ISO 9001:2008 Requirements – Documentation Requirements
Include in the quality management system documentation:? Documented statements of a quality policy and quality objectives? A quality manual? Documented procedures and records required by ISO 9001? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processesNOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:? Size of the organization and type of activities? Complexity of processes and their interactions? Competence of personnelNOTE 3: The documentation can be in any form or type of medium.4.2.2 Quality ManualEstablish and maintain a quality manual with:? Scope of the quality management system? Details and justification for any exclusions? Procedures or references to the procedures? Description of interaction between processes4.2.3 Control of Documents
Control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.
Establish a documented procedure to:? Approve documents for adequacy prior to issue? Review, update as necessary, and re-approve documents? Identify the changes and current document revision status? Make relevant documents available at points of use? Ensure the documents remain legible and readily identifiable? Identify external documents and control their distribution? Prevent obsolete documents from unintended use? Apply suitable identification if obsolete documents are retained4.2.4 Control of RecordsEstablish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.Establish a documented procedure to define the controls needed for record:? Identification? Storage? Protection? Retrieval? Retention? DispositionKeep records legible, readily identifiable, and retrievable.
Showing posts with label ISO 9001 Quality Management System. Show all posts
Showing posts with label ISO 9001 Quality Management System. Show all posts
Monday, September 21, 2009
Friday, August 28, 2009
Scope of the ISO 9001 quality management system
Scope of the ISO 9001 quality management system
The 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 9000 :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 management system.
This requirement responds to the System Approach Principle.
It is sensible to describe the scope of the management system so as to ensure effective communication. The scope of the 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 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.
The 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 9000 :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 management system.
This requirement responds to the System Approach Principle.
It is sensible to describe the scope of the management system so as to ensure effective communication. The scope of the 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 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.
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