ISO 9001 Quality Management Systems BSI Group

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taking steps to,improving your,internal auditing . ISO 9001 Tips for Internal Auditing, If you are developing or modifying your internal Audits should be carried out to look for ar . audit programme for ISO 9001 we offer these eas for improvement and best practice They. tips for auditing to the standard But first what should not be adversarial or confrontational . is an audit and why do them , Internal audits should be formal planned . According to ISO 9000 the Fundamentals and and organized They are conducted in an. Vocabulary standard an audit is impartial and objective manner following an. agreed scope and procedures Audits are used, A systematic independent and documented. to gather facts and determine the degree to,process for obtaining audit evidence and evaluat .
which requirements are being met , ing it objectively to determine the extent to which. audit criteria are fulfilled In other words mak Using the tips in this booklet should help you. ing sure that what is going on in practice is in achieve these audit objectives . line with policies processes and procedures ,Internal Auditors need to be competent. ISO 19011 defines an auditor as a person with structive manner If the organizational culture. the competence to conduct an audit Compe is correct and management commitment is. tence is further defined as the demonstrated given to undertake effective internal auditing . ability to apply knowledge and skills the benefits gained are unlimited Remember . an auditor must be impartial and objective and,New internal auditors should attend an internal. cannot audit their own work ,auditor course to learn good practice and how. to interpret and apply ISO 9001 requirements ,The internal auditor course explains the con .
cepts and terms of ISO 9001 to ensure consist ,ency in the application of its requirements You. will need evidence your auditors are qualified ,remember to keep records of their training. along with their required education skills and,experience It is also important to educate all. staff about the benefits of internal auditing and,about the significant impact it can have on the. organization when used in a positive and con , Review your Internal Audit procedure.
ISO 9001 explains what is required for your internal audit. procedure , The standard spells out that the procedure As well as meeting the conformity require . must define responsibilities and requirements ments of ISO 9001 much value can be added. for to an organization by making use of internal, audits to gather other valuable information. Planning audits Conducting audits, during the audit process Much can be learned. Reporting results Maintaining records about the overall performance of an organiza . tion by simply communicating with people,Prior audit results should be considered when. on other issues and ideas The message is not,planning the audit programme in addition to.
to simply limit internal audits to conformity,considering the status and importance of the. issues ,areas to be audited ie some areas may require. greater attention than others depending on There is a standard for Management Systems. how important they are to the organization Auditing ISO 19011 2002 Any organization. contemplating or conducting audits should, obtain this invaluable standard . using the 8 Management,Principles as a stamp of,continual improvement . Conduct your audits to the eight management,principles of ISO 9001.
The management principles are the foundation of the ISO. 9000 series of standards As such they provide a strategic. approach to how ISO 9001 is applied , All the clauses of ISO 9001 can be linked to the The Eight Management Principles are . principles Customer Focus, Leadership,Conducting internal audits using the manage . Involvement of People,ment principles will give an organization a. Process Approach,more toplevel approach this will provide senior. Systematic Approach to Management,management with a better insight into how.
Continual Improvement,well their organization is operating and where. Factual Approach to Decision Making,the more subtle areas for improvement may lie . Mutually Beneficial Supplier Relationships, Adopt a process approach to internal audits. The intent of ISO 9001 is to,encourage the adoption of the. process approach to manage an,organization As a result internal.
audits of your management systems ,need to adopt a similar approach . An activity that uses resources to transform For example auditing to the requirements for. inputs to outputs can be considered a process quality objectives requires considering clause. The output from one process may become the 5 4 1 quality objectives in addition to related. input to the next process To function well or clauses that refer to quality objectives such as. ganizations must identify and manage numer 5 6 1 Management Review and 8 5 1 Continual. ous interacting processes Improvement , The Process Approach involves the systematic Therefore to see if quality objectives have been. identification and management of these pro planned implemented monitored and im . cess interactions within an organization proved an audit will need to consider require . ments from multiple clauses ,For effective audits you have to understand the. process nature of the system and follow the,appropriate audit trails . Use of an electronic version of the standard Audit planning should identify process interac . can help identify important cross references tions and ensure these audit trails are followed. for more effective evaluations of your quality,ISO 9001 requires your processes to be identi .
management system ,fied 4 1 a and their sequence and interaction. to be determined 4 1 b Clause 4 2 2 c states,that these process interactions must be de . scribed in your quality manual , Learn to plan and perform your. own audit with BSI Training , View auditing courses. http www bsigroup ae en training , Evaluate the effectiveness of the system.
Auditors often struggle with or overlook assessing how well. the system has performed , Every audit situation should be examined from 3 Effectiveness Have you done it well . three perspectives , Do the results of the process indicate the. 1 Intent Have you said what you do desired outcomes have been achieved ISO. 9000 defines effectiveness as the extent, Do the defined or documented processes. to which planned activities are realized, adequately express your approach . and planned results are achieved In other, 2 Implementation Have you done what you words to judge effectiveness you look not.
said only at the conformance of a process but, also at its results compared to its objectives . Do the observed and recorded practices, show conformance with the stated intent . do not be afraid to,challenge and probe or,follow an audit trail to. see where it leads you , Remind Auditors how to verify conformity. Internal auditors often only rely upon documents and records. as evidence of process conformity and don t adequately. interview personnel and observe operations , After determining the audit criteria require 3 Review documents and records.
ments objective evidence should be gathered, Ask the persons being interviewed what docu . in four different ways for more complete and, ments and records are used in their work . effective audits , You may find documents records and forms. 1 Interview personnel beyond those identified in your audit planning . See if the documents are adequately controlled,Based on your audit planning and checklist. and available for use Refer to the documents,questions ask employees about their jobs .
and records to help you follow the work being,Listen to what they tell you and see if their. shown Verify the records described in the,explanations match the defined process Use. documents are being properly collected and,open ended questions to elicit more complete. controlled Also challenge the need for docu ,responses Do not be afraid to challenge and. mentation and always try to find better and,probe or follow an audit trail to see where it.
more effective ways of managing and control ,leads you Talking to people is the best possible. ling the processes being audited ,way to test their understanding and knowledge. about the processes and sub processes in 4 Examine records. which they are involved , Auditors cannot interview every person ob . 2 Observe operations serve every activity look at every document . and evaluate every record You should strive,Aid your own understanding of the process. for representative samples that allow you to,by watching it being performed See if the.
make informed judgements Since audits are,observed practices comply with requirements . limited due to sampling non conformities may,You will discover the persons being interviewed. continue to exist in the system beyond those,are more relaxed when you allow them to dem . identified and reported However with time and,onstrate their jobs In addition internal audits. well planned audits you can feel confident that,will be less disruptive since work is actually.
you have thoroughly reviewed your system and,being completed . its performance , Improve your current Internal Audit practices. Organizations with an existing internal audit programme. should review their results to ensure audit objectives are being. met and to identify opportunities for improvement . Ask yourself the following questions Have training sessions with your auditors to. go over previously written non conformity, Are our internal audit plans and schedules. statements and identify what clause references,being met . have been used for ISO 9001 Suggest to your, Do our plans focus on customer satisfac .
auditors that they follow these 6 C s for well,tion . written statements , How well are departments meeting their. requirements Complete include the specified require . Are we identifying the root cause of the ment and objective evidence. problem Correct take care to accurately and cor , Are our internal auditors writing good audit rectly convey the information. reports Concise express the statement as briefly, Are non conformities written clearly and and succinctly as possible. simply to be easily understood Clear use easy to understand words and. Are we giving compliments for good prac terminology. tices Categorized if used identify its severity, Are we identifying opportunities for im major minor or concern .
provement Confirmed verify the information needed, How long is it taking to close audit correc for corrective action is stated. tive actions , Of course internal auditors must prepare. What feedback are we receiving about our, reports as prescribed by their own audit pro . audits , cedure Remind them to audit for conformity. Are we looking at the whole organization as, not non conformity and to share some posi .
one entity , tive comments in their reports to encourage. Use the update of your internal audit pro improved conformance . cess as an opportunity to take corrective and,preventive actions and find the root cause of. the problem Look at past audit reports to see,if you are satisfied with current practices and. auditor consistency , Schedule your Internal Audits differently. The purpose of an internal audit programme schedule is to. plan the type and number of audits as well as to identify and. provide the necessary resources to conduct them , The Plan Do Check Act model can be applied to assess department interfaces Audits can also.
the management of internal audits be scheduled for a specific contract or project. to only assess the involved areas ,Plan Define the audit programme. Remember that key business processes tend,Do Implement the audit programme. to flow across the organization and hence may, Check Review the audit programme touch on many activities and departments . Other processes may flow more vertically,Act Improve the audit programme. within the organization For this reason alone it, The auditors must understand how the clause is very important to understand the interfaces.
structure and requirements will affect their within your business processes and sub pro . audit plans Instead of auditing by clause the cesses and plan your audits accordingly . organization may decide to audit by processes, Remember that ISO 9001 requires audits to. and across the organization , be planned based on the status prior audit. An earlier tip described the need to look at results and importance of the areas being au . requirements from multiple clauses to fully as dited Internal audits of critical areas or poorly. sess a particular activity Organizing audits by performing ones may be scheduled more. clause may limit the evaluation to just a subset frequently . of the planning doing checking and acting, If the scope of your system has changed based. requirements for a process , on permissible exclusions see clause 1 2 or. Another method of auditing is to trace custom outsourcing see clause 4 1 make sure your. er requirements as an input and the delivery of internal audits are scheduled an. ISO 9001 Tips for Internal Auditing Internal Auditors need to be competent If you are developing or modifying your internal audit programme for ISO 9001 we offer these tips for auditing to the standard But first what is an audit and why do them According to ISO 9000 the Fundamentals and Vocabulary standard an audit is

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