Documentation Structure For Iso 9. Learning ISO 9. 00. By: Mark Kaganov.
A guideline for Developing Quality Manuals, ISO 1. Standard, suggests a documentation structure for ISO 9. QMS. This model in the standard proposes use of a three- level arrangement. Most companies I worked with utilize four- level structures instead to include records, A typical four- level documentation structure consists of: Quality Manual - level 1. Procedures - level 2. Instructions - level 3.
- Which ISO 9001 quality management system document number format is best? Mike's recommended way to do ISO 9001 document numbering! Each ISO 9001 QMS manual page.
- . the International Organization for Standardization. ISO International Standards ensure that products and. Management system standards; ISO 26000.
Records - level 4. Actually, the documentation structure starts from the policy. The policy defines, among others, commitments with what standard a company intends to comply with. If you choose to use this approach, your quality management system will have five levels, similar to the structure below: Quality Policy - level 1. Quality Manual - level 2.
Procedures - level 3. Instructions - level 4. Records - level 5. Document titles for your ISO 9. QMSCompanies use various approaches to titling their manuals, procedures, instructions, etc.
For example, one of my customers titled their quality manual as "Quality Management System Quality Manual." This very descriptive title does define the document, but does not appear to be efficient. This tendency to use long titles and document identifiers like "Standard Operating Procedure" most likely comes from regulated industries. Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions. If a short name sufficiently describes a document, let's use it.
Document Reference Numbering. ISO 9001:2008 Quality Manual Guidance. Implementing a document management system could mean keeping certain records that your.
Guidance on the Documentation Requirements of. the way it chooses to document its quality management system. on the Documentation Requirements of ISO 9001.
I suggest streamlining all elements of management systems. Consider this and do not make your system more complicated than it can be. ISO 9. 00. 1 QMS document numbers.
In addition to tiles, document numbering systems very often can be optimized too. No standard requires assigning a document its number. This practice is an industry standard. Similar to part titles that we discussed above, document numbering practices often may be simplified too. Look at the example below: A company had some 1. They had two part number formats: one for procedures, another for drawings. Procedures used XX- XXX number format.
2653 S. Iris St. Lakewood, CO 80227 USA 303-985-7942. Document Numbers. Quality Management System. Numbering your documents. It is not a specific requirement of the. . suggests a documentation structure for ISO 9001. document numbering. save yourself the trouble of reading all those zeros and make your numbering system. . suggests a documentation structure for ISO 9001. document numbering systems very often. for Quality management system as well as ISO 9001. Information Technology Management. ISO 9001:2008 Reference: 4.2.3. (DCN) in accordance with the WCRC Document Numbering system. ISO 9001 Document Control System. SharePoint Based ISO 9001 Document Management System. ISO 9001 Document Management Request Information. ISO 9001 Quality Systems Toolbox. What the ISO 9001 standard requires for document control and some practical. Control of Documents. Document control is.
Drawings were numbered as XXXXXXX- XXX. One of the drawings had a number 0. Assemblers simplified the system and called it "twenty two."One can certainly use these long- long numbers, but is it practical? So far I did not meet a single company that could justify such an approach. When I audited this client, the organization had less than 2. There were no indications that the company will significantly grow. Therefore, to use document number format allowing hundreds of thousands of numbers could hardly be justified.
The most unreadable part numbers I had to deal with was at a mid size company with 1. Try to write those in your audit report!
I hope it is clear that only when extensive part numbers are justified, we do not have other options. If you build helicopters or satellites, you, no doubt, will need millions of parts and therefore will need long part numbers. If not, make your life easy and stay away from all those zeros. The most practical system I worked with used a three- digit format for their part numbers. Worked just fine! So far we explored opportunities for improvements in the area of document titles and numbers. Yet, there is another issue with part numbers.
Many companies relate a document number to a document type. For example, 2. 0- xxxx indicates a procedure, 3. POP- xxxx indicates a Production Operating Procedure, etc. My practice with a few QMS that used designation approaches showed that "no designation" systems are more practical. Several QMS that used designation I have worked with have failed.
Not long ago, one of my clients mentioned that they ran out of range in their document numbering format. The QMS initially permitted for identifying suppliers through a two- digit extension within the part number.
While the company grew, the number of supplier increased beyond expectations and eventually the company needed more than 9. This resulted in the document number format not being able to support new needs. To get around this issue, there is a simple solution - a "no designation" system. Part or document numbers in such systems are assigned sequential unique numbers. Areas of use, materials, suppliers, and other attributes are not reflected in part numbers. Moving in this direction, you can simplify your system even more.
I worked with a company that did not use document No. That documentation system used just document name followed by a revision number, like Process Validation Protocol AB. Article Source: http: //www.
ISO 9. 00. 1 Quality Systems Toolbox. Document control is core to ISO 9. From ISO 9. 00. 1: 2. Documents required by the quality management system shall be controlled.”It is one of the six procedures that you must document in ISO 9.
In the new version, ISO 9. The other difference is that ‘documents’ is now broadened to ‘documented information’, which includes what used to be called ‘records’. Writing down what you do will make it much easier to train new staff and to audit the process, so even though it’s no longer a required procedure in ISO 9. So what are the “controls needed”? Answer these questions in your documented procedure and you’ll satisfy the requirements for ISO 9.
Document Control: When a new document is found, or is created, how is it approved for release? How will I know a document has been approved? How is documented information identified? Do you specify titles, numbering, dates? Can a document be referred to without any confusion? How will you provide access to released documents everywhere it’s needed? Can everyone to get them from the server?
What about workers on the shop floor, out on site, on the road? Will they need hard copies, or some other offline distribution method? How do you protect the documented information from unauthorised changes, or loss? Can anyone edit and delete the files?
Do you have master copies stored safely? What about backups?
When changes are made, how do you identify them? How will people know if they do, or don’t, have the updated information? How will I know what has changed between this version and the latest release?
How do I know what version my copy is, or the version of this paper copy I found? How do you review, update and re- approve documents? Do you review on a regular basis to make sure the information is still correct? Who does the review?
How often? Who is responsible for making changes? How is an updated version approved? How do you find and control documents from external sources?
Control’ being all the previous questions on approval, review, updates, access…How do you prevent the use of obsolete documents? How will you make sure that ONLY current documents are in use? Are there hard copies to update? How do you keep track of them? Will you make end users responsible for checking the status of their hard copies before each use? Will you delete/destroy old documents?
How will you identify/segregate/archive obsolete documents you might want to keep? Enough with the questions – how about some answers! So what do you need to do, in a practical sense, to control documents?#1 – put some control information on the document itself – on every controlled document. Some information will go at the front of the document, and some needs to be on every page (usually in the footer),Here’s an example of a basic header: Title 4. Control of Documents. Person Responsible Management Representative. Date Last Updated 3 March 2.
Status Released Location Quality Systems Toolbox This header shows what document I’m looking at (‘4. Control of Documents’), and answers the questions on how to tell this document has been approved (‘Released’), and the version (‘3 March 2. Management Representative’), and where to find it (‘Quality Systems Toolbox’)Here’s an example footer showing information that should be on each page of the document: 4. Control of Documents Revision Date: 3 March 2. Why on every page?
Some people use the file path or URL of the master copy. G: \Documents\Control.
Documents. doc”, or “https: //demo. Nominate a single place to keep master copies and a register of documents. This is where end users will go to check whether the version they have is the latest version. It may also be the place where they access the documents they need. In the past, this would have been paper master copies kept in the office, or on the document controller’s hard drive.
Access to the documents was through a ‘gate keeper’ person. More commonly now it is a file server, or online (e. Quality Systems Toolbox) and access is granted through user accounts, permissions and passwords. The documents register is simply a list of all the documents you control. You’ll need one to keep track of all your management system documents and it helps you to know what needs to be reviewed. Ideally the register will include the title, revision info (date or number or both), status (draft, released, etc.) and who is responsible for the document (a name and/or a job title).
Number Title Revision Number Revision Date Document Owner Status MSP- 0. General Requirements 2.
March 2. 01. 3 Jill Jones Released FORM- 0. Purchase Order 1. Sept 2. 00. 8 Bookkeeper Released POL- 0. Health and Safety Policy 3. June 2. 01. 1 WHSO Released POL- 0. Drugs and Alcohol Policy 0. May 2. 01. 3 Michael Draft Paper- based registers are hard work – each time you update a document you must also update the register – often striking out the old line and adding a new line.
Spreadsheet based registers are not much easier to maintain but at least they allow sorting and searching. Online database document systems are easier, since updating the information stored with the document itself should flow through to the register, and sorting documents, searching and creating custom lists (e. Establish (and document) the process. This is where you answer those other questions.
Approval: Approving new and edited procedures is best spread around, and approval by the process owner makes the most sense – e. Sales Manager will approve sales related processes. Management system documents (like the procedure for document control), will be the responsibility of the Management Representative. The actual editing of the document may be delegated to someone else. The process of releasing a new document or update can be as simple as making the document available at the designated central location – either adding it to the repository or changing the permissions to make it available. Notification of the new release to relevant people is usually a good idea, but be wary of sending every new document notification to everyone in your organisation – too many notifications means they will all be ignored.
It is good practice to have some indication on the document itself so that the status of hard copies can be easily determined, e. Released’ in the header example above, an approval signature and date added to the footer of a master paper copy. Review: You need to review documents regularly to make sure they are up- to- date, suitable and still reflect your practices.
If the practice has changed (for the better) then the document should be updated, rather than enforcing the old practices from the out- of- date document. Your review will include checking for changes in standards, regulations, specifications and other external documents. How often will depend on the process – how important it is and also how new and changeable it is. Some documents have regulations stipulating how often they must be reviewed e. MSDS must be less than 5 years old. Some of this will be incorporated into Internal Auditing and Management Review, but make sure all your documents are covered (check the document register).
Changes: In file- server and paper- based management systems, changes are usually tracked in a table on the document itself. Sometimes this can be stored external to the document in the register. Document Management software will usually store the change information in the database, and a changes table is not required on the document itself. The document itself should indicate it’s revision status (on the hard copy). Access: These days, access is usually via logging on to the file server or online document repository. However, don’t assume this is enough for all situations. The practicalities of accessing the computer may be difficult/impossible for some locations or some personnel and you may have to distribute hard copies in these cases.
Keep track of where hard copies go for future reference when updates need to go out and you need to remove the obsolete versions. External Documents: Finding new external documents required for your business will come about during normal operations as well as through management review.
Control processes are the same as for internal documents. Obsolete documents: Keeping a distribution list for hard copies will help you track down the old copies that must be removed. It’s also common to put the onus on the end user to check their version against the version shown in the document register or the current version in the central repository.> > Take a look at Document Control with Quality Systems Toolbox.