ISO 9000 Standards – Document Approval

ISO 9000 Standards – Document Approval

The ISO 9000 Standards requires that documents be approved for adequacy prior to issue.

Approval prior to issue means that designated authorities have agreed the document before being made available for use. Whilst the term ade-
quacy is a little vague it should be taken as meaning that the document is judged as fit for the intended purpose. In a paper based system, this means approval before the document is distributed. With an electronic system, it means that the documents should be approved before they are published or made available to the user community.

The ISO 9000 Standards document control process needs to define the process by which documents are approved. In some cases it may not be necessary for anyone other than the approval authority to examine the documents. In others it may be necessary to set up a panel of reviewers to solicit their comments before approval is given.
It all depends on whether the approval authority has all the information
needed to make the decision and is therefore ‘competent’. One might think that the CEO could approve any document in the organization but just because a person is the most senior executive does not mean he or she is competent to perform any role in the organization.

Users should be the prime participants in the approval process so that the
resultant documents reflect their needs and are fit for the intended purpose. If the objective is stated in the document, does it fulfil that objective? If it is stated that the document applies to certain equipment, area or activity, does it cover that equipment, area or activity to the depth expected of such a document? One of the difficulties in soliciting comments to documents is that you will gather comment on what you have written but not on what you have omitted. A useful method is to ensure that the procedures requiring the document specify the acceptance criteria so that the reviewers and approvers can check the document against an agreed standard.

To demonstrate documents have been deemed as adequate prior to issue,
you will need to show that the document has been processed through the
prescribed document approval process. Where there is a review panel, a simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the drafting process you may undertake several revisions. You may feel it
necessary to retain these in case of dispute later, but you are not required to do so. You also need to show that the current issue has been reviewed so your comment sheets need to indicate document issue status.

Identifying and Recording Design Changes In ISO 9000 Standards

Identifying and Recording Design Changes In ISO 9000 Standards

The documentation for design changes in ISO 9000 Standards should comprise the change proposal, the results of the evaluation, the instructions for change and traceability in the changed documents to the source and nature of the change. You will therefore need:
- A Change Request form which contains the reason for change and the results of the evaluation – this is used to initiate the change and obtain approval before being implemented.
- A Change Notice that provides instructions defining what has to be changed this is issued following approval of the change as instructions to the owners of the various documents that are affected by the change.
- A Change Record that describes what has been changed – this usually forms part of the document that has been changed and can be either in the form of a box at the side of the sheet (as with drawings) or in the form of a table on a separate sheet (as with specifications).
Where the evaluation of the change requires further design work and possibly experimentation and testing, the results for such activities should be documented to form part of the change documentation.
At each design review a design baseline should be established which identifies the design documentation that has been approved. The baseline should be recorded and change control procedures employed to deal with any changes. These change procedures should provide a means for formally requesting or proposing changes to the design. For complex designs you may prefer to separate proposals from instructions and have one form for proposing design changes and another form for promulgating design changes after approval. You will need a central registry to collect all proposed changes and provide a means for screening those that are not suitable to go before the review board, (either because they duplicate proposals already made or because they may not satisfy certain acceptance criteria which you have prescribed). On receipt, the change proposals should be identified with a unique number that can be used on all related documentation that is subsequently produced. The change proposal needs to:
- Identify the product of which the design is to be changed
- State the nature of the proposed change identify the principal requirements, specifications, drawings or other design documents which are affected by the change
- State the reasons for the change either directly or by reference to failure reports, nonconformity reports, customer requests or other sources
- Provide for the results of the evaluation, review and decision to be recorded

Documents That Ensure Effective Planning, Operation And Control

Documents That Ensure Effective Planning, Operation And Control

The ISO 9000 standard requires management system documentation to include documents required by the organization to ensure the effective planning, operation and control of its processes.
The documents required for effective planning, operation and control of the processes would include several different types of documents. Some will be
product and process specific and others will be common to all processes. Rather than stipulate the documents that are needed, ISO 9000 Standards now provides for the organization to decide what it needs for the effective operation and control of its processes. This phrase is the key to determining the documents that are needed.
There are three types of controlled documents, namely:
- Policies and practices (these include process descriptions, control procedures, guides, operating procedures and internal standards)
- Documents derived from these policies and practices, such as drawings,
specifications, plans, work instructions, technical procedures and reports
- External documents referenced in either of the above
There will always be exceptions to this model but in general the majority of
documents used in a management system can be classified in this way.
Derived documents are those that are derived by executing processes;
for example, audit reports result from using the audit process, drawings result from using the design process, procurement specifications result from using the procurement process. There are, however, two types of derived document:
prescriptive and descriptive documents. Prescriptive documents are those that prescribe requirements, instructions, guidance etc. and may be subject to change. They have issue status and approval status, and are implemented in doing work. Descriptive documents result from doing work and are not
implemented. They may have issue and approval status. Specifications, plans, purchase orders, drawings are all prescriptive whereas audit reports, test reports, inspection records are all descriptive. This distinction is only necessary because the controls required will be different for each class of documents.

Evaluation of Compliance In ISO 14001 Standards

Evaluation of Compliance In ISO 14001 Standards

The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.

Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

Operational Control In ISO 14001 Standards

Operational Control In ISO 14001 Standards

Operational Controls over Significant Environmental Aspect Activities, ?4.4.6.a&b – ISO 14001requires the organization to identify and plan the operations associated with its identified significant environmental aspects in order to establish documented operational control procedures that preclude deviation from the Environmental Policy or not achieving objectives and targets.

Opportunities to apply operational controls can be found by reviewing operations. As shown in the accompanying text box, once the operations that can produce significant impacts are identified, it is a relatively simple step to establish operational control procedures that are consistent with the aims of the Environmental Policy and the objectives and targets and that stipulate operating criteria.

Significant Environmental Aspects of Goods and Services, §4.4.6.c – This requirement of ISO 14001 requires careful reading. Here is a parsed interpretation of the Operational Control requirement as it relates to goods and services furnished by others:

“The organization shall identify those operations that are associated with [its] identified significant environmental aspects… The organization shall plan these operations in order to ensure that they are carried out under specified conditions by… [1] establishing and maintaining procedures related to the identifiable significant environmental aspects of goods and services used by the organization and [2] communicating relevant procedures and requirements to suppliers and contractors.”

An easy way to conform to this requirement is to:

1. Identify the operations associated with the significant environmental aspects;

2. Identify the environmental aspects of goods and services furnished by others;

3. Determine how these aspects contribute to the organization’s significant aspect operations;

4. Establish appropriate/relevant requirements for the providers of these services; and

5. Communicate the requirements to suppliers and contractors.

Confusion in conforming to this requirement can arise because it is easy to read sub-clause c) independently of the first sentence of §4.4.6.

This first sentence gives context to the rest of the section in that it requires that we first “identify those operations… associated with the identified significant environmental aspects.” Once we have identified these operations, we look to the significant aspects of goods and services supplied by others and assess their contribution to the potential environmental impact. The accompanying example is offered to help clarify the intent of the requirement.

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