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What are in Clause 8 of ISO 9001

ISO 9001:2015 Clause 8

Explanation of clause 8 of ISO 9001

Clause 8 is the most important clause among other clauses of ISO 9001 2015 standard. It works with the main process of the company. The central process which is direct related with the product or services. If a company effectively implements the requirement of this clause then easily it can achieve the customer requirement.

This clause 8 has some sub clauses: 1- Operational Planning and control. 2- Requirement for product and services. 3-Design and development of product and services. 4-Control of Externally provided processes for product and services. 5-Production and Service Provision. 6-Release of Products and Services. 7- Control of non-conforming product and services.

Desription of Sub Clauses of 8

The above sub clauses of clause 8 of ISO 9001 describes the systematic way to go production or processing of services it provides to the clients. Before production or processing the services the company needs planning then product or service requirement. Then about design. However, some company outsources this part(8.3)

After doing plan and setting product and service requirement it is necessary to import or purchase raw material from the supplier or vendors. So, 8.4 expresses the suppliers requirements- Maintaining approved supplier list and evaluating them once in a year is must doing things for a company who are advancing to achieve ISO 9001 Certificate.

Sub clause 8.5 of 8 of ISO 9001 explains Production related various steps including production and service control, identification and traceability, customer property for production or service processing, Product preservations after production, Any service warranty or guarantee after delivery of the product or services and control of any changing during the production etc.

Sub clause 8.6 tells Product releasing terms , During the production if any nonconforming products are found that should be controlled and separated by attaching sticker on the product in the production area for stopping unwanted mixing with good quality product.

Summary of Clause 8 of ISO 9001 2015

Production of product and service providing related all requirements are found in this clause 8.

To read clause 7 go here

ISO 9001 Clause 7

ISO 9001 Clause 7 for 2015 version is also known as Support. This support is for the organization for establish implementation and maintain of quality management system. Top management will provide it. There is several sub clauses and sub sub clauses in this standard. Resources, Competence, Awareness, Communication and documented information are the main topics of this standard of ISO 9001 Clause 7.

People, Infrastructure, Environment, Monitoring and Measuring Devices, Organizational Knowledge are the main sub sub clauses of Resources. For proper implementation of QMS the above topics are necessary and the top management will ensure that those all are present in the organization.

To ensure competence the company will verify the education, work experience training etc for the people.

After setting quality policy and objectives that shall be communicated to the all staffs for effective implementation of QMS ISO 9001 2015.

Communication guideline shall be there for external and internal communication. To ensure this guideline what, when whom to how to and who word can be used.

The company will determine what documented information is required for the effectiveness of the qms. Based on company size, type, activities, processes this documents may differ from company to company. The company may also follow the document control procedure in this regard. All kind of support including the above should be placed by top management according to the ISO 9001clause 7.

Quality Certificate in ISO

Quality Certificate is a popular keyword right now in Bangladesh. So, this is the keyword of my post in this month. Though there is many meaning of quality but here in this post I will discuss only quality certificate in ISO.

ISO 9001 is also known as quality certificate or Quality Management System Certificate. It is also known as QMS in a nutshell. It is issued by a Certification Body.

9001:2015 is the latest version of ISO 9001 standard. It started in 1987. Until now it is revised five times since then. Now it is in fifth version. If you want to get quality certificate then ISO 9001:2015 is the right version for you.

What does it mean quality certificate? In ISO it means quality of a organization.  Quality of different sections or quality of different department in a organization. Quality for HR Admin, Sales marketing, Procurement, Production etc. In a word quality for organization means maintaining quality in different departments of a organization.

As an example for quality in production, what does it mean? It means how you are maintaining quality of your product? Are you monitoring the measurement of the product when it is producing, Does it meet the client’s requirement or your own specification data? Are you keeping record of your error products? Are you taking CA Plan against frequently happened error? All these things are checked during ISO audit.

Participating in audit is mandatory for achieving and holding your ISO Quality certificate. Audit helps to find the facts in your production. Production staffs are asked to show the quality checking record, wastes record, machine breakdown record etc. during the ISO audit.

Not only ISO audit. Internal audit is mandatory for ISO Certification or after ISO Certification. Usually internal audit (IA)is done inside the organization by it’s own staffs or it can be done by hiring an ISO Consultant. Without performing IA you cannot hold your iso quality certificate. It will be suspended if you do not perform IA on regular basis.

So, getting a quality certificate means you are appointing your supervisor or manager who will give you report of your whole organization. ISO Quality auditor will find the real facts actually what are happening in your organization during the audit, usually once in a year.

Worldwide quality certificate has a great demand. Specially for EU and Middle East Buyers it is asked to the exporters or suppliers to have this certificate. It ensures the quality of your organization.

For smooth and efficient operation of a company quality certificate has a great value. It is a great tool to see your organization. It helps to get new job from new buyers. It helps to increase your internal quality. Finally it helps to earn more revenue for your company.

AAS has been providing quality certificate since 2012. Until now it has certified more than 200 companies. The quality certificates come from the UK. AAS has experienced auditors who can help you to develop your organization and finally achieving the quality certificate.

Ownership and custodian of assets needs to be revised as per current scenario.

Leadership

Leadership is the direction from the top management to achieve certain goals in an organization. A good leadership creates good environment for work and motivate staffs to be involved to meet its customer requirements. Leadership is the fifth term and clause of ISO 9001:2015 Standard. A plenty of works have been described in this clause for the top management. Some of the major responsibilities have been described in below:

  • Take accountability of effectiveness of the quality management system
  • Be focused on customer satisfaction
  • Establish, implement and maintain a quality policy and share it to all interested parties
  • Engaging, directing and supporting persons for effective implementation of QMS
  • Work on improvement.
  • Ensure customer and applicable statutory and regulatory requirements are met
  • Identify the risks and opportunity which can affect the products or services it provides
  • The focus on enhancing customer satisfaction is maintained.
  • Assigning the roles and responsibilities and authorities of the staffs
  • Ensure the enough resources are there for effectively implementation of QMS

Context of the organization

It is the fourth clause of ISO 9001:2015 standard. Context means circumstances or condition of the company. So, in this clause details idea of the company should be clarified including what kind of product or services it provides, what are the necessary processes what are the external and internal issues, who are the interested parties what is the scope of the quality management system etc should be mentioned clearly before proceed to certification to ISO 9001:2015.

There are four sub clauses of this principal clause number 4. They are: 4.1 Understanding the organization and its context , 4.2 Understanding the needs and expectations of interested parties, 4.3 Determining the scope of the quality management system, 4.4 Quality management system and its processes

4.1: Understanding the organization and its context : The organization shall determine, regularly monitor & review the external and internal issues. External issues are legal, technological, competitive, market, cultural, social and economic environments, whether international, national etc. Internal issues are organizational values, culture, knowledge, and performance.

4.2: Understanding the needs and expectations of interested parties: Two things are mentioned in this sub clause. That are: determine the interested parties and assess the requirements of those parties which are relevant to its QMS. It can vary company to company. However the common interested parties are: customers, owners, employees, providers, bankers, regulators, unions, partners, community, news media, competitors, law enforcement, emergency responders etc.

4.3: Determining the scope of the quality management system: It is one of the required and mandatory requirements for company and it shall be maintained as documented information. Scope determining time the following things should be considered: a) external and internal issues (see 4.1); b) requirements of relevant interested parties (see 4.2); c) products and services of organization. The organization shall apply all the requirements of this QMS standard 9001:2015. However, provide logical justification if any clause is not applicable in scope of quality management system.

4.4: Quality management system and its processes: Determining the processes and showing their interactions among the processes is mandatory for effective implementation of the qms in the organization. In the processes following things should be included: a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; h) improve the processes and the quality management system. Documented information and retain documented information for the processes is also necessary. During the audit these documented information and retain documented information will be reviewed by the auditor. Go to read about ISO 9001 Clause number 5 

Scope

The first clause of ISO 9001 2015 is scope. Two things have been told in this clause. One is which kind of company needs this quality management system standard and why it is need? If we say who needs then the answer is any kind and any size of organization can adopt this standard

If we go why needs then two answers will come there first of all: If any company wants to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and secondly if any organization wants to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

In the clause 2 and 3 there is references of ISO 9000:2015 for normative reference, terms and definitions. So, there is no more to learn from those two clauses. However to know more about clause number 4 you may visit this post