ISO 9000 Standards – Document control procedures

ISO 9000 Standards – Document control procedures

The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document
control process is to firstly ensure the appropriate information is available
where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that
may require documented procedures in order to ensure consistency and
predictability. Procedures may not be necessary for each stage in the process.

Every process is likely to require the use of documents or generate documents and it is in the process descriptions that you define the documents that need to be controlled. Any document not referred to in your process descriptions is therefore, by definition, not essential to the achievement of quality and not required to be under control. It is not necessary to identify uncontrolled documents in such cases. If you had no way of tracing documents to a governing process, a means of separating controlled from uncontrolled may well be necessary.

The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures that deal with the controls that apply to all documents. The stages in the process may differ depending on the type of document and organizations involved in its preparation, approval, publication and use. One procedure may cater for all the processes but several may be needed.
The aspects you should cover in your document control procedures, (some
of which are addressed further in this chapter) are as follows
Planning new documents, funding, prior authorization, establishing need
etc.

- Preparation of documents, who prepares them, how they are drafted,
conventions for text, diagrams, forms etc.
- Standards for the format and content of documents, forms and diagrams.
- Document identification conventions.
- Issue notation, draft issues, post approval issues.
- Dating conventions, date of issue, date of approval or date of distribution.
- Document review, who reviews them and what evidence is retained.
- Document approval, who approves them and how approval is denoted.
- Document proving prior to use.
- Printing and publication, who does it and who checks it.
- Distribution of documents, who decides, who does it, who checks it.
- Use of documents, limitations, unauthorized copying and marking.
- Revision of issued documents, requests for revision, who approves the
request, who implements the change.
- Denoting changes, revision marks, reissues, sidelining, underlining.
Amending copies of issued documents, amendment instructions, and
amendment status.
- Indexing documents, listing documents by issue status.
- Document maintenance, keeping them current, periodic review.
- Document accessibility inside and outside normal working hours.
- Document security, unauthorized changes, copying, disposal, computer
viruses, fire and theft.
- Document filing, masters, copies, drafts, and custom binders.
- Document storage, libraries and archive, who controls location, loan
arrangements.
- Document retention and obsolescence.

With electronically stored documentation, the document database may provide many of the above features and may not need to be separately prescribed in your procedures. Only the tasks carried out by personnel need to be defined in your procedures. A help file associated with a document database is as much a documented procedure as a conventional paper based procedure.

Transition from ISO 9001:2000 to ISO 9001:2008

Transition from ISO 9001:2000 to ISO 9001:2008

This reference guide was developed to help you understand the nature of the changes to theISO 9001 standard.

Clause Change/Emphasis Not Auditable

0.1 General – Added language emphasizing statutory and regulatory requirements are a concern as it relates to products for this international standard.

0.4 Compatibility with Other Management Systems Standards - Emphasis was added on the consideration given to ISO 14001:2004 to ensure that the standards are compatible.

1.1 General

1.2 Application – “Statutory” was added in certain paragraphs to ensure the user is aware that these requirements must be taken into consideration. Additional notes were added to explain that where the word “product” appears, it refers to every stage of its existence, from raw material received to the final product being shipped to the customer.

2. Normative Reference – Reference to ISO 9000 (vocabulary and concepts) was updated to refer to the current revision (i.e. ISO 9000:2005).

3. Terms and Definitions – The supplier/organization/customer model was removed. These relationships, in reality, are not always linears.

The Auditable Requirements
Clause Change/Emphasis
4.1
In 4.1 a, “identify” was replaced with “determine” to emphasize that an organization must give careful consideration to what processes are needed in order to fulfill requirements.
A link is drawn to 7.4 in the additional note. This was done to show that the supplier approval, evaluation, and re-evaluation process is where evidence of controlled outsourced processes should be demonstrated.
4.2.1
References to records and documents were consolidated.
Also, the organization can require records not specified in this international standard that are created and maintained.
4.2.3
Clarification is given to the requirement for outsourced documents. Only those needed for the planning and operation of the QMS need to be controlled. This could exclude documents related to occupational health and safety since ISO 9001 contains requirements only concerned with product (see 0.1).
4.2.4
Rephrased, but no additional clarifications or emphasis added. Editorial change only.
5.5.2
The management representative must be from the organization’s management. This would exclude consultants and other individuals external to the organization (e.g. a management representative from the corporate entity). The purpose of this is to ensure that this individual, entrusted with the responsibilities of championing the quality management system, is not “out of touch” with the organization.
6.2.1
The boundaries of competence only extend to individuals who impact product conformity. However, this does not just include those who are directly involved in production. The decisions made by management affect product conformity; therefore, they must be competent as well.

6.2.2
If said personnel have not yet attained the competence needed to perform the assigned job, then the organization must provide training or some other remedy to ensure that competence is achieved. The organization must also have a mechanism to ensure that personnel have been evaluated based on how well they demonstrate their knowledge and skill (i.e. competence). It is not enough to merely provide training or consider an individual’s experience. The organization must prove to itself that this person can, in fact, perform.
6.3
Infrastructure also includes databases and information technology.
6.4
Emphasis is added in a note to highlight that the concept of “work environment” only extends to product quality.
7.1 c
“Measurement” is added.
7.2.1
“Post-delivery activity” is clarified in a note with examples.
7.3.1
A note emphasizes that design verification, validation, and review are different from one another and serve different purposes. Design review is where the organization evaluates if the design can meet requirements and if any changes need to be made. Design verification is where the organization has ensured that requirements have been met (e.g. is the widget blue and is it hexagonal?). Design validation is where the organization proves that the design can perform as required.
However, the records of design verification, validation, and review do not have to be separate.
7.3.3
Production and service provisions also extend to how product is preserved, handled, etc., to ensure product conformity. See 7.5.1
Design outputs must include requirements related to preservation. See 7.5.5.

7.5.2
Notes were added to give examples of the types of processes where this requirement would apply along with a statement that service organizations should have additional considerations in the planning stages when deficiencies and conformity are not likely to be identified prior to delivery.
7.5.3
Product status must be identified throughout product realization, not just the final product. See 1.2.
7.5.4
Wording was modified to add clarity, but the intent of the requirement has not changed.
7.5.5
Again, emphasis is added that care must be given to preserving the product regardless of where it falls in the realization process.
7.6
An obsolete reference to another ISO document was replaced.
The definition of “monitoring and measuring devices” has been clarified to include equipment and devices that are purposed for monitoring and measuring, regardless of their original or intended purpose.
An additional note regarding software was added.
8.2.2
Document and record requirements were reworded and their placement modified to improve clarity.
The reference to the auditing guidance document was updated (i.e. ISO 19011).

8.2.3
Wording was modified to emphasize that correction and corrective actions are not only to be taken to preserve the conformity of the product, but also to preserve the quality management system. For example, internal rejection/scrap rates could show evidence that the organization is preserving product conformity and is taking intermediate action to prevent bad product from being shipped to their customers; however, it could also be a sign that the organization is not efficient since the higher rejection/scrap rates are undesirable.
A note was added to clarify the meaning of “suitable methods” related to planning, monitoring and measurement processes. Suitability should be determined based on risk and the impact that nonconformity would have on the product or process.
8.2.4
Product can be released to other internal processes despite planned arrangements not being satisfactorily completed as long as it conforms prior to release to the customer. This relaxes requirements on intermediate inspection results and records.
8.3
Actions taken against nonconforming product must be proportional to its impact or potential impact. See 8.2.3 related to impact considerations for monitoring and measurement.
This would mean that in the planning stages of a product, the organization needs to customize responses to nonconforming products based on the risk or potential risk to the organization.
This requirement existed in ISO 9001:2000; however, its location has changed.

8.5.2
Nonconformity can have multiple causes (“cause”; i.e. a singular reason, was used in the 2000 version); therefore, the organization must consider this when conducting root cause analysis.
Also, it is not enough to simply review corrective action and ensure that procedures were changed, personnel have been re-trained, and that processes were amended. The organization must review whether or not the action(s) taken were effective; i.e. did they successfully eliminate the nonconforming condition?
8.5.3
Similar to the new emphasis on the effectiveness of corrective action, the organization must also document whether or not the preventive action(s) taken were effective in eliminating the risk of nonconformity.

How To Implement ISO 9001 Standards Using Template & Softwares

There are few ways of implementing the ISO 9000 in a particular organization. One of the easy way is hiring a ISO 9000 consultant in a turn key project basis. This definitely will incur cost. However, some of the organization will appoiint an employee to start up the ISO 9000, by learning thru seminar, preparing the ISO 9000 Quality Manual, Procedure & Form by using some of the ISO 9000 Template sell at internet. Some of the provider such as http://www.iso-consults.com & http://www.quality-template.com are providing such services.
Normally, the template provide will provides the ISO 9000 Quality Manual Template, Standand Procedure & also sample form for the ISO 9000 implementation. One of the provider like http://www.e-wia.com give a very complete set of the ISO 9000 Templates, which will help an organization to implement the ISO 9000 easily.
There are also some ISO 9000 Softwares which helps the organization in the ISO 9000 implementation. Some of the ISO 9000 Software are listed below:
a. Document Control Software – Software which Helps the organization to keep track & control of the ISO 9000 Documents.
b. Audit Control Software – Software which helps the organization to keep track of internal & external audit events.
c. Training Record Management Software – Software which helps the organization to keep track of Training records in a system.
d. Calibration Software – Software to maintain the calibration records for tool & machinery.
More Sites on ISO 9001 Standards Template & Softwares are as below:
http://www.iso9001store.com
http://www.iso14000store.com

ISO 14001 Template

The ISO 14001Template were created to help you to prepare the ISO 14001Quality Manual, ISO 14001 Operating Procedure & ISO 14001 Forms. This ISO 14001 Template contains prewritten Quality Manual, Operating Procedure along with sample forms and checklists included as Microsoft Word & Excel format. It provides sample practical documentation in the proper ISO format required by the latest ISO 14001:2004.
The ISO 14001 Template features:-
• Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.• Professional design and layout.• It is designed to fulfill the ISO 14001 : 2004 requirements. .• Easy to read, easy to understand, and easy to implement.• Easy to audit as it follows the structure of ISO 14001: 2004..• Includes the required Process Flowchart.
The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process. The ISO 14001 Environmental Management System (EMS) Template are consist of:
a. ISO 14001 EMS Manual TemplateThe Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative.ISO 14001 Manual Template Consist of:• Section 1: General EMS Requirement• Section 2: Environment Policy – Objectives, Targets & Programmes• Section 3: EMS Planning• Section 4: Implementation & Operation• Section 5: Checking & Monitoring• Section 6: Management Review
b. ISO 14001 Operating ProcedureThe ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation. The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 14001 : 2004.
ISO 14001 Operating Procedures Consist Of:• Objective & Targets Procedure• Environmental Management Program Procedure• Environmental Aspect & Impact Identification & Evaluation Procedure• Environmental Monitoring & Measuring Procedure• Legal & Others Requirement & Evaluation Of Compliance Procedure• Emergency Preparedness & Response Procedure• Chemical Control Procedure• Waste Management Procedure• 5S House Keeping Procedure
c. ISO 14001 FormsISO 14001 Forms Consist Of :• Environmental Non-Conformance Master List• Environmental Non-Conformance Notice Form• Environmental Management Program Form• Environmental Aspect & Impact Identification Form• Green Environment Internal Audit Master Plan• Green Environment Plan & Activities Form• Green Environment Material Purchase Master List• ISO 14001:2004 Internal Audit Summary Report• Equipment Monitoring Master List• Environment Preventive Action Report (PAR) Master List• Environment Preventive Action Report (PAR) Form.• Environmental Responsible Form• EMS Organization Chart.• Waste Management Schedule Form• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form
For more information, please visit us at:
http://www.e-wia.com
http://www.iso-consults.com
http://www.iso9000-software.com

Reasons a Company Becomes Certified in ISO 9001 Standards

ISO 9000 certification or registration can be an expensive process. A company must consider the reasons and promised benefits for going through this process. If a company decides to seek certification, they should consider making sure their suppliers are certified or at least compliant to the ISO 9000 standards.
Major reasonsIn the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
Improved businessA company can maintain a relationship with customers, as well as get increased business through complying to the ISO 9001 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.
You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.
Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.
ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.
One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.

Scope Of The Quality Management System

Scope Of The Quality Management System
The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.
It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.
The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.
It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.
For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

ISO 9001 Quality Policy

ISO 9001 Quality Policy
The standard requires the quality policy to be appropriate to the purpose of the organization.
The purpose of an organization is quite simply the reason for its existence and as Peter Drucker so eloquently put it there is only one valid definition of business purpose: to create a customer”(Drucker, Peter F., 1977)2 . In ensuring that the quality policy is appropriate to the purpose of the organization, it must be appropriate to the customers the organization desires to create. It is therefore necessary to establish who the customers are, where the customers are, what they buy or wish to receive and what these customers regard as value. As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9001 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.
Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to quality policy.
Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’
– thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.
In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the quality policy.
One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision. Omitting the strategy may not ensure uniformity of approach and direction.
The standard requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system.
A commitment to comply with requirements means that the organization should undertake to meet the requirements of all interested parties. This means meeting the requirements of customer, suppliers, employees, investors, owners and society. Customer requirements are those either specified or implied by customers or determined by the organization and these are dealt with in more detail under clauses 5.2 and 7.2.1. The requirements of employees are those covered by legislation such as access, space, environmental conditions, equal opportunities and maternity leave but also the legislation appropriate to minority groups such as the disabled and any agreements made with unions or other representative bodies. Investors have rights also and these will be addressed in the investment agreements. The requirements of society are those obligations resulting from laws, statutes, regulations etc.
An organization accepts such obligations when it is incorporated as a legal entity, when it accepts orders from customers, when it recruits employees, when it chooses to trade in regulated markets and when it chooses to use or process materials that impact the environment.
The effectiveness of the management system is judged by the extent to which it fulfils its purpose. Therefore improving effectiveness means improving the capability of the management system. Changes to the management system that improve its capability i.e its ability to deliver outputs that satisfy all the interested parties, are a certain types of change and not all management system changes will accomplish this. This requirement therefore requires top management to pursue changes that bring about an improvement in performance.