iso has 158 national members, out of

8/14/2019 ISO Has 158 National Members, Out Of

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ISO has 158 national members, out of the 195 total countries in the world.

ISO has three membership categories:

Member bodies are national bodies that are considered to be the most representative standards body ineach country. These are the only members of ISO that have voting rights.

Correspondent members are countries that do not have their own standards organization. These membersare informed about ISO's work, but do not participate in standards promulgation.

Subscriber members are countries with small economies. They pay reduced membership fees, but canfollow the development of standards.

Participating members are called "P" members as opposed to observing members which are called "O" members.

MembersCorrespondentmembersSubscribermembersOtherplaces with an ISO 3166-1 code who aren't members of ISO

Member -

Questions for complying with ISO standards

What steps must be taken with the management?How is the documentation written?What is the registration process?


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Specific Steps to Achieve ISO 9000 Registration

The process for complying with the ISO 9000 standards and obtaining certification can becomplex. From the experience of other companies, there are recommended steps to followin order to facilitate the process.

Questions you may have on preparing for registration are:

1. What steps must be taken with management?2. How is the documentation written?3. What is the registration process?

This lesson will answer those questions. There is a mini-quiz near the end of the lesson.

Steps to follow

These eight steps--along with their sub-steps--are based on what many major companieshave followed to achieve their own ISO 9000 registration. These steps are also useful forcompanies simple seeking to conform to the ISO 900 standards, but not formally becomecertified.

These steps are a good guide for establishing a timeline, schedule, and potential costs forthe process of becoming ISO 9000 certified.

(NOTE: Also see Simple Plan for ISO 9000 Certification for another outlook on this process.)

1. Get top management commitment

Top management considers ISO 9000 registration

Quality steering committee meets to evaluate process

Committee informs top management of ISO 9000 costs, schedule, etc. Top management commits to pursue ISO 9000 registration

2. Train personnel

Hold basic quality and ISO 9000training for all employees Select and train personnel to be internal auditors

3. Prepare Quality Policy Manual

Study and understand ISO 9000 requirements as they apply to your company

Write (or re-write) company Vision and Mission statements

Write basic Quality Policy Manual outline

Complete first draft of Quality Policy Manual

Send copy of manual to customer desiring ISO 9000 compliance (if necessary)

4. Prepare Operating Procedures Define responsibilities, using Quality Manual as a guide Have those responsible for functions outline their procedures

Interview managers and fine-tune procedures

Compare Operating Procedures with Quality Manual for consistency

5. Hold internal audit

Hold internal audit of ISO 9000 manual vs. ISO 9000 compliance

Implement corrective action items from audit6. Select registrar


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Research registrars and their cost

Qualify possible registrars Select third party registrar

7. Go through registration process

Apply for registration and audits

Agree to audit process etc. with registrar Hold pre-assessment audit

Take any needed corrective action

Have ISO 9000 registration audit Take any needed corrective action

Re-audit as needed

Take any needed corrective action

8. Obtain ISO 9000 registration

This verifies that you operate your business in compliance to the ISO 9000requirements.

SummaryThese simple steps can prove to be an effective guide to obtaining ISO 9000 registration:

1. Get top management commitment2. Train personnel3. Prepare Quality Policy Manual4. Prepare Operating Procedures5. Hold internal audit6. Select registrar


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7. Go through registration process8. Obtain ISO 9000 registration

Mini-quiz to check your understanding

1. What is the first thing that must be done for achieving ISO 9000 registration?

Get top management's commitment

Start writing manuals

Find important loopholes

2. Why write Operating Procedures after completing your Quality Policy Manual?

To save consultant fees

To be able to compare them for consistency of company policy It really doesn't matter which is first

3. What is the purpose of an internal audit?

Verify every department is following the standards

Save the registrar time and effort

Keep the workers guessing as to your intentions

Documentation

One of the most daunting aspects of an ISO 9000 project is the documentation. Manymanagers stay awake nights with visions of ream upon ream of bureaucratic paperwork.Often, people are forced to re-visit old fears from high school English class, where theirpapers were not well received. While it is possible that these fears will be realized, it is notreally necessary. There are several techniques that can make the process of creating adocumented quality system easier, more effective and less intimidating.

These techniques range from simply using the appropriate tools, and applying the

appropriate structure, to using the right personnel. As always, proper planning, clearlydefining responsibilities, and controlling the process are imperative in its success. There arefive areas that must be addressed in order to develop a quality system with the leastheadaches. These are process definition, structure, tools, format/grammar and flexibility.

Process Definition

Many pundits will tell you that each person at the company must write their own proceduresin order for them to be effective and appropriate. They argue that no one knows the process


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better than the person who performs it every day and that if they are not the ones todocument it, they will have no ownership. While this argument has some merit, it only workswell if everyone at your company is a capable writer with a proper word processor and hasthe time and inclination to write procedures.

The reality is probably that much of the staff, even those at management level, arent

capable writers and dont have access to or sufficient practice on word processors. Involvingmany people in the construction of a set of documentation will yield different styles, levelsof detail, formats, etc. creating considerable problems for the person responsible for pullingit all together. This person has probably already invested considerable time and effort in thetraining and support of people who will likely never write another document for theorganization. In addition, few people have the time to devote to procedure writing. Becauseof this, everyones involvement is a goal that is unachievable at most organizations.

Who then, should write the procedures? The company should designate a person who isresponsible for the generation of procedures. That person should decide format andstructure for the procedures and will do most, if not all of the writing. Designating a singleperson assures that the procedures are written in a timely manner without excuses andwithout people shirking their responsibilities. It also enables the company to assign acapable writer with the appropriate skills to determine the processes involved, identify theright level of detail, and document them in such a way as to avoid the "ownership" issue.Finally, having a single person write the procedures ensures that there is a consistent formatand structure. This is one area where considerable benefit can be achieved with the use ofan outside consultant. This frees up internal resources to focus on the key purposes of thebusiness and ensures an expert job.

The remaining problem is how to write the procedures. The person writing the proceduresmust ensure that the process is accurately depicted. This is typically done by interviewingthe staff in the area for which the procedure is being written. The interview is used to gatherneeded information about the process and to determine how compliant the process is. It alsoallows the staff to have input into the procedure, so they dont feel "out of the loop" and canfeel "ownership" of the documents once created. From the information gathered in theinterviews, the writer writes the procedure, reviews and edits it with the staff.

Structure

Before writing the documentation, it is important to determine the structure. It is a verycommon mistake to get the structure wrong and usually occurs in two ways. The first ishaving too many, too few or improperly structured levels of documentation. The second isstructuring the documentation around the standard as opposed to the business.

A proper ISO 9000 quality system is written in three levels. Level one consists of the QualityPolicies. This usually takes the form of a Quality Manual. Level two consists of the standardoperating procedures. Level three refers to the work instructions, checklists, forms, andother task specific documentation. This is the structure which has proven successful theworld over and is alluded to in ISO 100013. Some consider that records are the fourth level,but this is not the case. Records are evidence of facts and history; they are not documentsthat are maintained up to date. Once a form is filled and filed away it is not pulled out a yearlater because the format of the form has changed. The format of the form is a level threedocument but once filled in, it becomes a record. Yes, records are part of the


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"documentation" of the system but it is a mistake to assign them a level and assigning thema level serves to confuse the important difference between and procedure and a record.

There is often some confusion about what a quality manual is. Often, the company willbundle its entire quality system including procedures and forms into one manual and call itthe Quality Manual. Although this is one possible definition, it does not help an organized

structure. A Quality Manual is a document that describes the policies for quality, defines thestructure of the quality system and defines the structure of the organization andresponsibilities for employees. It does not include detail of operations and should avoid thespecifics of procedures.

A typical Quality Manual would include several sections. First, it would define the structure ofthe organization. It might do this by including and organizational chart and by defining theresponsibilities of key personnel. It would also describe the structure of the documentationused in the quality system. Finally it would reiterate each requirement of the standards andstate briefly how they will be addressed. In many cases, simple acknowledging therequirement and stating that they will be met is enough. Again, the Quality Manual is not theplace to describe specific procedures.

This brings us to level two. Level two refers to the procedures. These describe how thecompany operates on a department by department basis. Procedures typically do notinclude detailed task specific, or order specific instructions but focus on the managementlevel information. How is the department organized? What information is received? Whathappens with that information? What tasks are performed? What reviews take place? Andwhere does information go or get filed?

When writing procedures, it is important to structure them around your business, not aroundthe standard. Too many organizations take the easy route by generating one procedure foreach element of the standard. If you dont have a product identification and traceabilitydepartment, then you shouldnt have a product identification and traceability procedure.

This requirement of the standard should be included in your other procedures where itapplies. Consequently it is clear that when procedures have been structured around thestandard, the system has been designed to gain compliance, not to add value to the way thecompany is organized and managed.

Level three refers to the detail oriented, lower level documentation. This might includechecklists, blank forms, task instructions, blueprints, drawings or order specificdocumentation. It does not include completed forms or other records.

Tools

Documenting an entire system is a sizable task. Before embarking on such a task, it ishelpful to gather the appropriate tools. First, this means a current word processor. Having a

modern computer and word processor will pay for itself in cost savings and avoidedfrustration. The modern word processor includes automated spell checking, grammarchecking, and many formatting features.

Before diving into procedure writing, it is important to know how to use these features onyour word processor. Before starting, experiment until you are comfortable using the wordprocessors features. By doing this, you will be able to incorporate these features into yourfirst documents, rather than having to incorporate them later.


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A variety of software tools are available to help generate and manage ISO 9000documentation and systems. Generation software suffers the danger of leaving you with aboiler plate system, twenty procedures and focusing on compliance. Management softwarecan be useful as the sophistication of the requirement increases. Managing large numbers ofinstruments internally might warrant calibration control software, for instance. However,considerable sophistication already exists in current word processors, spreadsheets and

databases that come with your computer. These tools are often expensive, sometimescomplicated and do not always yield the promise.

Format/Grammar

When writing procedures, theres no need to be Ernest Hemmingway. Writing proceduresdoes not require creativity or a huge vocabulary. In fact, all of these things can hurt theprocess more than help it. The best procedures are simple, clear and concise. All you needto remember is to avoid passive voice and avoid excessive wordiness.

Passive voice makes procedures difficult to read, and should be avoided when possible. Forexample:

The Packing List will be signed by the Receiver and entered into the system. (passive voice)

The Receiver will sign the Packing List and enter it into the system. (active voice)

As you can see, the passive voice sentence is less clear and is longer.

Excessive wordiness or the use of complex words also makes procedures difficult to read. Itis important to keep procedures simple and appropriate for their audience.

The Receiver will be cognizant of any discrepancy in the materials prior to signing thePacking List. (difficult to understand)

The Receiver will note any damage or defect in the materials before signing the Packing List.(easier to understand)

Flexibility

Another common mistake when creating documentation is to create rigid procedures thatare difficult to follow and maintain. Procedures should be written in a manner that they areflexible and dont paint you into a corner. Also, they should avoid hard references, complexnumbering schemes and other unnecessary bureaucracy.

Several hard references are shown below.

If a nonconformance is found, the employee will document it according to SOP 4.14. rev 5

If a nonconformance is found, the employee will document it according to SOP 4.14

If a nonconformance is found, the employee will document it according to section 5.5 of thisprocedure.

All of these references pose problems. The first one references a procedure by number andreferences a revision. That means that every time the referenced procedure is updated, thisprocedure would have to change also. This is difficult to maintain and likely to be forgotten.

The second one references the procedure by number only. This eliminates the revisionproblem, but is still subject to number changes. It is also difficult for the reader to follow.


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The third one may seem simple enough, but it may still pose a problem. If a section wasadded to the procedure before section 5.5, then the number would change and thereference would be wrong.

A more appropriate method follows.

If a nonconformance is found, the employee will document it according to the CorrectiveAction Procedures.

This is clear to the reader and is unlikely to require changes.

Many companies number their procedures. This practice is not necessarily a problem. Itdoes, however, have the potential for problems. The most common problem is the use of ISO9000 section numbers ("SOP 4.5 Document Control", "SOP 4.18 Training"). This maydeem logical, but there may be instances where there are several different procedures thataddress a single ISO clause. There may also be instances where a single procedureaddresses several ISO clauses. How would these be numbered? In addition, the year 2000revision of the ISO 9000 standard does away with the 4.X numbering system. This will make4.X numbering systems obsolete. If your document numbering system is cumbersome,eliminate it. ISO doesnt require document numbering.

Finally, it is important to write procedures in a flexible manner so that they dont restrictyour employees unnecessarily. In short, dont make a rule unless its necessary.

The employee will retrieve the document and will stamp it in the upper left corner with a red"obsolete" stamp.

The employee will retrieve the document and will clearly mark it as obsolete.

The first statement would mean that you would have to train all of your employees to stampin red in the upper left corner. You would also have to ensure that the employees haveaccess to red ink and a stamp. Even after taking these steps, it is likely that the procedureoften isnt followed. The second statement provides the same protection, but does notrestrict the manner in which the employee complies. It is just easier to follow.

Conclusion

ISO 9000 documentation is an involved task it has to be! Done properly it will add value toyour business. Before embarking on your own documentation investigate the situationthoroughly and ensure you have expertise in the subject and time and resources to see theproject through. It will save you a lot of time and effort.

Finally, do not make the mistake of starting with the work instruction documentation. This isthe most common and wasteful mistake of ISO 9000 projects. ISO 9000 does not call for anylevel three, work instruction documentation, unless it is necessary and if its necessary, italready exists. This type of documentation may add value by better defining processes or

enhancing training, but you are not doing it for ISO 9000 compliance. Make sure you want it.


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16 Steps For ISO 9001:2000 Certification1. Top Management must take a firm decision to implement Quality ManagementSystem basedon ISO 9001:2000 standard.

2. Top Management must allocate proper resources to implement the above decision.

a. Human Resources (Management Representative {ISO coordinator} & Core Team toprepare, implement, maintain & improve the Quality System)b. Time (minimum two to three hours per day (of core team) for initial three months tillachievingISO Certification & afterwards at-least one to two hours per week (like every Saturday - ofcore team).c. Financial Resources. (Fees / charges for Trainings, documentation / consultancy (ifoutsourced) & ISO Certification / audit charges.

3. Form a core team comprising minimum two employees (one senior & one junior) fromeachdepartment and appoint one member of core team as a Management Representative (MR -ISOcoordinator) to co-ordinate all ISO 9000 related activities. (Which is mandatory as perISO standard)

4. Establish a Training Plan.

a. Awareness Training for all employees (as it is a team work and all employees are partof Quality Management System).b. Documentation training for core team &c. Internal Auditors training, to at-least three to four members of core team. [For trainingContact: Quality Management Institute E-mail: [email protected]

5. Implement training plan / Conduct in-house (within your company) training seminarsOR sendyour employees to attend open house training seminars (outside your company whichare open to all) for above mentioned training seminars.a. Awareness Training for all employees &

b. Documentation training for core team.


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6. Review the Existing Business Systems in your organisation in comparison with ISO9001requirements. (Gap analysis exercise)

7. Formulate Quality Policy [Guiding document] and Quality Objectives [functional /departmental

targets / goals]

8. Formulate Six Mandatory Quality Procedures required by ISO 9001:2000 standard.

9. Formulate other Quality Procedures (QP), process flow charts (QFC), departmentalworkinstructions (WI) & other documents [i. e. forms / formats & etc. (QR, FM, FILE, REG., etc.)]required to conduct the company operations and complete the Quality Manual.

10. Implement the Newly established Quality Management System from a planned /fixed date.

11. Arrange for Internal Quality Auditors Training to at-least three to four members ofCore

Team. (Develop Self Assessment Capability)

12. Conduct first Internal Quality Audit. (After a gap of at-least 30 days from the date ofimplementation of system).

13. Make Application for certification to Certification Body (Submit Manuals for Approval(Documentation review / audit. Pay Initial Certification charges to Certification Body at-leastone month in advance.) [For certification contact : E-mail: [email protected] ]

14. Conduct first Management Review Meeting and then call Certification Body forconductingon-site audit of your Quality System.

15. Initial Audit / Assessment by Certification Body and receiving RecommendationLetter,(like a provisional certificate) at the time of closing meeting. (if CB feels that yourorganizations QMS is conforming to ISO 9001 requirements)

16. Receive original Certificate from Certification Body. (normal time frame - within 21to 30 daysfrom date of recommendation letter)

Note: After certification, Certification Body carries out surveillance audits after every ninemonths.[0-9-18-27-36] and re-certification audit (after three years).


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10 Tips on Writing for ISO 9000

1. While preparing to meet ISO 9000 standards, write an action plan listing every activitythat must be accomplished along the way.

Before starting to pursue ISO 9001, the quality manager at Symbol Technologies wrote anaction plan of 267 steps-that was just for creating the quality manual. The plan listed everytask, the people responsible for it and an estimated time to complete the task. The first task,"List all procedures that are associated with each clause," was estimated to take a week.

This type of global thinking is also exemplified by the quality manager at Dynepco, who sentout a long memo to his staff about achieving certification for ISO 9002. The memo, partstrategy and part pep talk, listed 16 steps toward achieving certification. The first four are:

Obtain management commitment.

Appoint a management representative to lead the process.

Form a steering committee or team that includes hourly people and has all areasrepresented.

Educate the team about the ISO 9000 registration process.

2. Write ISO 9000 procedures that are specific but do not handcuff your people incompleting their work.

If you were writing, for example, a procedure on how a report was to be bound, you mightwrite: "Put all sheets in a 'Clear-Vue' see-through report cover and thread a black spine overthe left side of the cover to bind the report."

But what if you run out of "Clear-Vue" covers? Are others just as good? And what aboutthose black spines? Would a green one make a big difference? Perhaps you could write: "Put

all sheets in a see-through report cover and thread a spine over the left side of the cover tobind the report."

3. If any of those who must write ISO 9000 procedures are inexperienced writers, have themcreate flowcharts describing their tasks.

While flowcharts are not a substitute for narrative in an ISO 9000 procedure, they can helpprocedure writers explain what they do. Many engineers think visually and it's easier forthem to do a flowchart than to construct a paragraph or even a series of bullet points.


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Flowcharts should be easy to read and contain less than eight steps. Try to fashion a set ofprocedures based on the flowchart.

Streamline procedures by bulleting parallel items, especially those that start with verbs.Often, there's no need to put procedures in paragraph form. For example, instead of aparagraph filled with items separated by commas or semicolons, break out of the paragraph

by putting in a colon after that announces a break from the prose; then put in a series ofbullet points to line up the thoughts for the reader.

4. Keep your ISO 9000 quality policy manual to less than 40 pages.

The quality policy manual is sometimes thought of as pointing to or referencing lower-leveldocuments. The quality manual is not the place to go into detail about who does what orhow things are done. It is a place to set policy.

The quality manual should contain no proprietary material. In fact, it should be written as ifit were to be given to customers and, in some cases, competitors. If the manual has morethan 40 pages, it's probably going into more depth than necessary or is redundant. At thatpoint, the manual will start to resemble a list of procedures or work instructions.

5. Model your quality manual after the ISO 9000 standards.

The topic order in the ISO 9000 standard should guide you in organizing your quality policymanual. Even if you have a manual partially written, it's best to start again, mirroring thetopics and order of the particular ISO 9000 standard for which your company is trying tobecome certified. By making the manual's topics the same as the standard's, you helppotential auditors follow your thoughts and make sure you've covered the required topics.

6. Make quality manuals easily auditable and maintainable.

Making a quality manual auditable means making it easy to read, easy to reference andeasy to reread. By reflecting the ISO 9000 standards, the manual becomes easier to auditquickly.

Other format issues to consider include wide margins (a lot of white space makes readingeasy on the eyes); consistent spacing (helps highlight what's important); consistentnumbering (shows readers which topics are subsets of others); large, serif typefaces (helpsreadability, save italics for emphasis only); correct capitalization; and title blocks thatinclude the company name, document name, revision or signature line, page number anddocument number.

Title blocks help you maintain your manual by making it easy to see where revised pages fitand by telling you the last time a document was revised.

7. Keep documentation concise.

Don't throw in the kitchen sink. Like every other type of writing, documentation is selectiveand should contain the minimum amount necessary to convey the idea.

Avoid redundancies like, "All quality systems, current and new, used . . ." Knock out "currentand new." Here's another redundancy: "The sales division will completely document all theprocesses that affect the customer-supplier relationship between Acme and its customers."Leave out "customer-supplier."


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Avoid wordy expressions (e.g., "on an annual basis") and the obvious (e.g., "all staffreporting directly or indirectly will support this policy.")

Avoid clichs and puffery such as, "Quality is the basis of our corporate culture" or "We willproduce perfect products and services every time, on time."

8. Make documentation self-explanatory and authoritative.

Ralph Waldo Emerson once said you should write not just so that you'll be understood but sothat you cannot be misunderstood.

To do this, you must delete any hedging. Get rid of words like "basically," "perhaps," "undercertain circumstances" and "in most cases."

Here's a vague and weak purpose statement: "To assign the responsibilities and authoritiesof the various departments within the company."

Here's the sharper, more authoritative version: "To assure individual department compliancewith quality management system guidelines for managing responsibilities."

9. Use hierarchical, easy-to-follow numbering systems for sections and subsections.Stay consistent:

1.0 PURPOSE2.0 SCOPE3.0 DEFINITIONS

The headings are all capital. Subtopics are indented and line up underneath the headings:3.0 DEFINITIONS3.1 Document-The original media that conveys information or proof of an activity, task orprocedure.3.2 Standard Operating Procedure3.3 Process Sheet

10. When trying to explain your tasks to a layperson, ask yourself, "How would I explain thisto a very bright child?"

When talking to children, you automatically know to boil down difficult-to-grasp concepts.The same idea should apply when circulating documents to people who are not versed inyour technical field. Don't expect that they "know it." They may not. They often need helpfrom you in forming a mental image of the product or process you are trying to describe.

Avoid vague phrases such as, "To ensure that the requirements between ACME Co. and itscustomers are effectively communicated . . ."

Which requirements? Contractual? Procedures? Don't make the reader guess. "Use thecorrect word and not," as Mark Twain once said, "its second cousin."

iso has 158 national members, out of

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