Understanding ISO 9001:2015 (article5)

? Support

No business can succeed without some form of support. This article is directly relating to the resources and support a business requires to achieve its goals.

Resources

ISO 9001 requires the organization to determine and provide resources for the establishment, implementation, maintenance, and continual improvement of the QMS, taking into account the capabilities and constraints of existing internal resources and the need to obtain additional resources from external providers.

Resources to be obtained include people, infrastructure, environment for operation of the processes, monitoring and measuring resources, and organizational knowledge.

Knowledge of the organization according to ISO 9001

• What is organizational knowledge?

it is specific knowledge of the organization, generally gained by experience, which is used and shared to achieve the objectives of the organization. This can come internally, such as intellectual property, lessons learned from failure and successes, or the results of improvements; or it can come externally from conferences, customer knowledge, or supplier knowledge.

• The requirements for organizational knowledge within ISO 9001:2015 are threefold:

1.Determine the knowledge that you need to operate your processes and make your?products and services?conform to requirements.

2.Maintain this knowledge and make it available as needed.

3.Consider your current knowledge when making changes, and determine how you will gain additional or updated knowledge if necessary for the changing needs.

• How can you capture the organizational knowledge of your company?

Every company has special knowledge that sets them apart from the competition.

When this knowledge sits with certain long-term employees and is not captured, it is commonly called “tribal knowledge,” and while this can be powerful, it can be in danger of being lost when these employees leave the company.?

Here are a few simple ideas on how to easily capture the organizational knowledge of the company:

1. Work instructions:

Of course, the most obvious way to capture this information is within work instructions. If you have a process that needs to happen in one specific way to avoid problems, and this can be written down and easily understood, then work instruction can be one of the easiest ways to accomplish this knowledge capture.

2. Checklists:

Another obvious capture method for simple knowledge is checklists. If the knowledge is comprised of a number of things to check before a job is completed, then a checklist can be a beneficial tool to use.

3. Training packages:

Sometimes it is the main points of the process that need to be captured, and having this in some sort of training package can be the best way to record the knowledge.

4. On-the-job training:

When the knowledge just can’t be written down, it can be beneficial to use on-the-job training where a senior and experienced person will transfer the undocumented organizational knowledge to others.

5. Knowledge database:

Many companies leave lessons learned until the end of a program, and this can mean that designs in the process miss out on the benefits of these lessons learned until much later. You can capture the knowledge or problems or successes that have occurred with a product or service by writing them into a database for review during design. In this way, the knowledge is captured right away and can be reviewed when the next product design is created.

• Using the captured organizational knowledge

Once the organizational knowledge is captured, you then need to use it within your system, especially during?changes. Working the checklists and work instructions into your processes can be a challenge, but if everyone knows why you are asking them to do this, then the transition will become easier. Likewise, the training needs to be delivered consistently once it has been created. Update your processes to include the training and use of work instructions and checklists when you have a new person join the team and start working on the job in question.

The knowledge database is a unique idea in that it is a feedback mechanism into the?design?function, so you need to update your design process to ensure that you look at the lessons learned knowledge database during design and design changes to ensure that you have not missed a correction or improvement that has been identified and captured in the database. Learn to use this tool well, and you can improve your designs continually as you learn with minimal effort.

Competence

The organization needs to determine the necessary competence of its employees, and ensure those employees are competent on the basis of appropriate education, training, and experience. This means that the organization will need to have a process for determining the necessary competence and achieving it through training and other means.

1.Where to start?

Not everyone in your organization needs to know every word of the ISO 9001 standard, Whenever you start an ISO 9001 implementation process with an organization, you need to begin with an implementation training session, which should end by asking everyone to read the standard, where applicable according to the size of the company, and sign to provide evidence for their training record that they have done so.

In larger organizations, this may be limited to the project team, of course. how can you hope to achieve compliance and excellence against any standard if some team members are not fully aware of what the standard requires? Any employees who start with the organization during the process are asked to do likewise.?

2. How to maintain?

Whether you are on your way toward accreditation, or simply trying to maintain your QMS after a successful audit, you need to ensure that competence and awareness are at the forefront of your thoughts. There is no prescribed way to achieve this, but here are some ideas that may suit your organization:

• Build your digital workplace (subscribe to the Digital Workplace newsletter to know more)
• Create an awareness campaign to keep your employees informed by email.
• Ask your production and quality managers if you can hold a 5-minute update at the regular quality and production meetings to bring first-hand updates to the teams.

3. What is the required evidence?

If you are ensuring that competence and awareness are at an acceptable level during your audit preparation process, then you will need to provide evidence of the work you have done to facilitate this, Providing the auditor with documented evidence is vital, but a good auditor will quickly assess your staff’s knowledge and the importance they attach to the ISO 9001 process itself simply by talking to them during the audit. Therefore, it is important that you provide the guidance and knowledge to ensure that the workforce is educated and focused on the important aspects of the QMS and the 9001 standards. Given that knowing the objectives, expectations, and requirements of the standard is the fundamental starting point, there can be no continual improvement without competence and awareness, and remember – no continual improvement means no compliance at all.

Awareness

Awareness is closely related to competence in the standard. Employees must be made aware of the Quality Policy and its contents, any current and future impacts that may affect their tasks, what their personal performance means to the QMS and its objectives, including the positives or improved performance, and what the implications of poor performance may be to the QMS.

This is why everyone should be given some?training?in ISO 9001 awareness.

1.What should be contained in awareness training material?

Most people in your organization do not need to know the ISO 9001 standard thoroughly, and in many cases, they do not need to read the standard to be able to properly do their jobs in compliance with your quality management system (QMS). In many ways, it is more important that they understand why you are implementing your QMS per the ISO 9001 standard than understanding what ISO 9001 actually says.?

Here is a list of some of the most common topics that can be included in awareness training, but these can be changed depending on your particular company:

• Why are you implementing a quality management system? If you do not already have a QMS in place, then your employees will wonder why you are doing so now. If people see why you are doing this, they will more easily understand why they need help.
• What is a quality management system? Many employees may not know what a QMS is if you do not already have one in place, so give them a definition.
• What is the ISO 9001 standard? A brief explanation of what a standard is and how the ISO 9001 standard is applicable to a QMS goes a long way toward explaining that you want to make your QMS recognizable to regular industry practices.
• What are the general requirements of the ISO 9001 standard? Even for those employees who will not need to know the ISO 9001 standard, understanding the structure of the requirements is a good way for them to know how far reaching your QMS will be within your organization. In this way, employees know that everyone is involved in the QMS. This link has an explanation of the ISO 9001 Requirements and Structure.
• Why are you using ISO 9001 for your quality management system? There are other standards, so why use ISO 9001? If this is the standard recognized by your customer base or your industry, then your employees should know this.
• How do you expect employees to use the QMS? This is probably the most important information in your training. After you have told your employees about the QMS and how ISO 9001 is involved, what do you want them to do? They need to understand that the processes and procedures of the QMS need to be followed for consistency, but also that they should bring feedback on improvements when they see them, since this is part of the QMS. Employees are an integral part of the processes to make sure they work and help the QMS improve.

2.How should you create these training materials?

How the materials are presented is very much dependent on your company, and up to you. Many people will present this information through a PowerPoint presentation, but many other methods could be used: Your company's IntraNet, lunch and learn discussions, department meetings, orientation sessions, or even available written documents to read. The important part of the awareness training is employee understanding, so make sure you present in a language and method that your employees can understand. It can also be very helpful to allow lots of time for questions

Communication

Processes for internal and external communication need to be established within the QMS. The key elements that need to be decided and actioned are what needs to be communicated, when it needs to be communicated, how it should be done, who needs to receive the communication, and who will communicate. It should be noted here that any communication outputs should be consistent with related information and content generated by the QMS for the sake of consistency

To start, the requirements state that “the organization shall determine the internal and external communications relevant to the quality management system.” While this may seem simple, it does entail that you, as the implementer of the QMS, make a decision: What do I consider relevant communications for my QMS? This should be directly linked back to your QMS scope, which is the definition of what your QMS covers within your organization. Remember what your defined QMS products and services are, because this will help to determine what communication you consider relevant to your QMS. Included in this determination of relevant QMS communication, according to the requirements, are the following five items that need to be included in your communication plan:

1.What will be communicated?

You will most likely need to communicate on product and service?nonconformances

2. When will you communicate?

When do you need to let shareholders and stakeholders know of important developments in your Quality Management System?

3.With whom you will communicate?

Your list of people to communicate with might include employees, shareholders, suppliers, customers, business partners, or members of the public

4. How you will communicate?

You could use your company IntraNet, email, phone, text, press release, or even in-person discussions depending on what you need to communicate and to whom.

5.Who will do the communication?

his may change depending on the information to be relayed or the severity of the information. Critical failures may need to be communicated by the CEO, while smaller nonconformances may be communicated by a project team. You may even have dedicated individuals who can speak to the media about your company, and this should be part of your communication plan.

While there is no requirement in ISO 9001:2015 that your communication plan needs to be documented information it might be a good idea to do so if it is complicated. If you are a small organization that will have the CEO do all communication, and you will only communicate what is defined in your contracts and legal requirements, you may not need to document your plan, but if it becomes more complex with different people communicating to different parties, in different ways, on different topics, a documented plan might be a good idea.

It is also important to remember that these requirements apply to both internal and external communications, so don’t forget to include how you will communicate important QMS information to your employees within your communication plan.

• The message to take from these ISO 9001:2015 requirements is that it is important to plan your communication ahead of time, so as not to scramble to decide when something happens and you need to make a communication. When you do not have a plan, that is when people make mistakes due to high emotions rather than thoughts; and, if you need to communicate bad news, this can hurt your company’s reputation and credibility. If you have put in the effort to define a good Quality Management System, you owe it to yourself and all of your stakeholders to have a good communication plan that works for you.

Documented information

QMS documentation is comprised not only of the documents and records required explicitly by the standard but also of the documents and records the organization finds necessary to execute its activities and processes. The volume of the documentation is affected by many factors: it will depend on the size of the organization and the complexity of its processes, products, and services; the organization’s compliance obligations; and also on the competence of the employees.

The standard requires that documented information created or updated in the scope of the QMS must be properly identified and described, also considering its content presentation, and media used. All documented information must go under proper review and approval procedures to ensure it is fit for its intended purpose.

For proper control of documented information, the organization must consider the provision of processes regarding the distribution, retention, access, usage, retrieval, preservation and storage, control, and disposition of such information.

• It should also be noted that there must be controls in place to prevent the unintentional use of obsolete information.

Here comes the importance of having your organization's Digital Workplace like IntraNet

What is documented information?

ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and maintained by the organization and the medium on which it is contained. Notes to this definition indicate that documented information can refer to the Quality Management System (QMS) and its processes, documentation, and records.

The QMS needs to include documented information required by the ISO 9001 standard and documented information determined necessary for the effectiveness of the QMS. The QMS also needs to include the size of the organization and type of activities, the complexity of processes and interactions, and the competence of persons.

Additionally, there are requirements for creating and updating documented information, which includes identification, appropriate format, and review & approval of documented information. The final requirements about documented information deal with control, and in particular availability and suitability where it is needed, adequate protection, applicable distribution, access, retrieval, use, storage, preservation, control of changes, retention, and disposition. All of these requirements are much the same as those already in place for documented procedures and records but have been made into one set of requirements.

What documented information is required by ISO 9001:2015?

• Scope of the QMS
• Anything necessary to support the operation of the processes
• Anything necessary to be confident that the processes are carried out as planned
• The Quality Policy
• The Quality Objectives
• Evidence that monitoring and measurement resources are fit for the purpose
• Calibration standards when no internationally recognized standard exists
• Evidence of competence
• Evidence that processes have been carried out as planned
• Evidence to demonstrate the conformity of products and services to requirements
• Results of the review of requirements related to products and services
• Confirmation that design and development requirements have been met
• Outputs of the design and development process
• Design and development changes
• Results of evaluation, monitoring of performance, and re-evaluation of external providers
• Definition of characteristics of the products and services, including the activities to be performed and the results to be achieved
• Information necessary to maintain traceability when this is required
• The results of changes to the production and service provisions
• Release of product or service to the customer, including the person authorizing the release
• Actions taken on nonconforming process outputs, products, and services, including concessions, obtained
• Results of monitoring and measurement activities
• Evidence of the implementation of the audit program and audit results
• Evidence of the results of the management review
• Evidence of the nonconformities and actions taken, and the results of any corrective actions

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Understanding ISO 9001:2015:

• Article (1)
• Article (2)
• Article (3)
• Article (4)