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ISO/IEC 20000 Terms and Definitions: A definite area of Improvement | Vinod Agrasala's ITSM / ITIL Blog complaint definition iso

Vinod Agrasala’s ITSM / ITIL Blog Thoughts from day-to-day life in ITSM and ITIL October 10, 2011

ISO/IEC 20000 Terms and Definitions: A definite area of Improvement Posted by Vinod Agrasala under ISO 20000 , ITSM , ITSM general , Other frameworks & Standards , Service Management | Tags: certification , Change management , Event , Incident , Inconsistencies , ISO/IEC 20000 , ISO/OEC20000:2011 , ISO20k , ITIL , ITIL V3 , ITSM , Known error , Problem , Service , Service provider | [11] Comments   Some of the definitions of terms in ISO/IEC 20000 fall short of expectations from an international standard, to say the least.

Of course, Improvements are visible such as this:

ISO/IEC 20000: 2005 defined “Service Provider” as: “ the organization aiming to achieve lSO/lEC 20000 ”!.

ISO/IEC 20000: 2011 has a better definition: “ organization or part of an organization that manages and delivers a service or services to the customer ”.

However, more concerning are definitions which can create conflict or misinterpretation such as that of Incident are still existing:

The ISO20k:2011 defines Incident as :  “Unplanned interruption to a service, a reduction in the quality of a service or an event that has not yet impacted the service to the customer ” Though there is no official acknowledgement, it is very clear that this is adopted from ITIL® V3. But in that case, it is a case of incorrect or incomplete adoption. Here is why:

The latter part of the definition, which I underlined above says “or an event that has not yet impacted the service to the customer” – Now this dangerously equates ALL events to Incidents! An event is something that affects the service (mostly exception events causing interruption or reduction in quality) or that doesn’t affect a service (warnings and regular operation events). With this loose definition, all three types of events can now fall under the bracket of Incidents.

It may not be a major issue of compliance from ISO/IEC 20000 context – where there is no separate Event management process. However the following questions needs clarity:

Does ISO/IEC 20000 view entire event management process as a subset of Incident management? In such a case, the controls specified under Incident management don’t seem to be enough to take care of the requirements of an event management process. So will every event trigger Incident management process? I hope this is not what is implied by the standard. What is the meaning of the word event that is used by the standard in multiple places? Unfortunately there is no definition of the same. Here are some other definitions in ISO/IEC 20000 that may create misinterpretations and confusions:

Known Error:   Problem that has an identified root cause or a method of reducing or eliminating its impact on a service by working around it Problem: Root cause of one or more incidents NOTE: The root cause is not usually known at the time a problem record is created and the problem management process is responsible for further investigation. Problem is root cause which is not usually known at the time of problem record creation; known error is a problem with identified root cause OR a method of reducing/eliminating impact? Don’t we see a complete mix up of terms here? I do wonder how a person who is not conversant with ITIL will interpret the above definitions…

There are more definitions which could have been a bit clearer:

Service: means of delivering value for the customer by facilitating results the customer wants to achieve  (Again, clearly adopted from ITIL V3 – however, by eliminating the ‘without the ownership of specific costs and risks’ part, creates complete overlaps with Process – Might be intentional, t yoshrdis. saks moncler bootso be consistent with perspective of Service a type of product carried by other frameworks and standards like ISO 9000 and CMMi for Service.) Service component: single unit of a service that when combined with other units will deliver a complete service (Can cause multiple interpretation of  ‘unit of service’ – not defined anywhere) Request for change : proposal for a change to be made to a service, service component or the service management system  (Overlaps both Change Proposal and Request for Change which ITIL is trying to segregate) I have written earlier the confusion created by the wrong interpretation of terminologies by auditors. These new inconsistencies could lead to more such confusions. One wish that a bit more thought and care is put into preparation of proper terms and definitions, especially in auditable and certifiable global standards…

More importantly, the adopting organizations and auditors need to put more care in the right interpretation of the standard and its clauses, rather than getting picky on the textual definitions of the terms.

Advertisements Share this: Twitter Email Facebook Like this: Like Loading... Related   11 Responses to “ISO/IEC 20000 Terms and Definitions: A definite area of Improvement” Aale Roos (@aalem) Says: October 10, 2011 at 11:52 am

Good point although I blame ITIL too, The definitions in ITIL also change from version to version with no explanation.

I think there is a screaming demand for a logical set of definitions.

Reply Vinod Agrasala Says: October 10, 2011 at 1:31 pm

hi Aale, I agree. I see some level of improvement in the definition changes that ITIL brings in most of the terms. But that level of effort seems to be missing in ISO20k. Many of the definitions looks half-cooked and ambiguous which can lead a lot of misconceptions. As you mentioned, there is a definite need for having some consolidate and consistent and logical set of terminologies in ITSM – irrespective of the framework around that…

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Reply Amelia @ IT Management Says: October 23, 2011 at 8:19 am

ITIL changes as much as technology every year. The problem is the definition changes without any logical explanation.

Being some kind of “governing body” ITIL should do better. It can’t just make anything out of thin air.

Reply Lynda Cooper Says: November 10, 2011 at 8:49 pm

I am replying as project editor of ISO/IEC 20000-1. I am really pleased to see that the new edition of the standard is being read and used. Inevitably there will be diverse views about it. Please can I assure you that every word is examined carefully. The process of developing a standard includes input and review by over 25 countries. ITIL and ISO20000 are different – they have different purposes; one being best practice and one being a management system standard. They will therefore always be different although aligned in parts. The terms and definitions will therefore also be different. Additionally, the terms cannot be the same for copywrite reasons. If a term is not defined in a standard, then it is used in the english dictionary meaning. We have to remember that there are many people who use ISO20000 who are not ITIL knowledgable. For example, ‘event’ in the definition of ‘incident’ does not mean the same as ‘event’ in ITIL. It would have to be a defined term to have that same meaning. ‘Event’ is used as ‘something that has happened’. The definition of incident is therefore not implying that all events are incidents. I wil not go into all the definitions but please remember that this is not ITIL. ISO20000 can be achieved without ITIL by using other industry frameworks or an organisation’s own framework. Please do continue your search for knowledge about ISO20000 through courses and reading. Do make sure that any course you attend is given by a very knowledgable and experienced trainer who really knows the background to the 2011 edition – there have been criticisms of courses that have been given by trainers who do not really understand the standard. There is a book on the differences between the 2005 and 2011 editions which includes a table on the differences in the terms as well as many other useful parts. It is from BSI and can be accessed as below. There are also other books from BSI about the new standard.

http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030253279

Reply Vinod Agrasala Says: November 11, 2011 at 9:34 pm

Thanks for the time taken for a detailed response. I have no doubt in my mind that the standard would have gone through immense quality reviews ,still it might be a good idea to take feedback from industry in more constructive sense rather than writing it off us ill-informed criticisms.

My point of contention starts from the following: If the standard’s definitions are left to interpretations of reader, it creates large amount of misinterpretations.

Coming to the point about Incident definition – let us leave ITIL aside- ISO/IEC 20000 definition says: “an event that has not yet impacted the service to the customer”

As per your comment above, event (which is not defined in the standard) is to be treated as “Some thing that has happened”.

– A user logged in – A link utilization moved from 30% to 40% – Back up started – Back up completed

Aren’t the above “some thing that has happened” – and hence events?

(Btw, How is this different from ITIL’s view of events?)

Now, the above haven’t “yet impacted the service to the customer”. So those fall under the bracket of Incident definition right?

I am not saying this is only way it will be interpreted, but it will be interpreted this way ALSO. I have come across auditors and consultants whose interpretations of terms and clauses are worse.

As a practitioner in the field who interact with clients and auditors frequently, I would wish for better clarity on definitions from the standard.

Reply Lynda Cooper Says: November 12, 2011 at 6:10 pm

How words can be mis-interpreted – on blog posts and in standards. I have very much taken your comments as constructive feedback and was not criticising but trying to inform readers about the process to develop a standard. I apologise if the words I used came across in the wrong way. What I suggest is that if there is ambiguity in a term, then the SMS should add in more detail about what is meant in the service provider’ organisation. There are requirements to define emergency change, ermergency release, major incident. If there is doubt, then I would add to this list what the service provider means by an event in terms of incident management. In this way the service provider’s staff and the auditor can be certain of the meaning.

Reply Roshni Kamath Says: January 22, 2012 at 10:46 pm

Hi Vinod, Liked the assertion on having clarity in definitions. We (practitioners and auditors) would all benefit if there is commonality in treating terms between ITIL and ISO20000.

— Roshni

Reply Manish Says: February 10, 2012 at 10:03 pm

Totally agree. Good post.

Reply Sunil Rangreji Says: January 29, 2013 at 9:37 am

Good post Vinod. It’s helpful.

Reply Interior Design Says: November 18, 2014 at 7:29 am

I am curious to find out what blog system you have bwen using? I’m experiencing some minor security issues with my latest blog and I’d like to find something more secure. Do you have anny recommendations?

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Archived Entry Post Date : October 10, 2011 at 12:07 am Category : ISO 20000 , ITSM , ITSM general , Other frameworks & Standards , Service Management Tags: certification , Change management , Event , Incident , Inconsistencies , ISO/IEC 20000 , ISO/OEC20000:2011 , ISO20k , ITIL , ITIL V3 , ITSM , Known error , Problem , Service , Service provider Do More : You can leave a response , or trackback from your own site. Blog at WordPress.com.

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replica moncler jackets suppliers Major v's Minor Nonconformance Started by Markcra , Jul 25 2011 10:33 AM You cannot start a new topic Please log in to reply 11 replies to this topic #1 Markcra Markcra Grade - Active

IFSQN Associate 23 posts 5 thanks 0 Neutral Australia Gender: Male Posted 25 July 2011 - 10:33 AM

I am an experienced 3rd party auditor in both HACCP and ISO 9001. Recently I have started to audit against ISO22000, but only have one client under this standard. Last week I failed my witness audit (the overseeing accreditation body for the certification body that I work for) due to wrongly classifying a non-conformance (I raised 9 audit findings - 1 major and 8 minor). I would appreciate some opinions regarding how the following scenario could be rated eg minor or major non-conformance.

The client that I audited processes flexible packaging (printing, adding pinholes, shirring and laminating). The end product is used for casing cured meats and vacuum sealing. That is the product is food contact.

In a particular process, a machine (shirring) with a rotating knife blade is used on the plastic film. This process is identified as a CCP as there is a hazard of the knife blade breaking and becoming lodged on the film which is rolled up.

The CCP is monitored by an operator by regular visually checking for a damaged blade and there is a metal detector on the line, in the event that a broken blade enters the product. At the beginning of each shift the operator as part of the standard operating procedure checks the operation of the metal detector with a test piece.

During the audit I interviewed the operator and asked him how he monitored the CCP. He showed me how the machine is visually checked to determine if there had been any damage to the blade and how the metal detector worked when he put the test piece through. The metal detector sounded an audible alarm and the line stopped, so that the product could be isolated. I also checked with his Supervisor who verified that this check was done at the start of each shift.

The HACCP plan required the operator to record the start up operational check on a form. This was not being done. During the morning I was shown a critical incident report, where several months ago a blade did happen to break and the product was isolated and discarded. Customer complaint records show that there has never been a problem with a broken blade ending up in the finished film/product.

Given that the client had demonstrated that the monitoring process was effective in controlling the CCP, what rating would you apply to the audit finding that there were no records of the metal detector being checked at the start of each shift.

Regards

Mark

0 Back to top Thanked by 1 Member: #2 Madam A. D-tor Madam A. D-tor Grade - PIFSQN

IFSQN Principal 524 posts 155 thanks 18 Good Netherlands Gender: Female Interests: meat, meat products, ready to eat, food safety, QMS, audits, hazard analyses, IFS, BRC, SQF, HACCP, ISO 9001, ISO 22000 Posted 25 July 2011 - 12:26 PM

Dear Mark,

I would raise a major on 7.6.4. NC-description would be:

From records it is not demonstrable that the CCP is under control.
There are no records of measurements or observations.

All non-conformities relating to CCPs should be a major. Even if these are only theoretical. For HACCP-certification, ISO 22000 and FSSC 22000 the CCPs are the most important subject of the standard. If these do no comply with standard requirements there should be a major. If the organisation failed to show you the other evidence (interview, demonstration, critical incident report) it should have been a critical non conformity.

All above of course to my opinion.

0 Kind Regards, Madam A. D-tor Back to top Thanked by 1 Member: Markcra #3 Charles.C Charles.C Grade - FIFSQN

IFSQN Moderator 12,117 posts 3130 thanks 333 Excellent Earth Gender: Male Interests: SF TV Movies Posted 25 July 2011 - 12:31 PM

Dear Markcra,

No documentation = it was never checked = negative detection results hv no meaning. + failure of verification system + training system ++++

I am predicting you classified it as minor.

I'm not a professional auditor but I would hv thought the assessment might also depend on things like - did the form actually exist but simply not filled in ?, other CCPs handled correctly ?, audit history, eg first deviation from a well documented correct scenario, how long the discrepancy had existed, explanation (if any) ?

In the sense of the whole HACCP system relies on documented monitoring of the CCPs, it seems like a rather non-minor thing to me but .....

Rgds / Charles.C

0

Kind Regards,

 

Charles.C

Back to top Thanked by 1 Member: Markcra #4 mind over matter mind over matter Grade - SIFSQN

IFSQN Senior 369 posts 43 thanks 2 Neutral Philippines Posted 25 July 2011 - 01:40 PM

Hi Markcra,

What's the reason why you want to know the rating to the audit finding? If you do use major or minor, what do you expect client to do different when they address them? I am predicting it's the timetable by which they are resolved, but I'm curious and interested to hear the reason from you.

0 Back to top Thanked by 1 Member: Markcra #5 Madam A. D-tor Madam A. D-tor Grade - PIFSQN

IFSQN Principal 524 posts 155 thanks 18 Good Netherlands Gender: Female Interests: meat, meat products, ready to eat, food safety, QMS, audits, hazard analyses, IFS, BRC, SQF, HACCP, ISO 9001, ISO 22000 Posted 25 July 2011 - 02:53 PM

Dear Mind over Matter,

If an auditor raise a major for an initial certification audit, the organisation will not be certified, until it is proofed that the major is solved (re visit).

If there are too many majors and minors, a total new initial audit will be needed.

A major raised during a surveillance audit, needs to be followed up with an follow up audit. Minors are usually only verified during the next surveillance audit.

Above is applied for the standards ISO 9001, HACCP, ISO 22000, FSSC 22000, ISO 14001, etc.

Edited by Madam A. D-tor, 25 July 2011 - 02:53 PM.

0 Kind Regards, Madam A. D-tor Back to top Thanked by 1 Member: #6 Markcra Markcra Grade - Active

IFSQN Associate 23 posts 5 thanks 0 Neutral Australia Gender: Male Posted 26 July 2011 - 12:02 AM

Hi Markcra,

What's the reason why you want to know the rating to the audit finding? If you do use major or minor, what do you expect client to do different when they address them? I am predicting it's the timetable by which they are resolved, but I'm curious and interested to hear the reason from you.


I needed some other opinions, as I don't audit many clients for ISO 22000. This is my first certified food safety standard and my experience is with ISO 9001 where majors are not common. So I need to re calibrate my judgement as it seems that in the certified food safety standards majors are more common in every day audits.

The minor would be followed up at the next visit in 6 months time, but the major would need to be checked in 3 months. It is a good client and from past experience they would act immediately to restore the recording of the checks. 0 Back to top Thanked by 1 Member: #7 mind over matter mind over matter Grade - SIFSQN

IFSQN Senior 369 posts 43 thanks 2 Neutral Philippines Posted 26 July 2011 - 01:04 AM

Dear Mind over Matter,

If an auditor raise a major for an initial certification audit, the organisation will not be certified, until it is proofed that the major is solved (re visit).

If there are too many majors and minors, a total new initial audit will be needed.

A major raised during a surveillance audit, needs to be followed up with an follow up audit. Minors are usually only verified during the next surveillance audit.

Above is applied for the standards ISO 9001, HACCP, ISO 22000, FSSC 22000, ISO 14001, etc.

I completely understand your view point, and I was only refering to the process of treating both minors and majors as requiring corrective actions.
If there is a ruling, under the third party registration scheme, on categorizing nonconformities, it surely has something to do with the difference in grading of the nonconformities. But....

I would appreciate if someone could cite any references to grading nonconformities. Edited by mind over matter, 26 July 2011 - 01:05 AM.

0 Back to top Thanked by 1 Member: #8 Philips Philips Grade - AIFSQN

IFSQN Associate 43 posts 11 thanks 0 Neutral Kenya Gender: Male Location: Nairobi Interests: Reading, sharing with other professionals,driving and a humble drinker Posted 09 August 2011 - 01:54 PM

Well, I have a bit of experience in auditing food safety management system . One, you may have failed in your test if you could not be able to demonstrate the facts on the ground, however, your judgement was correct, this is a major non conformity. The issue here is, if an occurence would happen due to the failure of operator monitoring the CCP, Would it cause a negative impact to the consumer, and the answer is yes, thus a major; this is not when a document is not signed, but whe a ccp is not monitore, and the evidence of monitoring is the record maitained, your classification is okay, major with no mercy.

0 Back to top Thanked by 1 Member: Markcra #9 Yuri Yuri Grade - Active

IFSQN Active 5 posts 4 thanks 0 Neutral Belgium Posted 10 August 2011 - 10:31 PM

I completely understand your view point, and I was only refering to the process of treating both minors and majors as requiring corrective actions.
If there is a ruling, under the third party registration scheme, on categorizing nonconformities, it surely has something to do with the difference in grading of the nonconformities. But....

I would appreciate if someone could cite any references to grading nonconformities.


Maybe this can help - source: http://C*#!!.com/Forums/showthread.php?t=31370

Major nonconformity
Is one or more of the following:
• The absence or total breakdown of a system to meet a requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
• Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
• A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure control of processes and products.

Minor nonconformity
Is a failure to comply with the standard which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products. It may be one of the following:
• A failure in some part of the client's quality management system relative to the standard
• A single observed lapse in following one item of a company's quality management system. 0 Back to top Thanked by 1 Member: PremixBelle #10 Yuri Yuri Grade - Active

IFSQN Active 5 posts 4 thanks 0 Neutral Belgium Posted 10 August 2011 - 10:33 PM

As for the original question: this would be a major non-conformity for me: no proof of monitoring.

0 Back to top Thanked by 1 Member: #11 mind over matter mind over matter Grade - SIFSQN

IFSQN Senior 369 posts 43 thanks 2 Neutral Philippines Posted 13 August 2011 - 04:22 PM

Maybe this can help - source: http://C*#!!.com/For...ead.php?t=31370

Major nonconformity
Is one or more of the following:
• The absence or total breakdown of a system to meet a requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
• Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
• A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure control of processes and products.

Minor nonconformity
Is a failure to comply with the standard which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products. It may be one of the following:
• A failure in some part of the client's quality management system relative to the standard
• A single observed lapse in following one item of a company's quality management system.

Now, can you cite a reference to grading nonconformities from ISO 22000? 0 Back to top Thanked by 1 Member: #12 Dr Ajay Shah Dr Ajay Shah Grade - SIFSQN

IFSQN Senior 318 posts 105 thanks 4 Neutral Australia Gender: Male Location: Melbourne Posted 15 August 2011 - 12:45 PM

If the HACCP plan indicates that the start up should be monitored and recorded and it is not then from a due diligence perspective it is not meeting the requirements and so should be classed as a Major Non conformance.

0 Dr Ajay Shah., BSc (Hons), MSc, PhD, PGCE(FE) Managing Director & Principal Consultant AAS Food Technology Pty Ltd www.aasfood.com Back to top Thanked by 1 Member: Back to ISO 22000 0 user(s) are reading this topic 0 members, 0 guests, 0 anonymous users

Reply to quoted posts       Clear     International Food Safety and Quality Network → Global Food Safety Standards → ISO 22000

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1 Page – MS Word Document

5. Employee Memo on ISO 9001

Use this memo to introduce your employees to the upcoming ISO 9001 implementation at your company. This memo will give your employees a basic understanding of ISO 9001, tell them what is expected of them, and – most importantly – alleviate your employees of any fear regarding ISO 9001 they may have. In short, the “Employee Memo on ISO 9001” will make the ISO 9001 implementation smoother for you. In addition, you may use this memo to demonstrate to your ISO 9001 auditor that you provided basic ISO 9001 training to your employees.

1 Page – MS Word Document

6. ISO 9001:2015 Compliance and Gap Analysis

This comprehensive checklist is used to determine the level of ISO 9001 compliance at your company prior to the start of the ISO 9001 implementation. The purpose of this gap analysis is to identify the functional areas in your company that require attention in order to become ISO 9001 compliant. Another use of the “ISO 9001:2015 Compliance and Gap Analysis” is to demonstrate to your company's management where ISO 9001 will lead to tangible improvements. The “ISO 9001:2015 Compliance and Gap Analysis” evaluates your company against 285 criteria.

57 Pages – MS Word Document

7. Registrar Interview Checklist

This checklist is an invaluable tool to help you choose the ideal ISO 9001 registrar (the organization that issues your ISO 9001 certificate) for your company's individual circumstances. The “Registrar Interview Checklist” contains 24 important selection criteria that will have a significant impact on the success and on the cost of your ISO 9001 certification.

2 Pages – MS Word Document

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8. ISO 9001 Quality Policy (Template & Instructions)

The ISO 9001 quality policy is the most top level document of all the ISO 9001 required documents; it sets the corporate policy on quality for the company. The ISO 9001 standard includes specific requirements for the quality policy. To make it easy for you to establish your company's quality policy in accordance with all ISO 9001 requirements, we are providing you with a prewritten template that you can easily modify to fit your company's circumstances. Detailed customization instructions are included.

4 Pages – MS Word Document

9. Process Flowchart (Template & Instructions)

The “Process Flowchart” is designed to describe the key processes and the overall process flows of most companies. The result: an easy way to meet the ISO 9001:2015 requirements for “a description of corporate processes and their interaction” as you may not even need to customize our “Process Flowchart”. If however, you chose to customize it, simply follow the included step-by-step instructions.

2 Pages – MS Word Document

10. Scope Statement (Template & Instructions)

The “Scope Statement” describes the scope, boundaries and exclusions of your ISO 9001 quality management system according to several specific ISO 9001:2015 requirements. This template applies all pertinent requirements; detailed, word-by-word customization instructions are included.

4 Pages – MS Word Document

11. ISO 9001 Quality Manual

The “ISO 9001 Quality Manual” summarizes your company's ISO 9001 quality management system and contains the overall requirements. With the newest revision of the ISO 9001 standard (ISO 9001:2015), the ISO 9001 Quality Manual is no longer an explicitly required document (though some auditors argue that one only gained the flexibility to call it by another name). We include the ISO 9001 Quality Manual in this toolkit because it can be a very useful marketing tool, and customizing it is extremely easy and fast.

28 Pages – MS Word Document

12. Customization Instructions - ISO 9001 Quality Manual

The “Customization Instructions - ISO 9001 Quality Manual” make it very easy and fast to adapt the ISO 9001 Quality Manual to your company's circumstances - just follow the instructions step-by-step and you might be done in less than one hour!

11 Pages – PDF File (use the free Acrobat Reader to view)

13. ISO 9001 Procedures Manual

The “ISO 9001 Procedures Manual” is the very core of your ISO 9001 documentation. It contains all the procedures required for your ISO 9001 quality management system. The structure and numbering system reflects that of ISO 9001:2015 (and Annex A) in general though a few requirements have been combined and a few divided up for the sake of simplicity and easy usage. This complete manual contains 44 procedures - addressing each ISO 9001:2015 clause - including a procedure that makes it easy to establish your company's quality objectives. All procedures have been designed from scratch to be true templates that - together with detailed customization instructions - allow you to create your own, individual ISO 9001 documentation, error-free and fully ISO 9001:2015 compliant. The two key features are:

Easy Implementation of ISO 9001: This pre-written template has been developed for easy ISO 9001 setup. The customization is very easy and fast if you follow the included detailed, step-by-step customization instructions.

Easy Compliance with ISO 9001: Your ISO 9001 documentation, which you will create using this template, will make it easy for your company to actually follow the requirements of ISO 9001 without unnecessary bureaucracy and paperwork.

195 Pages – MS Word Document

14. Customization Instructions - ISO 9001 Procedures Manual

The “Customization Instructions - ISO 9001 Procedures Manual” are easy-to-understand and easy-to-follow, step-by-step instructions on how to edit the procedures templates to make them fit your company. Customization instructions have a major impact on the ease of customization and the quality of the final, customized documentation. We placed particular emphasis on the quality of our customization instructions to ensure that you will be able to develop excellent and individualized ISO 9001 documentation in the shortest amount of time.

75 Pages – PDF File (use the free Acrobat Reader to view)

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15. Work Instructions

Work instructions are the detailed, step-by-step instructions that are specific to your company's individual work processes. Our All-In-One Easy 9001 Toolkit ™ includes an easy to fill-in work instructions template, plus sample work instructions for the planning of new projects, products and services. Work instructions are typically written by the people performing the work; these two tools are designed to make it easy for them.

5 Pages – MS Word Document

16. Set of 32 ISO 9001 Forms & Checklists

Our “Set of 32 ISO 9001 Forms & Checklists” make the ISO 9001 implementation and the compliance with ISO 9001:2015 requirements so much easier as each form or checklist allows you to meet one, two or several ISO 9001 requirements in one easy step. These forms and checklists compliment the ISO 9001 Procedures Manual and make it easy to meet its requirements. All forms and checklists are professionally designed for ease of use: they are self-explanatory and they “walk” the user through an entire process (for example, the corrective action process). Due to this special feature, our forms replace many work instructions. All forms are ready for use either as paper form or electronic form. Though our ISO 9001 forms and checklists can be customized if needed, all that's really necessary is to enter your company name and logo.

Form 1: Archive Label The “Archive Label” is used to identify file storage boxes and to easily meet the ISO 9001 requirements for record retention and record destruction. You will find this easy-to-use label to be a real time-saver. Designed to meet ISO 9001:2015, clause 7.5.3 requirements.

1 Page – MS Word Document

Form 2: Calibration Form The “Calibration Form” is an important part of any calibration program. It includes calibration instructions and calibration records. The form can be easily used for a wide range of devices that require calibration. Designed to meet ISO 9001:2015, clause 7.1.3 and 7.1.5 requirements.

1 Page – MS Word Document

Form 3: Corporate Environment Form The “Corporate Environment Form” is an important strategic planning tool that is used to define the internal and external environment in which the company operates. This form addresses several ISO 9001:2015 requirements related to the 'context of the organization' (ISO 9001:2015, clause 4.1 and 4.2).

3 Pages – MS Word Document

Form 4: Corrective and Preventive Action Plan Our “Corrective and Preventive Action Plan” form (short, “CAP”) walks the user through the entire corrective action process (or the entire preventive action process) – it is not necessary to refer to separate instructions. The corrective action process is a key ISO 9001 requirement; using our self-explanatory form makes meeting requirements of ISO 9001:2015, clauses 4.4, 6.1, 6.3, 8.5.6, 9.1.1, 10.1, 10.2 and 10.3 particularly easy.

1 Page – MS Word Document

Form 5: Customer Complaint Resolution Resolving a customer complaint in a professional way can turn a disgruntled customer into a satisfied and loyal customer. Our “Customer Complaint Resolution” form ensures that no opportunity is missed to properly resolve every customer complaint. The form includes brief work instructions to ensure that all aspects of this important ISO 9001 requirement (ISO 9001:2015, clause 9.1.2) are met.

1 Page – MS Word Document

Form 6: Customer Survey Finding out what your customers really think of your business is not only crucial if you want to stay ahead of your competition but it is also a central ISO 9001 requirement. Use our innovative “Customer Survey” form as a template for your company-specific survey that allows you to gain valuable customer feedback without taking much of your customers' time. Designed to meet the requirements of ISO 9001:2015, clause 9.1.2.

1 Page – MS Word Document

Form 7: Employee Evaluation The “Employee Evaluation” form is used for the periodic employee performance evaluation – but it is more than just a regular employee review: we included several sections to cover a spectrum of ISO 9001 requirements in one easy step. Our innovative “Employee Evaluation” form saves you much time and efforts during the ISO 9001 implementation and while meeting ISO 9001:2015, clause 7.2 and 7.3 requirements.

4 Pages – MS Word Document

Form 8: Employment Checklist Hiring a new employee usually requires various documents, related to government regulations, company policy etc. Use the “Employment Checklist” to make the employment process easy for the hiring manager, to ensure that consistently all required documents are in place for each new employee, and to meet ISO 9001:2015, clause 7.1.2, 7.2 and 7.3 requirements.

1 Page – MS Word Document

Form 9: Employment Termination Checklist Many companies are increasingly afraid of firing employees due to the risk of lawsuits. Our “Employment Termination Checklist” is designed to minimize this risk as it includes a 15-point checklist that requires the firing manager to meet important requirements before terminating an employee. In addition, our “Employment Termination Checklist” includes a checklist used after an employee is terminated. Designed to meet requirements of ISO 9001:2015, clause 7.1.2, 7.2 and 7.3.

2 Pages – MS Word Document

Form 10: Engineering Change Request The “Engineering Change Request” (ECR) form is used to have engineering evaluate a concern or improvement suggestion. The “Engineering Change Request” form is comprehensive yet easy-to-use; it includes a section to describe the requested changes (including sketches), a section on effects on products and assemblies, a section for the evaluation and follow-up action. Using this form will save you time and prevent mistakes.

3 Pages – MS Word Document

Form 11: Interested Parties Worksheet The “Interested Parties Worksheet” is used to gather required information for the definition of the corporate environment during strategic planning. This user-friendly worksheet includes instructions for an easy way to meet the requirements of ISO 9001:2015, clause 4.2.

3 Pages – MS Word Document

Form 12: ISO 9001 Management Review Form The “ISO 9001 Management Review Form” is a particularly valuable form: it is used to keep a record of the ISO 9001 required Management Review Meetings, it includes the agenda points of the ISO 9001 Management Review Meetings, and it includes action plans that allow for easy follow-up. Using our “ISO 9001 Management Review Form” will allow you to meet several ISO 9001 requirements (ISO 9001:2015, clauses 9.1.3, 9.3.1, 9.3.2, 9.3.3, and 10.1); in addition, you will be able to avoid a typical ISO 9001 audit non-compliance.

3 Pages – MS Word Document

Form 13: Job Description Our comprehensive “Job Description” form allows you to easily meet various ISO 9001 requirements in one easy step. The form includes instructions that help filling out the form. Designed to meet ISO 9001:2015, clauses 5.3, 7.2 and 7.3 requirements.

2 Pages – MS Word Document

Form 14: Maintenance Form The “Maintenance Form” is an easy way to establish any kind of maintenance program (for example, equipment maintenance, maintaining work environment etc.). The form combines maintenance plan and maintenance records; instructions are included. This efficient form is designed to meet ISO 9001:2015, clauses 7.1.3 and 7.1.4 requirements.

2 Pages – MS Word Document

Form 15: Meeting Notes Template The “Meeting Notes Template” is designed to help you gain more benefits from any meetings. Use this simple form to not only keep meeting minutes but to end your meeting with a specific action plan.

2 Pages – MS Word Document

Form 16: New Employee Training Plan New employees typically require company-specific training and introduction to the company. The “New Employee Training Plan” is designed to consistently provide the needed training to new employees and keep a record of the training.

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