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All About ISO 9001

Updated on January 25, 2013

What is ISO 9001?

The Nuts and Bolts of ISO 9001

ISO 9001 is a common sense management system that focuses on consistency, reliability, and improving the way an organization operates. Specifically, it focuses upon organizational processes, the customer, and improvement. It provides a framework for the organization to operate within, not the specific s of HOW to operate.

Who is ISO 9001 for?

ISO 9001 is appropriate for:

- Any organization in any sector that wishes to formalize they way in which their organization operates;

- Any organization that is looking to improve the way in which it is managed.

No organization is too large or too small to reap the benefits of ISO 9001.

The best returns on investment (ROI) come from companies prepared to implement ISO 9001 throughout their organization rather than just in particular sites, departments or divisions.

Why introduce ISO 9001?

In general, there needs to be a structure as to how an organization operates, so that everyone knows how things work. Also, customer satisfaction can be addressed through ISO 9001 processes. Customers are the most important stakeholders in an organization. An organization needs to know and understand what their customers' needs are, not only now but also in the future, so that they can plan to meet those needs. ISO 9001 will enable an organization to introduce structure through the use of processes and knowing the needs of their customers.

Why do I need ISO 9001 Certification?

Acquiring ISO 9001 Certification for your organization is a demonstration to customers that the organization has a commitment to quality. Certification also requires that the organization undergo regular assessments to ensure that it continually uses, monitors and improves the processes established through the course of ISO 9001 certification. Certification Management can improve business performance, reduce uncertainty, and increase market opportunities. All of these things, when put together, can increase profitability, and that's really the bottom line for your business.

ISO 9001 is an effective management system that can be implemented and certified across a broad range of subject areas and standards. ISO 9001 certification for your organization is worth investigation. It can improve your business in many measurable ways.

Business Meeting
Business Meeting

Different Training Formats Available for Your Business

by Raylene Wall

Most organizations that offer business and leadership training provide different delivery options for those training sessions. Training is done in many different formats, allowing you to tailor the training and choose the best format for your business. Whether you are providing leadership training, ISO 9001 Certification, safety training, etc., there is usually a range of training options from which to choose.

Onsite Training

An On-Site training course is one that is held at your own facility and is typically open only to your employees. Training students on site eliminates their travel expenses and additional time away from the office. On-Site Training can be custom-tailored to your requirements and your environment.

Public Training

A Public Training course takes place in an open, public setting and is commonly available to anyone who registers. This type of training can be a convenient, low cost way to send a small number of employees off-site to learn. Attendees are away from office distractions and often benefit from exposure to people from other organizations. Depending on the location of the training, lodging and travel costs should also be considered if choosing this option. In general, public training events are geared toward larger audiences.


A Workshop is an interactive session led by an experienced instructor, in person, face-to-face, usually in a small group setting. By providing the student the opportunity to learn through case studies, group exercises and sharing best practices, workshops provide a hands-on learning experience. Workshops are generally customized to suit the specific needs of the organization and are a very pragmatic approach to improving staff skills and knowledge.

eLearning and Webinars

Relatively new to the training format options are delivery modes which employ the internet - eLearning and Webinars. eLearning is an innovate distance learning tool, where course content is delivered online. Webinars are interactive multi-media presentations that allow participants to hear the instructor through a telephone or online conference call while following the presentation online. These methods are particularly useful if your employees are spread out, or if the training you are looking for isn't offered in your area.

With the training options available, whether for in person teaching or for online and distance training, there are many ways to get your people the education and learning that they need to succeed. Talk with your training providers to decide what format best suits your business' needs.

About the Author:

Raylene is a transplanted American living in the Canadian Prairies. She is a married engineer- turned work-at-home mom with 3 great kids. You can find her on her blog It's OK to be WEIRD , Facebook and Twitter.

ISO Logo
ISO Logo

Benefits of ISO 9001

by Raylene Wall

ISO 9001 provides a framework for an organization to work within. Because of that, ISO 9001 Certification has many benefits for companies.

Strategic Benefits - having a management system that uses the ISO 9001 framework means that there can be the right controls in place to deal with the level of risks to the organization.

Managerial Benefits - the management of the processes that ISO 9001 requires means that management have a much clearer view as to how their organization operates.

Marketing Benefits - having ISO 9001 registration enables an organization to show their current and future customers that they are committed to ensuring they meet their requirements.

Financial Benefits - provided an organization knows where it has started from in regards to costs of running the organization, operating under ISO 9001 protocols can show that savings can be made due to increased efficiency and effectiveness of their management systems.

Operational Benefits - having a management system in place will help all the people in the organization to identify their responsibilities and what their role is in the organization. All people should be involved in the mapping of their processes so that they own their part of the overall processes and ultimately their contribution to the final product and service to the customer.

Customer Benefits - the overriding concept behind the ISO 9000 series of standards (including ISO 9001) is meeting customers' requirements. This is achieved by having a clear understanding of the customers' needs and having processes and competent people to deliver the products/services.

No matter the size or scope of business, all organizations can benefit from implementing ISO 9001 standards. Nearly every aspect of the business will see improvements when ISO 9001 certification is achieved and maintained.

7 Ways to Use Technology to Drive Continual Improvement in Your Business

by Raylene Wall

Where does time leak away from your work week?

What impact does this have on the effectiveness of your program?

If you could double your efforts what difference would that make?

7 Ways to Use Technology to Drive Continual Improvement in Your Business.

1) Don't Push Documents, Implement Procedures

Many systems include office documents collected in a manual (or intranet site).

Updating, reviewing and publishing documentation involves red tape of proof (Version numbers, history, reviewers, deployment, competency).

Finding documents can be time consuming (on the network, in the manual).

2) Move from Nagging to known Responsibilities

Many managers spend an excessive amount of productive work time, conducting email/phone follow-up calls, crafting email to remind people and drive actions, and creating task spreadsheets from meeting notes and project plans.

3) Close the Loop on your Audit Spreadsheets

Most audit programs start and finish with an audit program in MS Word or in Excel and email. This is ok for reporting on the audit activity but doesn't encourage the full cycle.

Integrating your audit activity with tools to support the process can add significant value. Example: Entropy Software workflow for audit and compliance module.

4) Move from Report Creation to Instant Visibility

Management systems inherently involve the need for good reporting. Many managers spend a disproportionate amount of time collating data for reporting via office documents and email.

Combining common processes with automated record keeping provides instant visibility. The kinds of things to consider for this process include:

· Objectives, targets, performance metrics

· Event notifications and follow-up for NCRs, OFIs and actions

· Integrating viewing of audit reports

· Performance Scorecards

· Risk assessment / FMEA

· Training records, needs analysis

· Procedures management

· Management review

5) Evolve ad hoc task completion into Action Plan Automation

Management systems involve many core processes that create actions and tasks. Most managers solve for this by tracking key actions in spreadsheets and documents that get updated periodically.

For each core area (audit, objectives, incidents, NCAPA) there can be multiple documents in play. The up-to-date performance view is based on the frequency of emails, phone calls and meetings. Tracking tasks over multiple shifts, operations, sites and regions with proper document control is challenging.

6) Turn rough awareness to need analysis and competency.

Compliance with training requirements is a key area of non-conformity in many management systems. Despite its importance in driving continual improvement many managers struggle with answering the fundamentals:

· Does everyone have an awareness of the requisite training to perform their job?

· When was the last time key procedures changed - are people competent to carry them out?

7) Move from Data Handling to Performance Review

Getting visibility of the entire program with a helicopter view is often a time consuming endeavor for most managers. Data handling costs rise at the end of each monthly, quarterly, and yearly cycle. Collate this picture for management review. Driving improved views of performance monitoring can lead to:

· Reduced time spent searching for, handling and collating data.

· Improved analysis and response.

· Opportunities for cost savings.

ISO 9001 Standards and Certification for a business can ensure that technologies are implemented to drive continual improvement in your business. Consider courses to help implement these standards and business management technologies to help move your business to the next level.

About The Author:

Raylene Wall is the owner and editor of It's OK to be WEIRD! She's been married to her best friend for 14 years and has 3 beautiful children. Raylene is a dual citizen of the United States and Canada, now living in Alberta. As an engineer-turned-work-at-home Mom, she enjoys writing, traveling, quilting and reading. She is an independent social media influencer, a social media manager, as well as being involved in local ministries and activities of various kinds.

ISO Training

by Raylene Wall

When it comes to ISO training, there are many courses that can be taken, and many specialties that can be the focus of the training. It is always important to be sure that a certified 3rd party teaches the courses, and that the courses themselves are ISO certified courses. These kinds of courses are offered in various formats and locations.

In relation to the Quality ISO 9001 standards, in general, there are courses on the Essentials of ISO 9001, Key Changes to ISO 9001 for the latest series, Essentials of Root Cause Analysis, Plan-Do-Check-Act (PDCA), and Problem-Solving Tools and Techniques.

Training is available for more specifics on ISO 9001 Quality Management Systems. Quality Management Systems give your business the framework needed to monitor and improve performance in any area necessary. ISO 9001 is, by far, the world's most established quality framework, which sets the standard not just for Quality Management Systems, but management systems in general. ISO 9001 certification is helping organizations in diverse industries to succeed through improved customer satisfaction and staff motivation.

ISO training in this area of Quality Management Systems starts with a basic understanding of ISO 9001, providing a working knowledge of ISO 9001 definitions, concepts, guidelines and requirements. This training provides the necessary knowledge of the ISO 9001 process approach, the eight quality management principles, an understanding of management roles, as well as the benefits of a quality management system.

Training then advances to ISO 9001 requirements. This kind of training teaches a general understanding of the concepts of ISO 9001 standards and how the requirements impact the day-to-day operations of organizations in any industry. Detailed explanations of the clauses in ISO 9001 provide a base for understanding the Quality Management Principles and include auditing the requirements of the standard.

Training on how to implement ISO 9001 is also necessary to actually put the management system to work for you. Implementing ISO 9001 training courses provide an understanding of the ISO 9000-series quality management definitions, concepts, guidelines, requirements, and purpose. The course should include best practices for implementation of each clause of ISO 9001 and how to build an efficient and effective quality management system. Part of implementation is also knowing how to prepare for an audit and plan for ISO 9001 registration.

These basic courses on ISO 9001 can then be followed up with training on Management Systems Auditing (for Auditors), and on Leading Management Systems Audit Teams (for Lead Auditors).

Business Supplies
Business Supplies

Considerations for Implementing ISO Standards and Working Toward Certification

by Raylene Wall

Operating a business in line with ISO Standards will help the organization to avoid many unproductive, even destructive, pitfalls. A few simple actions, which conform to the guidelines provided in the ISO Standards, will proactively mitigate risk. Therefore, becoming ISO 9001 certified and fully adopting the ISO standards is a worthy enterprise.

There are a few things to consider when a business undertakes to put new standards in place on the road to certification.

In order to implement the necessary standards and achieve ISO 9001 Certification, begin by enrolling employees with a common vision of change to work towards continued organizational and individual improvement.

Investigate management software right away. Do not underestimate the importance and necessity of a powerful, accurate, and carefully designed management program. Such software helps guide processes from beginning to end and will reduce paper trails, streamline operations and enable efficient auditing procedures.

Consider aligning the company's Return-on-Investment (ROI) metrics with ISO standards to provide a direct correlation between employee participation or productivity and the achievement of the standards. This will increase the value of certification, and clarify the importance of not only the certification process, but also of the general need for certification.

Develop an internal audit program to ensure that clear benchmarks are in place before post-certification operations commence. This will enable progress to be appropriately and accurately measured.

As more ISO standards are implemented, mobilize like-minded and enthusiastic employees in various departments to propel advancement and unify people toward a common vision.

Keep the process visible to all employees. Do not isolate the certification program as a separate project, but rather embed it in existing departments. Get everyone on-board and involved with the process.

Becoming ISO 9001 Certified is in the best interest of the business as a whole, as well as for the individuals who make up the organization. Starting the certification process with those employees who are enthusiastic and capable, getting management software in place immediately, and clearly articulating the value of the process will be key to laying a foundation of success. Having a system for internal auditing to monitor progress, unifying employees in a spirit of advancement and improvement, and involving all levels and departments in the process will help to ensure correct implementation of standards as well as certification success.

About The Author:

Raylene is the owner and editor of It's OK to be WEIRD! She's been married to her best friend for 13 years and has 3 beautiful children. Raylene is a dual citizen of the United States and Canada, now living in Alberta. As an engineer-turned-work-at-home Mom, she enjoys writing, traveling, quilting and reading. She is an independent social media influencer and small business owner.


ISO 9001 Auditors

by Raylene Wall

An audit is an official examination and verification of systems and records, and a necessary process in the ISO 9001 standard of operations. An audit is always based on the definitions, concepts and guidelines of the ISO 9001 standards, and includes such information as nonconformities and recommendations for improvement in the management systems. The staff members who conduct such audits are called auditors.

Auditors need to understand and practice internal auditing for ISO 9001 Certification Management. Internal auditing simply means that staff members from within the organization itself are conducting the audit. External audits also take place from time to time, to audit the audits, in essence.

Internal Quality Systems Auditors have an extensive knowledge of ISO 9001 definitions, concepts, guidelines, and requirements. They have been trained in depth regarding auditor's roles and responsibilities, the principles, and types of audits, as well as the overall certification scheme.

Auditors have the skills to create audit schedules, follow audit trails, and write nonconformance and audit reports. Most auditors are trained by experienced instructors who lead would-be-auditors through case studies and audit simulations during their course of study. This ensures that they are well equipped to undertake internal audits as necessary. It is most important for auditors to have a working knowledge of ISO 9001. Equally important is understanding the role of customer-specific requirements within the auditing process.

Internal auditors are competent in the principles and techniques of auditing a management system. As part of the audit process, the auditor must know how to: conduct a document review, apply audit sampling, practice effective audit communications, apply successful interviewing techniques, take sufficient audit notes, and appropriately follow-up after an audit.

More training is required to go from being an internal auditor to becoming certified as a Lead Auditor. Auditors at all levels are important to the audit process in the ISO 9001 system.

About the Author:

Raylene is a transplanted American living in the Canadian Prairies. She is a married engineer- turned work-at-home mom with 3 great kids. You can find her on her blog It's OK to be WEIRD , Facebook and Twitter.

Lead Auditors in ISO 9001 Management Systems Audits

by Raylene Wall

At all levels, auditors are important to the audit process in the ISO 9001 system. Audits are conducted by teams of auditors, under the supervision and guidance of a Lead Auditor. Auditors must go through a series of courses that meet the standards for ISO 9001 training Canada. More training is required to go from being an internal auditor to becoming certified as a Lead Auditor.

Lead auditors must be able to accurately interpret all clauses of the ISO 9001 standard. They must be confident in managing each process of an audit program for a quality management system, from understanding auditor responsibilities to reporting audit results, and everything in between.

Lead auditors are competent in the process of assigning objectives, scope and criteria to an audit. The Lead Auditors are the ones who do the audit planning and guide the audit team through the process.

As the director of an internal audit process, Lead Auditors understand management definitions, concepts and ISO 9001 guidelines, as well as the overall purpose for the ISO standard, and the requirements of the standard. Lead auditors are skilled in the process approach, and are able to work from the standards in place to identify nonconformities.

In the end, the Lead Auditor is responsible for the content of the audit report, so they are also very familiar with the larger purpose for this document. Lead auditors are in charge of conducting the opening and closing meetings of an audit process. They know the importance of keeping to an audit timetable. They are skilled in successful communication practices with the auditee and the audit team. As with most leaders, lead auditors are also responsible for issue resolution.

The process is finalized with the audit report distribution and any follow-up necessary. These steps are also directed by the Lead Auditor.

Lead Auditors in the ISO 9001 process are first fully trained ISO auditors who have completed extra training in order to lead a team of auditors. A Lead Auditor is key to the audit process.

Top 5 Major Non-Conformities found during ISO 9001 Certification

by Raylene Wall

According to a sample taken from companies going through the ISO 9001 Certification process between the dates of January 1, 2009 and June 30, 2009, the top 5 major non-conformities with the ISO 9001 Standard were found to be in the following areas:

ISO 9001 - Clause 4.1

ISO 9001 - Clause 5.6

ISO 9001 - Clause 7.6

ISO 9001 - Clause 8.2.2

ISO 9001 - Clause 8.5.2

Others - making up about 54% of all major non-conformities

ISO 9001 - Clause 8.2.2 - Internal Audit

Many non-conformities were found in relation to the following areas with regards to the Internal Audit Process:

- Plan the audit program taking into consideration:

o Status and importance of processes and areas.

o Results of previous audits.

- Define audit criteria, scope, frequency, and methods.

- Select auditors and conduct audits to ensure:

o Objectivity

o Impartiality

- Ensure auditors do not audit their own work.

- Prepare a documented procedure to address responsibilities and requirements for:

o Planning audits and conducting audits.

o Recording results and maintaining records.

- Ensure actions taken without undue delay (management responsible for audited area).

- Verify actions taken and report the results (also refer to clause 8.5.2).

ISO 9001 - Clause 8.5.2 - Corrective Action

This is the area where most minor non-conformities are found. The clause states:

- Take action to eliminate the cause of nonconformities to prevent their recurrence.

- Take action appropriate to the effects of the problem.

- Define requirements in a documented procedure to:

o Review nonconformities (including complaints).

o Determine the causes of nonconformities.

o Evaluate the need for actions to prevent recurrence.

o Determine and implement corrective action.

o Record results and review action taken.

ISO 9001 - Clause 4.1 - General Requirements

Other minor non-conformities were in relation to the General Requirements of the standards, in these areas:

- The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this international standard:

o Determine the processes.

o Determine the sequence and interaction of these processes.

o Determine criteria and methods needed to ensure that both operation and monitoring of these process / availability of resources and information. o Monitor, measure where applicable, and analyze these processes.

o Implement actions necessary to achieve planned results.

ISO 9001 - Clause 5.6 and ISO 9001 - Clause 7.6 were also found among the Top 5 Minor Non-Conformities.

The appropriate ISO training will ensure that your organization is aware of these common major non-conformities, in addition to common minor non-conformities. These major non-conformities, if found in your organization during the pre-certification process, must be addressed before full ISO 9001 certification can be granted.

Top 5 Minor Non-Conformities found during ISO 9001 Certification

by Raylene Wall

According to a sampling of companies going through the ISO 9001 Certification process between January 1, 2009 and June 30, 2009, the top 5 minor non-conformities with the ISO 9001 Standard were found to be in the following areas:

ISO 9001 - Clause 7.6

ISO 9001 - Clause 4.2.4

ISO 9001 - Clause 5.6

ISO 9001 - Clause 4.2.3

ISO 9001 - Clause 6.3

ISO 9001 - Clause 7.6 - Control of monitoring and measuring equipment

This is the area where most minor non-conformities are found. The clause states:

· The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determine requirements.

· The organization shall establish processes to ensure that monitoring and measurements can be carried out and are carried out in a manner that is consistent with monitoring and measurement requirements.

ISO 9001 - Clause 4.2.3 and 4.2.4 - Control of documents

Non-conformities were found in relation to the following areas:

· Documents required by the quality management system shall be controlled...

o A documented procedure shall be established to define the controls needed:

§ Approve documents for adequacy prior to issue

§ Review and update as necessary and re-approve documents

· A documented procedure shall be established to define the controls needed.

o Ensure that changes and the current revision status of documents are identified.

o Relevant versions of applicable documents are available at point of use.

o Documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled.

o To prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.

· Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

· The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposal of records.

· Records shall remain legible, readily identifiable and retrievable.

ISO 9001 - Clause 5.6 - Management Review

Approximately 20% of minor non-conformities were found in this clause, related to these areas:

· Top Management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.

o This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

ISO 9001 - Clause 6.3 - Infrastructure

Other minor non-conformities were in relation to the infrastructure within a company, in these areas:

· The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable:

o Buildings, workspace and associated utilities.

o Process equipment (both hardware and software).

o Supporting service (such as transport, communications or information systems).

These minor non-conformities, as well as any major non-conformities found, will be addressed through the ISO 9001 certification process, and must be addressed before full certification can be granted.

Staff Party
Staff Party

Five Good Opportunities for an Office Party to Boost Morale

by Raylene Wall

People spend a huge part of their lives at their workplace. Avoiding the office doldrums is important in maintaining employee morale and continued progress. Engaging employees and clients in fun activities will build loyalty. Finding appropriate ways and occasions to celebrate can help keep the workplace fun and still productive. Here are a few good reasons to have a little party with the staff.

Business Anniversaries

Take time to commemorate the starting date or other important anniversaries of the business. Highlight those dates by establishing special traditions specific to the organization.

Staff Achievement

When people in the organization are promoted to new positions or reach certain levels of personal achievement in the company, it's definitely worth recognition. Celebrating with the staff on such occasions will encourage others to work toward personal achievement.

Organizational Milestones

As the business continues to advance, it is important to make a big deal out of the milestones reached by the group as a whole. Organizational achievements, such as ISO 9001 Certification, Business Excellence Awards, and the like, are accomplished only through teamwork, so it is fitting to celebrate that teamwork once the milestone is attained.

Personal Special Dates

Each and every employee in the organization is a real person. People like to be noticed and celebrated. Consider celebrating employee birthdays and special real-life out-of-work kinds of events (weddings, new babies, landmark wedding anniversaries, new homes, completion of personal goals, etc.) with the staff.


Beyond the infamous office Christmas party, celebrating holidays with the staff can be fun for everyone. Another option is participating in local and regional festivities like County Fairs, which often create a holiday feel in the area.

Any of these celebrations can be simple affairs - no need to be too fancy. Regardless of how it's done, recognizing staff achievement and organizational milestones with appropriate celebrations will encourage overall progress and advancement. Taking the time with the staff to commemorate business anniversaries, personal special days and holidays will also help improve morale. Even the little things can make the workplace atmosphere more positive, and employees will better enjoy spending their valuable time at work and they will be more productive while they are there.


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      6 years ago

      If you want to take interest about ISO 9001 Quality Management System then please visit :


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