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ISO Update aims to provide information, resources, and updates around the Standards and Certification industry. We believe that organizational standards can help businesses of all shapes and sizes become more efficient and successful on a local, federal, or global scale.
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What Does Schedule 16 of Bill 70 Really Mean for Companies in Ontario?

On the 8th of December in 2016 Schedule 16 of Bill 70, the Building Ontario Up for Everyone Act (Budget Measures), 2016, gained royal assent and its amendments to the Occupational Health and Safety Act came into effect:

Schedule 16 – Occupational Health and Safety Act – says:

“The Schedule amends the Occupational Health and Safety Act to give the Chief Prevention Officer the power to accredit health and safety management systems, and to give recognition to employers who use accredited health and safety management systems. The Chief Prevention Officer may also establish standards and criteria that must be met by health and safety management systems or employers in order to receive accreditation or recognition. Related amendments are also made.”

What Schedule 16 Means

What this means in a nutshell is that once the CPO (Chief Prevention Officer) has defined the requirements through bill 70 for an accredited health and safety management system, companies could then become certified to that system. Certified companies that are then able to demonstrate their commitment to using a coordinated system to improve their OHAS would then be able to benefit from things such as reduced routine inspections through the MOL.

In addition, the CPO will need to put in place a system that will recognize and incentivize companies to become certified. Details of those companies and their performance can then be made publicly available through the CPO.

Currently the CPO has not yet released any standards for accredited health and safety management systems and has said that they will be holding an “extensive consultation” to develop an “accreditation standard and employer recognition program”. Until the CPO actually defines the standards for accredited health and safety systems, the changes implemented by this act will have no real effect on anyone.



ISO 45001 as a Framework for OHS Standards in Ontario

Of course, an accredited standard is currently on the verge of being released should the CPO want to use the framework provided by ISO. The new standard ISO 45001 Occupational health and safety management system – requirements will follow a similar framework to that of ISO 9001 and 14001 giving companies an accredited standard against which they can be certified by a third party. This new worldwide standard will become available hopefully towards the end of 2017.

Assuming that this will meet the expectations of the CPO and interested parties then this would be a perfect way for companies to start putting in place processes, procedures, and other measures to drive continuous improvement in occupational health and safety.

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Documented Information for ISO 9001:2015

As we move into the final months for transitioning to ISO 9001:2015, many companies are still asking themselves what documentation is required. Back with the 2008 release, most companies were comfortable with the six mandatory procedures that were expected of them as well as the need for a quality policy and manual. The update to 2015 has however removed the requirement for a quality manual and blurred the distinction between procedures and records.



With the new release, both documents and records are termed “documented information” and must be controlled and maintained. This is what will form the evidence required to show that you are conforming to the requirements of your quality management system.

Clause 4.4 of ISO 9001 requires your organization to maintain the documented information that is required to support the operation of your processes and to retain that information to be able to have confidence that those processes are being completed as planned.

So what is required by the standard?

The following is a clause-by-clause breakdown of what is required by the standard. However, some of these clauses can be excluded if the company does not perform the relevant processes:

Mandatory records:

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

Other Mandatory Documents:

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

So what does this mean?

You should still tailor your quality management system to meet the requirements of your own business and all of the interested stakeholders. This can be done in any way that your organization sees fit; although a quality manual is still one of the easiest methods. As long as these processes and associated records can be shown to meet the requirements of ISO 9001:2015 effectively then that is fine. If not then the relevant action should be taken to ensure that all of the required clauses are covered.



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Even if you have an informal quality management system within your business it is often difficult to implement the requirements of ISO 9001:2015. Depending on the size of your business this could be a task that may take six to twelve months to complete depending on the established current systems. It is vital that your staff are fully trained and engaged to make any implementation a success. The following 10 tips are vital to smoothly and effectively implementing an ISO 9001 management system:

  1. Get senior management commitment; while this may sound a little cliché, without the full commitment of your management team throughout the business it is going to be very difficult to drive home the changes and improvements that are required.
  1. Provide training at all levels in the business. Your staff needs to understand not only about the requirements of ISO 9001 but also the different quality principles that they should strive to implement within their every day work. Training should be provided on an ongoing basis according to perceived needs.
  1. Ensure that you have effective internal communication. Without this you are not going to be able to maintain the constancy of purpose that is required.
  1. Establish an implementation team with the authority to make things happen. You cannot just implement an ISO 9001 management system by assigning a management representative and expecting them to do everything in isolation. You need to identify the staff that will be required at all levels throughout the business to craft your system.
  1. Conduct a Gap Analysis; you need to fully understand where your current system meets or fails to meet the expectations of ISO 9001:2015 so that you can allocate resources accordingly.
  1. Involve customers and suppliers in analyzing your current systems. It is important to understand how others view the effectiveness of what you currently do and what they expect from you to improve things.
  1. Plan your implementation fully; responsibilities, roles and schedule. As with any project, the better that you plan it the more likely you are to have success.
  1. Create clear and concise policies and objectives for quality to provide the company with a common direction. Well communicated and understood these will help your company to move forward together.
  1. Encourage everyone to question and improve. It is not enough to only have auditors looking for issues with the systems; everyone should continually seek better ways to do things.
  1. Conduct regular reviews of your ISO 9001 management system through your auditing process to ensure that you are continually improving how your systems function.

In addition to the above, foster a good relationship with your certification body. Your auditor is not there to catch you out. They will want to help you to develop and grow a system that will significantly benefit your business, so use them fully.

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Lean System

Introduction to the Lean System

As with anything in life, you will get out as much from your ISO 9001 management system as you put into it. If you treat it as a documentation requirement and burden on your business just to get certification then you are unlikely to see any real benefits; in fact, you may even stifle your own growth.

The aim of any ISO 9001 QMS is to enhance your businesses product or service quality by standardizing and continually improving all of your business processes. This in turn will help you to increase productivity and drive out waste of all forms within your business.

Why Use Lean System with ISO 9001?

ISO 9001 outlines what is required for a certifiable QMS. However if you read ISO 9004 you will see that it suggests a huge amount more than 9001 requires as a minimum. Merely aiming for what the standard requires so that you achieve certification is not going to help you actually improve your business in a way that is going to help you grow it.

A QMS should always consider the customer first, not the standard. It should also be put in place to continually improve the business and its output. Something that is also provided through implementing a Lean system.

Lean Manufacturing has grown out of what is known as the Toyota Production System (TPS), and is why Toyota managed to dominate the world automotive market in such a short space of time. Lean is in its simplest form just another QMS; when you implement Lean you put in place the controls and systems to provide the customer exactly what they want, where they want it, when they want it, in the right quantity, without any waste or delays.

Lean provides you with a host of tools such as 5S, which helps you to set up a highly visual, organized and efficient working space, through to continuous improvement techniques such as Kaizen. Lean fits perfectly within any ISO 9001 QMS and can only help you to further improve and grow your business using proven tools and techniques.

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Top 5 Tips for Effective Procedures

The ISO 9001 quality management system requires for organizations to write different procedures to prevent non-conformances and to guaranty that specific jobs and processes are carried out correctly.

When writing these effective procedures it is essential to take the following into account:

1. Identify what type of procedure or document needs to be developed.

 

Different documents are essential in the QMS and each type of procedure or document has a specific role and objective. Some of the most commonly used documents in an ISO 9001 QMS are:

  • Manuals: define the general aspects of business management (Quality Management Manual).
  • Operating Procedures: Explain how an activity or process unfolds. Usually the most common documents.
  • Technical notes and instructions: further develop the content of an activity. They are mainly focused on fieldwork.
  • Guides: These are similar to the procedures and technical notes, but with the proviso that they are not binding guidance.

2. Know in detail the structure of a procedure or document.

Organizations need to define a structure and a standard way to write these effective procedures in order to guaranty that they are written in a consistent manner. Knowing the structure will facilitate the process of gathering the essential information necessary to write an effective procedure.

The structure may vary from organization to organization; however, a structure that many organizations use is provided below:

  • Home: the first page of the procedure usually includes the title, code, date of writing, version number (or revision), table of contents, total number of pages, name and signatures of the persons who have prepared, reviewed and approved it.
  • Purpose and Scope: Describes a summary of the purpose and content of the procedure.
  • References: documents that have influenced the development of the procedure are listed.
  • Definitions: technical words that are used in the content of the procedure.
  • Responsibilities: list of individuals or departments responsible for carrying out the activities described in the procedure.
  • Development (or description): describe in detail the activity performed.
  • Annexes: everything that is considered important but that takes up too much space to include it in the description section (tables, drawings, diagrams).

3. Review the document with the people that will use it.

In order for a procedure or any document to be effective, it must be understood by the people who will ultimately use it. That’s why it is important for these people to review the document at different stages of its development. Effective procedures have been reviewed directly by the people who will be using it the most.

4. Consider different people’s views and perspectives.

A procedure should not be developed with the view or information of just one person. Most processes or activities that need to be document could be complex and having different perspectives can enrich the procedure. Effective procedures will multiple views into account.

 

5. Make it simple.

Procedures should not be difficult to read. On the contrary, they must be clear and concise. Sentences must be as short as possible to make sure that it is comprehensive and easy to read. If procedures are never read or understood by the intended audience, they are not likely to serve as an effective tool in any process. Effective procedures need to be readable by everyone involved in the process.

 

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ISO 9001 and ISO 9004 are standards that complement each other and their implementation aims to ensure quality success and reach improved performance in any organization. Both these standards can be implemented independently or simultaneously; however, the most common scenario is for organizations to implement ISO 9001 and later use ISO 9004 to improve their processes and to obtain long term benefit from a more broad-based Quality Management System.

These standards are both similar in terms of structure and terminology used to allow easy integration. They are also based on the same quality management principles, therefore, when an organization has successfully implemented ISO 9001, it is relatively simple to integrate ISO 9004 and achieve an improved performance.

The best way to integrate these complementary standards is by doing the following:

Organizations need to identify and rank their quality needs, where the most basic needs are at the bottom and address ISO 9001 requirements and at the top are the needs to achieve improved performance. After identifying and ranking these needs, organizations must work up from ISO 9001 to ISO 9004 one step at a time.

Effectiveness

One of the basic needs that should be addressed is the effectiveness of the quality management system, that include areas such as

  1. meeting customer requirements;
  2. prevention of customer dissatisfaction;
  3. recalls and defects; and
  4. the production of safe products.

Efficiency

After meeting the effectiveness of the system, the efficiency should be then addressed. Here the focus should be

  1. the efficient use of resources;
  2. the reduction of material costs;
  3. the decrease of cycle times; and
  4. the increase of the organizations productivity.

Competitive Advantage

Achieving competitive advantage should be the last need to address; here it is essential to focus on ensuring delighted customers, increasing market share and increasing profitability.

This process is continuous, because an organization may never relegate it’s basic needs to address its top ones. It must constantly work in meeting all of them and ISO 9004 gives guidance on how to achieve this continuous improved performance.

Before attempting to integrate ISO 9001 and ISO 9004, it is essential to fully understand them both; even though they complement each other, they have different roles and different approaches. They each have a role to play in providing value to any organization that decides to embrace them both to improve their quality management system and achieve long term success.

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Here are five key elements that will help organizations reach a successful ISO 14001 Environmental Management System (EMS):

1. Employee Involvement

The first key element for having a successful EMS is to achieve full participation of all employees, from top management to shop-floor workers. If people are not involved, every goal and target will require a lot more time and effort to be reached. Many believe that only a small group of people in an organization are responsible for the EMS but nothing is farther from the truth; the whole organization is responsible for the implementation, maintenance and improvement of the EMS.



2. Regulatory Compliance

One of the main objectives of an ISO 14001 EMS is for organizations to obtain regulatory compliance. Organizations need to use the EMS as a tool to effectively define and monitor applicable legal requirements and other requirements. By using the EMS as a tool for assuring regulatory compliance, an organization can better plan the expenses associated with permits, reporting and monitoring legal requirements, which will reduce the frequency and severity of violations and their associated costs.

3. Higher Efficiency

Organizations need to focus on improving the efficiency of their processes and not just on controlling environmental aspects after they have been generated. It’s essential to control and prevent contamination, but an ISO 14001 EMS needs to go beyond this point and focus on improving processes. For example, a higher level of administrative efficiency may reduce legal liabilities and shorter permitting procedures due to better relations with regulators and communities. A greater operational efficiency usually involves renewal of equipment or facilities, and an improved design of production processes that will result in a reduction of inputs (energy, water and other resources) and also a reduction of waste.

4. Using the Right Performance Indicators

Every organization is different and so are their environmental aspects and impacts. It is essential to define and use the performance indicators that will allow organizations to effectively monitor their performance and identify opportunities for improvement.

5. Improving Customer Relations

Organizations need to establish relationships based on trust and respect with regulatory bodies, communities and everyone that may affect their EMS. Good relationships with internal and external customers will contribute in the success of the ISO 14001 EMS.

It is important to remember that every EMS is different and a continuous monitoring process is essential in determining the organization’s progress in meeting its goals and objectives.



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Internal Auditor Training - ISOUpdate.com

Internal Auditors require 3 types of training; formal, theoretical and practical auditor training. 

Auditor Formal Training

Formal auditor training must consist of the following:

  • Audit principles
  • Objectives of an audit.
  • Types of audits.
  • Benefits of implementing internal audits.
  • Different auditing approaches.
  • Competences of an auditor.
  • Responsibilities of an auditor
  • How to Prepare for an audit
  • How to Conduct an audit
  • Reports and Follow-up
  • Evaluations

How to prepare for the audit: Establishing the audit program, defining the elements of the management system to be audited, preparation of checklists, selecting the audit team.

How to conduct an audit: How to contact the auditee, developing the audit plan, carrying out the opening meeting, how to gather evidences, defining findings, conducting the closing meeting.

Reports and Follow-up: Categorization of findings, preparing the report, approval and distribution of the report, monitoring.

Competence and evaluation of auditors: General, personal attributes, knowledge and skills, training and work experience, maintenance and enhancement of skills, auditor evaluation.

Auditor Theoretical Training

In addition to this basic auditor training regarding the skills, knowledge and competences of auditors and how to prepare, conduct and monitor audits, it is essential for internal auditors to fully know and understand the standard that they will be auditing against. Here an additional training session will be required. The most frequent standards that organizations use that require the execution of internal audits are ISO 9001, ISO 14001 and OHSAS 18001; however, the standards use will depend on the needs and objectives of each organization.

Auditor Practical Training

After an auditor has received this theoretical auditor training, they can now begin their practical training by participating in an internal audit. This practical auditor training usually is done following these steps:

  1. Participate in at least 2 audits as an observer or auditor in training. Here they usually participate in the planning stage of the audit but when the audit is being conducted they only observe; they do not take any actions in any of the activities during the audit.
  2. Participate in at least 2 internal audits with supervision of a lead auditor. Here they take a more active role in the preparation and in the conducting of the audit.
  3. After having successfully carried out a number of internal audits and having sufficient skills, knowledge and experience as an internal auditor, he or she may start to conduct audits as an internal auditor leader. This leader takes full action in all of the stages of the audit.

Note: Training can vary. Each organization may decide to train their auditors in a way that is best for them. It is important for auditors to receive a constant and progressive auditor training that allows them to acquired the necessary skills and knowledge to conduct objective and impartial audits that meet the objectives for which they audits are carried out for.

Looking for auditor training? Check our listing to see what’s available near you.

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One of the main objectives of an ISO 9001 management system is “continuous improvement”; however, the standard ISO 9001 provides little information on how organizations can reach and maintain it. In this specific aspect is where a lean system will provide the biggest benefit to any quality management system. Lean systems require the implementation of different methodologies that will provide organization with the tools to continuously improve their processes and systems.

Lean manufacturing is characterized for aiming to reduce all the unnecessary in order to use a minimum amount of resources in every aspect of a system, especially on: human effort, manufacturing and storage space, and time.

This tool helps to eliminate all operations that do not add value to products, services and processes, increasing the value of each action and eliminating what is not required. By reducing waste and improving processes, lean manufacturing gives organizations the tool to survive in a global market that demands higher quality, faster delivery and an increase on customer satisfaction.

Some of the most common methodologies used in a lean system are 5S, Value Stream Mapping (VSM), Kanban, Key Performance Indicators (KPI), Shadow boards, Poka-yoke and many others. The implementation of these methodologies can bring many benefits to an ISO 9001 quality management system, such as:

  • Reduction in production costs.
  • Inventory reduction.
  • Reduction on delivery time (lead time).
  • Improved quality.
  • Decrease in labor.
  • Greater  equipment efficiency.
  • Waste reduction.
  • Reduction of overproduction.
  • Decrease on delays.
  • More efficient transport.

The requirements of ISO 9001 have many common aspects with lean production systems, especially in its design and mode of operation, suggesting a high potential for integration.

The integration of both systems will facilitate the implementation of a continuous improvement philosophy based on a systematic elimination of all types of waste, the respect and consideration of all employees and the continuous improvement of productivity and quality. This will enable organizations to reduce costs, improve processes and eliminate waste in order to increase customer satisfaction.

Furthermore, lean systems requires the ability to manage raw materials and components in small batches, which requires supply policies based on stable relationships with suppliers.

There are many organizations that are considering to integrate a lean system into their ISO 9001 management system. This is being done in a pursue to identify and reduce waste from their processes, reach an overall process that flows smoothly and ensure that the organization’s resources are effectively used to meet or exceed customer satisfaction.

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ISO Certification

This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.

Our lead assessors have countless years of experience in helping organisations to achieve ISO Certification. No matter the industry, they have worked tirelessly alongside our clients to aid the growth of their business. Whether it’s a charity, manufacturer or translation company, they have seen numerous successes.

That being said, there is one issue that is actually very common in our industry and that is the perception of ISO Certification as a necessity rather than an aid. Some organisations, (whether they are aware of it or not) put the ISO Certification in one ‘box’ while putting their business in another.

Many articles have been written which make a point of explaining the benefits and the importance of management buy-in with regards to certification. These are great and they are very important topics to highlight but sometimes people appreciate practical examples.

The Myths of Non-Conformances

One key example that our assessors highlight is that of non-conformances. A non-conformance is something that has happened which should not have happened. From experience the following are the most common misconceptions surrounding non-conformances:

  • Their recording is felt to be adding to their workload
  • Some employees feel like they are ‘telling tales’ on their colleagues
  • Or it is seen as a weakness

The concern that the recording of non-conformances adds to current workloads is very common and we have a simple mantra which will hopefully ease this:

“If a non-conformance takes longer to record than to rectify, it is not a non-conformance”

We have in fact suggested to clients that they change their name to ‘Opportunities for Improvements’. Secondly, recording non-conformances and acting upon them enable organisations to have the ability to make significant improvements. After all, if everybody’s jobs can be made that little bit easier, why wouldn’t you?

In some circumstances employees are reluctant to highlight non-conformances as they see them as a weakness that can give management a reason to criticize. This should not be the case and one way this can be remedied is by management taking the lead and demonstrating that they too are recording non-conformances.

Don’t Forget Communication!

One of the main reasons why there are issues with the non-conformance processes and procedures, or any change within the workplace for that matter, is communication.

Internal communication in the form of departmental meetings for example is important to get ‘buy-in’ from all areas of the business. If everyone understands why change is happening, how it will impact positively upon their job and how they can help then this will help with employee buy-in.

Taking the time to explain why change is needed and creating a sense of inclusion makes everyone feel appreciated.

The Bottom Line

The bottom line is that the ISO Standards provide a flexible framework that run parallel to an organisation instead of being a separate entity. Furthermore, when embraced and fully integrated, they are able to enhance business performance and make everyone’s job that little bit easier.

This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.

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