ISO 9001 QMS

 

WHAT IS QUALITY?

standard of something as measured against other things of a similar kind; The degree of excellence of something.

WHY IS EVERYONE TALKING ABOUT QUALITY?

-Quality makes brand distinct

-It gives organization a good face

-Give customers product or services assurance

-Reduce the risk of customers dissatisfaction

-Reduce the cost of providing warranty services

-Reduce the risk of being rejected due to compliance with national or international standard  issues.

-Quality is critical to satisfied customer.

IS QUALITY EXPENSIVE?

No it’s not!

Quality is not expensive, its priceless

ANALYZING  COST OF QUALITY VES COST POOR QUALITY

COST OF GOOD QUALITY

-Quality planning

-Process control

-Investing in quality related information

-Quality training and workforce development

-Product design vetting

-System development and management

-Final test

-Quality audit

-Field test

COST OF POOR QUALITY

-Rejection

-External failure cost

-Customer dissatisfaction cost

-Lost of reputation cost

-Lost of sales

-Penalties / punishment

-Cost of compensations

WHAT IS A QUALITY MANAGEMENT SYSTEM?

-A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

-A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

BENEFITS OF QMS

Improving processes

Reducing waste

Lowering costs

Facilitating and identifying training opportunities

Engaging staff

Setting organization-wide direction

WHO IS ISO?

The International Organization for Standardization

-Founded on 23 February 1947

-By representatives from various national standards organizations.

– Has its headquarters in  Geneva, Switzerland

– works in 164 countries.

WHAT EXACTLY IS ISO CERTIFICATION?

ISO certification certifies that a management system, manufacturing process, service, or documentation procedure has all the requirements for standardization and quality assurance.

ISO (International Organization for Standardization) is an independent, non-governmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems.

ISO 9001 DEFINITION

The certification ISO 9001:2008 includes three components: ISO, 9001, and 2015.

Here’s what each component represents:

9001 – Standard classification

2015-  The version of the standard that’s being met and is represented by the calendar year those standards were launched.

WHAT DOES ISO 19001 CERTIFICATION MEAN?

If an organization bills themselves as “ISO 9001 Certified,” this means that the organization has met the requirements designated under ISO 9001

THE INTERNAL AUDITOR COURSE

WHO IS AN INTERNAL AUDITOR?

• 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

WHY PERFORM INTERNAL AUDITING ?

(i)  Ensuring compliance to the requirements of internal, international and industry standards & regulations, and customer requirements

(ii) To determine the effectiveness of the implemented system in meeting specified objectives (quality, environmental, financial)

(iii) To explore opportunities for improvement

(iv) To meet statutory and regulatory requirements

(V)To provide feedback to Top management

PRINCIPLES OF INTERNAL AUDITING

Ethical conduct: Trust, integrity, confidentiality and discretion are essential to auditing.

Fair presentation: Audit findings, conclusions and reports reflect truthfully and accurately the audit activities.

Professional care: Auditors must exercise care in accordance with the importance of the task they perform;

Independence: Auditors must be independent of the activity being audited and be objective.

Evidence-based approach: Evidence must be verifiable and be based on samples of the information available.

PREPARING FOR THE AUDIT

Before the audit, prepare thoroughly!

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.

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.

Types of Internal Audit

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

.ISO 9001 QMS Auditors must be:

Be open-minded and mature

Possess sound judgment, analytical skills, and tenacity

Have the ability to perceive situations in a realistic way

Understand the role of individual units within the overall organization

Understand complex situations from a broad perspective

Audit program objectives

Objectives should be established for an audit program to direct the planning and conduct of audits. These objectives should be based on consideration of:

Management priorities

Commercial intentions

Management system requirements

Statutory, regulatory and contractual requirements

Need for supplier evaluations

Customer requirements

Needs of other interested parties

And risks to the organization

Audit program procedures

Planning and scheduling audits

Assuring the competence of auditors and audit team leaders

Selecting appropriate audit teams and assigning their roles and responsibilities

Conducting audits

Conducting audit follow-ups, if necessary

Maintaining audit program records

Monitoring the performance and effectiveness of the audit program

Reporting to top management on the overall achievements of the audit program

A Good Auditor

Good auditors realize very early  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.

every effort is made to reassure those being audited that the audit’s primary function is to drive improvement, not to name and shame.

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.

The Human Aspect of Auditing

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.

The checklist
The 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.

CHECKLIST PREPARATION

The primary aim of the checklist is to help the auditor to ensure the depth and continuity of the audit, plus it will save time during an audit and the auditor to come to an informed judgment. The company conducting the audit usually defines the format of the checklist.

CHECKLIST BENEFITS

Identifies relevant samples

Defines a formal audit process

Requires helpful research

Helps maintain the pace of audit

Keeps audit objectives clear

Gives historical reference as an audit record

Reduces workload on auditor during the audit

Assures auditee of auditor professionalism

Provide space for audit notes

Correct Use of the checklist
will provide the following benefits

Checklists can be used as a reference for planning future audits

Checklists can be provided to the auditee prior to the audit

Checklists can provide a means of communication

A completed checklist provides evidence the audit was performed

Ensures the audit is conducted systematically and consistently

Ensures a consistent audit approach

Actively supports the organization’s audit process

Provides a repository for notes collected during the audit process

Ensures uniformity in the performance of different auditors

Provides reference to objective evidence

Audit checklists provide assistance to the audit process

HOW TO CREATE AUDITORS CHECKLIST

Sketch out the main subject headings for the audit checklist to help paint a picture of the necessary pieces of an audit.

NOTE:

FOR A SYSTEM AUDIT: Subject headings should include “Management,” “Finance” and “Operations.” These subject headings relate to the various aspects of the business you should focus on when conducting an audit.

HOW TO CREATE AUDITORS CHECKLIST

1. Identify Requirements

Your first step in identifying requirements is to fully comprehend the audit objective and scope as well as the context of the audit.

I. Next, determine the relevant national  operational requirements by looking up regulations, standards, orders, and notices as well as related guidelines in manuals, handbooks, etc.

1. The requirements should be as narrow and focused as possible. For example, if you are auditing compliance with issuance of weather notices, you would review weather-related requirements.  Once you have identified a relevant requirement, enter it in the Requirement field of the Audit Checklist.  One checklist should be used for each requirement.

Develop Checklist Questions

The checklist questions should be worded so as to be answerable only by “yes,” “no,” or “not-verifiable.”  The questions should be explicit, evidence-based, and written in a way that elicits answers clearly indicating compliance or noncompliance with the requirement.

COMPLETING THE CHECKLIST, RECORD EVIDENCE OR OBSERVATION

In addition to determining compliance with the requirement, you should complete the Evidence and/or Observation field of the checklist for each question

You must provide a brief explanation of how you determined compliance.  Be sure to record specific information about what you reviewed and observed (e.g., name, document title, date, time, operation observed, position, etc.).

You should also consider peripheral issues that may be relevant to (but not necessarily mandated by) the specific requirement in the checklist.  Or, you may find safety critical or other items that should be recorded here, too.

ADDITIONAL COMMENTS

Use this space for additional comments or in the event you don’t have enough room in the evidence and/or observation box above.

IMPORTANT QUSTIONS TO INCLUDE IN YOUR AUDIT CHECKLIST ALSO

TYPICAL SAFETY CHECKLIST QUSTION:

CHECK DOCUMENTATION

ISO 9001: 2015 clause 4.2.2 said we check see that quality manual and process documentation are intact

CHECK DOCUMENTATION QUSTIONS?

Do you have a well written quality manual?

CHECK FOR DOCUMENT CONTROL

CHECK FOR CUSTOMER FOCUS

ISO 9001: 2015 clause 5.2 said we check see that management

Is customer focused.

CHECK FOR PLANNING OF PRODUCT REALIZATION

ISO 9001: 2015 clause 7.1 that organizational expectation of

Product realization is with quality as specified by quality objectives.

CHECK FOR CONTROL OF NONCONFOMITIES

ISO 9001: 2015 clause 8.3 is asking the organization to identify and track products that are not conforming to standard.

CHECK FOR MANAGEMENT COMMITMENT

ISO 9001: 2015 clause 5.1 said we check see evidence of management committeemen

SKILLED IN AUDIT QUSTIONS

Is this the best place in the plant for achieving this station’s objective?

How does the location fit into your process in terms of shipping, receiving and safety?

Does the station have the appropriate equipment and fixtures for the task?

Are error-proofing devices available and functioning correctly? Do operators use them every time?

CHECK PROCESS FOR REPORTING ISSUES

A robust process for reporting issues is critical to creating a culture of quality. Because if you don’t act on issues quickly, people are less likely to speak up when they see problems.

Process audit checklist questions for this area might ask:

CHECK DOCUMENTATION OF PROCESSES

ELEMENTRY AUDITING QUSTIONS

Is customer satisfaction data analyzed?

How do you ensure that products meet the stated requirements?

What happens when changes are made to product requirements?

What are the responsibilities/authorities for dealing with non-conformances

Are there trends in non-conforming products and what’s being done about it?

Is the non-conformance procedure linked to the corrective action process?

How are your records maintained?

How do you ensure that products meet the stated requirements?

Is customer satisfaction data analyzed?

How do you ensure that products meet the stated requirements?

What happens when changes are made to product requirements?

What are the responsibilities/authorities for dealing with non-conformances

Are there trends in non-conforming products and what’s being done about it?

Is the non-conformance procedure linked to the corrective action process?

GAP ANALYSIS

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

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.

THERE ARE 10 ISO 9001 CLAUSES

1. SCOPE

The first step of the process is Scope. The scope is something that is defined and written down by the company personnel, and essentially outlines the goals that they will go forth with during the ISO 9001 implementation process.

2. NORMATIVE REFERENCES

References provide a better understanding of the basic ISO terms through relatable comparisons, while the terms and definitions section highlights vocabulary words that are used in the ISO 9001 standard, along with exactly what they mean.

3. TERMS AND DEFINITION 

Definitions of various terms referred in the standard.

4. GENERAL QUALITY
MANAGEMENT SYSTEM

4.1 Represents the Organization and its Context:

evidence should be obtained that proves that your organization is reviewing all pertinent internal and external issues at periodic intervals.

4.2 a suitable understanding of the relevant interests of relevant interested parties that impact the QMS.

4.4 the QMS and its processes

review how your organization has designed its process-based management system.

Existing operational procedures, work instructions and flow charts are valid examples of documented information and can be used to evidence the requirement for ‘documented information to support the operation of processes is being met’.

. Look for evidence that your organization has:

1.Implemented measurement criteria; (Clause 9.0)

2. 2 Provided resources; (Clause 7.1)
3. Assigned duties/process owners; (Clause 5.3)
4. Assessed risks and opportunities; (Clause 6.1)
5. Improved its processes and the QMS; (Clause 10.0)
6. Maintained and retained documented information. (Clause 7.5.1)

Based upon the extent of your organization’s QMS and processes, you should seek and record evidence that your organization has maintained documented information to support the operation of its processes; and that it has retained documented information to provide confidence that the processes are being carried out as planned.

4.3 Determine the scope of QMS

You will need to verify that your organization’s scope exists as documented information (which may be in the form of a Quality Manual)

There is no requirement for documented information to define the context of the organization, your organization will find it helpful to retain the types of documented information listed below to help justify compliance:

1. Business plans and strategy reviews;\
2. Competitor analysis;
3. 3. Economic reports from business sectors or consultant’s reports;
4. 4. SWOT analysis;
5. 5. Minutes of meetings (Management and design review minutes);
6. 6. Process maps, tables, spreadsheets, mind mapping diagrams;

5. LEADERSHIP (MANAGEMENT COMMITMENT

This clause require top management demonstrate leadership and commit to ensuring that risks and opportunities that can affect the conformity of a product or service are determined and addressed.

i. Management commitment

ii.Customer focus

iii.Quality policy

6. RESOURCE MANAGEMENT

This clause  require your organization take action to identify risks and opportunities, and plan how to address the identified risks and opportunities.

1.  Resources that are provided by management
2. Work environment guidelines

iii. Human Resources training, awareness, competence, etc.

7. SUPPORT 

1. i. Deciding on product/service goals
2. Planning and executing

iii. Control of equipment (measurements, monitoring, etc.)

The product realization clause has to do with the general outputs of the company. More specifically, this is a set of guidelines for what the company produces and puts out to its customers.

The actual product realization steps include planning what the product or service will be and executing it.

8. SUPPORT 

Finding out customer requirements, designing, delivering, post delivery support.

Customer satisfaction

Internal audit guidelines

Monitoring of product/service execution

Control of non-conforming product/services

Improving/correcting upon non-conformities

9. PERFORMANCE EVALUATION  

Customer satisfaction, analysis, internal audits and management review.

10. PERFORMANCE EVALUATION  

Nonconformity, corrective actions and continual improvement.