Last year, the COVID-19 National Lockdown provided organisations with two things:
A preview of how important Risk Management is, for both the organisation and the country.
The opportunity to develop a management system, working towards ISO certification.
Documentation for the basics like document and record control, audits, corrective action, management review and several other topics were easily addressed without the distraction of operations.
Many with an already developed management system made use of the time to finalise their ISO Certification status.
If your organisation wasn’t yet ready to jump onto that bandwagon – it isn’t too late. Risk ZA offers a number of services that assist you in taking the steps towards achieving ISO Certification.
EXCERPT FROM OUR BLOG
You can read the full article here:
“ISO Auditing: How can you take your business to the ‘Next Level’?”
Here’s a roundup of the benefits offered by auditing your ISO Management System:
Audits help us to analyse the compliance of our process with respect to the set ISO standards.
Audits aid us in identifying our strengths and weaknesses, which are necessary for us to tackle the various opportunities and threats in our industry.
We are able to assess and identify the areas for improvement of our efficiency.
Audits help us to identify deviations from our objectives and goals and provide us with the opportunity to correct them.
Above all, audits helps to bring in positive changes in departments by correcting the nonconformities observed and preventing them from recurring.
RISK-BASED APPROACH TO AUDITING AND ISO MANAGEMENT SYSTEM
Auditing in the ISO sense is a verification activity and the ISO 19011:2018 Guidelines for auditing
management systems, sets out guidance on all aspects of the management systems audit.
Importantly, the new standard adopts a risk-based approach to auditing and places greater
focus on the competency of audit professionals. This Guide gives a general overview of the ISO
19011:2018 standard and references to the Risk-based approach under Audit Activities.
The Risk-based approach to auditing according to ISO 19011:2018, Guidelines
for Auditing Management Systems, is an audit approach that considers risks and
opportunities.
THE RISK-BASED APPROACH TO AUDITING
The risk-based approach should influence the planning, conducting, and reporting of audits to
ensure that audits are focused on matters that are significant for the audit client, and for achieving
the audit programme objectives.
ISO 19011:2018 DEFINITION OF RISK
Risk is defined in clause 3.19 as the “effect of uncertainty”. Notes explain that an “effect” is a
deviation from the expected – positive or negative and that “uncertainty” is the state, even partial,
of deficiency of information related to, understanding or knowledge of, an event, its consequence
and likelihood.
Additional Notes state that risk is often characterised by reference to potential events and
consequences, or a combination of these. The Notes also state that risk is often expressed in
terms of a combination of the consequences of an event (including changes in circumstances)
and the associated of occurrence.
THE 7 PRINCIPLES OF ISO AUDITING
The principles of ISO auditing contained in 19011:2018 help to ensure that audits are effective and
reliable tools and support the Management Systems they are auditing by providing actionable
information that organisations can use to improve performance. The principles are:
Integrity: the foundation of professionalism;
Fair presentation: the obligation to report truthfully and accurately;
Due professional care: the application of diligence and judgement in auditing;
Confidentiality: security of information;
Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions;
Evidence-based approach: the rational method for reaching reliable and reproducible audit
conclusions in a systematic audit process;
Risk-based approach: an audit approach that considers risks and opportunities.
THE KEY STAGES OF AN ISO AUDIT
CHOOSING YOUR AUDIT TEAM
You will want to have a number of trained internal auditors for your audit program. You will
be auditing each area of your facility at least once a year, with an audit team of 1 to 4 auditors
depending on the size of the organisation. You will want to have enough auditors to ensure they
will not be auditing their own area.
Look for employees who have a strength in investigating issues and are good communicators. An
audit team leader should have the competence to discuss strategic issues with top management
of the auditee to determine if they have considered these strategic issues when evaluating their
risks and opportunities.
AUDITOR COMPETENCE
In deciding the necessary competence for an auditor, clause 7.2 states that an auditor’s knowledge
and skills related to the types and levels of risks and opportunities addressed by the management
system should be considered. An auditor should be able to understand the types of risks and
opportunities associated with auditing and the principles of the risk-based approach to auditing.
The discipline and sector-specific competence of auditors should include the principles, methods,
and techniques relevant to the discipline and sector, such that the auditor can determine and
evaluate the risks and opportunities associated with the audit objectives.
PREPARING FOR AN ISO AUDIT
Broadly, an ISO audit involves a cycle of four main activities:
PLANNING
The audit team leader should adopt a risk-based approach to planning the audit based on the
information in the audit program and the documented information provided by the auditee.
An audit plan is prepared ahead of an audit. A Lead Auditor is appointed, who prepares the
plan after consulting with Management. The audit plan includes the scope of the audit, which
refers to the clauses and departments that are covered, the sampling rate, the audit dates and
the auditors. An auditor collects the evidence and determines the findings. The auditor should
be competent and authorised to conduct the audit. When performing a review of the auditee’s
documented information to prepare for the audit, clause 6.3.1 states that the review should take
into account the context of the auditee’s organisation, including its size, nature, and complexity,
and its related risks and opportunities.
AUDITING
The audit team starts the audit with an Opening meeting with the Management. Auditors later
audit the employees as per the audit plan and schedule. Nonconformity should be recorded
after collecting the objective evidence for that nonconformity. A nonconformity refers to the
non-fulfilment of a requirement of the chosen ISO standard. Objective evidence is evidence that
exists and is verifiable. The Auditor should help the auditee (the company/department being
audited) to identify the root cause of nonconformity and suggest a suitable corrective action for
the nonconformity.
OPENING MEETING
The purpose of the opening meeting, according to clause 6.4.3 is to:
Confirm the agreement of all participants to the audit plan
Introduce the audit team and their roles
Ensure that all planned audit activities can be performed
An important topic to introduce will be the audit methods that manage risks that the organisation
faces. These might only be brought to surface through the presence of the audit team members.
PREPARING FOR AN ISO AUDIT
Broadly, an ISO audit involves a cycle of four main activities:
PLANNING
The audit team leader should adopt a risk-based approach to planning the audit based on the
information in the audit program and the documented information provided by the auditee.
An audit plan is prepared ahead of an audit. A Lead Auditor is appointed, who prepares the
plan after consulting with Management. The audit plan includes the scope of the audit, which
refers to the clauses and departments that are covered, the sampling rate, the audit dates and
the auditors. An auditor collects the evidence and determines the findings. The auditor should
be competent and authorised to conduct the audit. When performing a review of the auditee’s
documented information to prepare for the audit, clause 6.3.1 states that the review should take
into account the context of the auditee’s organisation, including its size, nature, and complexity,
and its related risks and opportunities.
AUDITING
The audit team starts the audit with an Opening meeting with the Management. Auditors later
audit the employees as per the audit plan and schedule. Nonconformity should be recorded
after collecting the objective evidence for that nonconformity. A nonconformity refers to the
non-fulfilment of a requirement of the chosen ISO standard. Objective evidence is evidence that
exists and is verifiable. The Auditor should help the auditee (the company/department being
audited) to identify the root cause of nonconformity and suggest a suitable corrective action for
the nonconformity.
OPENING MEETING
The purpose of the opening meeting, according to clause 6.4.3 is to:
Confirm the agreement of all participants to the audit plan
Introduce the audit team and their roles
Ensure that all planned audit activities can be performed
An important topic to introduce will be the audit methods that manage risks that the organisation
faces. These might only be brought to surface through the presence of the audit team members.
AUDIT COMMUNICATION
During the audit, the audit team leader should periodically communicate the progress, any
significant findings, and any concerns to the auditee and audit client. Clause 6.4.4 states that
evidence collected during the audit that suggests an immediate and significant risk should be
reported without delay to the auditee and, as appropriate, to the audit client.
INFORMATION VERIFICATION
Clause 6.4.7 states that information relevant to the audit objectives, scope, and criteria, including
information relating to interfaces between functions, activities, and processes, should be collected
by means of appropriate sampling and should be verified, as far as practicable.
If during the collection of objective evidence, the audit team becomes aware of any new or
changed circumstances, or risks or opportunities, these should be addressed by the team.
REPORTING
The audit report should provide a complete, accurate, concise, and clear record of the audit. Clause
6.5 states the report should note that audits by nature are a sampling exercise, and therefore,
there is a risk that the audit evidence examined may not be representative.
The audit team records any observed nonconformity. During the closing meeting, a summary of
the audit and the audit findings are presented to Management.
AUDIT FINDING
An “audit finding” is defined at clause 3.10 as the results of evaluating the collected audit evidence
against audit criteria. Notes for that definition state that audit findings indicate conformity or
nonconformity, and can lead to the identification of risks, opportunities for improvement, or
recording of good practices.
NONCONFORMITY GRADING
According to clause 6.4.8, nonconformities can be graded depending on the context of the
organisation and its risks. This grading can be quantitative (e.g., 1 to 5) and qualitative (e.g., minor,
major). They should be reviewed with the auditee to obtain acknowledgement that the audit
evidence is accurate and that the nonconformities are understood.
CORRECTIVE ACTION
The auditees are given a time frame to correct the nonconformity and document the details
of the corrective action(s). The auditor should provide suggestions for improvement and any
preventive actions that can be taken. The auditor verifies whether the corrective action taken is
adequate and the nonconformity has been corrected.
TIPS FOR A SMOOTH INTERNAL AUDIT
The organisation and top management need to recognise the real worth of their internal auditors,
nurture and develop those people, and make use of their insight.
These are the people who are completely familiar with the business management system and can
significantly impact the bottom line if you listen to what they’re saying.
Internal auditors should attend Internal Auditor training to learn good practice and how to
interpret and apply the requirements of the specific ISO standard.
Our Internal Auditor training courses have been updated for the revised guidance in ISO
19011:2018.
It is important to educate all staff about the benefits of internal auditing and the significant
impact it can have on the organisation when it’s used in a constructive manner.
An auditor must be impartial and objective and cannot audit their own work.
Learn to plan and perform your own audit with Risk ZA Training.
HOW RISK ZA CAN ASSIST YOU
TRAINING
We offer an extensive range of training courses that are facilitated by industry experts and
registered educators. We are registered with the Southern African Auditor Training Certification
Authority (SAATCA) and our courses include but are not limited to:
Awareness training (in English, Afrikaans and isiZulu)
Introductory and intermediate courses
Advanced exposure to developing and implementing management arrangements to foster a
culture of continual improvement
Practical application of strategic elements of local and international best-practices
Internal and supplier auditing
Lead auditor training
AUDITING
Auditing is an integral function of continual improvement and of high value and importance to an
organisation’s ability to improve. We promote and make use of risk-based auditing in conducting
performance and conformance audits both for our clients or on their behalf. We conduct our
audits with influence from ISO 19011 and ISO 17021 and supply the following Auditing services:
First party internal audits
Second-party supplier audits
Third-party preparation audits (pre-certification)
CONSULTING
We specialise in consulting on all policies, procedures, processes, systems and other business
activities. Our risk-based approach enables our consultants to effectively advise on restraints or
potential areas of risk which could or are currently affecting the consistency of business processes
and/or hindering profitability.
Our expertise includes compliance with international standards, corporate governance legislation
and best practices and other enterprise-wide risk contributors.
Consulting Interventions include:
Gap Analysis and Project Planning
Steering Committees
Policy Development
Process Mapping and Evaluation
Corrective Action Systems
System Development and Implementation
Documentation Creation, Review and Control
ISO Auditing: How can you take your business to the ‘Next Level’? | Risk ZA Group
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ISO Auditing: How can you take your business to the ‘Next Level’?
24 Mar, 202130 Oct, 2019 by Fiona Wayman
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Organisations that use ISO Management Systems enjoy many advantages. Even if you don’t plan to go for ISO certification, your business can extract great value from an internal audit and it can provide top management a realistic view of how likely they are to meet objectives.
There are so many reasons to think about audit as a partner in your management operations, so let’s dive into the world of ISO audits and discover the benefits.
Learn more about the Risk-based Auditing Approach! Download our FREE guide Risk-Based Approach to Auditing an ISO Management System.
DOWNLOAD FREE GUIDE
WHAT IS AN ISO AUDIT?
An ISO audit can apply to an entire organisation or it may be applied to a specific function, process or production step. Some audits serve an administrative purpose, such as auditing documents, risk or performance or following up on completed corrective actions.
The formal definition of an ISO audit is found in the ISO standard – Guidelines for Auditing Management Systems Standards, which is:
“the systematic, independent and documented process for obtaining audit evidence (records, statements of fact or other information which are relevant and verifiable) and evaluating it objectively to determine the extent to which the audit criteria (a set of policies, procedures or requirements) are fulfilled.” ISO 19011:2018 – Guidelines for Auditing Management Systems.
TYPES OF ISO AUDITS AND THE BENEFITS
There are three main types of ISO audits:
First-party (internal)
Second-party (external / supplier)
Third-party (certification)
First-party Audit
An Internal Audit is conducted on a process or set of processes to ensure they meet the organisation’s internal requirements and is used for evaluating the effectiveness of the Management System. The value of the Internal Audit is that it takes a critical look at your company and how it operates and improves the effectiveness of risk management, control and governance processes.
Second-party Audit
A Second-party or Supplier Audit is valuable for strengthening a company’s supply chain and verifying that suppliers meet or exceed predetermined requirements. A Supplier Audit can prevent quality, environmental or health and safety issues from reaching your customers.
Third-party Audit
A Third-party or Compliance audit is carried out by a Certification Body (CB) and evaluates whether the Management System meets the requirements of a specific ISO standard. If successful, the Third-party Audit will provide the organisation with a certification of conformity with the given standard.
The ISO 19011:2018 standard stipulates that a third-party Auditor must acquire the necessary knowledge and skills to be employed by a CB and pledge to abide by a code of ethical conduct in the performance of an audit. ISO certification confers numerous benefits such as increasing your organisation’s credibility and enabling you to secure business.
Surveillance Audit
These audits are held in years one and two after initial certification and in years one and two following each recertification. The audit is conducted by a Certification Body.
Recertification Audit
These audits are held every three years with a Certified Body performing the audit The goal is to continue to demonstrate management’s commitment to and ongoing improvement of the Management System to ensure its effectiveness.
TRAIN YOUR AUDITORS AND DEVELOP THEIR INTERVIEW SKILLS
Knowledge of the ISO standard(s) and conducting effective interviews are essential parts of the Internal Auditor’s job. Unskilled auditors will collect little useful information and their interview questions are likely to elicit predictable answers which are of no value. So ensure that your Internal Auditors are properly trained.
Our ISO Auditor Training courses are an efficient way of doing this: View our public Auditor Training courses here or Sign Up for an Online Learning Course here.
SUMMARY
Audits are aimed at enhancing productivity, detecting problems at an early stage and ensuring that policy and objectives are being followed by everyone in the organisation. Below is a roundup of the benefits offered by auditing your ISO Management System:
Audits help us to analyse the compliance of our process with respect to the set ISO standards.
Audits aid us in identifying our strengths and weaknesses, which are necessary for us to tackle the various opportunities and threats in our industry.
We are able to assess and identify the areas for improvement of our efficiency.
Audits help us to identify deviations from our objectives and goals and provide us with the opportunity to correct them.
Above all, audits helps to bring in positive changes in departments by correcting the nonconformities observed and preventing them from recurring.
THE NEW RISK-BASED APPROACH TO ISO AUDITING
Are your Internal Auditors adequately trained to sufficiently audit ISO Management Systems?
Risk ZA’s focus is to conduct audits according to the new ISO 19011:2018 standard’s requirements which focus on a Risk-based Approach during the audit process.
ISO 14001:2015 – Internal Audits Drive Real Improvements | Risk ZA Group
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ISO 14001:2015 – Internal Audits Drive Real Improvements
20 Apr, 202128 Nov, 2018 by Fiona Wayman
Confronted with dramatic environmental challenges, plus a slew of regulatory requirements, many organisations have implemented environmental management systems (EMSs). An ISO 14001:2015 based EMS is the most popular, used to meet compliance obligations, monitor environmental policies and procedures, manage resources and control environmental harms.
ISO 14001:2015 is a systems-based management tool centering around the Plan-Do-Check-Act method, which drives continual improvement. The standard outlines in Clause 9.2 that internal audits at set intervals are necessary to support the theme of continual improvement underpinning the management system.
The purpose of internal audits is to ensure that the organisation’s environmental policies, objectives, compliance obligations and performance requirements are met and recorded, and that any corrective action is taken where necessary.
The COVID-19 National Lockdown provided organisations with two things: A preview of how important Risk Management is, for both the organisation and the country. The opportunity to develop a management system, working towards ISO certification. Documentation for the basics like document and record control, audits, corrective action, management review and several other topics were easily addressed without the distraction of operations. Many with an already developed management system made use of the time to finalise their ISO Certification status. If your organisation wasn’t yet ready to jump onto that bandwagon – it isn’t too late. Risk ZA offers a number of services that assist you in taking the steps towards achieving ISO Certification. |
Here’s a roundup of the benefits offered by auditing your ISO Management System: Audits help us to analyse the compliance of our process with respect to the set ISO standards. Audits aid us in identifying our strengths and weaknesses, which are necessary for us to tackle the various opportunities and threats in our industry. We are able to assess and identify the areas for improvement of our efficiency. Audits help us to identify deviations from our objectives and goals and provide us with the opportunity to correct them. Above all, audits helps to bring in positive changes in departments by correcting the nonconformities observed and preventing them from recurring. <!– /* Font Definitions */ @font-face {font-family:Helvetica; panose-1:2 11 6 4 2 2 2 2 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-536859905 -1073711037 9 0 511 0;} @font-face {font-family:Helvetica; panose-1:2 11 6 4 2 2 2 2 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-536859905 -1073711037 9 0 511 0;} @font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-536870145 1073786111 1 0 415 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:””; margin:0cm; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:”Times New Roman”,”serif”; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin;} h1 {mso-style-priority:9; mso-style-unhide:no; mso-style-qformat:yes; mso-style-link:”Heading 1 Char”; margin:0cm; margin-bottom:.0001pt; text-align:center; line-height:200%; mso-pagination:widow-orphan; mso-outline-level:1; font-size:19.5pt; font-family:”Helvetica”,”sans-serif”; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; color:red; letter-spacing:.75pt;} span.Heading1Char {mso-style-name:”Heading 1 Char”; mso-style-priority:9; mso-style-unhide:no; mso-style-locked:yes; mso-style-link:”Heading 1″; mso-ansi-font-size:19.5pt; mso-bidi-font-size:19.5pt; font-family:”Helvetica”,”sans-serif”; mso-ascii-font-family:Helvetica; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Helvetica; mso-bidi-font-family:Helvetica; color:red; letter-spacing:.75pt; mso-font-kerning:18.0pt; font-weight:bold;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-size:10.0pt; mso-ansi-font-size:10.0pt; mso-bidi-font-size:10.0pt;} @page WordSection1 {size:612.0pt 792.0pt; margin:72.0pt 72.0pt 72.0pt 72.0pt; mso-header-margin:36.0pt; mso-footer-margin:36.0pt; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} /* List Definitions */ @list l0 {mso-list-id:1293635158; mso-list-template-ids:165836904;} @list l1 {mso-list-id:1297377188; mso-list-template-ids:-1575333820;} ol {margin-bottom:0cm;} ul {margin-bottom:0cm;} –> Hi Siphiwe Billy Last year, the COVID-19 National Lockdown provided organisations with two things: A preview of how important Risk Management is, for both the organisation and the country. The opportunity to develop a management system, working towards ISO certification. Documentation for the basics like document and record control, audits, corrective action, management review and several other topics were easily addressed without the distraction of operations. Many with an already developed management system made use of the time to finalise their ISO Certification status. If your organisation wasn’t yet ready to jump onto that bandwagon – it isn’t too late. Risk ZA offers a number of services that assist you in taking the steps towards achieving ISO Certification. **INSIDE TIP: We have exciting news coming in May, that will fast-track this process, with our guidance. Keep an eye out for more…** EXCERPT FROM OUR BLOG You can read the full article here: “ISO Auditing: How can you take your business to the ‘Next Level’?” Here’s a roundup of the benefits offered by auditing your ISO Management System: Audits help us to analyse the compliance of our process with respect to the set ISO standards. Audits aid us in identifying our strengths and weaknesses, which are necessary for us to tackle the various opportunities and threats in our industry. We are able to assess and identify the areas for improvement of our efficiency. Audits help us to identify deviations from our objectives and goals and provide us with the opportunity to correct them. Above all, audits helps to bring in positive changes in departments by correcting the nonconformities observed and preventing them from recurring. RISK-BASED APPROACH TO AUDITING AND ISO MANAGEMENT SYSTEM Auditing in the ISO sense is a verification activity and the ISO 19011:2018 Guidelines for auditing management systems, sets out guidance on all aspects of the management systems audit. Importantly, the new standard adopts a risk-based approach to auditing and places greater focus on the competency of audit professionals. This Guide gives a general overview of the ISO 19011:2018 standard and references to the Risk-based approach under Audit Activities. The Risk-based approach to auditing according to ISO 19011:2018, Guidelines for Auditing Management Systems, is an audit approach that considers risks and opportunities. THE RISK-BASED APPROACH TO AUDITING The risk-based approach should influence the planning, conducting, and reporting of audits to ensure that audits are focused on matters that are significant for the audit client, and for achieving the audit programme objectives. ISO 19011:2018 DEFINITION OF RISK Risk is defined in clause 3.19 as the “effect of uncertainty”. Notes explain that an “effect” is a deviation from the expected – positive or negative and that “uncertainty” is the state, even partial, of deficiency of information related to, understanding or knowledge of, an event, its consequence and likelihood. Additional Notes state that risk is often characterised by reference to potential events and consequences, or a combination of these. The Notes also state that risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated of occurrence. THE 7 PRINCIPLES OF ISO AUDITING The principles of ISO auditing contained in 19011:2018 help to ensure that audits are effective and reliable tools and support the Management Systems they are auditing by providing actionable information that organisations can use to improve performance. The principles are: Integrity: the foundation of professionalism; Fair presentation: the obligation to report truthfully and accurately; Due professional care: the application of diligence and judgement in auditing; Confidentiality: security of information; Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions; Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process; Risk-based approach: an audit approach that considers risks and opportunities. THE KEY STAGES OF AN ISO AUDIT CHOOSING YOUR AUDIT TEAM You will want to have a number of trained internal auditors for your audit program. You will be auditing each area of your facility at least once a year, with an audit team of 1 to 4 auditors depending on the size of the organisation. You will want to have enough auditors to ensure they will not be auditing their own area. Look for employees who have a strength in investigating issues and are good communicators. An audit team leader should have the competence to discuss strategic issues with top management of the auditee to determine if they have considered these strategic issues when evaluating their risks and opportunities. AUDITOR COMPETENCE In deciding the necessary competence for an auditor, clause 7.2 states that an auditor’s knowledge and skills related to the types and levels of risks and opportunities addressed by the management system should be considered. An auditor should be able to understand the types of risks and opportunities associated with auditing and the principles of the risk-based approach to auditing. The discipline and sector-specific competence of auditors should include the principles, methods, and techniques relevant to the discipline and sector, such that the auditor can determine and evaluate the risks and opportunities associated with the audit objectives. PREPARING FOR AN ISO AUDIT Broadly, an ISO audit involves a cycle of four main activities: PLANNING The audit team leader should adopt a risk-based approach to planning the audit based on the information in the audit program and the documented information provided by the auditee. An audit plan is prepared ahead of an audit. A Lead Auditor is appointed, who prepares the plan after consulting with Management. The audit plan includes the scope of the audit, which refers to the clauses and departments that are covered, the sampling rate, the audit dates and the auditors. An auditor collects the evidence and determines the findings. The auditor should be competent and authorised to conduct the audit. When performing a review of the auditee’s documented information to prepare for the audit, clause 6.3.1 states that the review should take into account the context of the auditee’s organisation, including its size, nature, and complexity, and its related risks and opportunities. AUDITING The audit team starts the audit with an Opening meeting with the Management. Auditors later audit the employees as per the audit plan and schedule. Nonconformity should be recorded after collecting the objective evidence for that nonconformity. A nonconformity refers to the non-fulfilment of a requirement of the chosen ISO standard. Objective evidence is evidence that exists and is verifiable. The Auditor should help the auditee (the company/department being audited) to identify the root cause of nonconformity and suggest a suitable corrective action for the nonconformity. OPENING MEETING The purpose of the opening meeting, according to clause 6.4.3 is to: Confirm the agreement of all participants to the audit plan Introduce the audit team and their roles Ensure that all planned audit activities can be performed An important topic to introduce will be the audit methods that manage risks that the organisation faces. These might only be brought to surface through the presence of the audit team members. PREPARING FOR AN ISO AUDIT Broadly, an ISO audit involves a cycle of four main activities: PLANNING The audit team leader should adopt a risk-based approach to planning the audit based on the information in the audit program and the documented information provided by the auditee. An audit plan is prepared ahead of an audit. A Lead Auditor is appointed, who prepares the plan after consulting with Management. The audit plan includes the scope of the audit, which refers to the clauses and departments that are covered, the sampling rate, the audit dates and the auditors. An auditor collects the evidence and determines the findings. The auditor should be competent and authorised to conduct the audit. When performing a review of the auditee’s documented information to prepare for the audit, clause 6.3.1 states that the review should take into account the context of the auditee’s organisation, including its size, nature, and complexity, and its related risks and opportunities. AUDITING The audit team starts the audit with an Opening meeting with the Management. Auditors later audit the employees as per the audit plan and schedule. Nonconformity should be recorded after collecting the objective evidence for that nonconformity. A nonconformity refers to the non-fulfilment of a requirement of the chosen ISO standard. Objective evidence is evidence that exists and is verifiable. The Auditor should help the auditee (the company/department being audited) to identify the root cause of nonconformity and suggest a suitable corrective action for the nonconformity. OPENING MEETING The purpose of the opening meeting, according to clause 6.4.3 is to: Confirm the agreement of all participants to the audit plan Introduce the audit team and their roles Ensure that all planned audit activities can be performed An important topic to introduce will be the audit methods that manage risks that the organisation faces. These might only be brought to surface through the presence of the audit team members. AUDIT COMMUNICATION During the audit, the audit team leader should periodically communicate the progress, any significant findings, and any concerns to the auditee and audit client. Clause 6.4.4 states that evidence collected during the audit that suggests an immediate and significant risk should be reported without delay to the auditee and, as appropriate, to the audit client. INFORMATION VERIFICATION Clause 6.4.7 states that information relevant to the audit objectives, scope, and criteria, including information relating to interfaces between functions, activities, and processes, should be collected by means of appropriate sampling and should be verified, as far as practicable. If during the collection of objective evidence, the audit team becomes aware of any new or changed circumstances, or risks or opportunities, these should be addressed by the team. REPORTING The audit report should provide a complete, accurate, concise, and clear record of the audit. Clause 6.5 states the report should note that audits by nature are a sampling exercise, and therefore, there is a risk that the audit evidence examined may not be representative. The audit team records any observed nonconformity. During the closing meeting, a summary of the audit and the audit findings are presented to Management. AUDIT FINDING An “audit finding” is defined at clause 3.10 as the results of evaluating the collected audit evidence against audit criteria. Notes for that definition state that audit findings indicate conformity or nonconformity, and can lead to the identification of risks, opportunities for improvement, or recording of good practices. NONCONFORMITY GRADING According to clause 6.4.8, nonconformities can be graded depending on the context of the organisation and its risks. This grading can be quantitative (e.g., 1 to 5) and qualitative (e.g., minor, major). They should be reviewed with the auditee to obtain acknowledgement that the audit evidence is accurate and that the nonconformities are understood. CORRECTIVE ACTION The auditees are given a time frame to correct the nonconformity and document the details of the corrective action(s). The auditor should provide suggestions for improvement and any preventive actions that can be taken. The auditor verifies whether the corrective action taken is adequate and the nonconformity has been corrected. TIPS FOR A SMOOTH INTERNAL AUDIT The organisation and top management need to recognise the real worth of their internal auditors, nurture and develop those people, and make use of their insight. These are the people who are completely familiar with the business management system and can significantly impact the bottom line if you listen to what they’re saying. Internal auditors should attend Internal Auditor training to learn good practice and how to interpret and apply the requirements of the specific ISO standard. Our Internal Auditor training courses have been updated for the revised guidance in ISO 19011:2018. It is important to educate all staff about the benefits of internal auditing and the significant impact it can have on the organisation when it’s used in a constructive manner. An auditor must be impartial and objective and cannot audit their own work. Learn to plan and perform your own audit with Risk ZA Training. HOW RISK ZA CAN ASSIST YOU TRAINING We offer an extensive range of training courses that are facilitated by industry experts and registered educators. We are registered with the Southern African Auditor Training Certification Authority (SAATCA) and our courses include but are not limited to: Awareness training (in English, Afrikaans and isiZulu) Introductory and intermediate courses Advanced exposure to developing and implementing management arrangements to foster a culture of continual improvement Practical application of strategic elements of local and international best-practices Internal and supplier auditing Lead auditor training AUDITING Auditing is an integral function of continual improvement and of high value and importance to an organisation’s ability to improve. We promote and make use of risk-based auditing in conducting performance and conformance audits both for our clients or on their behalf. We conduct our audits with influence from ISO 19011 and ISO 17021 and supply the following Auditing services: First party internal audits Second-party supplier audits Third-party preparation audits (pre-certification) CONSULTING We specialise in consulting on all policies, procedures, processes, systems and other business activities. Our risk-based approach enables our consultants to effectively advise on restraints or potential areas of risk which could or are currently affecting the consistency of business processes and/or hindering profitability. Our expertise includes compliance with international standards, corporate governance legislation and best practices and other enterprise-wide risk contributors. Consulting Interventions include: Gap Analysis and Project Planning Steering Committees Policy Development Process Mapping and Evaluation Corrective Action Systems System Development and Implementation Documentation Creation, Review and Control ISO Auditing: How can you take your business to the ‘Next Level’? | Risk ZA Group window._wca = window._wca || []; window.ga=window.ga||function(){(ga.q=ga.q||[]).push(arguments)};ga.l=+new Date; ga(‘create’, ‘UA-126136462-1’, ‘auto’); // Plugins ga(‘send’, ‘pageview’); window._wpemojiSettings = {“baseUrl”:”https:\/\/s.w.org\/images\/core\/emoji\/12.0.0-1\/72×72\/”,”ext”:”.png”,”svgUrl”:”https:\/\/s.w.org\/images\/core\/emoji\/12.0.0-1\/svg\/”,”svgExt”:”.svg”,”source”:{“concatemoji”:”https:\/\/www.riskza.com\/wp-includes\/js\/wp-emoji-release.min.js?ver=3e7f3c147876d85d6bb4bf64929f5a1f”}}; !function(e,a,t){var n,r,o,i=a.createElement(“canvas”),p=i.getContext&&i.getContext(“2d”);function s(e,t){var 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#management”,”description”:”Your business can extract great value from an internal audit and it can provide top management a realistic view of how likely they are to meet objectives.\n”,”author”:{“@type”:”Person”,”name”:”Fiona Wayman”,”url”:”https:\/\/www.riskza.com\/author\/fiona-wayman\/”,”image”:{“@type”:”ImageObject”,”url”:”https:\/\/secure.gravatar.com\/avatar\/ea0bda4960190ff5786b8c241aa777a0?s=96&d=mm&r=g”,”height”:96,”width”:96}}} img#wpstats{display:none} <style>.woocommerce-product-gallery{ opacity: 1 !important; }</style> !function(f,b,e,v,n,t,s){if(f.fbq)return;n=f.fbq=function(){n.callMethod? n.callMethod.apply(n,arguments):n.queue.push(arguments)};if(!f._fbq)f._fbq=n; n.push=n;n.loaded=!0;n.version=’2.0′;n.queue=[];t=b.createElement(e);t.async=!0; t.src=v;s=b.getElementsByTagName(e)[0];s.parentNode.insertBefore(t,s)}(window, document,’script’,’https://connect.facebook.net/en_US/fbevents.js’); fbq(‘init’, ‘2631456417168260’, {}, { “agent”: “wordpress-5.3.7-2.2.0” }); 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Even if you don’t plan to go for ISO certification, your business can extract great value from an internal audit and it can provide top management a realistic view of how likely they are to meet objectives. There are so many reasons to think about audit as a partner in your management operations, so let’s dive into the world of ISO audits and discover the benefits. Learn more about the Risk-based Auditing Approach! Download our FREE guide Risk-Based Approach to Auditing an ISO Management System. DOWNLOAD FREE GUIDE WHAT IS AN ISO AUDIT? An ISO audit can apply to an entire organisation or it may be applied to a specific function, process or production step. Some audits serve an administrative purpose, such as auditing documents, risk or performance or following up on completed corrective actions. The formal definition of an ISO audit is found in the ISO standard – Guidelines for Auditing Management Systems Standards, which is: “the systematic, independent and documented process for obtaining audit evidence (records, statements of fact or other information which are relevant and verifiable) and evaluating it objectively to determine the extent to which the audit criteria (a set of policies, procedures or requirements) are fulfilled.” ISO 19011:2018 – Guidelines for Auditing Management Systems. TYPES OF ISO AUDITS AND THE BENEFITS There are three main types of ISO audits: First-party (internal) Second-party (external / supplier) Third-party (certification) First-party Audit An Internal Audit is conducted on a process or set of processes to ensure they meet the organisation’s internal requirements and is used for evaluating the effectiveness of the Management System. The value of the Internal Audit is that it takes a critical look at your company and how it operates and improves the effectiveness of risk management, control and governance processes. Second-party Audit A Second-party or Supplier Audit is valuable for strengthening a company’s supply chain and verifying that suppliers meet or exceed predetermined requirements. A Supplier Audit can prevent quality, environmental or health and safety issues from reaching your customers. Third-party Audit A Third-party or Compliance audit is carried out by a Certification Body (CB) and evaluates whether the Management System meets the requirements of a specific ISO standard. If successful, the Third-party Audit will provide the organisation with a certification of conformity with the given standard. The ISO 19011:2018 standard stipulates that a third-party Auditor must acquire the necessary knowledge and skills to be employed by a CB and pledge to abide by a code of ethical conduct in the performance of an audit. ISO certification confers numerous benefits such as increasing your organisation’s credibility and enabling you to secure business. Surveillance Audit These audits are held in years one and two after initial certification and in years one and two following each recertification. The audit is conducted by a Certification Body. Recertification Audit These audits are held every three years with a Certified Body performing the audit The goal is to continue to demonstrate management’s commitment to and ongoing improvement of the Management System to ensure its effectiveness. TRAIN YOUR AUDITORS AND DEVELOP THEIR INTERVIEW SKILLS Knowledge of the ISO standard(s) and conducting effective interviews are essential parts of the Internal Auditor’s job. Unskilled auditors will collect little useful information and their interview questions are likely to elicit predictable answers which are of no value. So ensure that your Internal Auditors are properly trained. Our ISO Auditor Training courses are an efficient way of doing this: View our public Auditor Training courses here or Sign Up for an Online Learning Course here. SUMMARY Audits are aimed at enhancing productivity, detecting problems at an early stage and ensuring that policy and objectives are being followed by everyone in the organisation. Below is a roundup of the benefits offered by auditing your ISO Management System: Audits help us to analyse the compliance of our process with respect to the set ISO standards. Audits aid us in identifying our strengths and weaknesses, which are necessary for us to tackle the various opportunities and threats in our industry. We are able to assess and identify the areas for improvement of our efficiency. Audits help us to identify deviations from our objectives and goals and provide us with the opportunity to correct them. Above all, audits helps to bring in positive changes in departments by correcting the nonconformities observed and preventing them from recurring. THE NEW RISK-BASED APPROACH TO ISO AUDITING Are your Internal Auditors adequately trained to sufficiently audit ISO Management Systems? Risk ZA’s focus is to conduct audits according to the new ISO 19011:2018 standard’s requirements which focus on a Risk-based Approach during the audit process. 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ISO 14001, iso standards, iso training, Management, management system, results, South Africa, Sustainable practice, Waste management”,”description”:”Confronted with dramatic environmental challenges, plus a slew of regulatory requirements, many organisations have implemented environmental management systems (EMSs). An ISO 14001:2015 based EMS is the most popular, used to meet compliance obligations, monitor environmental policies and procedures, manage resources and control environmental harms.ISO 14001:2015 is a systems-based management”,”author”:{“@type”:”Person”,”name”:”Fiona Wayman”,”url”:”https:\/\/www.riskza.com\/author\/fiona-wayman\/”,”image”:{“@type”:”ImageObject”,”url”:”https:\/\/secure.gravatar.com\/avatar\/ea0bda4960190ff5786b8c241aa777a0?s=96&d=mm&r=g”,”height”:96,”width”:96}}} img#wpstats{display:none} <style>.woocommerce-product-gallery{ opacity: 1 !important; }</style> !function(f,b,e,v,n,t,s){if(f.fbq)return;n=f.fbq=function(){n.callMethod? n.callMethod.apply(n,arguments):n.queue.push(arguments)};if(!f._fbq)f._fbq=n; n.push=n;n.loaded=!0;n.version=’2.0′;n.queue=[];t=b.createElement(e);t.async=!0; t.src=v;s=b.getElementsByTagName(e)[0];s.parentNode.insertBefore(t,s)}(window, document,’script’,’https://connect.facebook.net/en_US/fbevents.js’); fbq(‘init’, ‘2631456417168260’, {}, { “agent”: “wordpress-5.3.7-2.2.0” }); fbq(‘track’, ‘PageView’, []); <img height=”1″ width=”1″ style=”display:none” alt=”fbpx” src=”https://www.facebook.com/tr?id=2631456417168260&ev=PageView&noscript=1″ /> !function(f,b,e,v,n,t,s){if(f.fbq)return;n=f.fbq=function(){n.callMethod? n.callMethod.apply(n,arguments):n.queue.push(arguments)};if(!f._fbq)f._fbq=n; n.push=n;n.loaded=!0;n.version=’2.0′;n.queue=[];t=b.createElement(e);t.async=!0; t.src=v;s=b.getElementsByTagName(e)[0];s.parentNode.insertBefore(t,s)}(window, document,’script’,’https://connect.facebook.net/en_US/fbevents.js’); fbq(‘init’, ‘2631456417168260’, {}, { “agent”: “woocommerce-4.1.0-1.11.2” }); fbq( ‘track’, ‘PageView’, { “source”: “woocommerce”, “version”: “4.1.0”, “pluginVersion”: “1.11.2” } ); document.addEventListener( ‘DOMContentLoaded’, function() { jQuery && jQuery( function( $ ) { // insert placeholder for events injected when a product is added to the cart through AJAX $( document.body ).append( ‘<div class=\”wc-facebook-pixel-event-placeholder\”></div>’ ); } ); }, false ); .elementor-toggle .elementor-tab-title a { color: #ffffff !important; } .elementor-toggle .elementor-tab-title a:hover { color: #000000 !important; } #mc_embed_signup input.mce_inline_error { border-color:#6B0505; } #mc_embed_signup div.mce_inline_error { margin: 0 0 1em 0; padding: 5px 10px; background-color:#6B0505; font-weight: bold; z-index: 1; color:#fff; } ISO 14001:2015 – Internal Audits Drive Real Improvements by Fiona Wayman Confronted with dramatic environmental challenges, plus a slew of regulatory requirements, many organisations have implemented environmental management systems (EMSs). An ISO 14001:2015 based EMS is the most popular, used to meet compliance obligations, monitor environmental policies and procedures, manage resources and control environmental harms. ISO 14001:2015 is a systems-based management tool centering around the Plan-Do-Check-Act method, which drives continual improvement. The standard outlines in Clause 9.2 that internal audits at set intervals are necessary to support the theme of continual improvement underpinning the management system. The purpose of internal audits is to ensure that the organisation’s environmental policies, objectives, compliance obligations and performance requirements are met and recorded, and that any corrective action is taken where necessary. |
ISO 14001:2015 – Internal Audits Drive Real Improvements | Risk ZA Group
What to expect from an ISO 14001:2015 audit
A key point to emphasise is that the intended outcomes of ISO 14001:2015 have not changed. The EMS must:
- Protect the environment.
- Meet compliance obligations.
- Enhance environmental performance.
ISO 14001:2015 does, however, have a number of new requirements that will change the focus of an audit, which include:
- Context of the organisation
- Leadership
- Planning
- Support
- Documentation
- Operations
- Performance evaluation
- Improvement
ISO 14001:2015 – Clause 9: Performance evaluation
Performance evaluation is about measuring and evaluating an EMS to establish whether it meets the organisation’s planned outcomes. Evaluation provides valuable information for continual improvement by:
- Evaluating the EMS’s effectiveness.
- Establishing whether requirements of the standard are being met.
- Verifying whether compliance obligations have been met.
- Reviewing the EMs’s suitability, adequacy, effectiveness and efficiency.
- Demonstrating that planning has been properly implemented.
- Assessing the performance of processes against outcomes.
- Determining the need or opportunities for improvement.
Monitoring, measurement, analysis and evaluation
Monitoring in the sense of ISO 14001 means checking, reviewing, inspecting and observing planned activities to ensure that they are occurring as intended. So, for example, if an operational control states that water quality will be inspected twice weekly, then this is a monitoring process. Monitoring and measurement :
- Evaluates environmental performance;
- Analyses root causes of problems;
- Assesses compliance with compliance obligations;
- Identifies areas for corrective action;
- Improves performance and efficiency.
The Internal audit programme
Unlike an audit schedule or audit plan, an audit programme includes the full life-cycle of auditing. From the very decision to use audit as a tool through planning and initiating the audit, performing, reporting and follow-up, to improvement of the entire programme and its constituent parts.
All parts of the EMS should be audited at minimum yearly, this is typically dealt with in an annual audit schedule. The entire EMS can be audited at once or in parts for more frequent audits. To establish the frequency of EMS audits, consider:
- The nature of your operations;
- Risks and opportunities;
- Statutory and regulatory requirements and compliance obligations;
- Significant environmental aspects / impacts;
- Results of your monitoring programme;
- Results of previous audits.
There are two principle considerations when auditing:
Compliance/conformance audits – ensure that management arrangements, like procedures, are being followed in order to comply with the requirements of ISO 14001.
Performance Audits – ensure that the outputs of the management arrangements are achieving their intended outcomes. For example, the results of engineering controls applied to mitigate air pollution are achieving the legal limits.
ISO 14001 demands an approach that combines both a compliance/conformance and a performance approach to auditing.
Who should perform an environmental audit?
ISO 19011:2018 – Guidelines for auditing management systems – contains information on how to choose an Environmental Auditor. Environmental Auditors should have personal attributes, such as ethics, open-mindedness, perceptiveness and tact. They should understand audit principles, procedures and techniques, and have gained experience by conducting audits. They should know the subject matter they are auditing against and how this applies to different organisations.
Audit Team Leaders should be able to plan and resource effectively, have good communication and leadership skills. Environmental Auditors should complete training and have attained an appropriate level of education. When seeking an External Auditor consider the skills outlined here.
Auditor qualifications
All auditors need to receive initial and ongoing training. EMS auditors should be trained in auditing techniques and management system concepts, environmental regulations, and facility operations. For performance audits, an auditor needs to have a good understanding of the standard and the EMS, and a broad understanding of environmental issues. Auditors should be reasonably independent of the area or activity that is being audited and can definitely not audit their own work.
An effective audit programme should:
- Develop audit procedures and protocols.
- Establish an appropriate audit frequency.
- Train auditors.
- Maintain audit records.
- Link audit results to the corrective action system.
NEW! ISO 19011:2018: Guidelines for auditing management systems
Auditors are the ears and eyes of top management because they can provide an independent appraisal of an organisation’s operations and activities. In addition, a skillful auditor will add value to a management system by finding opportunities for improvement. It’s important to note that ISO 19011:2018 has significantly raises the bar on what constitutes essential competencies that management-systems auditors need to possess or acquire.
Revisions to ISO 9001:2015 (QMS), ISO 14001:2015 (EMS), and ISO 45001:2018 (OH&S) are all based on Annex SL of ISO Directive 1, the ISO High Level Structure. Consequently, ISO 19011 includes an annex to deal with how to audit organisational context, leadership and commitment, compliance and the supply chain, amongst others. The new standard will help with the effective audit of these management systems and facilitate a uniform approach to the auditing process where multiple systems are in place.
ISO 9001:2015 – Moving Towards Certification of a Quality Management System | Risk ZA Group
ISO 9001:2015 – Moving Towards Certification of a Quality Management System
by Fiona Wayman
Quality is something every organisation strives to achieve, and it is often very difficult to attain. Issues concerning efficiency and quality come up almost daily in business, and the goal of ISO 9001:2015 is to embed a quality management system within an organisation to add value to processes, products and services. Once an organisation has implemented the QMS, regular internal audits become essential to identifying opportunities for improvement and meeting the requirements of the standard. Internal auditors are extremely valuable as they are familiar with an organisation’s management system and can significantly improve the bottom line.
Our FREE downloadable guide HOW TO AUDIT AN ISO 9001:2015 QUALITY MANAGEMENT SYSTEM explores the areas a typical Quality Management Systems audit would cover.DOWNLOAD FREE GUIDE
Moving from procedure-based to process-based auditing
ISO 9001:2015 states that the organisation must monitor, measure and evaluate processes to ensure these achieve the Quality Management System (QMS) outcomes. This requires process-based auditing and necessitates a shift in thinking. The writers of the standard hope that by strengthening the process-based requirements, aligning the clauses to the PDCA methodology and the addition of risk-based thinking, audits will take place through a series of discussions and analyses, and focus on evaluating risk, the QMS processes, and mitigation of risk to determine whether customers are consistently receiving their expected outputs or services.
All QMS auditors, internal and external, must demonstrate competence in the concepts, tools and methods for risk management and use this knowledge to investigate and evaluate conformity and effectiveness of processes and QMS outcomes. Training should focus on the significant changes to the standard and highlight key areas such as the process approach, customer focus, interested parties, outcomes, and the integration of clauses when auditing a process.
How does Risk ZA assist in achieving such an outcome?
Risk ZA offers a multitude of ISO related courses – one of which is the ISO 9001:2015 – Developing and Implementing a QMS (Registered Lead Auditor Pre-requisite). This course takes you through the following areas of the standard and a QMS.
The purpose & objectives of a QMS
This includes policies, processes and procedures required for the planning and implementation of a QMS, how to integrate internal processes to provide a process approach for executing operational activities, and covers documentation requirements.
The High-level Structure: Annex SL, and the 10 clauses:
- Scope.
- Normative references.
- Terms and definitions.
- Context of the organisation.
- Leadership.
- Planning.
- Support.
- Operation.
- Performance evaluation.
- Improvement.
Identifying the context of the organisation
An auditor must understand what the organisation does and the influences this has on the business. Context of the organisation covers requirements that impact the business strategy and planning of the QMS, such as internal and external factors that impact the sustainability of the organisation. These may include technology, economics, social factors or values, capabilities and competence. These and other strategic factors need to be used to influence the structure, content and controls of the QMS.
Determining interested parties & their requirements
As part of the context of the organisation, ISO 9001:2015 places great emphasis on relevant interested parties, and their requirements, which are also used as input to the design of the QMS.
Customer expectations & satisfaction
Quality means meeting customer expectations and satisfying them. Conformance to customer requirements and achieving customer satisfaction are crucial concepts in managing performance.
The process approach
Managing and improving processes enhances the ability to meet customer requirements. A QMS is made up of processes that link, combine and interact with one another to deliver a product or service. Understanding these as a system allows the organisation to improve effectiveness and efficiency.
The Plan-Do-Check-Act methodology
Maintenance and continual improvement of processes is achieved by applying the PDCA methodology at all levels within an organisation. Actions to address risks and opportunities must be integrated into QMS processes using the PDCA cycle.
Risk-based thinking
Risk-based thinking prevents or reduces undesired effects and promotes continual improvement. It includes identifying opportunities and considering those that can or should be acted on. Top management must implement and promote a culture of risk-based thinking when planning the QMS.
Change management
ISO 9001:2015 focuses on change management more so than earlier versions of the standard. All changes must go through a defined change management process.
Support
What support mechanisms does an organisation need to meet its goals and objectives? Support includes competent resources, targeted internal and external communications, and documented information, to name a few.
Operational planning & control
This addresses the operational part of the management system requirements, and includes in-house and outsourced processes. An organisation needs to “…plan, implement and control processes…”, determine risks and opportunities associated with these processes, and how to react to non-conformities and incidents.
Internal audit
Internal auditing fits nicely into the “check” component of the PDCA cycle. It evaluates conformance of the QMS to planned arrangements to ensure that it will consistently meet customer requirements and that the management system conforms to the requirements of both the organisation and the standard.
Management review
This addresses the question of whether the management system is suitable, adequate and effective. Top management use this review to periodically revisit the performance of all elements that comprise the QMS. It is a strategic intervention that includes changes to the context of the organisation.
Improvement
Opportunities for continual improvement must be identified, corrective actions for non-conformities taken, and an organisation needs to retain controlled documentation of all improvement activities on a continuing basis.
HOW TO CONDUCT AN ISO 9001:2015 QUALITY MANAGEMENT SYSTEM INTERNAL AUDIT
The ISO 9001:2015 Quality Management System (QMS) is internationally
recognised as the world’s leading quality management standard, and
has been implemented by over a million organisations in more than
170 countries. ISO 9001:2015 implemented to its full potential becomes
an invaluable asset to your organisation, and the standard can be
used throughout an organisation to improve performance or within a
particular site, plant or department.
ISO 9001:2105 requires that internal audits be performed at planned
intervals to establish whether the QMS conforms to the organisation’s
own requirements for a Quality Management System, and the
requirements of the ISO 9001:2015 standard; as well as to determine
whether the QMS is effectively implemented and maintained. The
following Guide To An Internal Audit Process, highlights some typical
areas an audit could address.
PLEASE NOTE:
just a Guide and is not comprehensive and audit questions will vary and be
dependent on the audit scene. send an email to me billy.sigudla@gmail.com I will send you the guide in pdf