001:2008 – Sections 5.6 (all)
Contents:	· Boilerplate documented procedure, · Boilerplate management review meeting minutes and summary template, · Process “Owner’s Manual”, which contains recommendations and tips for effective process implementation, management, and continual improvement,
(Est.) Price:	$200 USD
(Est.) Rebate::	$20 USD		Rebate applies after receipt of customer satisfaction feedback.

Product Code:	AFC-06	ISO 9001 MEASUREMENT, ANALYSIS and IMPROVEMENT PROCESS		Available:	Jan 2012
Scope:	Complete strategy and process for defining how product and the quality management system (QMS) are measured, the data analyzed, and subsequently improved. (Also lots of tips re establishing and communicating the ‘quality policy’ and QMS goals and monitoring performance.
ISO Addressed:	ISO 9001:2008 – Sections 8.1, 8.2.3, 8.2.4, 8.4 & 8.5.1
Contents:	· Boilerplate documented procedure, · Recommended QMS goals, · Boilerplate/recommended ‘metrics board’ template, · Process “Owner’s Manual”, which contains lots of recommendations and tips for effective process implementation, management, and continual improvement,
(Est.) Price:	$200 USD
(Est.) Rebate::	$20 USD		Rebate applies after receipt of customer satisfaction feedback.

Product Code:	AFC-07	ISO 9001 CONTROL OF DOCUMENTS & RECORDS, AND TRAINING & COMPETENCE PROGRAMS		Available:	Feb 2012
Scope:	Complete strategies and processes for properly controlling both the documents and records required to manage the quality management system. Also contains a complete strategies and processes for training and ‘deeming competence’. (This package is ‘bundled’, because we use some common logs that tie controlled documents to training.)
ISO Addressed:	ISO 9001:2008 – Sections 4.2.3, 4.2.4 & 6.2
Contents:	· Boilerplate (ISO required) documented procedure defining control of QMS documents, · Boilerplate Index (list) of Controlled Documents, · Boilerplate QMS Procedure template, · Boilerplate QMS Form template, · Process “Owner’s Manual” for control of documents, which contains lots of recommendations and tips for effective process implementation, management, and continual improvement, · Boilerplate (ISO required) documented procedure defining control of QMS records, · Process “Owner’s Manual” for control of records, which contains lots of recommendations and tips for effective process implementation, management, and continual improvement, · Boilerplate documented procedure for competence, training, and awareness, · Boilerplate (ISO required record) template for recording training, · Boilerplate (ISO required record) template for recording competence, · Process “Owner’s Manual” for competence, training, and awareness, which contains lots of recommendations and tips for effective process implementation, management, and continual improvement,
(Est.) Price:	$500 USD
(Est.) Rebate::	$30 USD		Rebate applies after receipt of customer satisfaction feedback.

Product Code:	AFC-08	ISO 9001 COMPLETE QUALITY MANAGEMENT SYSTEM (QMS) PROGRAM!		Available:	April 2012
Scope:	Complete ISO 9001:2008-compliant quality management system program! (Encompasses all previous AFC products, and adds-in the other required and recommended docs necessary for a complete, effective, and 100% ISO 9001 compliant quality management system!
ISO Addressed:	ISO 9001:2008 – All Sections!
Contents:	· Boilerplate (ISO required) Quality Manual template, · (AFC-07) Strategies and documentation for control of documents, records, and training · (AFC-05) Boilerplate procedure and documentation for management review · Boilerplate documentation for (product and customer) requirements review · Boilerplate (recommended) procedure and documentation for design and development controls · Boilerplate (recommended) procedure and documentation for purchasing and supplier management · (AFC-04) Boilerplate procedure and documentation for control of measuring equipment & calibrations · (AFC-06) Boilerplate procedure and documentation for measuring, analysis, and improvement · (AFC-01) Boilerplate procedure and documentation for internal audit · (AFC-03) Boilerplate procedure and documentation for control of nonconforming product · (AFC-02) Boilerplate procedure and documentation for corrective and preventive actions · QMS “Owner’s Manual”, which contains recommendations and tips for addressing the other ISO 9001 requirements not address in the AFC products, and where a documented procedure is not required! Also, tips effective process implementation, management, and continual improvement,
(Est.) Price:	$1950 USD
(Est.) Rebate::	$150 USD		Rebate applies after receipt of customer satisfaction feedback.