iso documentation training leaflet

7/30/2019 ISO Documentation Training Leaflet

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ISO 9001: 2008 QMS DOCUMENTATION TRAINING

Tooltech Global Engineering Pvt. Ltd, An ISO 9001:2008 Certified Company of 3

1. Introduction2. What is a “document”? Why Documentation Reqd?3. ISO 9001:2008 General Requirements4. ISO 9001:2008 Documentation Requirements5. Pros & Cons of Documentation6. Types Of Quality System documentation

7. Now, What is ISO 9001?8. Final Note

1. Introduction

“ If you only have a hammer, you tend to see every problem as a nail .”

Two of the most important objectives of this sessionare1. To develop a simplified set of standards that will

be equally applicable to delivery as well as supportfunctions and Top Management in Tooltech,(However, we’ve well defined procedures for all processes, now time to understand & review ) and

2. For the amount and detail of documentationrequired to be more relevant to the desired resultsof the TGEPL’s process activities.

ISO 9001:2008, Quality management systems – Requirements has guidelines to achieve theseobjectives, and the purpose of this guidance is toexplain the intent of the new standard with specificregard to documentation.ISO 9001:2008 allows organization flexibility in theway it chooses to document its quality managementsystem (QMS). This enables each individualorganization to develop the minimum amount of documentation needed in order to demonstrate theeffective planning, operation and control of itsprocesses and the implementation and continualimprovement of the effectiveness of its QMS.

It is stressed that ISO 9001 requires (and always hasrequired) a “Documented quality management system ”, and not a “system of documents ”.

2. What is a “document”?

The following are some of the main objectives of anorganization’s documentation, independent of whether or not it has implemented a formal QMS;

a) Communication of Information: as a tool forinformation transmission & communication. The typeand extent of the documentation will depend on thenature of the organization’s products and processes,the degree of formality of communication systems and

the level of communication skills within theorganization, and the organizational culture.

b) Evidence of conformity: provision of evidencethat what was planned, has actually been done.

c) Knowledge sharing: to spread and preserve theorganization’s experiences. A typical example wouldbe a technical specification, which can be used as abase for design and development of a new product.It must be stressed that, according to ISO 9001:2008clause 4.2 Documentation requirements documents may be in any form or type of medium , examples:

• paper / magnetic

• electronic or optical computer disc

• photograph

• master sample

• Video Clips / Audio Clips

3. ISO 9001:2008 General Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document,implement , and maintain a quality management

system and continually improve its effectiveness inaccordance with the requirements of thisInternational Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

• documented statements of a quality policy andquality objectives;

• a quality manual

• documented procedures required by thisInternational Standard

• documents needed by Tooltech to ensure theeffective planning, operation and control of itsprocesses,(16-TT-QM-4.2.4_Records Control.pdf ) and

• records required by this International Standard;

The standard specifically requires a “documented procedure ”, the procedure has to be established,documented, implemented and maintained. It alsoemphasizes that the extent of the QMSdocumentation may differ from one organization toanother due to:

• the size of organization and type of activities;

• the complexity of processes and their interactions,and

• The competence of personnel.

All the documents that form part of the QMS have to

be controlled in accordance with clause 4.2.3 of ISO9001:2008, or, for the particular case of records,according to clause 4.2.4.

4. ISO 9001:2008 Documentation Requirements The following comments are intended to assist usersof ISO 9001:2008 in understanding the intent of thegeneral documentation requirements of theInternational Standard.

a) Documented statements of a quality policyand objectives:

• Requirements for the quality policy are defined inclause 5.3 of ISO 9001:2008. The documentedquality policy has to be controlled according to the

requirements of clause 4.2.3.( 07-TT-QM-5.3 Policy.pdf) • Requirements for quality objectives are defined in

clause 5.4.1 of ISO 9001:2008.(08-TT-QM-5.4 Objective.pdf)

b) Quality Manual:

• Clause 4.2.2 of ISO 9001:2008 specifies theminimum content for a quality manual. The formatand structure of the manual is a decision for eachorganization, and will depend on the organization’ssize, culture and complexity. Some organizationsmay choose to use the quality manual for other





purposes besides that of simply documenting theQMS

• A small organization may find it appropriate toinclude the description of its entire QMS within asingle manual, including all the documentedprocedures required by the standard.

• Large, multi-national organizations may needseveral manuals at the global, national or regionallevel, and a more complex hierarchy of

documentation.• The quality manual is a document that has to be

controlled in accordance with the requirements of clause 4.2.3.

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c) Documented procedures:

• ISO 9001:2008 specifically requires theorganization to have “documented procedures” forthe following six activities:

i. 4.2.3 Control of documentsii. 4.2.4 Control of recordsiii. 8.2.2 Internal auditiv. 8.3 Control of nonconforming productv. 8.5.2 Corrective action

vi. 8.5.3 Preventive action

• These documented procedures have to be controlledin accordance with the requirements of clause 4.2.3

• Some organizations may find it convenient tocombine the procedure for several activities into asingle documented procedure (for example,corrective action and preventive action). Others may choose to document a given activity by using morethan one documented procedure (for example,internal audits). Both are acceptable.

• Some organizations (particularly largerorganizations, or those with more complexprocesses) may require additional documented

procedures (particularly those relating to productrealization processes) to implement an effectiveQMS.

• Other organizations may require additionalprocedures, but the size and/or culture of theorganization could enable these to be effectively implemented without necessarily beingdocumented. However, in order to demonstratecompliance with ISO 9001:2008, the organizationhas to be able to provide objective evidence (notnecessarily documented) that its QMS has beeneffectively implemented. (\\Dataserver2\ISO\IS0-9000\ISO-MANUALS\Delivery_Dept )

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d) Documents needed by the organizationFollowing are the Documents needed by theorganization to ensure the effective planning,operation and control of its processes:

• In order for an organization to demonstrate theeffective implementation of its QMS, it may benecessary to develop documents other thandocumented procedures. However, the only documents specifically mentioned in ISO 9001:2008are:

i. Quality policy (clause 4.2.1.a)ii. Quality objectives (clause 4.2.1.a)iii. Quality manual (clause 4.2.1.b)

• There are several requirements of ISO 9001:2008where an organization could add value to its QMSand demonstrate conformity by the preparation of other documents, even though the standard doesnot specifically require them. Examples may include:i. Process maps, process flow charts and/or

process descriptionsii. Organization charts

iii. Specificationsiv. Work and/or test instructionsv. Documents containing internal

communicationsvi. Production schedulesvii. Approved supplier listsviii. Test and inspection plansix. Quality plans

All such documents have to be controlled inaccordance with the requirements of clause 4.2.3and/or 4.2.4, as applicable(\\Dataserver2\iso\IS0-9000\RECORDS\Miscellaneous\List_of_Defined_Procedures_QMS.pdf )

e) Records:

• Organizations are free to develop other records thatmay be needed to demonstrate conformity of theirprocesses, products and quality managementsystem.

• Requirements for the control of records are differentfrom those for other documents, and all recordshave to be controlled according to those of clause4.2.4 of ISO 9001:2008. ( 16a-TT-QM-4.2.4-ANX.pdf)

5. Pros & Cons of Documentation

Disadvantages:

• The actual change of operations can be very expensive.

• Usually designated people (limited no. of

Employees) have to take classes and be trained asthe company’s liaison for ISO 9000.

• As is well known in business and industry, it isdifficult to change the habits of longtime employees.

• New procedures are rarely welcomed with openarms. In fact, new ways are usually resisted by everyone.

• This resistance cuts into profits and also decreasescompany morale.

• There are times when companies feel that theexisting set of operational procedures is already working well and they do not feel a change isnecessary.

• Frequently, companies will have a customer whodemands that they be ISO 9000 certified tocontinue doing business.

• Now the company has the choice of losing acustomer or implementing ISO 9000. Either way money is lost in the short term.

• Even though there may be an initial implementingcost, ISO 9000 has been proven to reduce cost andimprove the total quality in the long run.

Advantages:-

• Ensure that products and services provided meetcustomer requirements





• Ensure consistency in the day to day operations i.e.Reduced operational expenses

• Ensure that processes are repeatable andpredictable i.e. Better management control

• Allow the company to create and retain satisfiedcustomers i.e. Increased customer satisfaction

• Boosted the efficiency and minimize unproductivetime.

• Increased marketability

• Improved internal communication• Enhanced customer service

• Reduction of product-liability risks

• A secure, centralized location for all of yourinformation

• Attractiveness to investors

So, the cons are no more valid, if one understandsthis, “ISO 9000 is not just a badge to be worn; it is a set of standards to be followed.”

6. Types of Quality System documentation

7. Now, What is ISO 9001?

ISO 9001 is nothing more than the latest version of preventive practices that have been used since thebeginning of the industrial revolution. 200 years agoEli Whitney built cotton gins and knew full well that if

you change a document or specification but don’tcontrol the change and notify people, that this wasgoing to cause a problem. He also knew that youdon’t assign someone to do something unless they were capable of performing the task correctly.

Today, document control and employee competenceare just two components of a full blown managementsystem that is described in ISO 9001. Every part of ISO 9001 is preventive and adds value to any serious user . Take a minute and look at any part of the ISO9001 requirements and ask yourself if you wouldwant to deal with any supplier that said they were notgoing to that one part – from corrective action topurchasing – it all makes sense. If you use this

approach to think through what ISO 9001 really expects you will eventually come to understand thevalue.

8. Final Note:Lots of people feel, ISO standards are just documentsthat provide a framework for management systems.What you get out of it is just about equal to what youput into it. That is, ISO itself doesn't provide anythingexcept guidance. Take it or leave it, make it so-so or make it great. Do as you will with it.

Broadly, there are two types of ISO User:

• Type A: Those who were made by their customers toobtain certification of their quality management

system; or• Type B: Those who enthusiastically embraced their

nation's basic standard for quality managementsystems

Type A users are forever complaining about thedocumented system they did not want. Because they were made to do it they probably made a hash of documenting their QMS (that is writing theprocedures around the standard instead of theirorganization). They may or may not enjoy themarketing benefits of sporting their certification logo.

Type B users saw the opportunity to develop their

organizations' management systems so they do aneven better job of converting customers' needs intocash in the bank. Their systems are well led,developed, used and improved to add value faster andprevent loss sooner. They may or may not enjoy themarketing benefits of sporting their certification logo.

I am not sure if Type A users ever become Type Busers, But we’ll try to make best out of QMS in ourDepartment, which will lead Tooltech to be the Best.

In the beginning, middle and end it's not about thestandard. It's about us and the people around us,who are trying to do a good job, so our customers willbe happy and we'll be successful.

Learn it, Use it, Win it.

Remember the purpose of Documentation / standard is to continually improving the Business as well as our Life.

So, Our Approach will be “Can Do / Will Do / Shall Do ”….Cheers….

It is not the product that is ISO registered, it is the company's Quality/Business System.

A Big Thank You From,

Sadananda