Stronghunter358

• Internal Audit Iso
• Contoh Soalan Audit Iso 9001 2015 Clause 8 2 4

Latihan Profesionalisme dalam bidang Pengurusan Strategik dan Pengurusan Kualiti:Latihan Luar Negara:i. Strategic Management & Leadership Skills: World Trade Institute, New York, USA (1996)ii. Quality (TQM) in Education: SEAMEO Innotech, Manila (1998)iii. Strategic Planning in Education: University of York, England (2000- 2004)iv. Strategy Performance Measurement Systems: U of Adelaide, Australia (2005)C. Mempunyai sijil profesional Juruaudit (Lead Auditor) ISO 9000 sejak 1997 dan Sijil Kejurulatihan MSISO 9000 dari MAMPU.Berpengalaman menjadi juruaudit bersama dengan MAMPU serta memberi konsultasi dalampembinaan dokumen kualiti dan Audit Kualiti Dalaman.D.

Dalam penerapan ISO 9001: 2015 diperlukan beberapa dokumen persyaratan yang wajib dimiliki atau dibuat oleh perusahaan sebagai persyaratan proses audit dan sertifikasi iso. Berikut adalah daftar dokumen yang harus ada atau wajib untuk penerapan ISO 9001 yang terbaru yaitu ISO 9001:2015. Dalam mengejar persyaratan dokumen ISO 9001:2015, banyak perusahaan/organisasi yang berfokus pada membuat banyak dokumen yang dianggap berkaitan dengan Sistem Manajemen Mutu, seringkali dokumen yang telah dibuat ternyata tidak masuk dalam persyaratan yang ditetapkan dalam ISO 9001. CONTOH CHECKLIST AUDIT No Item Audit Item Evaluasi Catatan Auditor. MS ISO 9001:2015 Audit Pemantauan 2 11 –15, 18 –20 & 25 –26 SEPT. 2017 Penambahan Entiti 1. Pusat Antarabangsa 2. Institut Antarabangsa Akuakultur dan Sains Akuatik 3. Pusat Pemajuan Kompetensi Bahasa 4. Institut Kajian Perladangan 5. Pusat Zakat MS ISO 9001:2008 PENGEKALAN PENSIJILAN ISO 9001 Tahun 2018 Audit Pensijilan Semula No. Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization 4.1 Understanding the organization and its context 4.1q1 The organization shall determine external and internal issues that are relevant to its purpose.

Portal rasmi Institut Teknikal Jepun Malaysia atau dikenali sebagai JMTi.Ia merupakan sebuah Institut Kemahiran Tinggi yang berada dibawah Kementerian Sumber Manusia(KSM). MS ISO 9001: 2015 – Quality Management Systems. Print MS ISO 9001-CT. Scope of standards? Quality Management Systems (QMS) What does certify to the standard means? An organisation has established a systematic approach to instill quality by ensuring that their products meet customer requirements. This does not mean that the. INTERNAL QUALITY AUDIT CHECK LIST Management Representative ISO 9001:2008Auditee Auditor Audit. Documents Similar To Contoh Audit Internal Check List (ISO 9001. Audit dalam ms iso 1. 1 SESI 1 PENGENALAN DAN KEPENTINGAN AUDIT DALAMAN 2. 2 PENGENALAN Kriteria Audit Bukti Audit Penemuan Audit Kepatuhan Ketidakpatuhan Major ObsMinor Kesimpulan Audit Persijilan Re-Audit Skop Audit Audit Kriteria Auditor 3.

Kursus audit kualiti dalaman iso 9001 2008 • 1. 1KURSUS AUDIT KUALITIDALAMANMS ISO 9001:2008olehMuhamad Bustaman b. Abdul Manaf(Pensyarah Cemerlang DG 54)Institut Aminuddin Baki, KPM/mbustaman@iab.edu.mymbustaman@iab.edu.my • Taklimat Kursus• Pengenalan Diri • Jadual Kursus danKandungan Kursus• Peraturan SemasaBerkursusmbustaman/IAB/KPM/102 • mbustaman/IAB/KPM/103BIODATAFASILITATORMUHAMAD BUSTAMAN BIN HAJI ABDUL MANAFPensyarah Cemerlang DG 54, Instutut Aminuddin Baki, KPMA. Pengalaman: Pengurus kursus Pengurusan Strategik dan Pengurusan Kualiti di Institut AminuddinBaki semenjak 1995.1. Pengurusan Kualiti dalam pendidikan 2. Perancangan StrategikB.

Windows 3.1 video driver. Manfaat pensijilan •.

Audit Iso 9001

Kitaran pensijilan? Proses dan kitaran pensijilan Bagaimana membuat permohonan? Senarai badan pensijilanyang diiktiraf oleh Jabatan Standard Malaysia boleh diakses melalui URL yang berikut * URL mungkin berubah dari semasa ke semasa. Sila rujuk semula laman web Jabatan Standard Malaysia di jika URL tidak berfungsi. Manfaat pensijilan •.

Dalam mengejar persyaratan dokumen ISO 9001:2015, banyak perusahaan/organisasi yang berfokus pada membuat banyak dokumen yang dianggap berkaitan dengan Sistem Manajemen Mutu, seringkali dokumen yang telah dibuat ternyata tidak masuk dalam persyaratan yang ditetapkan dalam ISO 9001:2015. Untuk menghindari hal tersebut, ISO Center Indonesia akan menyebutkan dokumen & rekaman wajib apa saja yang dibutuhkan untuk memenuhi persyaratan dalam klausul ISO 9001:2015. Selain persyaratan wajib, ISO Center juga akan menyebutkan dokumen non wajib yang bisa digunakan untuk menunjang implementasi Sistem Manajemen Mutu, yang mana dokumen tersebut lazim digunakan oleh kebanyakan organisasi/perusahaan dalam implementasi ISO 9001:2015.

Pelatihan Internal Audit ISO 9001:2008 di bagian purchasing PT.GTG, setelah pelatihan audit mutu internal, menjelang pelaksanaan eksternal audit. Pelatihan Internal Audit ISO 9001 2008 ini memberikan ketrampilan bagi calon internal auditor PT GTG agar dapat melaksanakan Internal Audit ISO 9001:2008 dengan baik dan Benar, Pelatihan Internal Audit ISO 9001:2008 ini di bimbing oleh fasilitator dari Global Management Indonesia, Setelah diadakan Pelatihan Internal Audit ISO 9001:2008 selama sehari, peserta diminta untuk praktek Live Audit Secara Langsung.

It must retain evidence of audit program implementation and audit results. Internal audit is the one of the important tool required by this standard used to gauge the health of your QMS. How effective is it in meeting ISO 9001, your own QMS, customer and regulatory requirements. You must have a documented procedure for your internal audit process.The scope of your internal audit program must cover the: • Audit of operation processes to determine conformity of both product / services and their processes to customer and applicable regulatory requirements. • Audit of the QMS to determine conformity to the ISO 9001 standard. • Audit of the QMS to determine conformity to organizational requirements. • Audit of QMS processes and their interaction to determine if the QMS has been effectively implemented and maintained.

Organisasi telah mewujudkan pendekatan yang sistematik untuk menerapkan kualiti dengan memastikan produknya memenuhi keperluan pelanggan. Pendekatan ini tidak bermakna produk itu telah mematuhi standard produk, tetapi organisasi tersebut mempunyai satu sistem yang konsisten untuk menghasilkan produk yang memenuhi keperluan pelanggan. Siapakah yang perlu memohon? Mana-mana organisasi tanpa mengira saiz Standard yang digunakan? Standard Kebangsaan • MS ISO 9001:2008 -Sistem Pengurusan Kualiti - Keperluan (SEMAKAN PERTAMA) (ISO 9001:2008, IDT) atau • MS ISO 9001: 2008 - Quality Management Systems - Requirements (FIRST REVISION) (ISO 9001:2008, IDT) atau Standard Antarabangsa • ISO 9001:2008 - Quality Management Systems - Requirements *Standard bagi siri MS ISO 9000 tentang Pengurusan Kualiti juga disediakan untuk rujukan lanjut.

Bidang kepakaran lain: Change Management, Benchmarking, Balanced Scorecard (KPI), StrategicLeadership Skills, Leadership Coaching, Strategic Thinking Skills & Personal Balanced Scorecard.E. Ahli panel Sistem Star Rating KPM 2008 & Ketua Pasukan 2010.F. Timbalan Wakil Pengurusan Ssitem Pengurusan Kualiti MS ISO 9000 IAB.

Iso 9001 Audit Plan Example

Audit criteria may relate to the whole audit program as well as each individual audit. Audit methods refer to the specific techniques that auditors use to gather objective audit evidence that can be evaluated to determine conformity to audit criteria. Examples of audit methods include interview of personnel, observation of activities, review of documents and records, etc. You must define the minimum qualification requirements for internal auditors. These requirements include knowledge of QMS processes and their interaction, related QMS controls, customer requirements, applicable regulatory requirements, the ISO 9001 standard, the audit process and audit techniques. Internal auditors needs to be trained in the ISO 9001 standard as they generally audit for conformity to organizational requirements and also for conformity to ISO 9001 requirements. Additionally, the ISO Guidelines for quality and environmental auditing says that auditors should have knowledge of quality management system standards and their application to the organization.

Aspek – aspek yang saya tanyakan diupayakan dalam kerangka menyeluruh untuk membahas sebuah sistem secara utuh. Seluruh cabang pikiran ini bisa ditanyakan atau hanya sebagian tergantung situasi dan kondisi pada saat audit. Contoh yang diberikan merupakan contoh sederhana ketika kita membahas prosedur penerimaan surat yang memang secara umum selalu ada pada setiap organisasi.

Are the practices being carried out well? The presence of nonconformities in a department or process may indicate the system is ineffective for those areas. 9.2 Internal Audit 9.2.1 The organization should conduct internal audits at planned intervals to provide information on whether the quality management system conforms to the organization’s own requirements, the requirement of ISO 9001:2015 standards and is effectively implemented and maintained 9.2.2 The organization must plan, establish, implement, and maintain an audit program, which must include frequency, methods, and responsibilities, planning requirements and reporting.

Sila layari untuk mendapatkan standard tersebut. Standard-standard lain bagi siriISO 9000 boleh didapati di. Kitaran pensijilan? Proses dan kitaran pensijilan Bagaimana membuat permohonan? Senarai badan pensijilanyang diiktiraf oleh Jabatan Standard Malaysia boleh diakses melalui URL yang berikut * URL mungkin berubah dari semasa ke semasa. Sila rujuk semula laman web Jabatan Standard Malaysia di jika URL tidak berfungsi.

• mbustaman/IAB/KPM/104 • mbustaman/IAB/KPM/105 • mbustaman/IAB/KPM/106 • mbustaman/IAB/KPM/107 • mbustaman/IAB/KPM/108 • m bustaman/IAB/KPM/10 9OBJEKTIF UTAMA• Untuk melengkapkan pesertadengan pengetahuan dankemahiran yang diperlukan untukmelaksanakan audit kualitidalaman ke atas pelaksanaansistem pengurusan kualiti MS ISO9001:2008 dengan berasaskanStandard Management SystemAuditing ISO.

The Process manager must also report any opportunities for QMS improvement. The Process manager must analyze the results of each audit as well as the annual audit program to determine strengths and weaknesses in QMS processes, interactions, functions, products, etc., to identify and prioritize opportunities for improvement. Audit records include annual audit schedule, audit planning such as criteria, scope, frequency, methods, auditor selection and assignment, etc., auditor competence and training, audit checklists and forms, audit notes and other evidence gathered, audit findings, nonconformity reports, audit reports, corrective actions and follow-up of internal audit nonconformities, analysis of audit program performance indicators and trends, and identified improvement opportunities. Performance indicators should be used to measure the effectiveness of your internal audit process and monitor trends in these indicators, to continually improve your audit program. Performance indicators may include reducing the number of – late or delayed audits, incomplete audits, incomplete audit records and late reports, auditor errors, auditee complaints, and use of untrained auditors, etc. The output of your internal audit program may be used as performance indicators to: • Determine the degree of conformity of the QMS to ISO 9001, customer and regulatory requirements. • Determine the effectiveness of QMS implementation and maintenance.

It must have management support and resources behind it. Audits must be performed in an impartial manner, which requires auditors to have freedom from bias or other influences that could affect their objectivity. For example, having responsibility for the work, or a vested interest or shares in a supplier or third party company they are assigned to audit, would be conflicts of interest. Internal audits must be carried out to a procedure according to requirements given in clause 9.2 of ISO 9001:2015. The procedure must address the responsibilities for conducting the audits, ensuring independence, recording results, and reporting to management. Audits obtain objective evidence of conformity with requirements. The evidence must be based on fact and may be obtained through observation, measurement, test, or by other means. Evaluating the extent to which audit criteria are fulfilled involves an assessment of both implementation and effectiveness. Is the organization practicing what it described in its documentation?

• Determine the degree of conformity of product to contractual and regulatory requirements. • Identify areas of the QMS that need improvement. Audit Objectives Always establish the objectives of the audit. Audit objectives are not limited to the ISO 9001 standard. Clear audit objectives help determine the scope and depth of the audit, as well as, the resources needed.

In determining the time frame for your audit program, you should consider organization size, complexity of product and processes, health of the QMS, customer, registrar and regulatory requirements, etc. The most common time frame is six months. Consider adjusting the audit frequency and perhaps even the audit scope, of specific processes or group of processes, when: • You experience internal or external nonconformities. • Get customer complaints. • Have critical or high risk processes. • Have frequent or significant changes to processes and product. Your internal audit program should consider the following: • Input from audited area and related areas • Key customer oriented processes • Process and product performance results and expectations • Opportunities for continual improvement • Feedback from customers Audit criteria, refers to the specific QMS policies, objectives, ISO requirements, documentation, customer and regulatory requirements, etc., that the audit is referenced to or conducted against.

While making an audit program, consideration must be given to the importance of concerned processes, changes impacting the organization and the results of previous audits. It must define audit criteria and scope for each audit.

ISO 9001:2015 Clause 9.2 Internal Audit Definition: ISO defines audits as “Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.” Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for management review and other internal purposes, and may form the basis for an organization’s declaration of conformity. In many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited. External audits include those generally termed second- and third-party audits. Second-party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing organizations,such as those providing certification/ registration of conformity to ISO 9001 or ISO 14001. When two or more management systems are audited together, this is termed a combined audit. When two or more auditing organizations cooperate to audit a single auditee, this is termed a joint audit. Introduction: An audit is a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Audits are structured and formal evaluations. The term systematic means the company must plan and document its system for auditing.

Sederhana kan?? Tapi kenapa pada saat mereka bertanya ternyata sering menyusahkan? (setidaknya untuk beberapa orang pertanyaan auditor eksternal cukup memusingkan hehehe) Ini disebabkan karena auditor eksternal telah terlatih untuk mengembangkan daftar pertanyaan sesuai dengan situasi dan kondisi serta respon dari auditeenya. Menanyakan beberapa pertanyaan yang sama berulang-ulang pada orang yang berbeda akan membuat anda kaya dengan segala macam respon yang timbul dari pertanyaan tersebut. Hal ini juga membuat anda terlatih untuk menggali informasi lebih dalam dari salah satu pertanyaan di atas.

Nah terkait dengan pertanyaan audit internal ini, sebagai konsultan saya sering ditanya bagaimana cara membuat pertanyaannya setidaknya yang sesuai dengan tujuan untuk memenuhi persyaratan? Wah klo di tanya seperti ini jawabannya adalah table di atas sayangnya table ini tidak aplikatif saat digunakan untuk audit internal karena keterbatasan kemampuan dan pengalaman auditor internal yang memang tidak di didik untuk menjadi auditor. Jadi saya mencoba menggambarkan pola pikir saya untuk lebih menjelaskan pertanyaan – pertanyaan apa saja yang perlu di pertanyakan pada saat audit internal. Gambar di atas adalah gambar yang memperlihatkan cabang – cabang pola pikir saya saat menyusun pertanyaan untuk audit internal.

Auditor should be Independence. During the audit Auditors should ensure that the objectivity and impartiality of the audit is not compromised. Auditors cannot audit their own work. Auditor independence must be ensured when assigning personnel to specific audits. Process owners must take timely corrective action on nonconformities found in their area. They should use the corrective action procedure to determine root cause, take appropriate action and follow-up to determine if results indicate that the root cause has been eliminated. Audit results must be summarized and reported for management review.

What is an ISO Internal Audit? The purpose of an internal audit is to assess the effectiveness of your organization’s quality management system and your organization's overall performance. Your internal audits demonstrate compliance with your ‘planned arrangements’, e.g. the Quality Management System (QMS) and how its' processes are implemented and maintained.

Contents

Why perform Internal Audits?

Your organization will likely conduct internal audits for one or more of the following reasons:

1. Ensuring compliance to the requirements of internal, international and industry standards & regulations, and customer requirements
2. To determine the effectiveness of the implemented system in meeting specified objectives (quality, environmental, financial)
3. To explore opportunities for improvement
4. To meet statutory and regulatory requirements
5. To provide feedback to Top Management

Principles of Internal Auditing

Auditing relies on a number of principles whose intent is to make the audit become an effective and reliable tool that supports your company’s management policies and policies whilst providing suitable objective information that your company can act upon to continually improve its performance.

Adherence to the following principles are considered to be a prerequisite for ensuring that the conclusions derived from the audit are accurate, objective and sufficient. It also allows auditors working independently from one another to reach similar conclusions when auditing in similar circumstances.

The following principles relate to auditors.

1. Ethical conduct: Trust, integrity, confidentiality and discretion are essential to auditing
2. Fair presentation: Audit findings, conclusions and reports reflect truthfully and accurately the audit activities
3. Professional care: Auditors must exercise care in accordance with the importance of the task they perform;
4. Independence: Auditors must be independent of the activity being audited and be objective
5. Evidence-based approach: Evidence must be verifiable and be based on samples of the information available.

Internal Audit Iso

Selection of Auditors

Contoh Soalan Audit Iso 9001 2015 Clause 8 2 4

Competence level may be measured by training, participation in previous audits and experience in conducting audits. Auditors may be external or internal personnel; however, they should be in a position to be impartial and objective.

When internal personnel are selected to perform an audit, a mechanism needs to be established to ensure objectivity, for instance, a representative from another department may be selected to do the audit.
Audits are demanding and require various forms of expertise. The size of the audit team will vary pending the size of the organization, size and type of operations and the scope of the audit.

Preparing for the Audit

Before the audit, prepare thoroughly! Spending time in preparation will make you much more effective during the audit - you will become a better auditor. Auditors should not skip this step as it provides much needed value to the audit. Taking the time to prepare and organize actually saves time during the audit.

You should have an up-to-date audit schedule and a well defined audit plan for each process. Be sure to communicate the audit schedule to all parties involved as well as to Top Management as this will help reinforce your mandate.

Gather together all the relevant documented information that relates to the process you will be auditing. Look at process metrics, work instructions, turtle diagrams, process maps and flowcharts, etc. If applicable, collect and review any control plans and failure mode effects analysis work sheets too. Review these thoroughly and highlight the aspects that you plan to audit. Using the documented information in this way ensures they become audit records.

Your organization’s documented information may not cover all of the requirements that may be relevant to the process. If certain information is not available, it may become your first audit finding, not bad for the pre-audit review!

Certain information and linkages should be audited. Some are required and some are simply good audit practice. Putting these sections into a worksheet format gives auditors a guide to follow, to ensure the relevant links are audited.

The Human Aspect of Auditing

Good auditors realize very early on that they are dealing with personalities as much as processes and systems. Whilst the intent of the audit a serious one, often light humor, politeness and diplomacy are the best ways to build rapport. It is vital every effort is made to reassure those being audited that the audit’s primary function is to drive improvement, not to name and shame.

If you are new to auditing, acknowledge this fact, be open and honest. It is also important to explain to the auditees that they are free to express their views during the audit. Remember that you, the auditor, are also there to learn.

Always discuss the issues you have identified with the auditees and always provide guidance on what is expected in terms rectifying any non-conformances or closing out observations you raised. Let the auditees know they are welcome to read your notes and findings; the audit is not a secret.

Try not to be drawn into arguments concerning your observations. It is never appropriate to directly name people in the audit report as this may lead to defensiveness which is ultimately counter productive.

Definition of Internal Auditing

'Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes.'

Source: International Professional Practices Framework (IPPF), The Institute of Internal Auditors Research Foundation. Florida, USA, January 2011

Types of ISO Internal Audit

Internal audits are commonly referred to as ‘first-party audits’ and are conducted by an organization to determine compliance to a set of requirements which might arise from standards like ISO 9001:2015, as well as customer or regulatory requirements.

There are common methods of internal auditing that may be used to determine compliance:

1. System Audits
2. Process Audits
3. Product Audits

System Audits

The system audits are best undertaken using the internal audit checklist. This type of audit focuses on the organization’s quality management system as a whole, and compares the planning activities and broad system requirements to ensure that each clause or requirement has been implemented.

Process Audits

The process audit is an in-depth analysis which verifies that the processes comprising the management system are performing and producing in accordance with desired outcomes. The process audit also identifies any opportunities for improvement and possible corrective actions. Process audits are used to concentrate on any special, vulnerable, new or high-risk processes.

Product Audits

The product audit may be a series of audits, at appropriate stages of design, production and delivery to verify conformity to any specified product requirements, such as dimensions, functionality, packaging and labeling, at a defined frequency.

So, how is an audit conducted?

Use an Internal Audit Checklist

An internal audit checklist will help you to determine the extent to which your organization’s quality management system conforms to the requirements by determining whether those requirements have been effectively implemented and maintained. The

The internal audit checklist is just one of the many tools which are available from the auditor’s toolbox that helps to ensure each internal audit addresses the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:

1. Checklists can be used as a reference for planning future audits
2. Checklists can be provided to the auditee prior to the audit
3. Checklists can provide a means of communication
4. A completed checklist provides evidence the audit was performed
5. Ensures the audit is conducted systematically and consistently
6. Ensures a consistent audit approach
7. Actively supports the organization’s audit process
8. Provides a repository for notes collected during the audit process
9. Ensures uniformity in the performance of different auditors
10. Provides reference to objective evidence
11. Audit checklists provide assistance to the audit process

The internal audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2015, each requirement is phrased as a question.

Do We Need An Internal Audit Procedure?

Yes, we recommend you document an Internal Audit Procedure - this addresses two of the ISO 9001 clauses - Performance Evaluation and Improvement. It will greatly help you with the process of auditing and internal audit management.

Control of Internal Audits Procedure

The purpose of this procedure is to define your organization’s process for undertaking QMS audits, process audits, and supplier and legislation audits in order to assess the effectiveness of the application of the quality management system and its compliance to ISO 9001:2015.

This procedure also defines the responsibilities for planning and conducting audits, reporting results and retaining associated records.

Looking For Help with Your Internal Audit Procedure?

Our Control of Internal Audits Procedure includes:

• Procedure - view sample
• Internal Audit Porcess Flowchart
  
• Audit Report
  
• Audit Feedback Form - view sample
• Internal Audit Process Map - view sample

Save Time and Money — Proven to Work

Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our Internal Audit Checklist.

A Gap Analysis

The gap analysis will likely be your first ISO 9001:2015 internal audit. The gap analysis checklist highlights the new requirements contained in ISO 9001:2015 but it not intended to cover all of the requirements from ISO 9001:2015 comprehensively.

The unique knowledge obtained about the status your existing quality management system will be a key driver of the subsequent implementation approach. Armed with this knowledge, it allows you to establish accurate budgets, time-lines and expectations which are proportional to the state of your current management system when directly compared to the requirements of the standards.

Your organization may already have in place an ISO 9001:2008 compliant quality management system or you might be running an uncertified system. If this is the case, you will want to determine how closely your system conforms to the requirements ISO 9001:2015.

The results of a gap analysis exercise will help to determine the differences, or gaps, between your existing management system and the new requirements. Not only will the analysis template help you to identify the gaps, it will also allow you to recommend how those gaps should be filled.

The gap analysis output also provides a valuable baseline for the implementation process as a whole and for measuring progress. Try to understand each business process in the context of each of the requirements by comparing different activities and processes with what the standard requires. At the end of this activity you will have a list of activities and processes that comply and ones that do not comply. The latter list now becomes the target of your implementation plan.

Don’t Try to Manage It All Alone!

Take a look at our Gap Analysis Checklists.

Preparing the Audit Report

A good summary report is the output which is the value of the audit. It deserves an appropriate amount of attention and effort. As you moved through the audit, you should have noted the issues and improvements you saw. These should have been marked clearly so you are now able to quickly review and capture them as you write the report.

These findings and conclusions should be formally documented as part of the summary report. Too often, the audit report only recites back facts and data the managers already know. The value is in identifying issues and opportunities they do not know! This summary should be reviewed first with the lead auditor, then the Process Owner and Management Team. Make final revisions and file the audit report and all supporting audit materials and notes.

Gather the whole audit package together, in an organized manner. The rest of the work instructions, flowcharts, notes and relevant papers should be gathered into the audit package as supporting records. All findings should also be documented on your corrective action forms. The audit summary and the corrective action forms should be attached to the audit package, which now becomes the audit record. Only the summary report and corrective actions need be given to the process owner.

Elementary Audit Questions

These basic audit questions will help guide the audit in the right direction since the answers they provide often unlock the doors to information the auditor requires in order to accurately assess the particulars of a process.

Consider these common audit questions:

1. What are your responsibilities?
2. How do you know how to carry them out?
3. What kind of training is given to new employees?
4. How is the effectiveness of training evaluated?
5. Are training records maintained?
6. What are the objectives of your processes?
7. What is the quality policy and where is it found?
8. Which documents do you use and are they correct?
9. What outputs does your process create?
10. How are your records maintained?
11. How do you ensure that products meet the stated requirements?
12. Is customer satisfaction data analyzed?
13. How do you ensure that products meet the stated requirements?
14. What happens when changes are made to product requirements?
15. What are the responsibilities/authorities for dealing with non-conformances
16. Are there trends in non-conforming products and what's being done about it?
17. Is the non-conformance procedure linked to the corrective action process?
18. Are employees made aware of the quality policy and objectives?
19. Are policies and objectives available and relevant?
20. How are quality objectives determined?
21. Is there a clear link between the policies and objectives?
22. How is progress towards objectives measured and communicated?
23. Has the number of customer complaints changed over time?
24. What tools are used to identify the causes of complaints?
25. How are improvement efforts and successes communicated to employees?

Getting the Most from the Audit Schedule

The audit schedule is divided up to reflect each section of ISO 9001 You should determine which of these sections are of greatest relevance to your business; in other words, which processes, should there be problems, will affect your customers the most. These are the processes that your company must make certain remain stable and consistent. You might wish to schedule these key processes for additional audits, perhaps two or even three times per year.

The audit schedule provides the following benefits:

1. Provides a visual plan of the audit programme
2. Demonstrates coverage of the whole standard
3. Provide current status of the audit programme
4. Promotes awareness

Other types of Audit

• Certification Audit (also know as an ISO Compliance Audit)
• Surveillance Audit (this is also an ISO Audit)

Is a Certified Auditor 'Required' To Do An ISO Audit or Can the Company do the ISO Audit Themselves?

You do not need a 'Certified Auditor' to undertake internal quality audits of your management system and its processes.

Certified Auditors normally work for external, third-party accreditation bodies such as DNV, UKAS, LRQA, who will perform the Certification Audit, that is, assess your organization's management system against the requirements of ISO 9001 and provide your certificate of compliance. They will also conduct Surveillance Audits to ensure that your certification is maintained. They would not be involved in day-to-day internal auditing operations.

Internal Auditors can be people from within your organization who posses the necessary competence and impartiality to undertake internal audits in order to ensure effective operation of your organization's processes. The Internal Auditors often report to the Quality Manager.

Internal Auditing & Gap Analysis