ISO 9000 CERTIFICATION IS AN APPRAISAL TO COMPANY

During World WarII, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. According to Seddon, “In 1987, the British Government persuaded the International Organization for Standardization to adopt BS 5750 as an international standard. BS 5750 became ISO 9000.”

ISO 9001: 2008 only introduces clarifications to the existing requirements of ISO 9001: 2000 based on eight years of experience of implementing the standard worldwide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001: 2004.. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is deliberately planning the next release as an amendment rather than a formal revision. The difference is that an “amendment” is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include:-

• a set of procedures that cover all key processes in the business;
• monitoring processes to ensure they are effective;
• keeping adequate records;
• checking output for defects, with appropriate and corrective action where necessary;
• regularly reviewing individual processes and the quality system itself for effectiveness; and
• facilitating continual improvement

ADVANTAGES OF ISO 9000 CERTIFICATION:

It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001: are also sound, according to Wade, and Barnes, who says “ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive.” Barnes also cites a survey by Lloyd’s Register Quality Assurance which indicated that ISO 9001 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in as less as three months. According to the Providence Business News, implementing ISO often gives the following advantages:

1. Create a more efficient, effective operation
2. Increase customer satisfaction and retention
3. Reduce audits
4. Enhance marketing
5. Improve employee motivation, awareness, and morale
6. Promote international trade
7. Increases profit
8. Reduce waste and increases productivity

In today’s service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability.

Why Does ISO 9000 Emphasis On Document Control?

Think of the Document Control Procedure as ‘evidence’ that an established process or procedure was adhered to in order to satisfy customer requirements. Both Registrars and Internal Auditors will always focus on the quality, continuity and flow of documentation; inconsistencies in this flow of information will indicate a problem and generate a non-conformance.

It is vital that your organization implements and maintains a robust document and record management system pursuant to Clause 4.2. of ISO 9001:2008.

Terms and definitions

To better understand the difference between a document and a record, the following terms and definitions are taken from ISO 9000:2005:

Term, Clause and Definition

Document, 3.7.2, Information and its supporting medium

Record, 3.7.6, A document stating results achieved or providing evidence of activities performed Control of Documents (4.2.3)

Implementing a quality management system might mean that you will be generating new documents and keeping some records that you might not be already keeping. Some of this documentation may seem burdensome until you become more familiar with the quality standard. In general though, the organization must:

- Approve documents before your distribute them
- Provide the correct version of documents at points of use
- Review and re-approve documents whenever you update them
- Specify the current revision status of your documents
- Monitor documents that come from external sources
- Prevent the accidental use of obsolete documents
- Preserve the usability of your quality documents

In order for any organization to demonstrate the effective implementation of its quality management system, it may be necessary to develop documents other than documented procedures. However, the only documents specifically required by ISO 9001:2008 are:

- Quality policy (4.2.1.a)
- Quality objectives (4.2.1.a)
- Quality manual (4.2.1.b)
- Control of Records (4.2.4)

A record is a document that provides traceability; it declares results or presents evidence that the activities undertaken met customer requirements. It is important to identify relevant quality records as you progress your documentation and ensure that records are defined within a procedure or by a system and that it exists and is controlled.

Types of Records required by ISO 9001:2008 Document Control Procedure

5.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any actions
7.4.1 Results of supplier evaluations and any actions arising from the evaluations
7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise unsuitable for use
7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action

Document Control Procedure Summary

Remember that you are in control of the documents and records and not vice versa. Only document and record what is necessary – the fewer documents and records you keep, the fewer things that will be audited, and the more time you will have to actually run your business.

ISO 9001 Documents Control – Elements and Requirements

The ISO 9001 standard is caring for us. It cares for us from several angles. One of these cares regards our documentation. The standard requires that we will document by all means.
But it also cares that we won’t get confused and mix up different documents from different sources. Therefore it requires all documents to be controlled. This is not a recommendation but a requirement. You must control your documents. In order to achieve documents control you must maintain a method. This method must be one of the organizations quality procedures and it should be called “Documents Control”. In this procedure you must refer to the next line of issues.

Types of records
At first, you must define what documents this procedure would include. Documents can be working procedures, diagrams, technical specifications, price quotes etc. In order not to “swirl” around too many documents, let’s make it clear. Let’s define what a document is: Communication of information, evidence for correspondence, sharing of any kind of knowledge, approved documents. Someone within the organization must supervise all documents and see that they are suitable for working before they are released.The reason is to prevent any faults where unsuitable documents are being used or information that is classified is handed to wrong bodies. It is required to define for whom it is authorized and when must he approve any document. Who is responsible? The same one who is responsible for the information documented. It must be part of his job description. There are situations that more than one function would be needed to approve one document. It happens when more than one process is documented on one document.

Updated documents
This requirement assures that always the last version is the version in use – and not an older. Therefore you must define a method for maintaining updated version and elimination of older versions. How would one know what is the last version? Usually organizations manage a list of editions and updates for documents. You can manage the document itself. But most important, it is required to indicate the document itself as the last edition. This way, any employee that would use the document, would be sure that he holds the last edition. Of course, don’t forget to document the method.It is also required to define what to do with the old versions that are now not updated. How do you handle them? Are they to be destroyed, archived etc. Managing editions must include: Date of last update, The reason for the update, The function who demanded the update, The function that authorized the update. Although the ISO 9001 standard doesn’t require these requirements specifically, it would help you to achieve its basic requirements. Of course you would use what is suitable for your organization. Today there is a lot of document management softwares. These software, naturally qualify for the standard requirements but it is recommended to review anyone before purchasing.

Availability and distribution of documents
This is an un separated part of the last requirement. Defining the availability and distribution of documents must include the following:User authorization – to which it is authorized to use the document, the location of the document – where must the document be kept before and after use. Most of today’s process management systems (such as ERP or CRM systems) provide documents control relevant to the process they handle. They present the user with a screen (a screen on a computer system is a document like any other document) with defined information to input. Most of these systems also has authorization module installed. But when systems like the ones mentioned do not exist in the organization, it must provide with his employees the relevant updated documents. That means the latest editions. In order to ensure that, the standard require a documented method. How to obtain that? Well, it depends on your organization and his substructures.

Identification of documents
Any document (internal or external) must be identified somehow. Any internal document must have a name, serial number, catalogue number or whatever. Somehow to define it. The ISO 9001 standard requires that you maintain a method to achieve identification. The identification must include the numbering, coding or however you decided to identify it. But it is required to document the method. You must also include location of documents. How one can trace the document. for example customer’s files are scanned to the computer or stored in some closet. The final purpose of all this is to achieve control of the documents – any employee, once he looks at a document or trying to trace a document, would know where to approach: a department, a process, some function or any kind of identification relevant to your organization. If we look again at process management systems, then it is much simpler. Any document in those systems is identified by a number of some kind, produced by the system. The number is given according to some internal method. In this case you must not document this method but mention it in the procedure that these specific documents are managed. In case there are documents that are manually managed you must document the method. All this also applies for external documents. Any documentation that arrives from outside (with presumption that it is a document as defined) is included in the ISO 9001 standard requirement. In this case you must specify what is to do with these documents and where one can trace them in the hour of need. For example, where to file the documents. Again, you define the method according to your organization’s nature.

Documents removal
You must define a method for documents removal for any reason: un updated, out of use, etc. the method must include what is it to do with the document and who is responsible, once it is out of use. For example, removing old documents from the organization’s server for no further use or removing old forms from the offices that no one would use them again. Some of this things sound trivial and they are, but still this is a ISO 9001 standard requirement..

Summary:
The ISO 9001 standard requires that we document all sorts of our documents. It also requires that we would not confuse all kinds of documents from different sources. Therefore we must define a method for documents control. This is not a recommendation but a requirement.
The method must be presented as a documented procedure.
The documented procedure would be called “Documents control”.
You must include a definition of documents within the method – what is a document.
All documents must be approved before use. The purpose is to verify that the documents are suitable for work.
All documents must be updated. You must define a method to ensure the use of updated documents only. The method should include management documents editions and documents indications.
All documents must be identified. The organization must specify a method for documents identification. The purpose is that any employee would know which document he holds or where to trace it.
It is also required to manage availability and distribution of documents. You must verify that the documents that are distributed to the employees are the correct ones.
You must define a method for documents removal. When and why to remove documents and in whose responsibility.