The Audit Report In ISO 14001

Once agreement has been reached, both among the audit team and with the auditee, it is time to prepare the audit report. Note that ISO 14001 does not require a documented audit report. However, it is very difficult to verify that the auditing requirement has been satisfied without a supporting record, which is typically a documented audit report.

The audit report is prepared by the lead auditor, although he or she may have other team members prepare portions. The content of the audit report is determined by the audit plan and the organization’s EMS audit procedures. Having completed the examination phase and evaluated the collected data observations, etc., the assessor is faced with the problem of documenting any deficiencies he or she may have found. There are many different methods of documenting deficiencies, ranging from inclusion in the body of the audit report to producing non-conformance notes or corrective action requests. Irrespective of which method is adopted, the basic principles to be followed are similar. ISO 14001 does not dictate what should be in the report, and ISO 14011 only suggests contents. ISO 14011 indicates that at a minimum, the findings need to be in the report. The findings appear as a statement that the EMS is or is not in conformance with the criteria, and states what the criteria and supporting evidence are for the statement. ISO 14011 also lists other optional items to include such as:

• the identification of the organization audited and of the client;

• the agreed objectives, scope and plan of the audit;

• the agreed criteria, including a list of reference documents against which the audit was conducted;

• the period covered by the audit and the date(s) the audit was conducted;

• the identification of the auditee’s representatives participating in the audit;

• the identification of the audit team members;

• a statement of the confidential nature of the contents;

• the distribution list for the audit report;

• a summary of the audit process including any obstacles encountered;

• audit conclusions such as:

- EMS conformance to the EMS audit criteria;

- whether the system is properly implemented and maintained;

- whether the internal management review process is able to ensure the continuing suitability and effectiveness of the EMS.

The format of such reports can vary considerably and may range from completion of a simple pro-forma to expansive documents describing all aspects of the audit performance and findings. However, irrespective of the style and format, the audit report should cover the key topics already identified as being essential for discussion and presentation at the opening and closing meetings. In constructing the report two specific objectives must be borne in mind.

(1) The report has to provide objective evidence of effective implementation of the audit procedure.

(2) The report has to allow for corrective action to be addressed and that the follow-up requirements can be established and initiated.

Where there are non-conformances, there are various options regarding deficiency reporting. One option is to describe each of the deficiencies identified in the main body of the report along with any supporting evidence, and if requested, corresponding recommendations. Although this may result in a comprehensive report of audit findings, it has the disadvantage that the individual

deficiencies are often difficult to locate, particularly when trying to monitor follow-up actions.

This can be partly overcome by writing separate corrective action requests for this purpose. A useful alternative that is less time consuming is to restrict the description of deficiencies in the body of the report to general summaries only. Details of deficiencies can then be included in non-conformance notes. Ideally, the non-conformance note should also provide space for agreeing corrective actions and recording subsequent monitoring of that corrective action. In this manner, any duplication of effort with respect to audit reporting is minimized, thus producing a more easily managed system. It is important that however non-conformances are handled, it be constant with the EMS correction action process (ISO 14001, Section 4.5.2).

Before considering the steps in preparing the non-conformance note we must be clear about their purpose.

• To convey to the auditee the findings in a clear and accurate manner so that they know what to do next.

• To advise the EMS personnel or other auditors what you have found so that he can follow it up.

• To present a record that can be reviewed remotely from the scene and be understood.

All non-conformance notes must contain certain basic information.

• The physical area being audited.

- Failure to record this often results in great confusion 3 to 6 months later when a follow up visit is carried out to review corrective action implementation.

• The specific clause(s) of the assessment standard(s) against which the non-conformance is issued.

- If the auditor is unable to readily identify the applicable section of the EMS manual or the procedure against which to issue the non-conformance, he must question whether or not he is justified in writing the non-conformance. It is good practice to re-read the

requirements of the relevant system documentation to confirm that these can be interpreted as supporting the non-conformance. If they do not, then the non-conformance cannot be issued.

• The detailed nature of the non-conformance including the specific identity of documents/procedures/material, etc.

Earlier we considered the requirements for recording observations during the assessment and emphasized the need for them to be factual and to contain objective evidence that the system requirements were not being satisfied. Although this appears to be fairly straightforward, in practice this is often not the case. It is not unusual for inexperienced auditors to identify a deficiency only to fail to communicate the findings in a manner that facilitates implementation of the appropriate corrective action. The non-conformance note, while not being over long, must contain sufficient information to enable a person not present during the audit to be able to gauge the seriousness or otherwise of the observation.

The use of descriptive terms such as extensive, several, isolated, etc… is essential to communicate accurately the nature and extent of the deficiency, but care must be taken to ensure that their use does not result in a lack of objectivity; e.g., the term extensive can only be included if there is irrefutable evidence to justify its use. The auditor must also take care to ensure that the description is not only accurate but it is also fair, e.g., a statement that 50% of manifests were incorrectly signed may be accurate but is hardly fair if only two manifests were sampled.

Having documented the nature of the deficiency, some audit systems require the auditor to grade the deficiency or non-conformance, e.g., major and minor. It is not intended to discuss grading systems in detail since there are many potential variations that companies may wish to adopt. Irrespective of what system is being adopted, the auditor must ensure that the grading given and

the text describing the deficiency are completely compatible.

Distribution of the audit report and nature of documentation are decided between the auditor and auditee, although this too is usually addressed in the audit plan. An audit is considered successful when the auditee and client feel that they have useful, constructive feedback that allows them to improve the system.

ISO 9001 Documents Control – Elements and Requirements

The ISO 9001 standard is caring for us. It cares for us from several angles. One of these cares regards our documentation. The standard requires that we will document by all means.
But it also cares that we won’t get confused and mix up different documents from different sources. Therefore it requires all documents to be controlled. This is not a recommendation but a requirement. You must control your documents. In order to achieve documents control you must maintain a method. This method must be one of the organizations quality procedures and it should be called “Documents Control”. In this procedure you must refer to the next line of issues.

Types of records
At first, you must define what documents this procedure would include. Documents can be working procedures, diagrams, technical specifications, price quotes etc. In order not to “swirl” around too many documents, let’s make it clear. Let’s define what a document is: Communication of information, evidence for correspondence, sharing of any kind of knowledge, approved documents. Someone within the organization must supervise all documents and see that they are suitable for working before they are released.The reason is to prevent any faults where unsuitable documents are being used or information that is classified is handed to wrong bodies. It is required to define for whom it is authorized and when must he approve any document. Who is responsible? The same one who is responsible for the information documented. It must be part of his job description. There are situations that more than one function would be needed to approve one document. It happens when more than one process is documented on one document.

Updated documents
This requirement assures that always the last version is the version in use – and not an older. Therefore you must define a method for maintaining updated version and elimination of older versions. How would one know what is the last version? Usually organizations manage a list of editions and updates for documents. You can manage the document itself. But most important, it is required to indicate the document itself as the last edition. This way, any employee that would use the document, would be sure that he holds the last edition. Of course, don’t forget to document the method.It is also required to define what to do with the old versions that are now not updated. How do you handle them? Are they to be destroyed, archived etc. Managing editions must include: Date of last update, The reason for the update, The function who demanded the update, The function that authorized the update. Although the ISO 9001 standard doesn’t require these requirements specifically, it would help you to achieve its basic requirements. Of course you would use what is suitable for your organization. Today there is a lot of document management softwares. These software, naturally qualify for the standard requirements but it is recommended to review anyone before purchasing.

Availability and distribution of documents
This is an un separated part of the last requirement. Defining the availability and distribution of documents must include the following:User authorization – to which it is authorized to use the document, the location of the document – where must the document be kept before and after use. Most of today’s process management systems (such as ERP or CRM systems) provide documents control relevant to the process they handle. They present the user with a screen (a screen on a computer system is a document like any other document) with defined information to input. Most of these systems also has authorization module installed. But when systems like the ones mentioned do not exist in the organization, it must provide with his employees the relevant updated documents. That means the latest editions. In order to ensure that, the standard require a documented method. How to obtain that? Well, it depends on your organization and his substructures.

Identification of documents
Any document (internal or external) must be identified somehow. Any internal document must have a name, serial number, catalogue number or whatever. Somehow to define it. The ISO 9001 standard requires that you maintain a method to achieve identification. The identification must include the numbering, coding or however you decided to identify it. But it is required to document the method. You must also include location of documents. How one can trace the document. for example customer’s files are scanned to the computer or stored in some closet. The final purpose of all this is to achieve control of the documents – any employee, once he looks at a document or trying to trace a document, would know where to approach: a department, a process, some function or any kind of identification relevant to your organization. If we look again at process management systems, then it is much simpler. Any document in those systems is identified by a number of some kind, produced by the system. The number is given according to some internal method. In this case you must not document this method but mention it in the procedure that these specific documents are managed. In case there are documents that are manually managed you must document the method. All this also applies for external documents. Any documentation that arrives from outside (with presumption that it is a document as defined) is included in the ISO 9001 standard requirement. In this case you must specify what is to do with these documents and where one can trace them in the hour of need. For example, where to file the documents. Again, you define the method according to your organization’s nature.

Documents removal
You must define a method for documents removal for any reason: un updated, out of use, etc. the method must include what is it to do with the document and who is responsible, once it is out of use. For example, removing old documents from the organization’s server for no further use or removing old forms from the offices that no one would use them again. Some of this things sound trivial and they are, but still this is a ISO 9001 standard requirement..

Summary:
The ISO 9001 standard requires that we document all sorts of our documents. It also requires that we would not confuse all kinds of documents from different sources. Therefore we must define a method for documents control. This is not a recommendation but a requirement.
The method must be presented as a documented procedure.
The documented procedure would be called “Documents control”.
You must include a definition of documents within the method – what is a document.
All documents must be approved before use. The purpose is to verify that the documents are suitable for work.
All documents must be updated. You must define a method to ensure the use of updated documents only. The method should include management documents editions and documents indications.
All documents must be identified. The organization must specify a method for documents identification. The purpose is that any employee would know which document he holds or where to trace it.
It is also required to manage availability and distribution of documents. You must verify that the documents that are distributed to the employees are the correct ones.
You must define a method for documents removal. When and why to remove documents and in whose responsibility.

The Difference Between Compliance Auditing and Systems Auditing In ISO 14001

The Difference Between Compliance Auditing and Systems Auditing In ISO 14001

Often however, there is confusion between regulatory compliance auditing and EMS auditing. This is because there are many elements of regulatory compliance that overlap with the EMS. Recall that the criteria in a compliance audit are the applicable regulations, whereas the criteria in an EMS audit would be ISO 14001. But does not ISO 14001 address compliance? The answer is yes, but from a system standpoint, not performance.

In other words, the standard requires that certain procedures exist regarding identification of legal and other requirements, that periodic compliance assessments be performed, that legal requirements be considered in setting objectives and targets, and that there be a commitment to compliance. However, actually being in compliance is a performance issue, and out of the purview of ISO 14001.

Of course, a system that is constantly out of compliance or does not identify and initiate action to correct noncompliances, will eventually fail due to system failure. The subtle, yet important point is that during an EMS audit, identified regulatory noncompliances are relevant only to the extent that they reflect a potential system problem. The finding therefore is not that the site is out of compliance with a given regulation, but that the noncompliance means some EMS element is not conformed to. For example, a regulatory noncompliance can be related to a problem with training, recordkeeping, or monitoring and measurement.

The EMS auditor is not to do a compliance audit as part of the EMS audit. If, as part of the statistical sampling to verify EMS element requirements, the auditor identifies a regulatory noncompliance, he or she treats it as any other evidence.

This point has been difficult to accept, especially in U.S. industry because of our long history of regulatory enforcement. The EMS auditor needs to constantly remember that compliance auditing is being done separately as part of the EMS requirements itself (4.5.1, paragraph 3) and to stay focused on the criteria at hand – ISO 14001 and the site’s EMS. There may be legal requirements regarding noncompliances encountered during the EMS audit, but this should be decided and addressed in the audit plan.

In summary, the goal of the compliance audit is to verify compliance with regulations, whereas the EMS audit’s goal is to verify that the EMS conforms to planned arrangements, including ISO 14001.

The Audit Plan In ISO 14001

The Audit Plan In ISO 14001

The audit plan is the document that establishes the scope, objectives and criteria, and schedule of the audit. It also goes into specific details on what areas will be audited, when, and by whom.

Other details such as which checklists may be used, how the report is to be formatted and distributed, and how meetings will be conducted can also be included in the plan. In essence, the audit plan reflects the programs, procedures, and methodologies of the EMS audit process, in accordance with element 4.5.4 of ISO 14001. These planning items are usually described in the procedures for element 4.5.4 and do not need to be re-created every time an audit occurs. For example, it can be determined that the entire EMS will be audited once per year, but in four partial events. This schedule then becomes part of the procedure.

The audit scope defines what part of the organization will be audited. Obviously, this should coincide with the scope of the EMS itself, and is usually the site in question. If the full EMS audit is divided in smaller segments conducted throughout the year, then the scope of any given segment is what portion of the organization will be audited at that time. Typically, an organization will create a chart or matrix showing the various divisions of the site or activity and when it will be audited. A typical entry may show the maintenance department being audited in the first quarter and production in the fourth quarter, for example.

Also noted in the audit plan is the audit objective(s). The audit objective describes why an audit is being conducted. Typically the reason is to conform to ISO 14001 4.5.4 requiring that the EMS be periodically evaluated. Another reason is demonstrate conformance to others.

Although EMS audits may appear in their own right to be “good practice”, it is essential that auditors have a clear concept of what the general objectives of such audits are.

The definition of EMS audits highlights the need to confirm conformance with planned arrangements and to ensure that these arrangements are effective and suitable to achieve objectives. ISO 14011 expands this to form a number of general objectives for any type of EMS audit. Audits should be carried out to:

- determine conformance of an auditee’s EMS with the EMS audit criteria

- determine whether the auditee’s EMS has been properly implemented and maintained

- to identify areas of potential improvement in the auditee’s EMS

- assess the ability of the internal management review process to ensure the continuing suitability and effectiveness of the EMS

- evaluate the EMS of an organization where there is a desire to establish a contractual relationship, such as with a potential supplier or a joint-venture partner.

Using this definition and sources such as ISO 14010 and 14011, the following statement of the specific objectives of an internal EMS audit has been developed. Internal audits should be carried out to ensure that:

- The EMS continues to meet the needs of the business

- The necessary documented procedures that exist are practical and satisfy any specified requirements

- The necessary documented procedures are understood and followed by appropriately trained personnel

- Areas of conformity and nonconformity with respect to implementation of the EMS system are identified and corrective action implemented

- The effectiveness of the system in meeting the EMS objectives is determined and that a basis is created for identifying opportunities and initiating actions to improve the EMS system

The above objectives imply that internal audits are concerned with more than just the policing of an established system. If auditors and managers are to remain committed to the implementation of the EMS system, it must also contribute to the process of developing that system and seeking improvements.

Internal auditing must not be carried out in a way that results in the transfer of responsibility from the operating staff to the auditor or auditing organization, i.e., at all times the individual or department must retain and accept responsibility for his or her role in the EMS.

If the internal audit process is not designed and implemented to meet the objectives and to avoid the pitfalls described above, it is unlikely that the top management commitment essential to an effective audit process will be readily forthcoming.

The audit criteria define what the “rules” are. For the sake of this guide, the criteria will be the elements of ISO 14001. A subtle point to note however is that the site’s EMS requirements are also part of the criteria. This means that in addition to responding to the requirements of ISO 14001, the EMS must also respond to “planned arrangements”, or what the organization said it was going to do. In audits, a common response is “the standard does not require such and such detail”. However, if the site’s procedure does require some specific response, then it becomes part of the criteria. In essence, the auditors are verifying the system not only to ISO 14001, but also to what the EMS documentation states.

How the audit is divided and scheduled throughout the time interval is up to the organization and will be a function of minimizing disruption to site operations and resource needs. The only requirement is that the full audit be completed within the frequency established in the procedures under 14001, 4.5.4. One of the requirements regarding frequency is that how often an area is audited be in part a function of prior audit results. This means that the planned frequency may change with time based on what auditors are finding.

How long each audit takes again is a function of resource needs and operations. It is recommended, however, that any individual audit event not be protracted out over long time periods. The longer a task takes, the easier it is to get distracted and lose focus.

Much has been written about how to audit a system if the full audit is not completed in one event. Unlike other audits, including quality audits, where a more segmented approach can be taken, ISO 14001 systems tend to be very sensitive to consistency. For example, the emergency planning process may conform to the standard element 4.4.7 in that a procedure exists; however,

it may not reflect the potential significant impacts identified in element 4.3.1. Had the audit team focused only on element 4.4.7, they would not have noted the apparent nonconformance.

When developing an audit plan, it is wise to consider the three C’s of ISO 14001 EMS auditing:

Conformance, Consistency, and Continual Improvement. Conformance relates to addressing each of the requirements of the standard, i.e., the “shalls”. Consistency relates to how well each procedure or process of the EMS relates to the others. In other words, do objectives and targets reflect the policy commitments? Are personnel trained on the correct legal and other requirements? Finally, Continual Improvement requires that the system lead to improvements in the system itself as well as with environmental performance. A system that has all the prerequisite procedures, but remains static, is not in conformance.

The concepts of consistency and continual improvement are more subtle because they are through-running threads of the standard and not always a definitive statement. The required commitment to continual improvement and the text of the standard itself however do go some way towards reminding the auditor.

With the three C’s in mind, one now sees why it is best to audit all applicable elements of the standard in a given area at one time, rather that tracing any one standard element throughout various areas. For example, during the first quarter audit event, Company X may audit all of ISO 14001 in maintenance. During the second quarter event, all of ISO 14001 will be audited in the production area, and so on. This is in contrast to auditing only a certain element, i.e., corrective action, across several site areas in one audit event.

Now we know what is being audited, when it is being audited, and to what “rules” it is being audited. The remainder of the plan is simply then the logistics of the audit. The logistics include identification of team members, noting if and what checklists will be used, schedule and formats of meeting to name a few. Below is the full list of recommended audit plan elements as described in ISO 14011:

• the audit objectives and scope;

• the audit criteria;

• identification of the auditee’s organizational and functional units to be audited;

• identification of the functions and/or individuals within the auditee’s organization having significant direct responsibilities regarding the auditee’s EMS;

• identification of those elements of the auditee’s EMS that are of high audit priority;

• the procedures for auditing the auditee’s EMS elements as appropriate for the auditee’s organization;

• the working and reporting languages of the audit;

• identification of reference documents;

• the expected time and duration for major audit activities;

• the dates and places where the audit is to be conducted;

• identification of audit team members;

• the schedule of meetings to be held with the auditee’s management;

• confidentiality requirements;

• report content and format, expected date of issue and distribution of the audit report;

• document retention requirements.

If the internal audit is to proceed smoothly, it is helpful for the internal auditor to establish a dialogue prior to the actual audit with the person responsible for the area being audited. This dialogue may be conducted by memo, telephone, or during a formal or informal meeting. The main factor that should influence the auditor’s choice of method for setting up this dialogue should be the organization’s normal style or culture. Irrespective of the method of communication the auditor adopts, the following points should be established:

• The overall duration of the proposed audit

• The starting location and time

• The proposed scope and areas to be covered by the audit

• A timetable for approximate progress of the audit where applicable, e.g., if a number of different departments or geographical areas are to be included in the scope of the audit

• The arrangements for any close out meeting where the findings of the audit can be agreed and corrective action requirements discussed

• The personnel liable to be involved at each stage of the audit

If an auditor does not give sufficient attention to ensuring that clear agreement is reached with respect to the above points, the potential for misunderstandings that can affect the conduct of the audit is greatly increased. However, these initial communications with the personnel of the area being audited not only affect the “tone” of the forthcoming audit, but they can significantly influence the commitment and level of cooperation shown by that area throughout the audit process and for many subsequent audits.

Prior to commencing the audit, but once the plan is prepared, the audit team assignments are made, and working documents are defined. Working documents are those documents such as observation logs and checklists that are used during the audit to collect evidence, but are not necessarily retained as records. In other words, they may be discarded after the audit is complete and the report prepared.

Of these, only the checklist should require an input at this stage from the auditor. However, before compiling a checklist, the auditor must determine if the function and format of the checklist are prescribed by the audit procedure or whether personal preference can be exercised.

The format of the checklist may vary considerably, depending on whether it is intended to act as an aide or as a part of audit records showing the scope and conduct of the audit. The former may consist only of general topics to be covered during the audit, whereas the latter may be an extensive and detailed questionnaire on which details of sampling and answers to the questions are to be recorded.

The need for checklists and the type appropriate will vary according to other experience of the auditors and the culture of the company. It is recommended that for purposes of internal audits, checklists, even if limited, should always be developed. However, standard questionnaire type checklists not prepared by the auditor that must be slavishly followed and completed, should be

avoided. This latter type is likely to result in an unnecessary restriction in the scope of the audit and a stifling of auditor initiative.

Although an auditor should always work within the scope defined for the audit, the working documents must not be designed so that they restrict additional audit activities or investigations that may become necessary as a result of information gained during the audit. There are differences of opinion over whether it is preferable to create the checklist anew or whether a previously developed checklist can be used. Although the former is desirable in principle, it is not always practical in terms of the best use of the resources available. The best compromise is to utilize whatever available checklists are already in existence, but to review these critically

against the relevant documents previously identified. In this way, time can be saved in using them as a foundation without detracting from effectiveness.

The Audit Report In ISO 14001

The Audit Report In ISO 14001

Once agreement has been reached, both among the audit team and with the auditee, it is time to prepare the audit report. Note that ISO 14001 does not require a documented audit report. However, it is very difficult to verify that the auditing requirement has been satisfied without a supporting record, which is typically a documented audit report.

The audit report is prepared by the lead auditor, although he or she may have other team members prepare portions. The content of the audit report is determined by the audit plan and the organization’s EMS audit procedures. Having completed the examination phase and evaluated the collected data observations, etc., the assessor is faced with the problem of documenting any deficiencies he or she may have found. There are many different methods of documenting deficiencies, ranging from inclusion in the body of the audit report to producing non-conformance notes or corrective action requests. Irrespective of which method is adopted, the basic principles to be followed are similar. ISO 14001 does not dictate what should be in the report, and ISO 14011 only suggests contents. ISO 14011 indicates that at a minimum, the findings need to be in the report. The findings appear as a statement that the EMS is or is not in conformance with the criteria, and states what the criteria and supporting evidence are for the statement. ISO 14011 also lists other optional items to include such as:

• the identification of the organization audited and of the client;

• the agreed objectives, scope and plan of the audit;

• the agreed criteria, including a list of reference documents against which the audit was conducted;

• the period covered by the audit and the date(s) the audit was conducted;

• the identification of the auditee’s representatives participating in the audit;

• the identification of the audit team members;

• a statement of the confidential nature of the contents;

• the distribution list for the audit report;

• a summary of the audit process including any obstacles encountered;

• audit conclusions such as:

- EMS conformance to the EMS audit criteria;

- whether the system is properly implemented and maintained;

- whether the internal management review process is able to ensure the continuing suitability and effectiveness of the EMS.

The format of such reports can vary considerably and may range from completion of a simple pro-forma to expansive documents describing all aspects of the audit performance and findings. However, irrespective of the style and format, the audit report should cover the key topics already identified as being essential for discussion and presentation at the opening and closing meetings. In constructing the report two specific objectives must be borne in mind.

(1) The report has to provide objective evidence of effective implementation of the audit procedure.

(2) The report has to allow for corrective action to be addressed and that the follow-up requirements can be established and initiated.

Where there are non-conformances, there are various options regarding deficiency reporting. One option is to describe each of the deficiencies identified in the main body of the report along with any supporting evidence, and if requested, corresponding recommendations. Although this may result in a comprehensive report of audit findings, it has the disadvantage that the individual

deficiencies are often difficult to locate, particularly when trying to monitor follow-up actions.

This can be partly overcome by writing separate corrective action requests for this purpose. A useful alternative that is less time consuming is to restrict the description of deficiencies in the body of the report to general summaries only. Details of deficiencies can then be included in non-conformance notes. Ideally, the non-conformance note should also provide space for agreeing corrective actions and recording subsequent monitoring of that corrective action. In this manner, any duplication of effort with respect to audit reporting is minimized, thus producing a more easily managed system. It is important that however non-conformances are handled, it be constant with the EMS correction action process (ISO 14001, Section 4.5.2).

Before considering the steps in preparing the non-conformance note we must be clear about their purpose.

• To convey to the auditee the findings in a clear and accurate manner so that they know what to do next.

• To advise the EMS personnel or other auditors what you have found so that he can follow it up.

• To present a record that can be reviewed remotely from the scene and be understood.

All non-conformance notes must contain certain basic information.

• The physical area being audited.

- Failure to record this often results in great confusion 3 to 6 months later when a follow up visit is carried out to review corrective action implementation.

• The specific clause(s) of the assessment standard(s) against which the non-conformance is issued.

- If the auditor is unable to readily identify the applicable section of the EMS manual or the procedure against which to issue the non-conformance, he must question whether or not he is justified in writing the non-conformance. It is good practice to re-read the

requirements of the relevant system documentation to confirm that these can be interpreted as supporting the non-conformance. If they do not, then the non-conformance cannot be issued.

• The detailed nature of the non-conformance including the specific identity of documents/procedures/material, etc.

Earlier we considered the requirements for recording observations during the assessment and emphasized the need for them to be factual and to contain objective evidence that the system requirements were not being satisfied. Although this appears to be fairly straightforward, in practice this is often not the case. It is not unusual for inexperienced auditors to identify a deficiency only to fail to communicate the findings in a manner that facilitates implementation of the appropriate corrective action. The non-conformance note, while not being over long, must contain sufficient information to enable a person not present during the audit to be able to gauge the seriousness or otherwise of the observation.

The use of descriptive terms such as extensive, several, isolated, etc… is essential to communicate accurately the nature and extent of the deficiency, but care must be taken to ensure that their use does not result in a lack of objectivity; e.g., the term extensive can only be included if there is irrefutable evidence to justify its use. The auditor must also take care to ensure that the description is not only accurate but it is also fair, e.g., a statement that 50% of manifests were incorrectly signed may be accurate but is hardly fair if only two manifests were sampled.

Having documented the nature of the deficiency, some audit systems require the auditor to grade the deficiency or non-conformance, e.g., major and minor. It is not intended to discuss grading systems in detail since there are many potential variations that companies may wish to adopt. Irrespective of what system is being adopted, the auditor must ensure that the grading given and

the text describing the deficiency are completely compatible.

Distribution of the audit report and nature of documentation are decided between the auditor and auditee, although this too is usually addressed in the audit plan. An audit is considered successful when the auditee and client feel that they have useful, constructive feedback that allows them to improve the system.

How Quality Management System is implemented?

How Quality Management System is implemented?

The terms ‘establish’, ‘document’, ‘implement’, ‘maintain’ and ‘improve’ are used in the ISO 9000 Standard as though this is a sequence of activities when in reality, in order to establish a system it has to be put in place and putting a system in place requires two separate actions:
- Design the Quality Management System using a process that transforms the system requirements into specific characteristics that results in a clear definition of all the processes that meet the system requirements.
- Construct the system using a process that documents, installs, commissions and integrates the processes to deliver the required business outputs.
The way in which these phases of quality system development are related is
illustrated in the management system process model shown in Figure 4.1. This diagram has some important features. Note that the design input to the system comprises internal and external requirements. On the right side there are four improvement routes:
- Improvements in conformity during operation of the system arise through
enforcing policy and practices – doing what you say you do
- Improvements in conformity during system construction arise through
enforcing policy and design rules on the system – reworking the system to
comply with the established policies and objectives
- Improvements in efficiency during system construction arise through
finding better ways of implementing the system design – shorter, less
wasteful routines, less complexity, lower skill levels, fewer resources
- Improvements in effectiveness arise as a result of identifying different
policies and objectives – higher targets, new objectives, new requirements,
regulations, and new technologies.
As indicated above, establishing a system means designing and constructing it, which can be referred to as system development. System design is dealt with under Identifying processes. Constructing the system covers documentation, resourcing, installation, commissioning, qualification and integration.

Documenting A Quality Management System

Documenting A Quality Management System

The ISO 9000 Standards requires the organization to document a quality management system in accordance with the requirements of ISO 9001. A document (according to ISO 9000 clause 2.7.1) is information and its supporting medium. A page of printed information, a CD ROM or a computer file is a document, implying that recorded information is a document and verbal information is not a document.
Clause 4.2 requires the management system documentation to include certain types of documents and therefore does not limit the management system documentation to the types of documents listed.
As a management system is the means to achieve the organization’s objectives, and a system is a set of interrelated processes, it follows that what has to be documented are all the processes that constitute the system.
While there is a reduction in emphasis on documentation in ISO 9001:2008 compared with the 1994 version, it does not imply that organizations will need less documentation to define their management system. What it does mean is that the organization is left to decide the documentation necessary for effective operation and control of its processes. If the absence of specific documentation does not adversely affect operation and control of processes, such documentation is unnecessary.
Before ISO 9000 came along, organizations prospered without masses of
documentation and many still do. Those that have chosen not to pursue the
ISO 9000 path often only generate and maintain documents that have a useful purpose and will not produce documents just for auditors unless there is a legal requirement. Most of the documentation that is required in ISO 9000 came about from hindsight – the traditional unscientific way organizations learn and how management systems evolve.
ISO 9000 contains a list of valid reasons for why documents are necessary as below:
- To communicate requirements, intentions, instructions, methods and results effectively
- To convert solved problems into recorded knowledge so as to avoid having
to solve them repeatedly
- To provide freedom for management and staff to maximize their contribution to the business
- To free the business from reliance on particular individuals for its effectiveness
- To provide legitimacy and authority for the actions and decisions needed
- To make responsibility clear and to create the conditions for self-control
- To provide co-ordination for inter-departmental action
- To provide consistency and predictability in carrying out repetitive tasks
- To provide training and reference material for new and existing staff
- To provide evidence to those concerned of your intentions and your actions
- To provide a basis for studying existing work practices and identifying
opportunities for improvement
- To demonstrate after an incident the precautions which were taken or which should have been taken to prevent it or minimize its occurrence
If only one of these reasons make sense in a particular situation, the
information should be documented. In some organizations, they take the
view that it is important to nurture freedom, creativity and initiative and
therefore feel that documenting procedures is counterproductive. Their view is that documented procedures hold back improvement, forcing staff to follow routines without thinking and prevent innovation. While it is true that blindly enforcing procedures that reflect out-of-date practices coupled with bureaucratic change mechanisms is counter productive, it is equally shortsighted to ignore past experience, ignore decisions based on valid evidence and encourage staff to reinvent what were perfectly acceptable methods.
Question by all means, encourage staff to challenge decisions of the past, but
encourage them to put forward a case for change. That way it will cause
them to study the old methods, select the good bits and modify the parts that are no longer appropriate. It is often said that there is nothing new under the sun – just new ways of packaging the same message.