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	<title>ISO 9001 Quality Manuals</title>
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	<link>http://9001manual.com/blog</link>
	<description>Organisational improvements from our quality management systems.</description>
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		<title>HACCP System Application using the ISO 22000:2005 standard</title>
		<link>http://9001manual.com/blog/83/haccp-system-application-using-the-iso-220002005-standard/</link>
		<comments>http://9001manual.com/blog/83/haccp-system-application-using-the-iso-220002005-standard/#comments</comments>
		<pubDate>Fri, 09 Oct 2009 07:54:04 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[Food Safety Legislation]]></category>
		<category><![CDATA[Food Safety Management System]]></category>
		<category><![CDATA[ISO 22000]]></category>
		<category><![CDATA[Opportunities for Improvement]]></category>
		<category><![CDATA[Food Safety]]></category>
		<category><![CDATA[Haccp]]></category>
		<category><![CDATA[ISO 22000 Certification]]></category>
		<category><![CDATA[Prerequisite Programmes]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=83</guid>
		<description><![CDATA[The requirements of ISO 22000 prescribe a comprehensive systematic way to producing a HACCP system that would be of great benefit to any organisation. Prerequisite programmes to control the introduction of food safety hazards through the work environment, preventing product contamination and controlling hazard levels in the product and product environment are required when implementing [...]]]></description>
			<content:encoded><![CDATA[<p>The requirements of ISO 22000 prescribe a comprehensive systematic way to producing a <a title="ISO 22000 Compliant Food Safety Management System" href="http://22000foodsafety.com/">HACCP system</a> that would be of great benefit to any organisation. Prerequisite programmes to control the introduction of food safety hazards through the work environment, preventing product contamination and controlling hazard levels in the product and product environment are required when implementing an ISO 22000 compliant HACCP system. ISO 22000 clause 7.2.3 states that construction and lay-out of buildings/premises, workspace, employee facilities; supplies of utilities, waste disposal, adequate equipment, management of purchased materials, storage and transport, prevention of cross contamination, sanitation, pest control and personnel hygiene should be taken into consideration when establishing prerequisite programmes.</p>
<p>The first step in developing an <a title="ISO 22000 Compliant Food Safety Management System" href="http://22000foodsafety.com/">ISO 22000 compliant HACCP system</a> is to establish a food safety team multi-disciplinary knowledge and experience. The food safety team are required to carry out a number of preliminary steps in order to carry out the hazard analysis. The first step for the team in implementing an ISO 2000 compliant HACCP system is to describe the product characteristics (Clause 7.3.3) including raw materials, ingredients, product contact materials and end product including its intended use (Clause 7.3.4).</p>
<p>Next the food safety team should construct flow diagram and conduct on site confirmation of the flow diagram (Clause 7.3.5.1 Flow diagrams. Next the food safety team describe each process step and the existing control measures applied at each step as required by ISO 22000 clause 7.3.5.2. This is the last step required prior to hazard analysis.</p>
<p>The food safety team now conduct a hazard analysis, as per the requirements of ISO 22000 clause 7.4.2, to identify all the food safety hazards that are reasonably likely to occur. In conducting the hazard analysis the food safety team are required to assess each hazard identified (Clause 7.4.3), consider and select control measures (Clause 7.4.4) required to achieve the acceptable level of hazard. Each control measure needs to be reviewed by the food safety team with respect to its effectiveness against the identified food safety hazards and then categorized as to whether they need to be operational prerequisite programmes or included in the HACCP plan. The food safety team need to review each control measure and its effectiveness to decide if the control measure is to be part of the HACCP plan or to be controlled by operational prerequisite programmes. ISO 22000 clause 7.5 requires the food safety team to establish and document operational prerequisite programmes including the food safety hazard to be controlled, the control measure, the monitoring procedures, corrections and corrective actions to be taken if out of control, the responsibilities and authorities and the records to be completed.</p>
<p>The next step of implementing an <a title="http://22000foodsafety.com/" href="http://">ISO 22000 compliant system</a> requires the food safety team to establish the HACCP plan. ISO 22000 clause 7.6 uses the same principles of HACCP implementation as CODEX, clause 7.6.2 requires identification of critical control points, clause 7.6.3 requires the food safety team to determine critical limits for critical control point, clause 7.6.4 requires monitoring of critical control points, clause 7.6.5 requires actions when critical limits are exceeded and clause 7.8 requires verification planning. The HACCP plan documents the food safety hazard to be controlled at the critical control point, the control measure, the monitoring procedures, critical limits the records to be used, the corrections and corrective actions to be taken if out of control, and responsibilities and authorities.</p>
<p>Clause 8.2 describes the requirement for validation of operational PRP and HACCP plan control measures and combinations. ISO 22000 has further specific documentation requirements are prescribed in clause 4.2 which requires that documents and records required by the <a href="http://22000foodsafety.com/">food safety management system</a> to be controlled.</p>
<p>ISO 22000 has further requirement with regards to implementing a HACCP system in that clause 7.7 prescribes the need for updating of  product characteristics, intended use, flow diagrams, process steps, control measures after the operational PRP(s) and/or the HACCP plan have been established. After updating the preliminary information the food safety team should then decide if the HACCP plan and/or prerequisite programmes documents need to be amended. When verification results do not indicate conformity ISO 22000 requires the food safety team to review of the conclusions of the hazard analysis, operational PRPs and the HACCP plan as per clause 8.4.2.</p>
<p>The last requirement is that the food safety team are to evaluate the <a href="http://22000foodsafety.com/">food safety management system</a> at planned intervals and then consider the need to review the hazard analysis, operational prerequisite programmes and the HACCP plan as described in ISO 22000 Clause 8.5.2 Updating the food safety management system.</p>
]]></content:encoded>
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		</item>
		<item>
		<title>ISO 22000 Food Safety Management System Documentation Requirements</title>
		<link>http://9001manual.com/blog/81/iso-22000-food-safety-management-system-documentation-requirements/</link>
		<comments>http://9001manual.com/blog/81/iso-22000-food-safety-management-system-documentation-requirements/#comments</comments>
		<pubDate>Sun, 13 Sep 2009 08:14:23 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[Food Safety Management System]]></category>
		<category><![CDATA[ISO 22000]]></category>
		<category><![CDATA[Food Safety]]></category>
		<category><![CDATA[ISO 22000 Certification]]></category>
		<category><![CDATA[Iso Certification]]></category>
		<category><![CDATA[Quality Manuals]]></category>
		<category><![CDATA[System Documentation]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=81</guid>
		<description><![CDATA[ISO 22000 states that an organisation requires the documents necessary to ensure the effective development, implementation and updating of the food safety management system.
There are specific references in the standard where it prescribes that the food safety management system will need to have documents. The following is a list of the documents required:
1 Food Safety Policy
2 Food [...]]]></description>
			<content:encoded><![CDATA[<p>ISO 22000 states that an organisation requires the documents necessary to ensure the effective development, implementation and updating of the <a title="ISO 22000 Compliant Food Safety Management System" href="http://9001manual.com/totalfoodpackage.php">food safety management system</a>.</p>
<p>There are specific references in the standard where it prescribes that the food safety management system will need to have documents. The following is a list of the documents required:</p>
<p>1 Food Safety Policy<br />
2 Food Safety Objectives<br />
3 Identification and Control of Outsourced Processes<br />
4 Document control<br />
5 Record control<br />
6 Documents that specify how prerequisite programme activities are managed<br />
7 Information required to conduct the hazard analysis<br />
8 Descriptions of raw materials to the extent needed to conduct the hazard analysis<br />
9 Descriptions of Ingredients to the extent needed to conduct the hazard analysis<br />
10 Descriptions of product-contact materials to the extent needed to conduct the hazard analysis<br />
11 The characteristics of end products<br />
12 Descriptions of the intended use to the extent needed to conduct the hazard analysis<br />
13 Descriptions of the reasonably expected handling of the end product to the extent needed to conduct the hazard analysis<br />
14 Descriptions of any possible unintended but reasonably expected mishandling and misuse of the end product to the extent needed to conduct the hazard analysis<br />
15 Descriptions of the methodology and parameters used for the categorization of control measures as belonging to the <a title="HACCP Manual" href="http://9001manual.com/haccpmanual.php">HACCP plan</a> or Operational prerequisite programmes<br />
16 The food safety hazard or hazards to be controlled by each operational prerequisite programme<br />
17 The food safety hazard or hazards to be controlled by each operational prerequisite programme<br />
18 The control measures used by each operational prerequisite programme<br />
19 The monitoring procedures used in each operational prerequisite programme<br />
20 The corrections and corrective actions for each operational prerequisite programme<br />
21 The responsibilities and authorities for each operational prerequisite programme<br />
22 Records for each operational prerequisite programme<br />
23 The HACCP plan and identified critical control points (CCPs)<br />
24 The food safety hazards to be controlled at each critical control point<br />
25 The control measures used at each critical control point<br />
26 The monitoring procedures used at each critical control point<br />
27 The critical limits applied at each critical control point<br />
28 The rationale for the chosen critical limits<br />
29 The corrections and corrective action to be taken if critical limits are exceeded for each critical control point<br />
30 The responsibilities and authorities for each aspect of the critical control point<br />
31 Critical control point monitoring records<br />
32 Procedures for the handling of potentially unsafe products, including the controls, methods and authorization levels.<br />
33 Procedures for withdrawing products including notification to relevant interested parties, handling of withdrawn products as well as affected products in stock and the sequence of actions to be taken.<br />
34 Procedure for Corrections including the identification and assessment of affected end products<br />
35 Records of the review of corrections carried out<br />
36 Procedure for Corrective Action that specifies the appropriate actions to identify and eliminate the cause of detected nonconformities, to prevent recurrence, and to bring the process or system back into control after nonconformity is encountered.<br />
37 The corrective action procedure must include a review of non-conformances including customer complaints<br />
38 The corrective action procedure must include a review of trends in monitoring results that may indicate development towards loss of control<br />
39 The corrective action procedure must include a review to determine the causes of non-conformances<br />
40 The corrective action procedure must include an evaluation of the need for action to ensure that nonconformities do not recur<br />
41 The corrective action procedure must include a how the actions needed are determined<br />
42 The corrective action procedure must include a how the actions needed are implemented<br />
43 Records of corrective actions<br />
44 Records of the review of corrective actions taken to ensure that they are effective<br />
45 Procedure for Internal Auditing including responsibilities and requirements for planning and conducting audits, for reporting results and maintaining records.<br />
46 Internal Audit records<br />
47 External documents relevant for the food safety activities including statutory, regulatory and customer requirements.</p>
<p>The extent of the <a href="http://9001manual.com/totalfoodpackage.php">food safety management system</a> documentation will differ from one organization to another depending on the size and complexity of the operation and the competence of personnel.</p>
]]></content:encoded>
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		</item>
		<item>
		<title>ISO 22000 Food Safety Management Systems &#8211; Principle Requirements</title>
		<link>http://9001manual.com/blog/77/iso-22000-food-safety-management-systems-principle-requirements/</link>
		<comments>http://9001manual.com/blog/77/iso-22000-food-safety-management-systems-principle-requirements/#comments</comments>
		<pubDate>Tue, 01 Sep 2009 09:03:29 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[Food Safety Management System]]></category>
		<category><![CDATA[ISO 22000]]></category>
		<category><![CDATA[Food Safety]]></category>
		<category><![CDATA[HACCP legislation]]></category>
		<category><![CDATA[ISO 22000 Certification]]></category>
		<category><![CDATA[Prerequisite Programmes]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=77</guid>
		<description><![CDATA[ISO 22000 was first published by the International Organisation for Standardisation (ISO) in September 2005 and hence is known as ISO 22000:2005. ISO 22000 is an internationally recognised standard for Food Safety Management System requirements for organisations throughout the food chain.
Although initially ISO 22000 can be a little confusing, there is little doubt it is [...]]]></description>
			<content:encoded><![CDATA[<p>ISO 22000 was first published by the International Organisation for Standardisation (ISO) in September 2005 and hence is known as ISO 22000:2005. ISO 22000 is an internationally recognised standard for <a title="ISO 22000 Compliant Food Safety Management System" href="http://9001manual.com/foodqualitymanual.php">Food Safety Management System</a> requirements for organisations throughout the food chain.</p>
<p>Although initially ISO 22000 can be a little confusing, there is little doubt it is one of the most useful standards developed by ISO. ISO 22000 specifies the requirements for a food safety management system and is applicable to all organisations in the food chain regardless of their size.</p>
<p>The aim of ISO 22000 is to harmonize on a global level the requirements for food safety management for businesses within the food chain and is particularly intended for organisations that seek a more focused and integrated <a title="ISO 22000 Compliant Food Safety Management System" href="http://9001manual.com/foodqualitymanual.php">food safety management system</a> than is normally required by law.<br />
 <br />
In order to comply with ISO 22000 an organisation needs to:</p>
<ul>
<li>Plan, implement, operate, maintain and update its food safety management system</li>
<li>Demonstrate compliance with applicable statutory and regulatory food safety requirements</li>
<li>Evaluate, assess and conform customer requirements related to food safety</li>
<li>Effectively communicate food safety issues to its suppliers, customers and relevant interested parties in the food chain</li>
<li>Conforms to its stated food safety policy</li>
<li>Demonstrate such conformity to relevant interested parties</li>
</ul>
<p>ISO states there are four key elements to ISO 22000:</p>
<ul>
<li>HACCP principles</li>
<li>Prerequisite programmes</li>
<li>Communication</li>
<li>System management</li>
</ul>
<p>HACCP principles<br />
ISO 22000 includes the Hazard Analysis and Critical Control Point (HACCP) system principles and application steps developed by the Codex Alimentarius Commission. Hazard analysis is fundamental to an effective food safety management system. ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, to be identified and subject to hazard assessment.</p>
<p>Prerequisite programmes<br />
ISO 22000 requires the combination of a HACCP plan with Prerequisite programmes (PRPs). Prerequisite programmes are the basic conditions and activities that are necessary to maintain a hygienic environment.</p>
<p>PRPs vary throughout the position in the food chain and are sometimes referred to as “Good Practices” such as Good Manufacturing Practice (GMP) and Good Hygienic Practice (GHP). Operational prerequisite programmes are implemented to control specific hazards in the process or product. During hazard assessment, the food safety team determine if hazards are to be controlled by PRP(s), operational PRP(s) or the HACCP plan.</p>
<p>Communication<br />
Communication along the food chain is required to ensure that all food safety hazards are identified and adequately controlled at each step. The standard views communication with customers and suppliers about identified hazards and control measures as an important part in delivering safe food products to the final consumer. Communication can take a variety of forms including:</p>
<ul>
<li>Labelling such as end product labels which inform the consumer of hazards such as if the product contains an allergen.</li>
<li>Specifications with details of any hazard present and prescribed control measures</li>
</ul>
<p>System management<br />
ISO 22000 requires that food safety systems are established, operated and updated within a <a title="ISO 22000 Compliant Food Safety Management System" href="http://9001manual.com/foodqualitymanual.php">structured management system</a>. ISO 22000 integrates existing HACCP and ISO 9001 systems so that a system compliant with ISO 9001 can be adapted to ISO 22000.</p>
<p>We add a fifth element to this which is Compliance:</p>
<p>It is essential that any organisation and its food safety management system complies with relevant customer, statutory and regulatory requirements.</p>
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		</item>
		<item>
		<title>What are the requirements of ISO 9001:2008 Clause 5.6 Management Review?</title>
		<link>http://9001manual.com/blog/74/what-are-the-requirements-of-iso-90012008-clause-5-6-management-review/</link>
		<comments>http://9001manual.com/blog/74/what-are-the-requirements-of-iso-90012008-clause-5-6-management-review/#comments</comments>
		<pubDate>Fri, 14 Aug 2009 06:09:50 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[ISO 9001 Information]]></category>
		<category><![CDATA[Opportunities for Improvement]]></category>
		<category><![CDATA[Quality Management Systems]]></category>
		<category><![CDATA[Best Tools]]></category>
		<category><![CDATA[Continuous Improvement]]></category>
		<category><![CDATA[Customer Focus]]></category>
		<category><![CDATA[ISO 9001:2008]]></category>
		<category><![CDATA[ISO 9001:2008 Certification]]></category>
		<category><![CDATA[Quality Manual]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=74</guid>
		<description><![CDATA[Clause 5.6.1 Management Review General
Regular Management reviews should be conducted in order to assess the effectiveness of the Quality Management System and to continually improve. The management review should be a formal analysis and review of the quality policy, quality objectives and quality management system performance which generates plans for corrective action, preventative action or [...]]]></description>
			<content:encoded><![CDATA[<p>Clause 5.6.1 Management Review General</p>
<p>Regular Management reviews should be conducted in order to assess the effectiveness of the <a title="ISO 9001 Quality Manual" href="http://9001manual.com/iso9001qualitymanual.php">Quality Management System</a> and to continually improve. The management review should be a formal analysis and review of the quality policy, quality objectives and quality management system performance which generates plans for corrective action, preventative action or opportunities for improvement all of which should be documented in the management review minutes.</p>
<p>Clause 5.6.2 Management Review Input</p>
<p>The first item on the management review agenda really should be a review of the Quality Policy to confirm it is pertinent to the quality management system and organisation or if any changes are required. Similarly the Quality Objectives should be reviewed and updated as necessary. There should be a review of the Management Structure and any changes and confirmation that there is adequate quality management system resource.</p>
<p>The meeting should cover the minutes and follow-up actions from previous review meetings and confirm actions to improve the quality management system as a result of the review have been completed.</p>
<p>Findings of internal and external <a title="ISO 9001 Quality Manual" href="http://9001manual.com/iso9001qualitymanual.php">quality management system</a> audits should be reviewed and outstanding non-conformances as a result of internal and external quality management system audits discussed. The Management Representative should conduct a trends analysis of the results of internal and external audits to present to the meeting. The management review team should also ensure that internal quality management system audits have been carried out as planned. Adverse trends such as an increased number of non-compliances should be identified and corrective action proposed. The results of third-party quality management system audits should be thoroughly scrutinised as these represent and independent view of the organisation.</p>
<p>The Quality Manager should present a trend analysis of Customer Complaints. This data should compare year on year performance especially when a product or service is seasonal. Volumes should be factored into the complaints analysis and so complaints should be presented taking this into consideration. Complaints are should also be categorise into critical and non-critical. Non-critical and total complaint analysis is useful for trends. Critical complaints should be closely analysed to determine if there is a common cause and if effective corrective action has been taken.</p>
<p>A standard format is to compare complaints per million units sold for each product. Industry standard complaint levels should be used for comparison. Again trends should be identified and if necessary plans for preventative action taken. Complaint analysis should also give an indication of opportunities for improvement of the quality management system. At this stage Safety incidents, recalls or withdrawals should also be reviewed. Corrective Action should have already been taken to deal with the causes of these incidents, the meeting should review the effectiveness of the quality management system in eliminating the cause of the incidents and also consider any common factor to the incidents in order to assess if preventative actions are required to improve the quality management system.</p>
<p>The meeting should review the quality management system Approved Supplier Register. A review of annual supplier performance should be presented normally by the Purchasing Manager. The report should include items such as percentage on time deliveries, percentage order completion, any non-conformances such as damaged deliveries or non-conforming products supplied plus any products rejected or accepted under concession. The report should also recognise exceptional supply performance and added value assistance received from suppliers as this should be factored into the quality management system when renegotiating contracts. Corrective Action plans should be formulated to deal with or change poor performing suppliers. Similarly to Customer Complaints, Supplier complaints should be analysed for trends.</p>
<p>The management review meeting should discuss quality management system process performance and confirm that the correct performance indicators are being monitored. Review and analysis of the quality management system Key Performance Indicator trends should be conducted to see if there is a visible improvement in performance. Sales levels should be one of the quality management system Key Performance Indicators as this will give an indication of company performance in the market place. Also the number and performance of new products successfully launched into the market place should be discussed. Again corrective action, preventative action and opportunities for improvement of the quality management system should be considered from the key performance indicator trend analysis.</p>
<p>The management review should cover the status of corrective and preventive action and compare numbers since the previous review and consider if the quality management system corrective and preventative actions are being completed in a timely fashion.</p>
<p>There should conduct a review of changes within the organisation and how this may have affected resource requirements including infrastructure, work environment, personnel and training requirements. At this stage proposed changes should be discussed and again quality management system resource requirements identified.</p>
<p>Review should also include Environmental performance and incidents,<br />
and Health and Safety performance and accidents</p>
<p>Clause 5.6.3 Management Review Output</p>
<p>The Management Review outputs should include resource requirements corrective and preventative actions identified as a result of analysis of the quality management system review inputs, all of which should be clearly documented in the minutes.</p>
<p>There will also be opportunities for Improvement in <a title="ISO 9001 Quality Manual" href="http://9001manual.com/iso9001qualitymanual.php">quality management system</a> effectiveness including product related customer requirements, change or elimination of non-productive elements, change or elimination of non-productive systems or procedures and supply of resource needed for improvement plans.</p>
<p>The results of the Management Review meetings should be documented in the minutes of the meeting and include a summary of all quality management system review inputs and outputs. The Management Representative should ensure the minutes of the Management Review meeting are distributed and effectively cascaded within the organisation.</p>
]]></content:encoded>
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		</item>
		<item>
		<title>What are the requirements of ISO 9001:2008 Clause 4.1 &#8211; General requirements?</title>
		<link>http://9001manual.com/blog/71/what-are-the-requirements-of-iso-90012008-clause-4-1-general-requirements/</link>
		<comments>http://9001manual.com/blog/71/what-are-the-requirements-of-iso-90012008-clause-4-1-general-requirements/#comments</comments>
		<pubDate>Sat, 08 Aug 2009 07:21:43 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[ISO 9001 Information]]></category>
		<category><![CDATA[Iso 9001 Certification]]></category>
		<category><![CDATA[ISO 9001 Document Requirements]]></category>
		<category><![CDATA[ISO 9001 minimum document requirements]]></category>
		<category><![CDATA[Iso 9001 Standard]]></category>
		<category><![CDATA[ISO 9001:2008]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=71</guid>
		<description><![CDATA[Clause 4.1 requires an organization to establish, document, implement and maintain a quality management system and continually improve the quality management system effectiveness.
Clause 4.1 requires an organization to
- determine the processes needed for the quality management system
- determine the sequence and interaction of these processes
- determine criteria and methods needed to ensure that both the operation and control [...]]]></description>
			<content:encoded><![CDATA[<p>Clause 4.1 requires an organization to establish, document, implement and maintain a <a title="ISO 9001 Manual for Small Businesses" href="http://9001manual.com/smallbusinessmanual.php">quality management system</a> and continually improve the quality management system effectiveness.</p>
<p>Clause 4.1 requires an organization to</p>
<p>- determine the processes needed for the <a title="ISO 9001 Manual for Small Businesses" href="http://9001manual.com/smallbusinessmanual.php">quality management system</a><br />
- determine the sequence and interaction of these processes<br />
- determine criteria and methods needed to ensure that both the operation and control of these processes are effective<br />
- ensure the availability of resources and information to support the operation and monitoring of these processes<br />
- monitor, measure, and analyse the processes<br />
- implement actions necessary to achieve planned results and continual improvement</p>
<p>Clause 4.1 requires an organization to manage the processes in accordance with the requirements of the ISO 9001: 2008 standard.</p>
<p>Clause 4.1 requires that when an organization outsources any process that can affect product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to must be defined within the quality management system.</p>
<p>Quality management system processes should include management activities, provision of resources, product realization, measurement, analysis and improvement.</p>
<p>An outsourced process is a process which the organization chooses to have performed by an external party but is still a part of the quality management system. The organization still assumes responsibility of conformity to all customer, statutory and regulatory requirements for all outsourced processes. The control applied to the outsourced process can be influenced by the potential impact of the outsourced process on the organization&#8217;s capability to provide product that conforms to requirements, the degree to which the control for the process is shared, and the capability of achieving the necessary control through the application of purchasing procedures</p>
<p>All of our manual packages come with our comprehensive guide to the process of implementing an <a title="ISO 9001 Manual for Small Businesses" href="http://9001manual.com/smallbusinessmanual.php">ISO 9001 compliant Quality Management System</a></p>
]]></content:encoded>
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		</item>
		<item>
		<title>What is a Quality Manual?</title>
		<link>http://9001manual.com/blog/65/what-is-a-quality-manual/</link>
		<comments>http://9001manual.com/blog/65/what-is-a-quality-manual/#comments</comments>
		<pubDate>Sat, 08 Aug 2009 06:30:52 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[ISO 9001 Information]]></category>
		<category><![CDATA[ISO 9001 Document Requirements]]></category>
		<category><![CDATA[ISO 9001:2008 Certification]]></category>
		<category><![CDATA[Quality Management System]]></category>
		<category><![CDATA[Quality Manual]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=65</guid>
		<description><![CDATA[A Quality Manual is a set of documents that describe an organization’s quality management system. Quality manuals include procedures for key elements of a quality management system with details of responsibilities and authorities for each element of the quality management system.
Typical contents of a Quality Manual include:
Quality Policy – A statement of intent from the [...]]]></description>
			<content:encoded><![CDATA[<p>A <a title="ISO 9001 Quality Manual" href="http://9001manual.com/iso9001qualitymanual.php">Quality Manual</a> is a set of documents that describe an organization’s quality management system. Quality manuals include procedures for key elements of a quality management system with details of responsibilities and authorities for each element of the quality management system.</p>
<p>Typical contents of a <a title="ISO 9001 Quality Manual" href="http://9001manual.com/iso9001qualitymanual.php">Quality Manual</a> include:</p>
<p>Quality Policy – A statement of intent from the organization with a commitment to providing a product or service to meet customer requirements</p>
<p>Quality Objectives – A set of defined, measureable goals that the organisation is committed to meeting in order to fulfil customer requirements</p>
<p>Top Level Procedures</p>
<p>Management Review – Describes the methods that senior management undertake to monitor and measure the performance of the organisation then take actions to improve performance</p>
<p>Control of documents – Describes the methods for ensuring that pertinent documents are available at their point of use</p>
<p>Control of records &#8211; Describes the methods for ensuring that pertinent records are available at their point of use</p>
<p>Internal audit – Describes the methods for auditing the quality management system to assess its effectiveness</p>
<p>Control of nonconforming product &#8211; Describes the methods for ensuring that product that does not meet requirements is prevented from delivery to the customer</p>
<p>Corrective action &#8211; Describes the methods for taking action to rectify non-conformances</p>
<p>Preventive action &#8211; Describes the methods for taking action to rectify potential non-conformances</p>
<p>Product Realization – Provides an overview of methods of manufacture or provision of service</p>
<p>Monitoring and Measuring &#8211; Describes the methods of measuring an organisation’s performance against customer requirements and company objectives</p>
<p>Purchasing &#8211; Describes the methods applied to ensure purchased goods meet requirements</p>
<p>Responsibility and Authority – Describes the organisational structure and chain of authority with responsibility of key personnel</p>
<p>Resource Management &#8211; Describes methods of managing resource to ensure the organization meets requirements in an efficient manner</p>
<p>Infrastructure and Work Environment – Describes an organization’s policy with regards to the prerequisite standards for infrastructure and work environment</p>
<p>The <a title="ISO 9001 Quality Manual" href="http://9001manual.com/iso9001qualitymanual.php">ISO 9001 Quality Manual</a> includes a comprehensive set of documents, records, checklists and implementation guides making ISO 9001:2008 certification even easier.</p>
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		<title>How to create a Quality Management System</title>
		<link>http://9001manual.com/blog/58/how-to-create-a-quality-management-system/</link>
		<comments>http://9001manual.com/blog/58/how-to-create-a-quality-management-system/#comments</comments>
		<pubDate>Mon, 03 Aug 2009 04:53:08 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[ISO 9001 Information]]></category>
		<category><![CDATA[Opportunities for Improvement]]></category>
		<category><![CDATA[Quality Management Systems]]></category>
		<category><![CDATA[Iso 9001 Certification]]></category>
		<category><![CDATA[Quality Assurance]]></category>
		<category><![CDATA[Quality Management System]]></category>
		<category><![CDATA[Quality Manuals]]></category>
		<category><![CDATA[System Documentation]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=58</guid>
		<description><![CDATA[The first step in the process of implementing a quality management system is to communicate with customers and potential customers and determine their expectations and requirements. Once this is completed confirm with the customers to ensure your understanding of their requirements is correct.
Senior management should decide which markets the company quality management system should address [...]]]></description>
			<content:encoded><![CDATA[<p>The first step in the process of implementing a quality management system is to communicate with customers and potential customers and determine their expectations and requirements. Once this is completed confirm with the customers to ensure your understanding of their requirements is correct.</p>
<p>Senior management should decide which markets the company quality management system should address and develop relevant policies.</p>
<p>Based on these policies, management should then establish objectives for the company products, environmental performance, occupational health and safety performance</p>
<p>Example Quality Policy</p>
<p>The company’s quality policy is to provide competitive products and services of the highest standards of performance and reliability, satisfy the needs and expectations of its customers and achieve business success.This level of quality is achieved through adoption of a <a title="Sample Quality Management System" href="http://9001manual.com/iso9001qualitymanual.php">quality management system</a> that reflects the competence of the Company to existing customers, potential customers, and independent authorities.</p>
<p>The next step is to determine the quality management system processes needed for achieving the policies and objectives. The Senior Management Team determines all the quality management system processes needed including Management Team Resources, Training &amp; Competence Product Realization Design and Development Sales, Planning, Measurement, Analysis, Improvement, Suppliers, <br />
Audits, Management System and Customer Service</p>
<p>The Senior Management Team should use flowcharts to support the development of the quality management system process sequences and their interactions.</p>
<p>Senior Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each quality management system process and its interactions. Establish a Process Management team that has an overview across all the quality management system processes, and which includes representatives (Process Owners) from each of the interacting processes.  </p>
<p>Determine the activities needed to achieve the objectives of the quality management system process. For example Product Realisation may require the following activities:<br />
Planning, Processing, Production, Packing, Final Inspection and Storage</p>
<p>Assess each quality management system process and determine and the most appropriate way of managing them and if they are to be documented. Documentation is to enable the consistent and stable operation of the quality management system processes. Determine which quality management system processes are to be documented, on the basis of the: </p>
<p>- size of your company and your activities<br />
- complexity of the processes and their interactions<br />
- criticality of the process<br />
- availability of competent personnel</p>
<p>Different methods of documentation can be used. Decide which is best to represent and comprehend the quality management system process. Suitable documents include graphical representations, written instructions, checklists, flow charts, visual media and electronic methods</p>
<p>Determine the resources including Human resources, Infrastructure, Work environment, Information, Natural resources, Materials and Financial resources that are needed for the effective operation of each quality management system process.</p>
<p>For example for product realization resources required may be:<br />
Human resources &#8211; Production Staff, Training &amp; Competence<br />
Infrastructure &#8211; buildings, workspace layout, process equipment, tools, supporting services and information systems<br />
Work environment &#8211; layout of facilities, plant equipment, pest control, waste control, work wear, noise, temperature, humidity, lighting and weather.</p>
<p>Determine where and how monitoring and measuring should be applied both for control and improvement of the quality management system processes.<br />
Develop a project for implementation that includes Communication, Awareness, Training, Change management, Management involvement, Review activities</p>
<p>Implement the quality management system processes and their activities as planned.</p>
<p>Measure or monitor to determine the effectiveness and efficiency of the quality management system process, taking into account such factors as Conformity with requirements, Customer satisfaction, Supplier performance, On time delivery, Waste, Process costs, Incident frequency, determine the need to record results</p>
<p>For example measurement criteria for measurement of customer satisfaction could be Complaint levels, % on time Deliveries, % Order Completion</p>
<p>Regularly analyze and evaluate quality management system information obtained from monitoring and measuring data in order to check your performance. Management Review is an ideal tool for this. </p>
<p>Key Areas for Business and quality management system improvement should be identified during Management Review and could include: Complaint Levels, Production Efficiency, Process Simplification, Waste Reduction, Delivery Performance and Order Lead Time</p>
<p>Our <a title="Small Business Quality Management System" href="http://9001manual.com/smallbusinessmanual.php">Small Business ISO 9001 Manual </a>contains the basic requirements of a quality management system and comes with implementation guides and <a title="ISO 9001 QMS implementation checklist" href="http://9001manual.com/dlz/ISO9001%20Quality%20Manual%20Implementation%20Checklist.pdf">implementation checklists</a>.</p>
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		<title>What does HACCP stand for?</title>
		<link>http://9001manual.com/blog/55/what-does-haccp-stand-for/</link>
		<comments>http://9001manual.com/blog/55/what-does-haccp-stand-for/#comments</comments>
		<pubDate>Mon, 03 Aug 2009 03:36:08 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[Food Safety Legislation]]></category>
		<category><![CDATA[Opportunities for Improvement]]></category>
		<category><![CDATA[Continuous Improvement]]></category>
		<category><![CDATA[Food Safety]]></category>
		<category><![CDATA[Haccp]]></category>
		<category><![CDATA[HACCP Calculator]]></category>
		<category><![CDATA[HACCP legislation]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=55</guid>
		<description><![CDATA[HACCP is the acronym for Hazard Analysis Critical Control Point.  The concept was originally developed in the 1960’s by NASA to ensure food safety for the manned space programme. The Pillsbury Food Company in association with NASA developed the first HACCP programme for astronaut food. Pillsbury presented it at the first American National Conference for [...]]]></description>
			<content:encoded><![CDATA[<p>HACCP is the acronym for Hazard Analysis Critical Control Point.  The concept was originally developed in the 1960’s by NASA to ensure food safety for the manned space programme. The Pillsbury Food Company in association with NASA developed the first HACCP programme for astronaut food. Pillsbury presented it at the first American National Conference for Food Protection in 1971. The Food and Drug Administration (FDA) in the US liked the HACCP programme and had Pillsbury assist them with it – it was first applied to low-acid tinned food in 1973. HACCP has gradually made its way around the globe since then. HACCP is managed globally by Codex Alimentarius. Its primary aim is to prevent food safety problems and effectively control food borne disease. The <a title="HACCP System Samples" href="http://9001manual.com/haccpmanual.php">principles of HACCP </a>can be used for all product and hazard types.</p>
<p>The Hazard Analysis Critical Control Point (HACCP) system is internationally recognised as the most effective method of ensuring food safety. </p>
<p>HACCP is a system, which identifies specific hazards and implements measures for their control.  HACCP’s systems are developed using the seven basic principles detailed below:</p>
<p>Principle 1<br />
Prepare a flow diagram of the steps in the process.  Conduct a hazard analysis by identifying potential hazards.  Assess likelihood of occurrence of these hazards and identify control options</p>
<p>Principle 2<br />
Identify the Critical Control Points in the process using the decision tree</p>
<p>Principle 3<br />
Establish critical limits, which must be met to ensure each Critical Control Point is under control</p>
<p>Principle 4<br />
Establish a monitoring system to ensure control of the Critical Control Point by scheduled testing or observations</p>
<p>Principle 5<br />
Establish the corrective action to be taken when monitoring indicates that a particular Critical Control Point is moving out of control</p>
<p>Principle 6<br />
Establish documentation concerning all procedures and records appropriate to these principles and their application</p>
<p>Principle 7<br />
Verify that HACCP is working effectively</p>
<p>On the 29 April 2004, the European Parliament and the Council issued Regulation (EC) No 852/2004 on the hygiene of foodstuffs.<br />
Article 5 states that: Food business operators shall put into place, implement and maintain a permanent procedure based on the principles of hazard analysis critical control points (HACCP).</p>
<p>At <a href="http://www.9001manual.com/">www.9001manual.com</a> we have completely simplified the process of developing HACCP system by offering the unique © <a title="HACCP Calculator" href="http://9001manual.com/haccpmanual.php">HACCP Calculator </a>with our “off the shelf” HACCP manuals.</p>
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		<title>What is ISO certification?</title>
		<link>http://9001manual.com/blog/51/what-is-iso-certification/</link>
		<comments>http://9001manual.com/blog/51/what-is-iso-certification/#comments</comments>
		<pubDate>Sun, 02 Aug 2009 17:44:33 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[ISO 9001 Information]]></category>
		<category><![CDATA[Quality Management Systems]]></category>
		<category><![CDATA[Iso 9001 Standard]]></category>
		<category><![CDATA[ISO 9001:2008 Certification]]></category>
		<category><![CDATA[Iso Certification]]></category>
		<category><![CDATA[Quality Management System]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=51</guid>
		<description><![CDATA[ISO Certification normally refers to certification of your quality management system to ISO 9001. It is an internationally recognised standard for quality management system requirements. It is a certification that enhances your company reputation with your customer especially as it demonstrates your commitment to quality.
 
ISO 9001 was developed by ISO (International Organization for Standardisation), the [...]]]></description>
			<content:encoded><![CDATA[<p>ISO Certification normally refers to certification of your <a title="ISO 9001 Manual for Small Businesses" href="http://9001manual.com/smallbusinessmanual.php">quality management system to ISO 9001</a>. It is an internationally recognised standard for quality management system requirements. It is a certification that enhances your company reputation with your customer especially as it demonstrates your commitment to quality.<br />
 <br />
ISO 9001 was developed by ISO (International Organization for Standardisation), the world&#8217;s largest developer and publisher of International Standards. ISO is a network of 156 national standards bodies, based in Geneva, Switzerland. ISO is a non-governmental organisation that forms a bridge between the public and private sectors.<br />
 <br />
<a title="ISO 9001 Manual for Small Businesses" href="http://9001manual.com/smallbusinessmanual.php">ISO 9001:2008 Quality Management Systems </a>Requirements is the latest version of the standard and is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfil if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual improvement of the Quality Management System.</p>
<p>This is the only standard in the ISO 9000 series for which third-party auditors may grant certification.</p>
<p>ISO 9001:2008, the approval standard, has 5 main sections:</p>
<p>- Quality Management System<br />
- Management Responsibility<br />
- Resource Management<br />
- Product Realization<br />
- Measurement Analysis and Improvement</p>
<p> <br />
There are many other standards in the ISO series including the food safety related ISO 22000 standard. The ISO 22000 international standard specifies the requirements for a <a title="Total Food Quality Management System" href="http://9001manual.com/totalfoodpackage.php">food safety management system</a> that involves the following elements:</p>
<p>- interactive communication<br />
- system management<br />
- prerequisite programs<br />
- HACCP principles</p>
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		<title>5 Stage Process to ISO 9001:2008 Certification</title>
		<link>http://9001manual.com/blog/45/5-stage-process-to-iso-90012008-certification/</link>
		<comments>http://9001manual.com/blog/45/5-stage-process-to-iso-90012008-certification/#comments</comments>
		<pubDate>Fri, 24 Jul 2009 07:08:47 +0000</pubDate>
		<dc:creator>Tony</dc:creator>
				<category><![CDATA[Opportunities for Improvement]]></category>
		<category><![CDATA[Quality Management Systems]]></category>
		<category><![CDATA[Benefit]]></category>
		<category><![CDATA[ISO 9001 Document Requirements]]></category>
		<category><![CDATA[ISO 9001:2008]]></category>
		<category><![CDATA[ISO 9001:2008 Certification]]></category>
		<category><![CDATA[Quality Management System]]></category>

		<guid isPermaLink="false">http://9001manual.com/blog/?p=45</guid>
		<description><![CDATA[Simplify your ISO 9001 certification by following our 5 stage process.
Follow the five stages below and use our guaranteed ISO 9001:2008 package and you will be surprised how simple the ISO 9001:2008 implementation can be.
Stage 1: Understanding of ISO 9001:2008
ISO 9001:2008 is an international standard for quality management systems. Our introduction to ISO 9001:2008 presentation [...]]]></description>
			<content:encoded><![CDATA[<p>Simplify your ISO 9001 certification by following our 5 stage process.<br />
Follow the five stages below and use our <a title="Guaranteed Certification Package" href="http://9001manual.com/iso9001certification.php" target="_blank">guaranteed ISO 9001:2008 package </a>and you will be surprised how simple the ISO 9001:2008 implementation can be.</p>
<p>Stage 1: Understanding of ISO 9001:2008</p>
<p>ISO 9001:2008 is an international standard for quality management systems. Our introduction to ISO 9001:2008 presentation guides you through the whole standard. We recommend that you obtain the actual ISO 9001:2008 standard for reference purposes.<br />
Use our Introduction to ISO 9001:2008 and Benefits of an ISO9001:2008 compliant Quality Management System Presentation to brief Senior Management. You should ensure that the Senior Management Team completely support the ISO 9001 system. The presentation will help you to explain to them the advantages an ISO 9001:2008 compliant will bring to your organisation including:<br />
Competitive advantage<br />
Improves business performance<br />
Enhanced reputation<br />
Saves you money<br />
Streamlines operations and reduces waste<br />
Encourages internal communication and raises morale<br />
Increases customer satisfaction</p>
<p>Stage 2 Quality Management System Initial Development</p>
<p>Senior Management Input<br />
The start of developing a Quality Management System requires Senior Management to assess Customer, Potential Customer and other interested parties requirements and as a result of that review establish policies and objectives. We include an ISO 9001 Senior Management Implementation Checklist for Customer Requirements and establishing policies and objectives which will guide you through this process.<br />
At this stage the Senior Management team should appoint a Management Representative. This is normally a quality manager or senior manager of your company, it needs to be somebody who has sufficient authority to change the way that the company works. This person is responsible for the ISO 9001 quality management system implementation. This person will need to have a thorough understanding of the principles of the standard so will have to be qualified and/or trained.<br />
You should also brief all employees using our Introduction to ISO 9001:2008 Quality Management System Presentation</p>
<p>Stage 3 Documenting your Quality Management System Quality Manual, Quality Policy, Quality Objectives, Procedures and Records Implementation</p>
<p>Using a sample of good ISO 9001:2008 documentation is an excellent training tool. The procedures and records provided in our manual are excellent templates. We also highly recommend you see our Guide to the Process of Implementing an ISO9001 Compliant Quality Manual.<br />
Developing the various documents required by ISO 9001:2008 is for most companies the most difficult part of the ISO 9001:2008 implementation. These documents have to meet the requirements of the ISO 9001:2008 standard and it is not always clear exactly what is required, so this represents the biggest hurdle for an organisation.<br />
With our Manual packages it couldn’t be easier:<br />
We have made this task simple and straightforward as we provide the entire compulsory documentation required by ISO 9001:2008 in our Manual packages.<br />
Our <a title="ISO 9001 Manual for Small Businesses" href="http://9001manual.com/smallbusinessmanual.php" target="_blank">Small Business manual</a> contains all the Documents required by ISO9001:2008:</p>
<p>QMD 001 Quality Manual<br />
QMD 002 Quality Policy<br />
QMD 003 Quality Objectives<br />
QMD 004 Control of Documents<br />
QMD 005 Control of Records<br />
QMD 006 Internal Audit<br />
QMD 007 Control of Non-Conforming product<br />
QMD 008 Corrective Action<br />
QMD 009 Preventive Action</p>
<p>Our Small Business manual contains all the Records required by ISO9001:2008:</p>
<p>QMR 001 Management Review Minutes     <br />
QMR 002 Training Record<br />
QMR 003 Product Release Record <br />
QMR 004 Design and Development Records<br />
QMR 005 Supplier Assessment Record<br />
QMR 006 Validation Record<br />
QMR 007 Identification and Traceability Record<br />
QMR 008 Register of Customer Property<br />
QMR 009 Calibration Record<br />
QMR 010 Internal Audit Record<br />
QMR 011 Records of Non-conforming Product<br />
QMR 012 Corrective Action Request Form<br />
QMR 013 Preventative Action Request Form</p>
<p>We also include our ISO 9001  implementation checklist for using your quality manual, procedures and records using the useful procedures and records included in the Manual Package, all of which you can use as templates. These templates are easily edited to suit your organisation.<br />
You can now complete this crucial step quickly and easily<br />
Once you have established you quality manual and procedures you will need to brief all the staff and train staff in those procedures and records pertinent to their areas. Identify the training needs for all employees and set up a training plan. Nominate qualified trainers to carry out the training.<br />
Stage 4: Confirm you Quality Management system works</p>
<p>Take Corrective Actions and Preventative Actions<br />
You will need to implement corrective actions and preventative actions and review these actions to ensure they are effective<br />
Carry out a Management Review using our QMR 001 Management Review Minutes templates as a guide and Analyze your data and make improvements<br />
Carry out Internal Audits<br />
Internal audits need to be scheduled and performed. Ensure you have enough qualified resource to carry out the audits as per the schedule. Training of internal auditors may be required. The role of the auditor is to verify that your company meets the requirements of ISO 9001 as they are described in your Quality Manual. You can use QMR 010 Quality System audit form for this.<br />
Once you have performed a complete internal audit schedule that didn’t uncover any significant gaps in your system or major non-compliances, you are probably ready for the certification audit</p>
<p>Stage 5: Certification</p>
<p>We would recommend using a well recognised certification body as they will issue your certificate and this will only enhance your quality management system credibility with your customers. After all they will want to see a copy of your certificate.<br />
Once you successfully passed the certification audit, you can use your certification freely in marketing your organisation. You may want to prepare a press release and print your certification mark on business cards and letterheads.<br />
Our final words: Your ISO 9001 quality management system is designed to continually improve your performance, maintain your system and continue your internal audits, and we are convinced you’ll see a continual improvement in performance.</p>
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