ISO 9001: 2008 QMS DOCUMENTATION TRAINING

1. 2. 3. 4. 5. Introduction What is a document? Why Documentation Reqd? ISO 9001:2008 General Requirements ISO 9001:2008 Documentation Requirements Pros & Cons of Documentation 3. electronic or optical computer disc photograph master sample Video Clips / Audio Clips ISO 9001:2008 General Requirements

6. Types Of Quality System documentation

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

ISO 9001:2008 clause 4.1 General requirements requires an organization to establish, document, 1. Introduction implement, and maintain a quality management system and continually improve its effectiveness in If you only have a hammer, you tend to see every accordance with the requirements of this problem as a nail. International Standard Two of the most important objectives of this session are 1. To develop a simplified set of standards that will be equally applicable to delivery as well as support functions and Top Management in Tooltech, (However, weve well defined procedures for all processes, now time to understand & review) and 2. For the amount and detail of documentation required to be more relevant to the desired results of the TGEPLs process activities. ISO 9001:2008, Quality management systems Requirements has guidelines to achieve these objectives, and the purpose of this guidance is to explain the intent of the new standard with specific regard to documentation. ISO 9001:2008 allows organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. It is stressed that ISO 9001 requires (and always has required) a Documented quality management system, and not a system of documents. 2. What is a document? Clause 4.2.1 General explains that the quality management system documentation shall include: documented statements of a quality policy and quality objectives; a quality manual documented procedures required by this International Standard documents needed by Tooltech to ensure the effective planning, operation and control of its processes,(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 also emphasizes that the extent of the QMS documentation may differ from one organization to another 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 ISO 9001:2008, 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 users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.

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

a) Communication of Information: as a tool for a) Documented statements of a quality policy information transmission & communication. The type and objectives: and extent of the documentation will depend on the Requirements for the quality policy are defined in nature of the organizations products and processes, clause 5.3 of ISO 9001:2008. The documented the degree of formality of communication systems and quality policy has to be controlled according to the the level of communication skills within the requirements of clause 4.2.3.( 07-TT-QM-5.3 Policy.pdf) organization, and the organizational culture. Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. b) Evidence of conformity: provision of evidence (08-TT-QM-5.4 Objective.pdf) that what was planned, has actually been done. c) Knowledge sharing: to spread and preserve the b) Quality Manual: organizations experiences. A typical example would Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format be a technical specification, which can be used as a and structure of the manual is a decision for each base for design and development of a new product. organization, and will depend on the organizations It must be stressed that, according to ISO 9001:2008 size, culture and complexity. Some organizations clause 4.2 Documentation requirements documents may choose to use the quality manual for other may be in any form or type of medium, examples: paper / magnetic

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ISO 9001: 2008 QMS DOCUMENTATION TRAINING

purposes besides that of simply documenting the There are several requirements of ISO 9001:2008 QMS where an organization could add value to its QMS and demonstrate conformity by the preparation of A small organization may find it appropriate to other documents, even though the standard does include the description of its entire QMS within a not specifically require them. Examples may single manual, including all the documented include: procedures required by the standard. i. Process maps, process flow charts and/or Large, multi-national organizations may need process descriptions several manuals at the global, national or regional ii. Organization charts level, and a more complex hierarchy of iii. Specifications documentation. iv. Work and/or test instructions The quality manual is a document that has to be v. Documents containing internal controlled in accordance with the requirements of communications clause 4.2.3. (\\Dataserver2\iso\IS0-9000\ISO-MANUALS\Apex_Manual) vi. Production schedules vii. Approved supplier lists c) Documented procedures: viii. Test and inspection plans ISO 9001:2008 specifically requires the ix. Quality plans organization to have documented procedures for All such documents have to be controlled in the following six activities: accordance with the requirements of clause 4.2.3 i. 4.2.3 Control of documents and/or 4.2.4, as applicable ii. 4.2.4 Control of records (\\Dataserver2\iso\IS09000\RECORDS\Miscellaneous\List_of_Defined_Procedures_QMS.pdf) iii. 8.2.2 Internal audit e) Records: iv. 8.3 Control of nonconforming product Organizations are free to develop other records that v. 8.5.2 Corrective action may be needed to demonstrate conformity of their vi. 8.5.3 Preventive action processes, products and quality management These documented procedures have to be controlled system. in accordance with the requirements of clause 4.2.3 Requirements for the control of records are different Some organizations may find it convenient to from those for other documents, and all records combine the procedure for several activities into a have to be controlled according to those of clause single documented procedure (for example, 4.2.4 of ISO 9001:2008. (16a-TT-QM-4.2.4-ANX.pdf) corrective action and preventive action). Others may choose to document a given activity by using more 5. Pros & Cons of Documentation than one documented procedure (for example, internal audits). Both are acceptable. Disadvantages: Some organizations (particularly larger The actual change of operations can be very organizations, or those with more complex expensive. processes) may require additional documented Usually designated people (limited no. of procedures (particularly those relating to product Employees) have to take classes and be trained as realization processes) to implement an effective the companys liaison for ISO 9000. QMS. As is well known in business and industry, it is Other organizations may require additional difficult to change the habits of longtime employees. procedures, but the size and/or culture of the New procedures are rarely welcomed with open organization could enable these to be effectively arms. In fact, new ways are usually resisted by implemented without necessarily being everyone. documented. However, in order to demonstrate This resistance cuts into profits and also decreases compliance with ISO 9001:2008, the organization company morale. has to be able to provide objective evidence (not There are times when companies feel that the necessarily documented) that its QMS has been existing set of operational procedures is already effectively implemented. working well and they do not feel a change is (\\Dataserver2\ISO\IS0-9000\ISO-MANUALS\Delivery_Dept) necessary. (\\Dataserver2\ISO\IS0-9000\ISO-MANUALS\SUP_DEPTS) Frequently, companies will have a customer who d) Documents needed by the organization demands that they be ISO 9000 certified to Following are the Documents needed by the continue doing business. organization to ensure the effective planning, Now the company has the choice of losing a operation and control of its processes: customer or implementing ISO 9000. Either way In order for an organization to demonstrate the money is lost in the short term. effective implementation of its QMS, it may be Even though there may be an initial implementing necessary to develop documents other than cost, ISO 9000 has been proven to reduce cost and documented procedures. However, the only improve the total quality in the long run. documents specifically mentioned in ISO 9001:2008 Advantages:are: Ensure that products and services provided meet i. Quality policy (clause 4.2.1.a) customer requirements ii. Quality objectives (clause 4.2.1.a) iii. Quality manual (clause 4.2.1.b)

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ISO 9001: 2008 QMS DOCUMENTATION TRAINING

Ensure consistency in the day to day operations i.e. Reduced operational expenses Ensure that processes are repeatable and predictable i.e. Better management control Allow the company to create and retain satisfied customers i.e. Increased customer satisfaction Boosted the efficiency and minimize unproductive time. Increased marketability Improved internal communication Enhanced customer service Reduction of product-liability risks A secure, centralized location for all of your information Attractiveness to investors Today, document control and employee competence are just two components of a full blown management system 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 ISO 9001 requirements and ask yourself if you would want to deal with any supplier that said they were not going to that one part from corrective action to purchasing it all makes sense. If you use this approach to think through what ISO 9001 really expects you will eventually come to understand the value.

8. Final Note: Lots of people feel, ISO standards are just documents that provide a framework for management systems. What you get out of it is just about equal to what you So, the cons are no more valid, if one understands put into it. That is, ISO itself doesn't provide anything this, ISO 9000 is not just a badge to be worn; it except guidance. Take it or leave it, make it so-so or is a set of standards to be followed. make it great. Do as you will with it.
6. Types of Quality System documentation

Broadly, there are two types of ISO User: Type A: Those who were made by their customers to obtain certification of their quality management system; or Type B: Those who enthusiastically embraced their nation's basic standard for quality management systems Type A users are forever complaining about the documented system they did not want. Because they were made to do it they probably made a hash of documenting their QMS (that is writing the procedures around the standard instead of their organization). They may or may not enjoy the marketing benefits of sporting their certification logo. Type B users saw the opportunity to develop their organizations' management systems so they do an even better job of converting customers' needs into cash in the bank. Their systems are well led, developed, used and improved to add value faster and prevent loss sooner. They may or may not enjoy the marketing benefits of sporting their certification logo. I am not sure if Type A users ever become Type B users, But well try to make best out of QMS in our Department, which will lead Tooltech to be the Best. In the beginning, middle and end it's not about the standard. It's about us and the people around us, who are trying to do a good job, so our customers will be happy and we'll be successful. Learn it, Use it, Win it.

7. Now, What is ISO 9001? ISO 9001 is nothing more than the latest version of preventive practices that have been used since the beginning of the industrial revolution. 200 years ago Eli Whitney built cotton gins and knew full well that if you change a document or specification but dont control the change and notify people, that this was going to cause a problem. He also knew that you dont assign someone to do something unless they were capable of performing the task correctly.

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

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

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