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La norme ISO 19011 v2018 qui donne les lignes directrices pour l'audit des systèmes de management
Prestataires daudit de la sécurité des systèmes dinformation
14 févr. 2013 a) L'auditeur doit maîtriser les bonnes pratiques et la méthodologie d'audit décrite dans la norme ISO. 19011 et être en mesure de réaliser des ...
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les modalites de certification iso 19011
La certification « Certification OICA Audit de Systèmes de Management iso 19011 » est soumise à des pré-requis (Formation initiale et professionnelle
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ISO/PC 302 Guidelines for auditing management systems. This third edition cancels and replaces the second edition (ISO 19011:2011)
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ISO 19011:2018 (traducción oficial). DOCUMENTO PROTEGIDO POR COPYRIGHT. © ISO 2018. Publicado en Suiza. Reservados los derechos de reproducción. Salvo
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ISO 2018. Guidelines for auditing management systems. Lignes directrices pour l'audit des systèmes de management. STANDARD. ISO. 19011. Third edition.
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ISO. 19011. Tercera edición. 2018-07. Directrices para la auditoría de los sistemas de gestión. Guidelines for auditing management systems.
Norma internacional ISO 19011
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NORME. INTERNATIONALE. ISO. 19011. Première édition. 2002-10-01. Lignes directrices pour l'audit des systèmes de management de la qualité.
Norme belge ISO 19011:2018 EN ISO 19011:2018 NBN EN ISO
NBN EN ISO 19011:2018. Lignes directrices pour l'audit des systèmes de management (ISO. 19011:2018). Valable à partir de 28-08-2018.
les-modalites-de-certification-iso-19011.pdf
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Méthodologie de laudit qualité (ISO 19011) Qualité Sécurité
Apprendre la technique de l'audit interne selon la norme ISO 19011. Lieu : Dans nos locaux de formation et/ou en entreprise. Nombre de participants :.
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INTERNATIONAL ISO STANDARD 19011
ISO 19011:2018(E) This document adopts the combined audit approach when two or more management systems of different disciplines are audited together Where these systems are integrated into a single management system the principles and processes of auditing are the same as for a combined audit (sometimes known as an integrated audit)
INTERNATIONAL ISO STANDARD 19011 - parsetrainingcom
ISO 19011:2018(E) This document adopts the combined audit approach when two or more management systems of different disciplines are audited together Where these systems are integrated into a single management system the principles and processes of auditing are the same as for a combined audit (sometimes known as an integrated audit)
ISO 19011 - 2018 MANAGEMENT SYSTEM AUDITING: WHAT’S NEW
ISO 19011:redline:2014(E) Introduction TheSince ISO 9000 andthe first ISO 14000 seriesedition of International Standards emphasize the importance of audits as a management tool for monitoring and verifying the effective implementation of an organization’s quality and/or environmental policy Audits are also an essential part of conformity
INTERNATIONAL STANDARD 19011 - iTeh Standards Store
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Sampling Plans for Quality Audits - FDAnews
ISO 19011:2018 Guidelines for Auditing Management Systems Annex A Additional guidance for auditors planning and conducting audits Annex A 6 Sampling Audit Sampling Steps Annex A 6 1 provides steps for audit sampling Establish the objectives of the sampling plan Select the population to be sampled Select the sampling method Judgement or Statistical
ISO 19011-2018 MANAGEMENT SYSTEM AUDITING: WHAT’S NEW AND
The ISO 19011 Guidelines for auditing management systems has become the widely accepted standard for auditing not only management systems but operational auditing in general
Introduction to ISO 19011 Guidelines for Auditing Management
The ISO 19011:2011 standard contains guidance on the following topics: • Principles of auditing • Managing an audit program • Audit activities • Competence and evaluation of auditors Principles of Auditing Clause 4 of ISO 19011 sets out six general principles that guide the performance of management system audits These principles are
NORMA ISO INTERNACIONAL 19011 - archivosssomacesaccom
ISO 19011 Tercera edición 2018-07 Directrices para la auditoría de los sistemas de gestión Guidelines for auditing management systems Lignes directrices pour l'audit des systèmes de management Publicado por la Secretaría Central de ISO en Ginebra Suiza como traducción oficial en español avalada por el Translation
ISO 9001 Auditing Practices Group Guidance on: Effective Use
ISO 19011:2018 Guidelines for auditing management systems provides guidelines for first second and third-party auditing of management systems The standard contains guidelines relating to managing an audit program auditing methods and auditor competence
Searches related to iso 19011 filetype:pdf
ISO 19011:2018(E) This document adopts the combined audit approach when two or more management systems of different disciplines are audited together Where these systems are integrated into a single management system the principles and processes of auditing are the same as for a combined audit (sometimes known as an integrated audit)
What are the ISO 19011 guidelines for auditing management systems?
- The ISO 19011 Guidelines for auditing management systems has become the widely accepted standard for auditing not only management systems, but operational auditing in general. The newest edition of the standard, released in July 2018, has some important changes based on the experience gained from implementation of past editions.
What is ISO 19011:2002(E) 30?
- ISO 19011:2002(E) 30 © ISO 2002 – All rights reserved ? certification/registration and accreditation requirements; ? the role of the audit process in the management of the organization to be audited; ? the level of confidence required in the audit programme; ? the complexity of the management system to be audited.
What is the ISO 19011:2002(E) PDF disclaimer?
- ISO 19011:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.
Ombu Enterprises, LLC1
Sampling Plans for
Quality Audits
Dan O'Leary CBA, CQA, CQE, CRE, SSBB, CIRM
President
Ombu Enterprises, LLC
Dan@OmbuEnterprises.com
www.OmbuEnterprises.com OMBUENTERPRISES, LLC
©2019, Ombu Enterprises, LLC
Ombu Enterprises, LLC2
Topics
Overview of a Quality Audit
ISO 19011:2018
Sampling Approaches to an Audit
Statistics of Sampling
Compliance Tests
FDA Device Inspections
Summary and Conclusions
Questions
Ombu Enterprises, LLC3
Overview of a Quality Audit
Ombu Enterprises, LLC4
Data Collection and Analysis
The auditor"s task is to:
-Collect factual audit evidence using the sampling method -Analyze that evidence -Evaluate the evidence against the audit criteria -Draw conclusions from the evaluation -Generate audit findingsOmbu Enterprises, LLC5
Audit Evidence
The auditor obtains evidence from two primary sources: -Interviews of people involved in the process -Records generated by the process Sampling methods apply to evidence obtained from recordsOmbu Enterprises, LLC6
Procedures and Records
Documented procedures, work instructions, and
drawings provide information on how to perform a process in a consistent manner.Records are a particular kind of document that provide objective evidence that activities have been performed or results have been achieved.
Ombu Enterprises, LLC7
Records
ISO 9000:2015, 3.8.10 provides a definition for a record -Recordmeans a document stating results achieved or providing evidence of activities performed. Because ISO 13485:2016 cites ISO 9000:2015 as a normative reference, this definition applies FDA QSR does not define a record, but uses the term extensivelyOmbu Enterprises, LLC8
Date, Information, and
Document Concepts
Source: ISO 9000:2015 Fig. A.11
Partial Diagram
Data (3.8.1)
Facts about an object
Information (3.8.2)
Meaningful data
Objective evidence (8.3.3)
Data supporting the existence or
verity of somethingDocument (3.8.5)
Information and the medium on
which it is recordedRecord (3.8.10)
Document stating results
achieved or providing evidence of activities performedSpecification (3.8.7)
Document stating
requirementsDocumented information
(3.8.6)Information required to be
controlled and maintained by an organization and the medium on which it is containedProject management plan
(3.8.11) Document specifying what is necessary to meet the objectives of the projectInformation system (3.8.4)
Network of communication
channels used within an organizationOmbu Enterprises, LLC9
Control of Records
Following ISO 13485:2016, clause 4.2.5, a company should control two kinds of records: -Records established to provide evidence of conformity to requirements -Records established to provide evidence of the effective operation of the quality management systemOmbu Enterprises, LLC10
Control of Records
Following ISO 13485:2016, clause 4.2.5, create documented procedures for record control including:IdentificationStorageProtection
RetentionRetrievalDisposition
Records must:
-Remain legible -Be readily identifiable -Be retrievableOmbu Enterprises, LLC11
ISO 19011:2018
Ombu Enterprises, LLC
ISO 19011:2018
ISO 19011:2018 Guidelines for Auditing ManagementSystems
Annex A Additional guidance for auditors planning and conducting auditsAnnex A.6 Sampling
12Ombu Enterprises, LLC
Audit Sampling Steps
Annex A.6.1 provides steps for audit sampling
-Establish the objectives of the sampling plan -Select the population to be sampled -Select the sampling methodJudgement or Statistical
-Determine the sample size -Conduct the sampling -Compile, evaluate, document, and report the results The report should include a description of the population, the sampling method, the size, estimates based on the sample, and the confidence level 13Ombu Enterprises, LLC
Judgement Samples
Annex A.6.2 discusses judgement sampling
-Relies on the knowledge, skill, and experience of the audit teamConsiderations include:
-Previous experience with the audit scope -Complexity of the requirements to meet the audit objectives -Complexity of the processes and the quality management system -Previously identified areas of risk -Previously identified areas of improvement Judgement samples don"t provide a statistical estimate of the audit findings 14Ombu Enterprises, LLC
Statistical Samples
Annex A.6.3 discusses statistical sampling
Use probability methods for the sample selection method -Attribute sampling for pass/fail, conforming/nonconforming, etc. -Variables sampling when the sample outcomes are continuous values Sampling plans depend on the risk the auditor is willing to accept -This is usually called the acceptable confidence level -For example, a sampling risk of 5% corresponds to an acceptable confidence level of 95%The reported results should include:
-A description of the population sampled -The sampling criteria used the evaluate the sample -The statistical parameters and methods -The number of samples evaluated -The results 15Ombu Enterprises, LLC16
Sampling
Ombu Enterprises, LLC17
Tracing
Tracing follows a process:
-Forward tracing moves downstream" -Backward tracing moves upstream" -The Auditor could start in the middle and trace in either direction Tracing establishes that the process and procedures operate as described Unannounced visits for the EU-MDD often use backward tracing product audits starting with final acceptanceOmbu Enterprises, LLC18
Audit Overview
Collect Evidence
InterviewCheck Records
Judgment
SampleStatistical
Sample
Ombu Enterprises, LLC19
Judgment Samples
Judgment samples don"t use statistical methods The advantageis that judgment samples can often provide a sense" of the process without a lot of work -Judgment samples tend to be smaller The disadvantageis that judgment samples don"t allow the quantification of the results -Statistical samples tend to be largerOmbu Enterprises, LLC20
Judgment Samples
Judgment sampling relies on the knowledge, skills, and experience of the audit team.A drawback to judgment sampling is the lack of a statistical estimate of the effect of uncertainty in the findings of the audit and the conclusions reached.
Ombu Enterprises, LLC21
Compliance Tests
Compliance tests show that process operation is satisfactory.-These tests determine whether process control is effective by counting the number of nonconforming records
Compliance tests use sampling methods
-Judgment samples may be acceptable -Statistical samples may be required (especially for critical processes)Ombu Enterprises, LLC22
Contrasting the Methods
Tracing is an audit method to
follow the process, a process walk through. Tracing usually follows the process using procedures, flow charts, etc.Compliance tests check the
records for existence, correctness, completeness, etc. based on the procedures and flow charts.Ombu Enterprises, LLC23
Statistics of Sampling
Binomial Distribution
Confidence Intervals
Ombu Enterprises, LLC24
Judgment Samples
Judgment samples rely on the knowledge and
experience of the auditorThe Lead Auditor says to the audit team, When you use judgment samples, look at 3, 5, 7, or 11 records."
One team member asks why, and the Lead auditor responds, I really like prime numbers".Ombu Enterprises, LLC25
The Binomial Distribution
Ombu Enterprises, LLC26
The Bernoulli Trial
Bernoulli trials are a sequenceof nindependenttrials, where each trial has only two possible outcomes.Example -Flip a coin fifty times
-This is a sequence of trials -n = 50 -The trials are independent, because the coin doesn't "remember" the previous trial -The only outcome of each trial is a head or a tailOmbu Enterprises, LLC27
The Binomial Distribution
The Bernoulli trial has two possible outcomes. -One outcome is success" with probability p. -The other failure" with probability q = 1 -p. The binomial distribution is the probability of xsuccesses in ntrials ,,1,0,1PrOmbu Enterprises, LLC28
Excel Example
n = 20 , p = 0.1 What is the probability of exactly 0 successes, 1 success, etc. BINOMDIST(number_s,trials,probability_s,cumulative) sPr(s)00.1216
10.2702
20.2852
30.1901
40.0898
50.0319
60.0089
70.0020
80.0004
90.0001
100.0000
110.0000
120.0000
200.0000
0.00000.05000.10000.15000.20000.25000.3000
01234567891011121314151617181920
Pr(s) sBinomial Distribution
n=20, p=0.1Ombu Enterprises, LLC29
Counting and
Classifying Records
Ombu Enterprises, LLC30
Records
An auditor examines a certain number of records -Could be a judgment sample -Could be a statistical sample -a conformance testTypically, the audited process generates records at specific points as described in the procedure or process flow.
Example: The record uses a form on one sheet of paper with 10 fields to complete.quotesdbs_dbs10.pdfusesText_16[PDF] iso 20000 certification
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