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 in
each 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 members
are 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 can
follow the development of standards.

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

Members
Correspondent members
Subscriber members
Other places 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?
Specific Steps to Achieve ISO 9000 Registration

The process for complying with the ISO 9000 standards and obtaining certification can be
complex. From the experience of other companies, there are recommended steps to follow
in 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 companies
have followed to achieve their own ISO 9000 registration. These steps are also useful for
companies simple seeking to conform to the ISO 900 standards, but not formally become
certified.

These steps are a good guide for establishing a timeline, schedule, and potential costs for
the 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 audit
6. Select registrar
 • 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 9000
requirements.

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

1. Get top management commitment

2. Train personnel
3. Prepare Quality Policy Manual
4. Prepare Operating Procedures
5. Hold internal audit
6. Select registrar
 7. Go through registration process
8. 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. Many
managers 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 their
papers were not well received. While it is possible that these fears will be realized, it is not
really necessary. There are several techniques that can make the process of creating a
documented 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, clearly
defining responsibilities, and controlling the process are imperative in its success. There are
five areas that must be addressed in order to develop a quality system with the least
headaches. 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 procedures
in order for them to be effective and appropriate. They argue that no one knows the process
better than the person who performs it every day and that if they are not the one’s to
document it, they will have no ownership. While this argument has some merit, it only works
well if everyone at your company is a capable writer with a proper word processor and has
the time and inclination to write procedures.

The reality is probably that much of the staff, even those at management level, aren’t
capable writers and don’t have access to or sufficient practice on word processors. Involving
many people in the construction of a set of documentation will yield different styles, levels
of detail, formats, etc. creating considerable problems for the person responsible for pulling
it all together. This person has probably already invested considerable time and effort in the
training and support of people who will likely never write another document for the
organization. In addition, few people have the time to devote to procedure writing. Because
of this, everyone’s involvement is a goal that is unachievable at most organizations.

Who then, should write the procedures? The company should designate a person who is
responsible for the generation of procedures. That person should decide format and
structure for the procedures and will do most, if not all of the writing. Designating a single
person assures that the procedures are written in a timely manner without excuses and
without people shirking their responsibilities. It also enables the company to assign a
capable writer with the appropriate skills to determine the processes involved, identify the
right 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 format
and structure. This is one area where considerable benefit can be achieved with the use of
an outside consultant. This frees up internal resources to focus on the key purposes of the
business and ensures an expert job.

The remaining problem is how to write the procedures. The person writing the procedures
must ensure that the process is accurately depicted. This is typically done by interviewing
the staff in the area for which the procedure is being written. The interview is used to gather
needed information about the process and to determine how compliant the process is. It also
allows the staff to have input into the procedure, so they don’t feel "out of the loop" and can
feel "ownership" of the documents once created. From the information gathered in the
interviews, 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 very

common mistake to get the structure wrong and usually occurs in two ways. The first is
having too many, too few or improperly structured levels of documentation. The second is
structuring 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 Quality
Policies. This usually takes the form of a Quality Manual. Level two consists of the standard
operating procedures. Level three refers to the work instructions, checklists, forms, and
other task specific documentation. This is the structure which has proven successful the
world 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 documents
that are maintained up to date. Once a form is filled and filed away it is not pulled out a year
later because the format of the form has changed. The format of the form is a level three
document but once filled in, it becomes a record. Yes, records are part of the
"documentation" of the system but it is a mistake to assign them a level and assigning them
a 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 will
bundle its entire quality system including procedures and forms into one manual and call it
the 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 the
structure of the quality system and defines the structure of the organization and
responsibilities for employees. It does not include detail of operations and should avoid the
specifics of procedures.

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

This brings us to level two. Level two refers to the procedures. These describe how the
company operates on a department by department basis. Procedures typically do not
include detailed task specific, or order specific instructions but focus on the management
level information. How is the department organized? What information is received? What
happens with that information? What tasks are performed? What reviews take place? And
where does information go or get filed?

When writing procedures, it is important to structure them around your business, not around
the standard. Too many organizations take the easy route by generating one procedure for
each element of the standard. If you don’t have a product identification and traceability
department, then you shouldn’t have a product identification and traceability procedure.
This requirement of the standard should be included in your other procedures where it
applies. Consequently it is clear that when procedures have been structured around the
standard, the system has been designed to gain compliance, not to add value to the way the
company is organized and managed.

Level three refers to the detail oriented, lower level documentation. This might include
checklists, blank forms, task instructions, blueprints, drawings or order specific
documentation. 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 is

helpful 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 avoided
frustration. The modern word processor includes automated spell checking, grammar
checking, and many formatting features.

Before diving into procedure writing, it is important to know how to use these features on
your word processor. Before starting, experiment until you are comfortable using the word
processor’s features. By doing this, you will be able to incorporate these features into your
first documents, rather than having to incorporate them later.
A variety of software tools are available to help generate and manage ISO 9000
documentation and systems. Generation software suffers the danger of leaving you with a
boiler plate system, twenty procedures and focusing on compliance. Management software
can be useful as the sophistication of the requirement increases. Managing large numbers of
instruments 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, sometimes
complicated and do not always yield the promise.

Format/Grammar

When writing procedures, there’s no need to be Ernest Hemmingway. Writing procedures

does not require creativity or a huge vocabulary. In fact, all of these things can hurt the
process more than help it. The best procedures are simple, clear and concise. All you need
to remember is to avoid passive voice and avoid excessive wordiness.

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

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. It
is important to keep procedures simple and appropriate for their audience.

The Receiver will be cognizant of any discrepancy in the materials prior to signing the
Packing 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 that
are difficult to follow and maintain. Procedures should be written in a manner that they are
flexible and don’t paint you into a corner. Also, they should avoid hard references, complex
numbering 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 this
procedure.

All of these references pose problems. The first one references a procedure by number and
references a revision. That means that every time the referenced procedure is updated, this
procedure 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 revision
problem, but is still subject to number changes. It is also difficult for the reader to follow.
The third one may seem simple enough, but it may still pose a problem. If a section was
added to the procedure before section 5.5, then the number would change and the
reference would be wrong.

A more appropriate method follows.

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

Action 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. It
does, however, have the potential for problems. The most common problem is the use of ISO
9000 section numbers ("SOP 4.5 – Document Control", "SOP 4.18 – Training"). This may
deem logical, but there may be instances where there are several different procedures that
address a single ISO clause. There may also be instances where a single procedure
addresses several ISO clauses. How would these be numbered? In addition, the year 2000
revision of the ISO 9000 standard does away with the 4.X numbering system. This will make
4.X numbering systems obsolete. If your document numbering system is cumbersome,
eliminate it. ISO doesn’t require document numbering.

Finally, it is important to write procedures in a flexible manner so that they don’t restrict
your employees unnecessarily. In short, don’t make a rule unless it’s 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 stamp
in red in the upper left corner. You would also have to ensure that the employees have
access to red ink and a stamp. Even after taking these steps, it is likely that the procedure
often isn’t followed. The second statement provides the same protection, but does not
restrict 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 to
your business. Before embarking on your own documentation investigate the situation
thoroughly and ensure you have expertise in the subject and time and resources to see the
project 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 is
the most common and wasteful mistake of ISO 9000 projects. ISO 9000 does not call for any
level three, work instruction documentation, unless it is necessary – and if its necessary, it
already 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.
16 Steps For ISO 9001:2000 Certification

1. Top Management must take a firm decision to implement Quality Management

System based
on 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 to

“prepare, implement, maintain & improve” the Quality System)
b. Time (minimum two to three hours per day (of core team) for initial three months till
achieving
ISO Certification & afterwards at-least one to two hours per week (like every Saturday - of
core team).
c. Financial Resources. (Fees / charges for Trainings, documentation / consultancy (if
outsourced) & ISO Certification / audit charges.

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

4. Establish a Training Plan.

a. Awareness Training for all employees (as it is a team work and all employees are part
of Quality Management System).
b. Documentation training for core team &
c. Internal Auditors training, to at-least three to four members of core team. [For training
Contact: “Quality Management Institute” E-mail: iso9001training@gmail.com

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

b. Documentation training for core team.

6. Review the Existing Business Systems in your organisation in comparison with ISO
9001
requirements. (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), departmental
work
instructions (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 of
Core
Team. (Develop Self Assessment Capability)

12. Conduct first Internal Quality Audit. (After a gap of at-least 30 days from the date of
implementation 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-least
one month in advance.) [For certification contact : E-mail: iso9001certification@gmail.com ]

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

15. Initial Audit / Assessment by Certification Body and receiving “Recommendation

Letter”,
(like a provisional certificate) at the time of closing meeting. (if CB feels that your
organizations QMS is conforming to ISO 9001 requirements)

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

Note: After certification, Certification Body carries out surveillance audits after every nine
months.
[0-9-18-27-36] and re-certification audit (after three years).
10 Tips on Writing for ISO 9000

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

Before starting to pursue ISO 9001, the quality manager at Symbol Technologies wrote an
action plan of 267 steps-that was just for creating the quality manual. The plan listed every
task, 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 sent
out a long memo to his staff about achieving certification for ISO 9002. The memo, part
strategy 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 areas
represented.
• Educate the team about the ISO 9000 registration process.

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

If you were writing, for example, a procedure on how a report was to be bound, you might
write: "Put all sheets in a 'Clear-Vue' see-through report cover and thread a black spine over
the 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 about
those 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 to
bind the report."

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

While flowcharts are not a substitute for narrative in an ISO 9000 procedure, they can help
procedure writers explain what they do. Many engineers think visually and it's easier for
them to do a flowchart than to construct a paragraph or even a series of bullet points.
Flowcharts should be easy to read and contain less than eight steps. Try to fashion a set of
procedures 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 a
paragraph 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 of
bullet 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-level

documents. The quality manual is not the place to go into detail about who does what or
how 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 if
it were to be given to customers and, in some cases, competitors. If the manual has more
than 40 pages, it's probably going into more depth than necessary or is redundant. At that
point, 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 policy
manual. Even if you have a manual partially written, it's best to start again, mirroring the
topics and order of the particular ISO 9000 standard for which your company is trying to
become certified. By making the manual's topics the same as the standard's, you help
potential 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 and
easy to reread. By reflecting the ISO 9000 standards, the manual becomes easier to audit
quickly.

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

Title blocks help you maintain your manual by making it easy to see where revised pages fit
and 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 selective
and should contain the minimum amount necessary to convey the idea.

Avoid redundancies like, "All quality systems, current and new, used . . ." Knock out "current
and new." Here's another redundancy: "The sales division will completely document all the
processes that affect the customer-supplier relationship between Acme and its customers."
Leave out "customer-supplier."
Avoid wordy expressions (e.g., "on an annual basis") and the obvious (e.g., "all staff
reporting directly or indirectly will support this policy.")

Avoid clichés and puffery such as, "Quality is the basis of our corporate culture" or "We will
produce 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 so
that you cannot be misunderstood.

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

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

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

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

Stay consistent:

1.0 PURPOSE
2.0 SCOPE
3.0 DEFINITIONS
The headings are all capital. Subtopics are indented and line up underneath the headings:
3.0 DEFINITIONS
3.1 Document-The original media that conveys information or proof of an activity, task or
procedure.
3.2 Standard Operating Procedure
3.3 Process Sheet

10. When trying to explain your tasks to a layperson, ask yourself, "How would I explain this
to 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 in
your technical field. Don't expect that they "know it." They may not. They often need help
from 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 its
customers are effectively communicated . . ."

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