Short Note - Effective operation and control of processes

Short Note - Effective operation and control of processes

Please refer to clause 4.4.1(c) of ISO 9001:2015 QMS standard.

The organization needs to first determine and then apply the criteria and methods needed to ensure the effective operation and control of its (organization's) processes. Effective operation and control of processes is possible by applying process control criteria and methods including monitoring and measurement, using process parameters, specifications for products/services, performance indicators, reports, charts, audit results etc. Therefore, first determine process control criteria and methods and then apply such determined control criteria and methods.

Best wishes,

Keshav Ram Singhal

Short Note - Determining sequence and interaction of processes

Short Note - Determining sequence and interaction of processes

Please refer to clause 4.4.1(b) of ISO 9001:2015 QMS standard.

The organization needs to determine the sequence and interaction of its (organization's) processes. When we look to the definition of a process, we find that a process is a set of interrelated or interactive activities that use inputs in order to deliver intended results (outputs). Sequence and interaction mean the links with the inputs and outputs of the previous and subsequent processes. Output of one process may be input to subsequent process. There are various methods (such as, process map, flow diagram, written description, etc.) for providing the details of the sequence and interaction of the processes and it depends on the organization the method it uses.

Best wishes,

Keshav Ram Singhal

Short Note - Determining inputs required and outputs expected from processes

Short Note - Determining inputs required and outputs expected from processes

Please refer to clause 4.4.1(a) of ISO 9001:2015 QMS standard.

The organization needs to determine the inputs required and the outputs expected from its (the organization's) processes. Inputs required for a process may be determined by considering what are the inputs that will implement the processes effectively as planned. inputs may be tangible (such as - materials, components, equipment, machinery, human resource etc) and/or intangible (such as - data, information, knowledge, experience etc.). Expected outputs from a process may be determined by considering the expectation of intended result by the subsequent process or customer. Outputs may be tangible and/or intangible.

Example - Process of Cooking Rice
Inputs - Person, Kitchen, Rice, Water, Cooking pan, Gas stove and lighter
Outputs - Cooked rice, Cooking pan for cleaning

Example - Process of reading a book
Inputs - Person and book
Outputs - Person with added information

Best wishes,

Keshav Ram Singhal

ISO 9001:2015 QMS - Understanding organization and its context - Source of information about internal and external issues

ISO 9001:2015 QMS - Understanding organization and its context - Source of information about internal and external issues

What can be the source of information about internal and external issues?

There are many sources that can provide information about internal and external issues of an organization, such as:
- Internal records / documented information of the organization,
- Internal and external meetings,
- National and international news and reports,
- Various websites, for example - website of government, regulatory body, tax authority, competitors etc.
- Various publications, for example - government, professional, technical, sector publications,
- Conferences,
- Professional and business associations, such as - Confederation of Indian Industry (CII), Association of Computing Machinery (ACM), SME Chamber of India, Ajmer Zila Laghu Udhyog Sangh etc.

Best wishes,

Keshav Ram Singhal

Adding Value to Internal QMS Audit - Outside auditor be asked to internal audit the QMS

Adding Value to Internal QMS Audit - Outside auditor be asked to internal audit the QMS

The purpose of internal audit is to ensure that the quality management system of the organization conforms to the planned arrangements to the requirements of the ISO 9001:2015 QMS standard and the quality management system requirements established by the organization. The other purpose of the internal audit is to ensure that the quality management system is effectively implemented and maintained by the organization. I had posted an article 'Adding Value to Internal QMS Audit' in my blog on 'ISO 9001:2008 QMS Awareness'. The article is relevant, however to further improve internal audit, top management of the organization should consider outside auditor to internal audit the organization's QMS as an added improvement action. It is observed that internal auditors, selected within the organization, generally leave auditing leadership requirements of ISO 9001:2015 QMS. Internal auditors, selected within the organization, are working in the position below the top management, they do not report non-compliances of clause 5 of ISO 9001:2015 QMS standard and avoid auditing leadership requirements due to interpersonal organizational relationship. Bringing an outside auditor will bring transparency, fairness and impartiality.

Best wishes,

Keshav Ram Singhal

Organize training programmes for effective implementation of ISO 9001:2015 QMS in your organization

Organize training programmes for effective implementation of ISO 9001:2015 QMS in your organization

Staff awareness, towards ISO 9001:2015 QMS, is necessary for effective implementation of ISO 9001:2015 QMS in an organization. For creating general staff awareness towards ISO 9001:2015 QMS, organizations should conduct 'ISO 9001:2015 QMS Awareness' programme to communicate to the employees the aim of ISO 9001:2015 QMS,the advantages it offers to employees, customers and organizations, how it will work, and employees' role and responsibilities within the quality management system. The training programme should be conducted by a trainer, who can be an internal or outsider. If a lead auditor trained person is available in the organization, he may be able to conduct such programme. In case internal trainer is not available, then the organization may engage an outside trainer. The duration of 'ISO 9001:2015 QMS Awareness' programme should be four to eight hours depending upon the organization's needs and the level of knowledge its employees possess.

Leadership and active involvement of the top management facilitate proper implementation of ISO 9001:2015 QMS. The top management must be convinced that implementation and certification will enable the organization to demonstrate a visible commitment to quality and continual improvement. The top management must be aware of the overview of ISO 9001:2015 QMS. For the top management awareness, a meeting should be organized covering the following issues:
- Overview of ISO 9001:2015 QMS,
- Identification of goals and expectations,
- Role of the top management within iSO 9001:2015 QMS,
- Formulation of quality policy,
- Formulation of quality objectives,
- Organizational roles, responsibilities and authorities,
- Establishing a steering committee and a task force,
- Why appoint a consultant,
- Step-by-step process for implementation and certification.

Training programmes will provide necessary knowledge to people involved in ISO 9001:2015 QMS implementation, so these should be organized for different categories, such as managers, supervisors, workers, task force, steering committee members etc. In addition, training may also be necessary for creating and updating documented information, auditing and its principles, laboratory management techniques, calibration, testing procedures etc.

An in-depth training programme covering the following areas should be organized for members of task force, steering committee and employees selected for internal auditing, as necessary:
- ISO 9001:2015 QMS and its requirements,
- Internal quality audit,
- Statistical tools,
- Creating and updating documented information,
- Risk-based thinking.

The organization can organize such trainings as in-house programmes. The consultant (if appointed), an outside trainer or an external training institution could be invited to conduct in-house training programmes. When in-house capacilty, to carry out such training programmes, is not available, the organization should depute its personnel to external training programmes organized by professional training organizations.

- Keshav Ram Singhal

Seven Signs of a Strong Culture of Quality

Seven Signs of a Strong Culture of Quality

I read an article 'Seven Signs of a Strong Culture of Quality' written by Rachel Beavins Tracy that looked to seven signs of a strong quality culture: (i) Quality starts at design, (ii) Monitoring and measurement are priorities, (iii) Risk is part of decision-making criteria, (iv) The goal is not compliance, (v) Accountability is built-in, (vi) Leadership is clearly supportive, and (vii) People take ownership of problems.

The article is published at EtQ blog. Please CLICK HERE to read the article.

Thanks,

Keshav Ram Singhal

Quality Concepts and ISO 9001:2008 QMS Awareness: Understanding the meaning – Continual improvement ...

Quality Concepts and ISO 9001:2008 QMS Awareness: Understanding the meaning – Continual improvement ...: I was addressing a group of participants in a training programme on ‘ISO 9001 QMS Awareness’, while discussing and telling requirements r...

Difference between 7.1.6 and 7.2

Difference between 7.1.6 and 7.2

One of the readers asked difference between 7.1.6 and 7.2.

Clause 7.1.6 of ISO 9001:2015 QMS standard deals with the requirements related to the knowledge specific to the organization, which is a support resource for an organization. Clause 7.2 of ISO 9001:2015 QMS standard deals with the requirements related to the comptence of persons. Competence is the ability to apply knowledge and skills to achieve desired results. Competent person is also a resource for an organization.

Clause 7.1.6 requires determining organizational knowledge (necessary for the operation of its processes), maintaining it and making it available. When addressing changes, it requires considering current knowledge and determining the ways to acquire/access necessary knowledge/updates.

Clause 7.2 requires determining necessary competence of persons, ensuring competent persons doing the job, taking necessary actions to acquire necessary competence, evaluating the effectiveness of the actions taken and retaining documented information.

Clause 7.2 appears compliment to clause 7.1.6.

With best wishes,

KRS

New Blog on ISO 45001:2018 OH&SMS Awareness

Dear friends,

A new blog has been created to increase awareness on ISO 45001:2018, Occupational health and safety management system standard.

I seek your blessings.

Please CLICK HERE to visit the blog.

Thanks,

Keshav Ram Singhal