ISO 9001 Internal Auditing System Program

WHY DO INTERNAL QUALITY SYSTEM AUDITS?

INTERNAL AUDITS ARE A KEY ‘CONTINUAL IMPROVEMENT’ TOOL FOR ANY BUSINESS!

Internal auditing is one of the most important business and quality management system processes compliance, ‘effectivity monitoring’, and continual improvement tools. Historically, organizations with thorough and effective internal audit programs, and that address and correct issues and opportunities discovered in internal audits in a timely fashion, not only ‘maintain’ a healthy quality system, but enjoy the financial benefits of continual operational improvement!

INTERNAL AUDITS ARE AN ISO 9001 REQUIREMENT!

(All from ISO 9001:2008, section 8.2.2 Internal audit) KEY POINTS ONLY!

ü The organization shall conduct internal audits at planned intervals to determine whether the quality management system (QMS):

• conforms to the requirements of this (ISO 9001) Standard,

• is carried out according to the requirements established by the organization (called ‘planned arrangements’),

• and, is effectively implemented, maintained, and effective?

ü The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. (And, the referenced guidance document ISO 19011, requires that auditors be trained and competent.)

ü The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure. (This standard defines ‘documented procedure’ as establish, documented, implemented and maintained.)

ü The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.

WHY CHOOSE ACCUFAST CONSULTING’S “Do-It-Yourself” INTERNAL AUDIT PROGRAM?

1.0 AccuFast Consulting’s “Do-It-Yourself” INTERNAL AUDIT PROGRAM/SYSTEM IS A THOROUGH AND PROVEN SOLUTION! (Not just a pile of forms and documents…and a “Good Luck!”)

THOROUGH and COMPLETE PROCESS/SYSTEM! In order to meet all these ISO 9001 (and the guidance document ISO 19011) requirements, and to provide our customers with a comprehensive and effective internal auditing program and process, AccuFast Consulting’s system provides for: All Required and Necessary Documentation:

ü The (ISO required) documented procedure for internal audit,

ü A detailed auditor training instruction and test, and templates for training and competence records,

ü An internal audits scheduling and status template,

ü 12 internal audit forms, which together include all ISO requirements, and each includes:

• auditing tips from AFC for each audit scope/focus,

• the ability to insert in the organization’s ‘planned arrangements’ for that audit scope,

• all necessary audit questions,

• an audit summary template, which serves as the ISO-required internal audit record!

ü And, (very important) a system “Owner’s Manual”, which contains all the plans, recommendations, and tips necessary for effective internal audit process implementation, management, and continual improvement!

PROVEN SOLUTION! This internal auditing strategy has been developed, tested, and continually improved upon over a 20 year period. This system is suitable for a wide range of organizations, small to large, and with or without previous internal auditing or internal audit program experience. For the past 10 years AccuFast Consulting has provided to and used this system with the numerous customers we assisted in achieving an ISO 9001 registration. All of our customers have continued to use this system (because they find it to be very effective).

SYSTEM TRACK RECORD for Initial (year 1) ISO Registration Audits?:

1. Our customers that properly completed all internal audits, and then at least started formal corrective actions for all audit nonconformities….have NEVER received a major nonconformity finding from their registrar! (Data from: 18 certs with 4 ISO registrars)

2. Six of our recent customers that implemented a complete AFC-guided quality management system, and then completed all internal audits, and started formal corrective actions for all audit nonconformities….received no nonconformity finding on their initial audit from their registrar! (Almost unheard of!) (Data from: 6 certs with 3 ISO registrars)

SYSTEM TRACK RECORD for Surveillance (year 2 & 3) ISO Certification-continuance Audits?:

1. Our customers that properly completed all internal audits, and then at least started formal corrective actions for all audit nonconformities….commonly receive no nonconformity findings from their registrar!

Interesting Note from AccuFast Consulting: Our experience with ISO registrars during our customer’s registration audits (initial or surveillance) has shown that ISO registrars will often not even report the finding of a nonconformance if it was indeed pointed out in an internal audit and formal corrective action has already commenced. (Because it would therefore not be a value-added input to their client!) Another benefit!

2.0 There are BIG BENEFITS in a “Do-It-Yourself” implementation strategy, INCLUDING A BETTER UNDERSTANDING OF THE ISO REQUIREMENTS AND YOUR PROCESS, TEAM BUILDING, AND SELF-OWNERSHIP!

Benefits from the system/program implementation Journey include:

þ A review of your current process (if applicable),

þ Training regarding the ISO requirements for the process owner/manager, the auditors & internal audit customers,

þ Increased awareness of the other aspects of the quality system (when inserting ‘planned arrangements’ into the appropriate audit form).

Benefits from properly implementing and managing this program will include:

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

þ The organization now has an internally ‘owned’ and self-managed internal audit system, and trained staff
(i.e., not dependant on expensive outsiders).

þ All of your organization’s quality management system is now being audited at appropriate intervals, to all the requirements of ISO 9001 and your ‘planned arrangements”.

þ And, assuming corrections are made in the areas where weaknesses, inefficiencies, or nonconformities were determined, the organization’s QMS should remain ‘in control’, continually improve in effectiveness over time, and be ready to pass any ISO-based audit (i.e., customer or ISO registrar) at any time!

3.0 AccuFast Consulting’s “Do-It-Yourself” INTERNAL AUDIT PROGRAM/SYSTEM IS A VERY COST EFFECTIVE INTERNAL AUDIT PROGRAM SOLUTION!

The REWARDS of purchasing and implementing this “Do-It-Yourself” audit program include:

ü Total cost is much cheaper than other solutions (see below)

	Documentation Costs	Consulting Fees	Staff Hours	Total Cost
Strategy 1: Task the staff to improve current internal audit program, or create and implement a new internal audit program	High (Done by possibly inexperienced staff)	(None)	VERY HIGH (Done by possibly inexperienced staff)	Typically VERY HIGH (Due to high number of staff hours, and possibly hit-miss results)
Strategy 2: Buy a ‘turnkey’ software, and then implement it internally	LOW to MEDIUM (Depends on how much internal need to be edited to accommodate software)	MEDIUM (Depends on system selected. Some require consulting, some come with)	MEDIUM (Depends on system selected. Typically high IT hours and always staff training hours)	Typically MEDIUM to HIGH
Strategy 3: Bring in a consultant to provide docs, system & training	HIGH (Typically created at $100/hr rate.)	HIGH (Figure on several days minimum at $1000/day)	LOW to MEDIUM (Staff always has to be involved in and trained on the system!)	Typically HIGH (Depends on experience and capabilities of the staff)
Strategy 4: Buy AFC’s Do-It-Yourself system!	LOW (All included in package)	(None) (AFC is available for help on an hourly basis, if needed!)	MEDIUM (Staff needs to be assigned and follow the plan!)	LOWEST! (Cost of package plus staff project mgmt/ support and training hours only!)

ü and (very importantly) the sense of “we implemented our system!”. (And, the process won’t stop when the consultant leaves!)

The RISKS of purchasing and implementing this “Do-It-Yourself” audit program include:

ü wasted time and wasted money! (However, this Risk can be eliminated by simply following AccuFast’s step-by-step strategies and instructions for training, implementation, and long-term process monitoring and management!)

NOTE: AccuFast Consulting can assist remotely with system, implementation, and/or training questions at the rate of $95 per hour, as needed.

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