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.


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:

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.


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:

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.


Download a free internal audit checklist example courtesy of ISO 9001 Checklist:

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.

Monday, 18 October 2010

Adding Quality to your ISO 9001 Quality Manual

Adding Quality to your ISO 9001 Quality Manual

Every customer expects value for money when purchasing any product, and in accordance with this; organizations understand that operating an efficient quality management system will help to ensure these expectations are realised. It is therefore no surprise that your ISO 9001 quality manual is at the heart of any effective quality management system.

By acting as a centralised resource for information such as policies, objectives and procedures, the ISO 9001 quality manual demonstrates an organization’s approach to delivering customer satisfaction.

Who uses your ISO 9001 Quality Manual?

The ISO 9001 quality manual contents will be directly relevant to employees, whilst other sections will be more relevant to corporate customers, business partners or internal and external auditors.

The quality manual reveals how the requirements of ISO 9001:2008 are implemented by acting as a central resource that demonstrates how an organization’s processes interact and how those processes are controlled in order to deliver customer satisfaction.

The quality manual is also useful in helping to communicate management's approach to the application and incorporation of quality management principles into the organization’s daily activities.

What must be Included in your Manual?

ISO 9001 requires an organization to compile an ISO 9001 quality manual in order to define how each requirement of the standard will be applied. The latest version of ISO 9001:2008 provides a generalised framework that outlines how an organization should set about the task of meeting customer requirements and achieving satisfaction. Based on this standard, the ISO 9001 quality manual should address the following:

- the scope of the QMS
- details of and justification for any exclusion or non-application
- references to the documented procedures
- a description of interaction between the processes of the QMS
- an outline of the structure of the documentation used in the quality management system

What can be Excluded from your Manual?

It is essential to look into the permissible exclusions allowed by the standard when preparing your ISO 9001 quality manual. All the exclusions must be properly documented within the manual by giving appropriate justification. Exclusions from section 7 - Product Realisation, are permitted as long as the exclusion does not adversely impact an organization's ability to meet the requirements of its customers.

Only activities that an organization does not do itself can be considered as permissible exclusions. For example, if an organization does not design; this is a permissible exclusion. If an organization does not use equipment requiring calibration, then paragraph 7.6 is a permissible exclusion. In order to exempt one’s self from a requirement, a statement such as the following would suffice:

‘Company XYZ does not engage in designing, developing or changing the design of the products we manufacture. Therefore, our QMS does not encompass product design and development processes and paragraph 7.3 of ISO 9001 is not applicable to our business.


Download a free ISO 9001 quality manual template example courtesy of ISO 9001 Checklist.

The quality manual is ideal for organizations that require an affordable, basic manual that will satisfy the requirements of ISO 9001 whilst providing a framework for a formal in-house quality system. To learn more please visit ISO 9001 Checklist:

The Value of ISO Implementation

The Value of ISO Implementation

During these uncertain economic times, organizations realise they must improve their performance in order to position themselves more effectively to take advantage of the inevitable recovery. Organizations understand the potential for new opportunities to gain a better market share as the recovery phase adds momentum, and that ISO implementation could provide the edge needed to gain that market share.

Beginning the ISO Implementation Journey

A consultant will often provide a quicker start to your ISO implementation project, in the long run; you will save time but at the expense of cost. Or, you could do it yourself; many organizations have, and succeeded. If you study the standard and you have more time than budget, the DIY approach could be a foregone conclusion!

Begin by reading through each requirement of ISO 9001:2008 and ask yourself ‘what evidence do I have that shows we are actually doing this?’ List the organization’s processes using post-it notes and arrange each one in sequence and then link each process to a set of documentable outputs. Align the quality policy, objectives and the quality manual to achieve those outputs.

Begin auditing the outputs of these processes as soon as you have sufficient documentary evidence to demonstrate conformance. This can take several months to generate or it can be as soon as a month after the initial implementation phase.

Should I do a Gap Analysis?

Yes. By performing and documenting an initial Gap Analysis between the organization’s existing systems and the requirements of ISO 9001:2008, the true scope of effort needed to achieve certification will be revealed.

The Gap Analysis will help to highlight:

- the required processes that are not currently in place
- non-compliant processes that must be redesigned
- processes that comply but need to be documented
- documented processes that comply

Experience of performing an initial Gap Analysis for ISO implementation has revealed a common stumbling block to compliance; companies mostly lack a provable and effective corrective and preventive action process or program. This is a key tenet of the quality management system and promotes much of system’s future improvements.

A common key problem is that personnel, which includes management, have not received adequate training - thus making implementation much more difficult. ISO implementation can be a struggle if people do not fully understand the principles.

Pre-assessment audit

If you choose to use ISO consultants we recommend you take advantage of your chosen registration company’s pre-assessment audit (this is often free). Have their auditor come in for a day and assess various aspects of your system. He will appreciate the depth of evidence at this early stage and allow for it when making an assessment. Ask him to have them look at two, three or more processes - his feedback is often useful in streamlining top management’s overall approach to ISO implementation.


Learn more about ISO implementation with their free project plan.

Devise a system that benefits your company by mapping the processes to give an overview of how each process interacts; from there, you can now produce detailed procedures to control the inputs and outputs of each process. Try not to make every organizational nuance fit the standard; keep it simple!

To learn more about ISO implementation please visit ISO 9001 Checklist:

Tuesday, 12 October 2010

ISO 9001 Audit Checklist

Understanding the ISO 9001 Audit Checklist

If an organization has recently embarked on the journey of implementing ISO 9001:2008, a generic ISO 9001 audit checklist can be very helpful in determining gaps in compliance. As the system matures however, generic audit checklists lose their effectiveness and it becomes critical for the organization to delve deeper in terms of conformance when assessing the effectiveness of operational controls and specific processes.

Why use an ISO 9001 Audit Checklist?

Internal auditors often use an ISO 9001 audit checklist to determine compliance since the ISO 9001 audit checklist covers each requirement of the standard as a question. This type of questionnaire is very useful for internal auditors, because it helps them to discover how a specific requirement is implemented. The auditor has only to check that the defined procedure meets the requirements and if the procedure is preformed correctly.

The shortcoming of this approach is that the audit often fails to evaluate the effectiveness and efficiency of the process being audited. What happens if the process does not meet procedure? Should you change the process to be compliant with the procedure, or should you verify whether the process is effective and change the procedure? These are questions to consider in any procedure-based audit.

Instead, use the ISO 9001 audit checklist only as a guide and allow the auditor to delve freely into whatever process is deemed critical. This model will produce more meaningful findings, but, there is a risk that auditors focus on auditing processes that are familiar to their particular specialty. Furthermore, as time goes by, completing the audit checklist could become mandatory and overburdened with detail resulting in less time for in-depth auditing.

Process Auditing and Checklists

Process audits are undertaken to verify whether a process meets the planned goals and objectives and to identify opportunities for improvement. The main thing to understand when auditing a process is the actual process concept. One does not need to know or understand the details of a specific process to be able to audit it, although it does help. A good auditor should be able to audit any process without knowing anything about it by monitoring the process inputs to determine whether the desired process outputs have been achieved.

As with other ISO standards which require internal auditing, audit checklists based on the standard have minimal benefit when it comes to auditing a process. It is best to develop a specific audit questionnaire based on actual management system policies, processes and procedures. This allows a more in-depth approach that identifies not only failures in the processes but also potential failures, while also ensuring the internal auditors are much more rigorous during their enquiries.

Controlling the Audit Checklist

The basic ISO 9001 audit checklist template should be controlled but the actual audit checklist for each process is subject to change and should not be controlled.


Download a free ISO 9001 audit checklist example courtesy of ISO 9001 Checklist.

Sometimes the ISO 9001 audit checklist and auditing in general are treated as a separate agenda items which are often put back in the closet until the next internal audit or registration audit. An effective internal audit process can prevent that from happening by maintaining visibility throughout the organization. To learn more please visit ISO 9001 Checklist:

Thursday, 7 October 2010

ISO 9001 Quality Manual

Top 5 questions about your ISO 9001 Quality Manual

An ISO 9001 quality manual details how an organization will actively ensure customer satisfaction through the application of established quality management principles. For this reason, the ISO 9001 quality manual is one of the most scrutinised high-level documents present in an organization. This article discusses a number of issues surrounding the format and content of the quality manual.

Format & Content

There are no requirements defining the format of the ISO 9001 quality manual, most organizations often use a pre-formatted template which is easily modified as the quality system develops. Using a quality manual template will afford an organization more time to focus on documenting systems and processes with greater accuracy during the implementation phase.

There is often considerable debate about the format and content of the quality manual. The balance of opinion is divided between those who believe the manual’s format does not matter, as long as, what occurs out in the field complies with the requirements and those who believe the quality manual should say something 'personal' about the organization’s approach to quality management.

It would be true to say that every company has their own style of operation which will inevitably be reflected in the quality manual and procedures. This variance is fine; all that matters is that the quality manual and procedures are able to respond positively to these questions:

1. Does it define the scope of the organization’s approach to quality management?
2. Does it define how the scope is applied?
3. Does it give suitable reason for permissible exclusions from that scope?
4. Does it contain, or make reference to, documented procedures?
5. Does it ensure a cycle of feedback exists to allow improvement?

It is important to maintain a clear distinction between the contents of the ISO 9001 quality manual and the purpose and scope of the procedures. The quality manual should define top management’s intent to operate an effective quality management system, while the procedures define how those intentions will be implemented at an operational level.

The quality manual should not be over burdened with excessive detail which requires frequent change to ensure relevance is maintained. The approach taken many companies to avoid over-burdening their manual is by allowing lower-level documents, such as procedures and work instructions to contain operational detail. Then, simple reference is made to the procedures and work instructions from within the quality manual itself. In other words, let the procedures take the strain of controlling day-to-day activities; after all, they are ‘working’ documents the organization uses to achieve the goal of customer satisfaction.


Compilation of the ISO 9001 quality manual can be challenging task as it tends to be a key information resource to multiple audiences. By using a consistent approach to content input and formatting, it becomes much easier to communicate to those audiences about your organization’s approach to quality.

To learn more about our Quality Manual Solution, please visit ISO 9001 Checklist:

Wednesday, 6 October 2010

Do I need an ISO Consultant?

Organizations often engage the services of an independent ISO consultant to help plan and implement their quality management system. However, it is entirely possible to learn and implement the requirements of the standard yourself using the browser based training resource provided free by

This resource will provide your organization with immediate access to a body of knowledge that could help your organization ensure the effectiveness of its quality management system; in short, it has the potential to save you thousands in unnecessary consultancy fees.

Four Reasons to Hire an ISO Consultant

1. To plan the implementation project.

The efficient implementation of the standard starts with a robust plan, taking into account all variables that you might encounter, omitting the areas that are already in place and by developing an estimate of the duration of each phase.

2. To interpret the standard.

An ISO consultant who understands the requirements of the standard will help your organization avoid wasting time undertaking things the standard does not require, or undertaking things that do not meet the requirements of the standard.

3. To benefit from previous experience.

Employing an ISO consultant to guide your organization towards efficient implementation from the start, without having to learn the ropes on your own which thereby reduces the need to ‘learn as you go’.

4. To manage the implementation programme.

An ISO consultant will liaise with your ISO 9001 implementation team and ensure that work is completed in accordance with the implementation programme.

Why not go it alone?

In order to ensure that your organization has got what it takes to build a compliant quality management system and then to achieve certification might appear to be a very daunting challenge. Seeking the help of an ISO consultant is the most common response to this challenge, yet it is an unnecessary option to take.

Once you have read through our body of knowledge you will begin to understand the requirements more thoroughly. This guidance helps you go through the entire implementation process effortlessly because the training resource divides ISO 9000 into four sections, Plan, Do, Check and Act. The page menu then sub divides each section into Principles, Base Clauses and Requirements for easy comparison.


Rather than paying an ISO Consultant high consultancy fees, it is possible to purchase quality system templates which are ready to use and which could save you thousands of pounds. We provide easy to edit and fully customizable quality system templates along with free training resources to help your organization achieve a competitive edge.

To learn more about implementation without an ISO consultant, visit ISO 9001 Checklist:

Friday, 1 October 2010

ISO 9001 Training

ISO 9001 Training

Implementing ISO 9001 in any organization first requires the development of the necessary knowledge, skills and understanding to enable the practical application of the standard. At this stage organizations often seek the help of a consultant but this is often unnecessary since the required understanding can easily be sought for free.

The ISO 9001 training section provided by is intended to give any business a knowledgeable foundation that ensures their quality management system is highly robust. It could save you £0000's in consultancy fees.

The Concept behind ISO 9001 Training

ISO 9001 training is a unique internet browser based tutorial solution that provides expert practical guidance for businesses wishing to interpret ISO 9000 fundamentals to help better understand and implement the requirements of ISO 9001:2008. It could help your business to get the most out of your quality management system, and it’s free to use!

The ISO 9001 training section represents a body of knowledge which explains the requirements of the standard in plain English coupled with practical guidance and interpretation. The online ISO 9001 training section divides the standard into four sections that follow the Plan, Do, Check and Act cycle. The page menu then subdivides each section into Principles, Base Clauses and Requirements for easy comparison. Each stage of the cycle then relates each clause of ISO 9001:2008 to the key concepts that lie at the heart of quality management.

How does it Work?

Simple, it encourages the use of the PDCA cycle as a means to implement your quality management system by prompting the user to:

PLAN your quality system’s high level processes, define your quality policy and establish your quality objectives in accordance with the expected output. Consider; how will the quality management system be documented, what resources will be needed, who will have responsibility for what and how will the effectiveness of the system be evaluated and communicated.

DO carry out day-to-day activities by performing the necessary processes in accordance with any planned arrangements. Gather performance information by undertaking audits and other measurements as planned.

CHECK the results and analyse the information gathered through various measurements and monitoring activities to determine whether the quality management system has achieved what it set out to do.

ACT by using the results from internal audits, preventive actions and management reviews to ensure the continual improvement of your quality management system; continual improvement should be the organization’s permanent objective.

What Happens after Implementation?

You need to choose a registrar. The registrar is a third party certification auditor who will assess your quality management system and issue a certificate if it meets the requirements of ISO 9001:2008. In choosing a registrar you should consider their industry experience, geographic coverage, price and service level offered. The key is to find a registrar who can meet your requirements. For further information regarding national accredited certification bodies, please visit

Pre-assessment by your registrar normally takes place about 6 weeks before registration. The purpose of the pre-assessment audit is to identify areas where you may not be operating in accordance with the standard. This allows you to correct any deficiencies before registration.

Prior to registration, you should arrange an initial assessment with your registrar. At this point the registrar will review your quality management system (by interviewing staff, observing activities and checking records) to decide whether you should be recommended for registration.


Once you have achieved certification, you can begin to communicate your success and promote your business. To maintain registration, you need must be able to demonstrate that your quality management system continually improves.

To learn more about free online ISO 9001 training please visit ISO 9001 Checklist: