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iso 9001 forms
ISO 9001: 2008 permits a business mobility in the way that decides to help document the top quality management technique (QMS). This lets each one corporation to formulate the minimum level of records necessary so that you can illustrate the useful arranging, function and handle involving the processes and the execution and constant advancement involving the potency of the QMS. -
Quality Manual in ISO 9001:2015
The ISO 9001:2015 is still not published, only available information about it is DIS ISO 9001:2015 which is draft version of the standard and may suffer a lot of changes until the final version. According to the DIS ISO 9001:2015 the Quality Manual won't be mandatory but again there must be some document that would describe the context of organization, scope of QMS, etc.
We are planning to release the documentation toolkit for ISO 9001:2015 as soon as the FDIS ISO 9001:2015 (the final draft of the standard that will be given to adoption by ISO Committee) is released. If you decide to buy our current ISO 9001 documentation toolkit, you will get our new ISO 9001:2015 Documentation Toolkit free of charge.
For more information read this article: 5 Main Changes Expected in ISO 9 001:2015 from the 2014 Draft International Standard (DIS) https://advisera.com/9001academy/knowledgebase/5-main-changes-expected-in-iso-90012015-from-the-2014-draft-international-standard-dis/ -
7.5.4 Customer Property and intellectual property
The only info I have in my possession is customer orders that specifies what features customer wants, i.e. customer orders. Is this considered as "Intellectual Property" and therefore Clause 7.5.4 apply? I select from the suppliers' catalog that meets my customers' specifications. Also I have not been asked by my customer to treat his purchase order info as "Confidential".
My question is do Clause 7.5.4 apply for my above services when I have nothing in my possession of property that belongs to my customer other than customer order specifying what hardware they want in the lap or desk top.
Can you please tell when "in tellectual property" makes Clause 7.5.4 applicable?
Answer:
The clause 7.5.4 doesn't apply to your business, customer orders are not considered as a property. You just need to explain in your Quality Manual that this clause don't apply to your organizations since you don't perform processes that include customer property. However, if your business includes repairing the computers or servicing them, you will need to include this clause in your QMS.
The intellectual property in your case would be some working instructions or software, etc.
Here is one interesting article regarding the subject:
- Understanding Product & Service Provision in ISO 9001 https://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/ -
Implementing ISO 9001
The best way to implement the standard is to observe the implementation as a project. Define the responsibilities, deadlines and all activities that need to be performed.
I suggest you to start with Quality Policy, Quality Manual and mandatory procedures and then develop the procedures for your processes. Next step would be to ensure that the procedures are implemented and followed, this can be accomplished through internal audit and management review.
Once you create all necessary documents and ensure that they are implemented you will be ready for certification.
Here you can find the List of Mandatory Documents for ISO 9001 https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ and a free sample of our Project Plan for ISO 9001 implementation https://info.advisera.com/9001academy/free-download/project-plan-for-iso-9001-implementation-ms-word/
You can also take a look at this article that you may find interesting: Four things you need to start your ISO 9001 project https://advisera.com/9001academy/blog/2015/02/10/four-things-need-start-iso-9001-project/ -
Step by step implementation of ISO 9001
Before entering the certification process you must first implement the ISO 9001 standard, which means to document and implement all mandatory procedures and procedures you find necessary for your organization.
Once you document and implement your quality management system you are ready for certification. Some certification bodies expect you to conduct internal audit and management review before they come to perform certification audit.
Here are some articles that you may find useful:
Four things you need to start your ISO 9001 project https://advisera.com/9001academy/blog/2015/02/10/four-things-need-start-iso-9001-project/
Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/ -
Roles and responsibilities of Internal Auditor
Answer:
The main role of the internal auditor is to acquire evidences that organization complies with requirements of the standard. Depending on whether you are part of internal auditors team or single auditor your roles and responsibilities can vary. Here I will explain the audit performed by a single auditor who has the same responsibilities as the lead internal auditor in case of internal auditor team.
Internal auditor must manage the internal audit process which means establishing internal audit plan (when and which processes will be audited) and the scope of the audit (in this case compliance with ISO 9001:2008). Than you should organize the opening meeting where you present to the auditees the schedule and the scope of the internal audit.
When you start auditing process by process, you need to look at the documents and procedures to see whether they are compliant with the standard or not and than to interview the process own ers and employees to determine whether they follow the defined procedures and do they keep records prescribed by procedures.
If you spot some nonconformity, you should present it during closing meeting at the end of the internal audit. The participants of the closing meeting should be process owners and higher management. Besides nonconformities, you can also present some good practices identified in processes and recommendations for improvements.
After closing meeting internal auditor creates internal audit report and delivers it according to procedure for internal audit. -
Steps in Internal Audit
It is very important to follow your current Internal Audit Procedure, but here are some steps.
Firs thing you need to do is to make a Internal Audit Program (https://advisera.com/9001academy/documentation/internal-audit-program/) where you will write when you'll do the audit of each process of your organization.
Once you start planning the internal audit, you'll need to identify the standard requirements that refers to each process. Using Internal Audit Checklist (https://advisera.com/9001academy/documentation/internal-audit-checklist/) can help you identify all requirements and prevent you from missing something out.An then you perform the internal audit by acquiring evidences that the processes are compliant with requirements of the standard.
At the end you need to create the Internal Audit Report (https://advisera.com/9001academy/documentation/internal-audit-report/) where you will write your findings during internal audit.
This, of course is a short version of internal audit process. For more information take a look at this articles:
- 13 Steps for ISO 9001 Internal Auditing using ISO 19011 https://advisera.com/9001academy/knowledgebase/13-steps-for-iso-9001-internal-auditing-using-iso-19011/
- Five Main Steps in ISO 9001 Internal Audit https://advisera.com/9001academy/knowledgebase/five-main-steps-in-iso-9001-internal-audit/
- Writing an Audit Checklist for ISO 9001 Processes https://advisera.com/9001academy/blog/2014/11/25/writing-audit-checklist-iso-9001-processes/ -
Starting QMS implementation
Here you'll find an article that explains all the ISO 9001 implementation steps: Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
You may also find these materials useful: Project Plan for ISO 9001 implementation (Word) and ISO 9001 Implementation Diagram (PDF) - you'll find both materials here: https://advisera.com/9001academy/free-downloads// -
Form of writing procedures
The standard does not prescribe the way of writing procedures or some mandatory elements of procedure. In case of smaller company you can even insert the procedures into the Quality Manual.
There are some elements that are very common and logical, such as purpose, scope, users and reference documents. Take a look at free preview of our Procedure for Document and Record Control https://advisera.com/9001academy/documentation/procedure-document-record-control/
Here are some very informative articles that you can find interesting:
How to structure quality management system documentation https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
Some Tips to make Document Control more useful for your QMS https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
Deciding Which Procedures to Document in QMS https://advisera.com/9001academy/blog/2013/11/26/deciding-procedures-document-qms/ -
Configuration Management vs Record Control
Configuration management (CM) is a systems engineering process for establishing and maintaining consistency of a product's performance, functional and physical attributes with its requirements, design and operational information throughout its life and it is just a part of Quality Management System since it refers only to product not the whole management system.
Control of records (and documents) covers not only the record requirements of Configuration Management but also the management system requirements for records. The principles are the same but the scope is different.
Here is one informative article regarding the subject:
- Some Tips to make Control of Records more useful for your QMS https://advisera.com/9001academy/blog/2014/01/28/tips-make-control-records-useful-qms/