Using your ISO 9001 Audit Checklist
Whether an organization is implementing ISO 9001:2008 or just improving their quality management system, they will undoubtedly need to review and analyse their current systems and processes in order to identify gaps in compliance. Gap analysis requires that organizations review their existing processes, procedures and documentation, etc. The framework for this review technique is often provided in the format of an ISO 9001 audit checklist which many organizations and auditors consider to be an indispensable tool that actively supports the audit process.
The Advantages of the ISO 9001 Audit Checklist
Regular internal audits are carried out to ensure compliance is maintained and the ISO 9001 audit checklist comes in handy for this purpose. This is just one of many tools that are available from the auditors’ toolbox that help ensure the audit addresses the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:
- Ensures the audit is conducted systematically
- Promotes audit planning
- Ensures a consistent audit approach
- Actively supports the organization’s audit process
- Serves as an aide memoire
- Provides a repository for notes collected during the audit process
- Ensures uniformity in the performance of different auditors
- Provides objective evidence
Structuring the Audit Checklist
One of the simplest methods of structuring the ISO 9001 audit checklist is by taking the applicable requirements from an organization’s policies, procedures and of course, from the standard itself, and turning each requirement into a question. Be sure to include the ‘organization shall’ requirements as well.
Add a section for comments, add check boxes for compliant or non-compliant and you can even add a column to note objective evidence and to provide an audit trial. Each element of the audit process should have customized checklists to serve as documentation outputs from the audit process itself.
This type of approach is primarily utilised by external auditors, including registration and certification body auditors, but the technique can equally be applied by any organization actively seeking to enhance their audit process.
Adding Value to the Checklist
Organizations should assess the potential value that the ISO 9001 audit checklist can bring in helping their audit process to develop. It’s worth remembering that a good checklist is no substitute for an enquiring mind and a good questioning technique.
If an internal auditor uses the checklist to ask narrowly focused questions then little benefit will be derived from the audit. If, on the other hand, the auditors conduct detailed preparation of the requirements of the process they intend to cover during the audit; the checklist then becomes an invaluable output for recording and communicating that preparation work.
Using the ISO 9001 audit checklist should not restrict the scope of audit activities, since that scope may change as a result of information actually collected during the audit. The key to unlocking the checklist’s value is the willingness of the organization to use it as a guide rather than being a slave to it.
Summary
The ISO 9001 audit checklist and gap analysis tool is ideal for organizations that require a quick and affordable approach to developing a reliable framework for their internal audit process.
Download a free internal audit checklist example courtesy of ISO 9001 Checklist:
http://www.iso-9001-checklist.co.uk/internal-audit.htm.
Tuesday, 2 November 2010
Thursday, 28 October 2010
Understanding the ISO 9001 Quality Manual
Understanding the ISO 9001 Quality Manual
The ISO 9001 Quality Manual is a top-level document describing how an organization intends to manage, maintain and improve its quality management system (QMS). At the core of the ISO 9001 quality manual is the quality policy statement. This statement acts as a narrative describing an organization’s approach to achieving customer satisfaction whilst also providing focus and direction to the procedures which must be implemented in order to meet the requirements of ISO 9001:2008.
Structuring the ISO 9001 Quality Manual
Often, it is common to align the structure of the ISO 9001 quality manual with that of the ISO 9001 standard itself, but this ‘belt and braces’ approach is not always necessary. Conversely, a four page quality manual may do little to inspire confidence that your quality management system has the necessary elements to be truly effective.
As long as the quality manual clearly shows how the quality management system processes interact, and at the highest level, what policies and methods are established to maintain and control those processes, an auditor is less worried about the structure of the manual.
Don’t try to structure the ISO 9001 quality manual to suit an external auditor’s expectations, this is the wrong approach. It is not for external auditors to ‘agree’ with the structure of the quality manual, instead, they must simply determine whether the manual’s content complies with the requirements of the standard.
The ISO 9001 quality manual undertakes the essential role of formalising and communicating the relationship between the organization’s processes. Everyone expects something different from their quality manual but as long as it meets the stated requirements of ISO 9001 as well as organizational needs, the question of structure becomes irrelevant.
Who uses the Quality Manual?
Customers want to understand how your organization and more importantly, how your quality management system will take care of their needs. They want to know that you know how to plan, implement, and control the processes that will deliver satisfaction.
Auditors want to know how the organization meets the requirements of the standard, and if the system is effective in achieving the objectives. If the requirements of the standard are addressed in the manual, along with some details of the method, then auditors can use the manual as a guide to help them find the evidence they need.
Management and other users should be able to see from the manual how the organization’s quality management system is designed to work. It should show how the processes of the system interact.
Amending the Quality Manual
Amendment of the quality manual or procedures should be initiated by the departmental heads as and when the need for amendment becomes apparent. The amendment should be approved by an authorised signatory before the actual changes are implemented.
It is not a requirement to wait for a formal management review prior to amending the documentation. If major changes must be made to key documents, such as the quality policy or quality objectives, it is prudent to include these for inclusion during the management review process.
Summary
The Quality Management Representative is responsible for developing the ISO 9001 quality manual with a clear understanding of the organization’s vision, mission, goals, key objectives, policies and procedures needed to achieve certification.
Download free quality manual examples here:
http://www.iso-9001-checklist.co.uk/quality-manual-examples.htm
The ISO 9001 Quality Manual is a top-level document describing how an organization intends to manage, maintain and improve its quality management system (QMS). At the core of the ISO 9001 quality manual is the quality policy statement. This statement acts as a narrative describing an organization’s approach to achieving customer satisfaction whilst also providing focus and direction to the procedures which must be implemented in order to meet the requirements of ISO 9001:2008.
Structuring the ISO 9001 Quality Manual
Often, it is common to align the structure of the ISO 9001 quality manual with that of the ISO 9001 standard itself, but this ‘belt and braces’ approach is not always necessary. Conversely, a four page quality manual may do little to inspire confidence that your quality management system has the necessary elements to be truly effective.
As long as the quality manual clearly shows how the quality management system processes interact, and at the highest level, what policies and methods are established to maintain and control those processes, an auditor is less worried about the structure of the manual.
Don’t try to structure the ISO 9001 quality manual to suit an external auditor’s expectations, this is the wrong approach. It is not for external auditors to ‘agree’ with the structure of the quality manual, instead, they must simply determine whether the manual’s content complies with the requirements of the standard.
The ISO 9001 quality manual undertakes the essential role of formalising and communicating the relationship between the organization’s processes. Everyone expects something different from their quality manual but as long as it meets the stated requirements of ISO 9001 as well as organizational needs, the question of structure becomes irrelevant.
Who uses the Quality Manual?
Customers want to understand how your organization and more importantly, how your quality management system will take care of their needs. They want to know that you know how to plan, implement, and control the processes that will deliver satisfaction.
Auditors want to know how the organization meets the requirements of the standard, and if the system is effective in achieving the objectives. If the requirements of the standard are addressed in the manual, along with some details of the method, then auditors can use the manual as a guide to help them find the evidence they need.
Management and other users should be able to see from the manual how the organization’s quality management system is designed to work. It should show how the processes of the system interact.
Amending the Quality Manual
Amendment of the quality manual or procedures should be initiated by the departmental heads as and when the need for amendment becomes apparent. The amendment should be approved by an authorised signatory before the actual changes are implemented.
It is not a requirement to wait for a formal management review prior to amending the documentation. If major changes must be made to key documents, such as the quality policy or quality objectives, it is prudent to include these for inclusion during the management review process.
Summary
The Quality Management Representative is responsible for developing the ISO 9001 quality manual with a clear understanding of the organization’s vision, mission, goals, key objectives, policies and procedures needed to achieve certification.
Download free quality manual examples here:
http://www.iso-9001-checklist.co.uk/quality-manual-examples.htm
Monday, 25 October 2010
Understanding the Document Control Procedure
Understanding the Document Control Procedure
ISO 9001:2008 Clause 4.2.3 outlines the requirements for an effective document control procedure to manage the flow of information that might impact an organization’s ability to deliver a compliant product or service. Documents are considered by ISO 9000:2005 as ‘information and its supporting medium’. It implies that documents evolve as information is superseded and that this natural transition must be managed to ensure personnel have access to the latest versions of drawings and specifications, etc.
The Value of Controlling Documents
An organization’s ability to store, index, access and retrieve the right information efficiently and effectively is paramount if the organization is to continually improve its products or services. The ability to deliver reliable and relevant information underpins the delivery of high-quality products or services when information is accurate, up to date and accessible for use where needed.
The majority of non-conformances arising from both quality management system audits and registration audits continues to be the ineffective application of Clause 4.2.3. Discontinuity is often discovered in the documentation because auditors will focus on the continuity and flow of information through the system. Inconsistencies will hinder the prospects of a successful registration audit since the success of the audit is determined by the availability of documented information.
Getting the most out of your Document Control Procedure
In order to comply with the document control clause, it is essential that all personnel understand what type of documents should be controlled and more importantly, how this control is exercised. To get the most out of your document control procedure, it must communicate the steps necessary to ensure that staff and other users of the organization’s documentation understand what they must do in order to manage that information effectively and efficiently.
Your document control procedure should specify how the following controls will be achieved:
- How documents are approved for suitability prior to use,
- How documents are reviewed and updated,
- How to identify the correct versions of documents
- How the correct versions of documents will be accessed,
- How legibility is ensured,
- How external documents are controlled and distributed,
- How to prevent unintended use
Document Control Responsibilities
Departmental managers should always be responsible for promoting good document and record management practices in their area whilst supporting overall compliance to the document control procedure.
Individuals and their line managers should be responsible for the documents and records that they create, as well as being responsible for their retention and disposal in line with legislative requirements and organizational procedures and practices.
Summary
The Quality Management Representative should be responsible for providing advice and guidance on the application of the document control procedure. They should also instigate training in relation to document and record management and take the lead role in the co-ordination and monitoring of compliance throughout the organization.
Download a free document control procedure example here: http://www.iso-9001-checklist.co.uk/documentation-management-examples.htm
ISO 9001:2008 Clause 4.2.3 outlines the requirements for an effective document control procedure to manage the flow of information that might impact an organization’s ability to deliver a compliant product or service. Documents are considered by ISO 9000:2005 as ‘information and its supporting medium’. It implies that documents evolve as information is superseded and that this natural transition must be managed to ensure personnel have access to the latest versions of drawings and specifications, etc.
The Value of Controlling Documents
An organization’s ability to store, index, access and retrieve the right information efficiently and effectively is paramount if the organization is to continually improve its products or services. The ability to deliver reliable and relevant information underpins the delivery of high-quality products or services when information is accurate, up to date and accessible for use where needed.
The majority of non-conformances arising from both quality management system audits and registration audits continues to be the ineffective application of Clause 4.2.3. Discontinuity is often discovered in the documentation because auditors will focus on the continuity and flow of information through the system. Inconsistencies will hinder the prospects of a successful registration audit since the success of the audit is determined by the availability of documented information.
Getting the most out of your Document Control Procedure
In order to comply with the document control clause, it is essential that all personnel understand what type of documents should be controlled and more importantly, how this control is exercised. To get the most out of your document control procedure, it must communicate the steps necessary to ensure that staff and other users of the organization’s documentation understand what they must do in order to manage that information effectively and efficiently.
Your document control procedure should specify how the following controls will be achieved:
- How documents are approved for suitability prior to use,
- How documents are reviewed and updated,
- How to identify the correct versions of documents
- How the correct versions of documents will be accessed,
- How legibility is ensured,
- How external documents are controlled and distributed,
- How to prevent unintended use
Document Control Responsibilities
Departmental managers should always be responsible for promoting good document and record management practices in their area whilst supporting overall compliance to the document control procedure.
Individuals and their line managers should be responsible for the documents and records that they create, as well as being responsible for their retention and disposal in line with legislative requirements and organizational procedures and practices.
Summary
The Quality Management Representative should be responsible for providing advice and guidance on the application of the document control procedure. They should also instigate training in relation to document and record management and take the lead role in the co-ordination and monitoring of compliance throughout the organization.
Download a free document control procedure example here: http://www.iso-9001-checklist.co.uk/documentation-management-examples.htm
Thursday, 21 October 2010
The Power of the ISO 9001 Checklist
The Power of the ISO 9001 Checklist
When making any purchase decision, a major concern is the quality of the product. It is vital to know whether a supplier or contractor is capable of delivering a product that will meet customer expectations. It is not always possible to opt for pre-dispatch inspection; also, the pre-assessment of a supplier’s quality capabilities may incur extra cost. This is especially true in the case of overseas suppliers. To overcome this uncertainty; many organizations operate universally accepted quality assurance system such as ISO 9001 where inspection checklists are commonly used to demonstrate and communicate evidence of conformity.
Why use a Checklist?
In general, a simple checklist is an ideal tool that helps to identify missed activities while performing a task and often, the success of a task relies on a task-oriented checklist. In fact, for any process to operate smoothly and to yield benefits to product quality; the process requires a comprehensive checklist covering a pre-determined set of requirements.
A common fallacy exists that becoming ISO 9001 certified is a complex task and that the implementation of a quality management system distracts from the every day running of a business. An ISO 9001 checklist makes implementing a quality management system a much more simple process since the ISO 9001 checklist doubles as a gap analysis tool.
Preparing the ISO 9001 Checklist
It is always preferable to prepare the ISO 9001 checklist yourself since you will get better understanding of how the requirements apply your business processes. Some requirements of ISO 9001 may not be applicable to your organization, such as clauses from section 7 – Product Realisation, can therefore be excluded from the ISO 9001 checklist. Ensure that all applicable requirements are covered by the ISO 9001 checklist by:
- Identifying the relevant requirements from ISO 9001:2008.
- Converting each requirement into question, e.g. ‘does the organization have a documented quality policy?’ (Clause 4.2.1a)
- Gathering evidence to validate ‘yes’ answers.
- Taking action to remedy ‘no’ answers in order to fill a compliance gap.
This method of preparing the ISO 9001 checklist and subsequent interrogation of the quality management system is very similar to the method undertaken by certification body auditors when assessing an organization’s compliance to the standard.
What Records are Required?
According to ISO 9001:2008; there are 21 different records that are required to be maintained for various clauses throughout the standard. The checklist of these records should be included in the main ISO 9001 checklist for ease of reference during audits. Include any other records necessary to demonstrate process conformance. When referring to records within the ISO 9001 checklist, it is essential to note document title or document number of each record to avoid confusion later.
Summary
Download a free internal audit checklist example courtesy of ISO 9001 Checklist:
http://www.iso-9001-checklist.co.uk/internal-audit.htm
The ISO 9001 checklist and gap analysis tool is ideal for organizations that require a quick and affordable approach to assessing compliance with the requirements of ISO 9001. It provides an invaluable framework for internal auditors.
When making any purchase decision, a major concern is the quality of the product. It is vital to know whether a supplier or contractor is capable of delivering a product that will meet customer expectations. It is not always possible to opt for pre-dispatch inspection; also, the pre-assessment of a supplier’s quality capabilities may incur extra cost. This is especially true in the case of overseas suppliers. To overcome this uncertainty; many organizations operate universally accepted quality assurance system such as ISO 9001 where inspection checklists are commonly used to demonstrate and communicate evidence of conformity.
Why use a Checklist?
In general, a simple checklist is an ideal tool that helps to identify missed activities while performing a task and often, the success of a task relies on a task-oriented checklist. In fact, for any process to operate smoothly and to yield benefits to product quality; the process requires a comprehensive checklist covering a pre-determined set of requirements.
A common fallacy exists that becoming ISO 9001 certified is a complex task and that the implementation of a quality management system distracts from the every day running of a business. An ISO 9001 checklist makes implementing a quality management system a much more simple process since the ISO 9001 checklist doubles as a gap analysis tool.
Preparing the ISO 9001 Checklist
It is always preferable to prepare the ISO 9001 checklist yourself since you will get better understanding of how the requirements apply your business processes. Some requirements of ISO 9001 may not be applicable to your organization, such as clauses from section 7 – Product Realisation, can therefore be excluded from the ISO 9001 checklist. Ensure that all applicable requirements are covered by the ISO 9001 checklist by:
- Identifying the relevant requirements from ISO 9001:2008.
- Converting each requirement into question, e.g. ‘does the organization have a documented quality policy?’ (Clause 4.2.1a)
- Gathering evidence to validate ‘yes’ answers.
- Taking action to remedy ‘no’ answers in order to fill a compliance gap.
This method of preparing the ISO 9001 checklist and subsequent interrogation of the quality management system is very similar to the method undertaken by certification body auditors when assessing an organization’s compliance to the standard.
What Records are Required?
According to ISO 9001:2008; there are 21 different records that are required to be maintained for various clauses throughout the standard. The checklist of these records should be included in the main ISO 9001 checklist for ease of reference during audits. Include any other records necessary to demonstrate process conformance. When referring to records within the ISO 9001 checklist, it is essential to note document title or document number of each record to avoid confusion later.
Summary
Download a free internal audit checklist example courtesy of ISO 9001 Checklist:
http://www.iso-9001-checklist.co.uk/internal-audit.htm
The ISO 9001 checklist and gap analysis tool is ideal for organizations that require a quick and affordable approach to assessing compliance with the requirements of ISO 9001. It provides an invaluable framework for internal auditors.
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