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ISO 9001: 2015

ISO 9001: 2015

Is Your Organization Concerned?
  1. Superior Quality 
  2. Risk-based thinking
  3. Customer Satisfaction 
  4. Better Market Image 
  5. Productivity & efficiency Improvement
  6. conformance to international standards
  7. International acceptance  
  8. Topline growth & bottom-line improvement

ISO 9001 requirements are generic and intended to be applicable to any type of organization

How Can “Aisc Group” Help?

Our Team offers a variety of Consulting Services and Solutions.

We understand that each organization or person is unique. Our Solutions are comprehensive and will be customized to meet your specific needs.

  1.   Provides a well-planned and stage-by-stage audit program.
  2.   A sound, coherent and non-disruptive assessment.
  3.   We have an enviable record of customer satisfaction.
ISO 9001 Quality Management Principles

The ISO 9001 series of standards-based is on eight dynamic Quality Management System Principles. These Principles are:- 

  1. Customer Focus
  2. Leadership
  3. Engagement of People
  4. Process Approach
  5. Continual improvement
  6. Evidence-based decision making
  7. Relationship management
ISO 9001, the requirement standard, includes the following main sections:
  1. Quality Management System
  2.     Management Responsibility
  3.     Resource Management
  4.     Product Realization
  5. Measurement Analysis and Improvement

 

How Do Businesses Benefit from ISO 9001: Certification?

Your organization, whatever your business lines are, realizes a handful of benefits through certification against ISO 9001:2015 Standards, which confers upon your business an infinite vista for returns. Such benefits can be categorized as follows.

Internal Benefits: -
  • Better management of core business processes.
  • ­   Increased awareness of quality among staff.
  • ­   Improved productivity and quality.
  • ­   Improved internal communications.
  • ­   Reduced wastage and cost per unit/service through
  • ­  improved product reliability
  • ­  better process control and flow of internal processes and improving process design
  • ­  improved consistency of service and product performance
  • ­  optimal use of resources and time
  • ­  reduction in product scrap, rework, and rejection
External Benefits: -
  • ­Competitive Advantage and increased marketing and sales opportunities through access to new markets.
  • Improves Customer Demand.
  • Protect Your Business.
  • Easy & Cost-Effective.
  • Qualify for Contracts.
  • Increased Credibility.
  • Enhancing higher customer satisfaction levels.
  • Better meeting the continuously increasing customer needs and minimizing risks inherent in unmet customer expectations.

Compliance to 9001:2015 required by customers in their tendering and purchase specificationPlacing the business on the competitive edge through consistent quality products providing greater confidence on the part of customers

Describing and documenting the business’s commitment to quality, as well as to its policies and procedures

Involving and motivating the management and staff leads to higher performance levels as well as improved staff communication, morale, and job satisfaction

Through its worldwide acceptance and use, the 9001:2015 Standards provide an effective means for improving the performance of individual organizations and provide confidence to people and organizations that products, goods, and services will meet their expectations, thereby enhancing trade, global prosperity, and individual well-being

What is ISO 9001 standard/certification?

ISO 9001:2015 is an international standard that gives requirements for an organization’s Quality Management System (“QMS”). It is part of a family of standards published by the International Organization for Standardization (“ISO”) often referred to collectively as the “ISO 9000 series”. For this reason, you may sometimes hear your suppliers refer to being “ISO 9000 certified”, or having an “ISO 9000-compliant QMS”. 

This will normally mean that they are claiming to have a QMS meeting the requirements of ISO 9001:2015, the only standard in the ISO 9000 family that can be used for the purpose of conformity assessment. It is important to understand however, that ISO is the body that develops and publishes the standard – ISO does not “certify” organizations, certification done by various certification bodies against ISO 9001 QMS standard published by ISO.

The objective of ISO 9001:2015 is to provide a set of requirements that, if they are effectively implemented, will provide you with confidence that your supplier can consistently provide goods and services that:

  1. Meet your needs and expectations and – comply with applicable regulations
  2.  It covers a wide range of topics, including your supplier’s top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery, and relevant administrative and support processes),
  3. Quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions, and a requirement to drive continual improvement of the QMS.
  4. Finally, yet importantly, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides.

ISO 9001 is an international quality certification that defines minimum requirements for a company’s Quality Management System (QMS). A company’s QMS comprises the organization’s policies, procedures, and other internal requirements that ensure customer requirements are met with consistency resulting in customer satisfaction.

Some of the areas of the company within the scope of ISO 9001 include:
  • Context of the organization
  • Risk-based thinking
  • Customer contracts
  • Hiring and employee training
  • Design and development of products and services
  • Production and delivery of products and services
  • Selection and managing of suppliers
  • Management responsibility
    •   Internal quality audits
    •   Monitoring and measuring
    •   Continual improvement
    •   Corrective and preventive action-

To receive an ISO 9001 certification a company must put the required QMS processes and controls in place, monitor the performance of its processes, and demonstrate continual improvement. Most companies hire an experienced consulting firm to assist with these preparations. Once the QMS is in place, a registrar (or certification body) is hired to audit the company’s compliance with ISO 9001 requirements. If discrepancies are found during the audit, they must be corrected before the ISO 9001 certificate is issued. The ISO 9001 certification must be maintained through regular audits (bi-annual or annual) conducted by the selected registrar.  

What is a Quality Management System?

A Quality Manual will describe briefly how your quality system meets the requirements of the standard. There will be procedures for required areas of the standard and procedures you determine needed.

Work Instructions will describe how specific tasks are done. You decide what work instructions you need to provide a consistent product or service and to serve as training tools. Work instructions can be detailed or outlined or checklists.

Records will be kept demonstrating that documented procedures and work instructions were followed. All required records must be maintained.

 

Procedures, work instructions, job descriptions, or other responsibility documents will clearly describe employee responsibilities.

An internal audit program will continually evaluate the quality system and highlight areas for improvement.

Corrective and preventive action processes will allow problems to be fixe and verified for effectiveness.

Information from corrective actions, internal audits, process measurements, and product measurements will review by management on a regular basis. Management will be informed on the quality system performance and will act for continual improvement. Registration and surveillance audits by the registrar will confirm your system is working effectively.

What are the benefits of the ISO 9001:2015 Quality Management System?

Increased Quality Awareness and Internal Advantages There are many reasons to implement an ISO 9000 based quality management system. Often the market or client is the driving factor. Once an ISO quality system is in place, companies realize that there are internal benefits, which are as important as the external ones.

Benefits during implementation:
  • Process Improvements As you implement the system; you have the opportunity to improve your processes. You will outline the current process, and the requirements of the standard, and then optimize the process with input from the process users.
  • As the system, is implemented, quality awareness will increase because all staff must be trained on ISO 9000 and the processes as they are implemented. Staff will have “ownership” of processes they are involved in developing and improving.
Benefits after implementation:
  • Market Advantages Surveys of registered companies show more than 40% asked by a client to obtain registration. Using a registered supplier reduces the amount of vendor audits a company must perform.
  • When a client requests a vendor to seek ISO registration, it can take anything from 6 to 18 months or more to comply. Therefore, the vendor who is already registered has an advantage. This can be used as a strong marketing tool. ISO is becoming a requirement to do business in many markets. Registered companies currently have an advantage over their competition. As registration becomes more common, this will shift, and the unregistered companies will be at a disadvantage.
  • Once registered, companies often find the greatest payoffs are internal, as processes experience continual improvement.
  • The quality system has built-in systems to report on key quality indicators: Corrective and Preventive Action, Internal Audits, and Management Review. Management is required to take action based on this information.
  • These built-in systems also contribute to continual improvement by significantly reducing the reoccurrence of problems. Corrective actions issued must be addressed, the root cause determined, and action is taken to prevent reoccurrence. Follow-up will make sure the action was effective.
  • Internal audits will evaluate the effectiveness of the system and identify opportunities for improvement. Nonconformities must be addressed. Internal auditors are also able to make observations and suggestions.
  • Management review is a chance for management to evaluate the performance of the quality system. Information provided from corrective actions, internal audits, purchasing information, and client complaints.
  • The operation will run more smoothly, with fewer crises and “fires”. The quality system promotes consistency in how work is done and recorded. It helps employees learn more easily and quickly what should do. It reduces misunderstandings with customers.
  • When a problem occurs, it is corrected at the root cause. It does not have to be “fixed” repeatedly by someone else, meanwhile, productivity is lost.
  • There is a strong quality culture. Internal audits, corrective action, and training result in “top of mind” awareness of the system. Increased confidence in workmanship results in a more confident staff. Systems in place allow staff to address problems. Staff recognizes problems as systems or process issues. Problems solved, not blamed on anyone.
What is Process Approach?

The process approach is an activity that uses resources to transform inputs to outputs, for an organization to function effectively, they need to identify and manage numerous interrelated and interacting processes. The ISO 9001:2015 Standard is designed to manage and improve those processes.

  1. Input to a process are generally output to another process (e.g.: the output, becomes an Input to a process)
  2. Processes in an Organization are generally planned and carried out under controlled conditions to add value to your business.
  3. A process where the conformity of the resulting product, cannot be readily or economically verified is frequently referred to as a “special process”.
  4. The ISO standard requires that you identify your processes and determine the sequence and interaction of the processes. This is most easily accomplished by preparing flow charts of your product realization processes.
What is Risk-based thinking?

One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to considering risk, rather than treating “prevention” as a separate component of a quality management system.

Risk is inherent in all aspects of a quality management system. There are risks in all systems, processes, and functions. Risk-based thinking ensures these risks are identified, considered, and controlled throughout the design and use of the quality management system.

In previous editions of ISO 9001, a clause on preventive action was separated from the whole. By using risk-based thinking the consideration of risk is integral. It becomes proactive rather than reactive in preventing or reducing undesired effects through early identification and action. Preventive action is built-in when a management system is risk-based.

Risk-based thinking is something we all do automatically in everyday life.

Risk-based thinking has always been in ISO 9001 – this revision builds it into the whole management system.

In ISO 9001:2015 risk-based thinking needs to be considered from the beginning and throughout the system, making preventive action inherent to planning, operation, analysis, and evaluation activities.

Risk-based thinking is already part of the process approach.

Not all the processes of a quality management system represent the same level of risk in terms of the organization’s ability to meet its objectives. Some need more careful and formal planning and controls than others.

Risk is commonly understood to have only negative consequences; however, the effects of risk can be either negative or positive.

In ISO 9001:2015 risks and opportunities are often cited together. Opportunity is not the positive side of risk. An opportunity is a set of circumstances that makes it possible to do something. Taking or not taking an opportunity then presents different levels of risk.

Risk-based thinking considers both the current situation and the possibilities for change.

Where is risk addressed in ISO 9001:2015?

The concept of risk-based thinking is explained in the introduction of ISO 9001:2015 as an integral part of the process approach.

  •   ISO 9001:2015 uses risk-based thinking in the following way:
  •   Introduction – the concept of risk-based thinking is explained
  •   Clause 4 – the organization is required to determine its QMS processes and to address its risks and opportunities
  •   Clause 5 – top management is required to
  1.   Promote awareness of risk-based thinking
  2.   Determine and address risks and opportunities that can affect product /service conformity
  •   Clause 6 – the organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them
  •   Clause 7 – the organization is required to determine and provide necessary resources (risk is implicit whenever “suitable” or “appropriate” is mentioned)
  •   Clause 8 – the organization is required to manage its operational processes (risk is implicit whenever “suitable” or “appropriate” is mentioned)
  •   Clause 9 – the organization is required to monitor, measure, analyze and evaluate the effectiveness of actions taken to address the risks and opportunities
  •   Clause 10 – the organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities
Process risk and planning risk—Ref. Clauses 4.1 and 6.1
Product and Process Risks and Opportunities—Ref. Clause 5.1.1

Risk, as it relates to product and process conformance, can be quite broad. The following are some areas where risk is usually addressed by organizations:

Why use risk-based thinking?

By considering risk throughout the system and all processes the likelihood of achieving stated objectives is improved, the output is more consistent, and customers can be confident that they will receive the expected product or service.

Risk-based thinking:
  • improves governance
  • establishes a proactive culture of improvement
  • assists with statutory and regulatory compliance
  • assures consistency of quality of products and services
  • improves customer confidence and satisfaction

Successful companies intuitively incorporate risk-based thinking

Risk-based thinking:
  • is not new
  • is something you do already
  • is on-going
  • ensures greater knowledge of risks and improves preparedness
  • increases the probability of reaching objectives
  • reduces the probability of negative results
  • makes prevention a habit
Other useful documents
  • ISO 31000:2009 Risk Management – Principles and guidelines
  • PD ISO/TR 31004:2013 Risk management – Guidance for the implementation of ISO 31000
  • ISO 9001:2015 Risk-based thinking – PowerPoint presentation
  • ISO 31010:2010 Risk management – Risk assessment techniques

How many procedures are required by the standards?

Mandatory documents and records required by ISO 9001:2015

Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes.):

  • Scope of the QMS (clause 4.3)
  • Quality policy (clause 5.2)
  • Quality objectives (clause 6.2)
  • Criteria for evaluation and selection of suppliers (clause 8.4.1)

And, here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):

  • Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
  • Records of training, skills, experience, and qualifications (clause 7.2)
  • Product/service requirements review records (clause 8.2.3.2)
  • Record about design and development outputs review* (clause 8.3.2)
  • Records about design and development inputs* (clause 8.3.3)
  • Records of design and development control* (clause 8.3.4)
  • Records of design and development outputs *(clause 8.3.5)
  • Design and development changes record* (clause 8.3.6)
  • Characteristics of product to be produced and service to be provided (clause 8.5.1)
  • Records about customer property (clause 8.5.3)
  • Production/service provision change control records (clause 8.5.6)
  • Record of conformity of product/service with acceptance criteria (clause 8.6)
  • Record of nonconforming outputs (clause 8.7.2)
  • Monitoring and measurement results (clause 9.1.1)
  • Internal audit program (clause 9.2)
  • Results of internal audits (clause 9.2)
  • Results of the management review (clause 9.3)
  • Results of corrective actions (clause 10.1)
Non-mandatory documents

There are numerous non-mandatory documents that can be used for ISO 9001 implementation. However, I find these non-mandatory documents to be most commonly used:

  • Procedure for determining the context of the organization and interested parties (clauses 4.1 and 4.2)
  • Procedure for addressing risks and opportunities (clause 6.1)
  • Procedure for competence, training, and awareness (clauses 7.1.2, 7.2, and 7.3)
  • Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
  • Procedure for document and record control (clause 7.5)
  • Sales procedure (clause 8.2)
  • Procedure for design and development (clause 8.3)
  • Procedure for production and service provision (clause 8.5)
  • Warehousing procedure (clause 8.5.4)
  • Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
  • Procedure for monitoring customer satisfaction (clause 9.1.2)
  • Procedure for internal audit (clause 9.2)
  • Procedure for management review (clause 9.3)
How often should we have management review meetings?

There is no specific requirement for the frequency of management review meetings. We recommend quarterly meetings at the lower management level and six monthlies at the senior management level. This allows you to stay on top of upcoming issues and collect data between meetings that are meaningful to the organization. We have found annual meetings are not acceptable to all registrars. With annual meetings, you may not be able to prevent issues or resolves problems in a timely manner.

Are Job descriptions required?

The ISO standards do not specifically mention that a job description is required. The standard requires that the organization:

  • define responsibility and authority, and
  • define competency in terms of education, experience, skills, and training.

Normally Job descriptions are one way of accomplishing this, there are also other ways, including preparing organizational, job responsibility lists, and competency matrices.

Who in the organization should be involved?

Everyone needs to be involved, either in the planning, implementation, or maintenance of the Quality Management Systems.

Management involvement is critical. Management must support the project by providing resources, removing roadblocks, and watching the timeline. Employees should be involved in evaluating and documenting the processes in which they are involved.

Employee involvement is critical to getting buy-in and support from people throughout the facility. Their support will help successfully implement the new processes. Employee involvement also gives employees a chance to give input into changes and modifications for process improvements.

Should we use outside help - Consultant?

A consultant can help you use your time and resources effectively. Consider using a consultant:

To help plan your project

An efficient implementation begins with a solid plan, considering those things you need to work on, leaving out those things which are already in place, and developing an accurate estimate of how long each implementation phase should take.

To help keep your project on time and on budget

Everyone is stretched thin on their jobs these days. Staff working on the implementation internally is often pulled to help fight fires or assist with production. With external assistance, it is easier to keep the focus on the plan without interfering with day-to-day operations.

To help interpret the standard

A consultant who understands the standard’s requirements can prevent wasted time doing things the standard does not require, or that otherwise might be spent on unnecessary or non-compliant work. QCG Quality Consulting Group experienced staff is very familiar with ISO standards and requirements.

To allow you to benefit from the experience

Using a consultant allows you to begin work right away without having to learn things on your own, and without having to learn from your mistakes.

What is process auditing?

Recently we have been receiving questions regarding process auditing and what it means. If you are auditing your quality management system by area or department and then auditing all the applicable ISO elements while in that department, you are doing process auditing. If you are auditing your quality system by ISO elements throughout the organization, you are not set up currently for process auditing. Process Auditing

How often should we audit each department or process?

The ISO standard requires that all processes are audited within the certification scope. The audit schedule should be based on the level of importance and on the results from the previous audits and customer complaints. In a newly developed system, you will need to audit frequently, perhaps monthly, to make sure that all processes are implemented and working. For established systems, the normal recommended practice is every three months to one year with options to increase the audits if nonconformity is identified (Internally or by the customer).

How long will it take to implement ISO 9001:2015?

An implementation project can take anything from 3 months to 6 months. You will need a minimum of three months of records to show your registrar. Plan your registration audit no less than three months after finalizing your ISO QMS.

Factors that affect the timeline include:

  • Size and complexity of the organization
  • How much existing documentation is available?
  • Amount of resources available for the project
  • Amount of ISO expertise available

Starting with a gap analysis performed internally or externally will help give you a handle on the correct timeline for your implementation.

ISO 9001:2015 QMS Standard Requirements: -

The main elements of ISO 9001:2015 are outlined below and cross-referenced to the relevant Clause of the standard.

Major changes to the ISO 9001:2008
When ISO 9001:2015 is implemented in an organization:
  • Well defined and documented procedures improve the consistency of outputs
  • Quality is constantly measured
  • Procedures ensure corrective action is taken whenever defects occur
  • Defect rates decrease
  • Defects are caught earlier and are corrected at a lower cost
  • Defining procedures identifies current practices that are obsolete or inefficient
  • Documented procedures are easier for new employees to follow
  • Organizations retain or increase market share, increasing sales or revenues
Top reasons are given for registration:
  • Internal operational efficiency
  • Lower production costs because of fewer nonconforming products, less rework, lowered rejection rates, streamlined processes, and fewer mistakes.
  • Access to new markets
  • Some markets require ISO 9001 Registration, some markets favor companies with ISO 9001 Registration
  • Customer request
  • Many organizations are asked by a customer to obtain registration as a requirement to continue or to start doing business with them.
  • Reducing costs
  • Organizations are recognizing that an effective Quality Management System leads to reduced costs and greater operating margins
What will ISO 9001:2015 do for my organization?

A well designed and implemented Quality Management System, based on ISO 9001 has been shown to provide organizations with the following benefits:

  • Reduced costs are obtained through:
  • Improved product reliability
  • Better process control and flow
  • Better documentation of processes,
  • Greater employee quality awareness
  • Reductions in product scrap reword, and rejections
How to implement & achieve ISO 9001 standard compliance?
STEP 1 AWARENESS PROGRAMME
  • Basic ISO understanding through awareness presentation.
  • Workshop on Derivation of Quality Policy and its Objectives
STEP 2 GAP ANALYSIS
  • For existing documentation with respect to new documents.
  • To find out the degree of compliance of the existing system to the ISO requirements.
STEP 3 QUALITY POLICY AND OBJECTIVES
  • Setting objectives and targets on a SMART basis
  • Setting Departmental goals with respect to the overall objectives of the organization.
STEP 4 DOCUMENTATION
  • Apex Manual
  • Procedural Manual
  • Work Instructions, Formats, and Specification
  • Development of Process Maps
STEP 5 TRAINING ON IMPLEMENTATION
  • Departmental Sitting for the understanding of the implementation of the department-specific procedures.
  • Departmental sitting for implementation of generic procedures.
STEP 6 INTERNAL AUDIT
  • To train adequate no. of auditors for effective implementation & assessment of ISO-9001:2015.
  • Internal audits are conducted by the organization at least once before certification and after implementation of the new system.
STEP 7 MANAGEMENT REVIEW MEETING
  • Management Review Meeting to be conducted by the organization to review the effectiveness of the implemented system.
STEP 8 SHADOW/PRE- ASSESSMENT AUDIT
  • Conducted by AISC to assess the effectiveness of QMS implementation.
STEP 9 CERTIFICATION BODY AUDIT
  • The organization achieves ISO 9001:2015 certification.