Short Note - Understanding the organization and its context

Short Note - Understanding the organization and its context

Clause 4.1 of ISO 9001:2015 QMS standard provides the requirements related to captioned matter.

The organization needs to (i) determine internal and external issues (positive and negative factors or conditions) relevant to the organization's purpose, strategic direction and that can affect organizational ability to achieve intended results or desired outcomes, and (ii) monitor and review information (data) about the determined external and internal issues (positives and negative factors or conditions).

We should have a clarity that there are many issues that can help or make easier the understanding the external context of the organization and such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local. There are many other issues that can help or make easier the understanding the internal context of the organization and such issues may relate to the organization's values, culture, knowledge and performance.

To know more on the understanding the organization and its context, please refer to the following relevant articles:
- ISO 9001:2015 QMS - Understanding organization and its context - Source of information about internal and external issues - CLICK HERE.
- Understanding the organization and its context - CLICK HERE.
- ISO 9001:2015 QMS - Understanding the organization and its context - CLICK HERE.

Best wishes,

Keshav Ram Singhal

Short Note - Documented information

Short Note - Documented information

Please refer to clause 4.4.2 of ISO 9001:2015 QMS standard.

The organization needs to (i) maintain documented information to support the operation of the organization's processes, and (ii) retain documented information that provides confidence and evidence about the processes carried out as planned.

Requirements with regard to the documented information are mentioned in clause 7.5 of ISO 9001:2015 QMS standard.

To know more on documented information, please refer to relevant articles:
- ISO 9001:2015 QMS - Creating and updating Documented information - Part 1 - CLICK HERE
- ISO 9001:2015 QMS - Creating and updating Documented information - Part 2 - CLICK HERE

Best wishes,

Keshav Ram Singhal

Short Note - Improving the quality management system including the processes

Short Note - Improving the quality management system including the processes

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

The organization needs to improve its (organization's) processes and its (organization's) quality management system.

In this connection, requirements as mentioned in clause 10 are relevant. Determining the necessary actions by using the analysis results and evaluation results are important to improve the quality management system including the processes of the organization. Improvements can be carried out in an individual process by reducing variations in its activities and by reducing unnecessary paperwork associated with the system, so as to enable persons associated with the system to concentrate more on process implementation and management.

Best wishes,

Keshav Ram Singhal

Short Note - Evaluating processes and implementing any changes

Short Note - Evaluating processes and implementing any changes

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

With a purpose to ensure that organization's processes achieve intended (desired) results (outcomes), the organization needs to (i) evaluate its (organization's) processes, and (ii) implement any changes needed. For evaluating processes, the organization should (i) consider the performance facts obtained through monitoring, measurement and internal audit, and (ii) analyze and evaluate these performance facts. In this connection, implementing requirements of clause 9 of ISO 9001:2015 QMS standard is relevant.

Best wishes,

Keshav Ram Singhal

Accreditation

Accreditation

When an organization decides to implement and obtain certification to ISO 9001:2015 QMS or any other standard, the first work is to choose a certification body from which the organization will obtain the certification. A number of certification bodies are operating in our country, so you have a wide choice to select a certification body. It is always suggested to obtain accredited certification. A question may arise in our mind - What is accreditation? Accreditation is a link in the chain of trust. If an organization meets the requirements of ISO 9001:2015 QMS standard, the organization will receive a certificate of conformity to the standard from a certification body (also known as assessing body or conformity assessment body) after formal assessment. This certificate has most value if the certification body is professional, impartial, competent and independent. The accreditation body with the aim of checking the expertise, impartiality and independence of certification bodies carries out accreditation task. If the results are positive, an accreditation mark is issued to certification body. Accreditation is a term widely used in certification industry. It provides us confidence in the certification body that grants us management systems certification, such as ISO 9001 certification, ISO 14001 certification etc. In simple terms, accreditation is the action or process of officially recognizing someone as having a particular status or qualified to perform a particular activity. It is an acknowledgement of someone's responsibility for achievement of something.

Accreditation really means 'creating trust'. Accreditation by an authoritative body is the formal recognition of the competence of the certification body to perform a specific task such as analysis, calibration, inspection or certification. Accreditation is the mechanism for indicating that the assessing organization for a demarcated area, the 'scope', justified confidence. Accreditation is the formal recognition that is based upon a series of international standards that focus particularly on the elements of expertise, independence, impartiality and continuity.

Nationally and internationally buyers want to be able to trust blindly the quality and safety of products/services provided by the certified organizations. If these are guaranteed, it not only benefit the buyer but also to the organization that supply the product/service. This strengthens the supplier organization's position in the market. In order to be able to provide an objective guarantee, the organization can have its quality management system assessed by an accredited certification body.

When an organization opts for ISO 9001:2015 QMS or any other standard certification, it finds in the initial stage that the certification body is accredited from an accreditation body. There are a number of accreditation bodies operating in the world that carry out the accreditation work. In India, NABCB (National Accreditation Board of Certification Bodies) grants accreditation to certification bodies. There are many accreditation bodies in the world, such as UKAS (United Kingdom Accreditation Service) in UK, RvA (The Dutch Accreditation Council - Raad Voor Accreditatie) in Netherlands, ANAB (ANSI-ASQ National Accreditation Board) in USA, JAS-ANZ (Joint Accreditation System) in Australia and New Zealand etc.

RvA Public Report 2016 says, "Accrediting really means: creating trust. Nationally and internationally buyers want to be able to trust blindly the quality and safety of products and services provided. If these are guaranteed, it not only benefits the buyer but also the supplier. This strengthens his position in the market. In order to be able to give an objective guarantee, the supplier can have his products and services assessed by an accredited organization. This also applies to every area imaginable: health, environment, construction, energy, food, transport, finance etc."

The certificate issued by a certification body which has been accredited by an accreditation body which is an IAF MLA signatory for the scope covering the certificate should be acceptable in the world under the principle of international equivalence. This is a very significant reason for making an appropriate choice of a certification body.

International Accreditation Forum (IAF)

The International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited.

Accreditation in India

Since 1992 a need had been felt for the establishment of an accreditation body in India to establish internationally acceptable mechanism for recognition of conformity assessment results. As regards laboratories, an accreditation body under the Ministry of Science and Technology was already functioning. A committee which included various interested ministries and stakeholders including industries was established to make suitable recommendations. The work was coordinated by the then Department of Industries (Department of Industrial Policy and Promotion) and the recommendations were submitted to the Cabinet in 1996. Key recommendations included the Need for establishing an organization jointly by the Government and the industry and the need for the organization to be self-sustaining and be away from the government. Accepting the recommendations, the Cabinet Committee decided to set up Quality Council of India (QCI) as a non-profit autonomous society registered under Societies Registration Act XXI of 1860 to establish an accreditation structure in the country and to spread quality movement in India by undertaking a National Quality Campaign. Accordingly, QCI was established as the National body for Accreditation on recommendations of Expert Mission of EU after consultations in Inter-ministerial task force, Committee of Secretaries and Group of Ministers in 1996.

There is a governing council (known as Council) as the apex level body responsible for formulating the strategy, general policy, constitution and monitoring of various components of Quality Council of India (QCI) including the accreditation boards with objective to ensure transparent and credible accreditation system. Following accreditation boards are working under the structure of QCI:
- National Accreditation Board for Certification Bodies - NABCB
- National Accreditation Board for Education and Training - NABET
- National Accreditation Board for Hospitals and Healthcare Providers - NABH
- National Accreditation Board for Testing and Calibration Laboratories - NABL - However, it should be noted that NABL continues to be a separate legal entity.
The National Accreditation Board for Certification Bodies (NABCB) provides accreditation to Certification and Inspection Bodies based on assessment of their competence as per the Board's criteria and in accordance with International Standards and Guidelines. The National Accreditation Board for Certification Bodies (NABCB) is internationally recognized and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international Multilateral / Mutual Recognition Arrangements (MLA / MRA).
NABCB is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. Global G.A.P., Food Safety Management Systems and Information Security Management Systems NABCB is also a full member of International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection. National Accreditation Board for Certification Bodies (NABCB), linked to Quality Council of India (QCI), grants accreditation to certification bodies. In addition to this, many foreign accreditation bodies have also granted accreditation to certification bodies operating in India. Some of the foreign accreditation bodies are:
- UKAS - United Kingdom Accreditation Service
- RvA - Raad voor Accredatie (The Dutch Council of Accreditation)
- ANAB - ANSI-ASQ National Accreditation Board
- JAS-ANZ - Joint Accreditation System of Australia and New Zealand
- SCC - Standards Council of Canada
- JAB - Japan Accreditation Board
- IAR - IAR Accreditation Service

There are accreditation bodies in neighbouring countries too, some of which are:
- CNAS - China National Accreditation Service for Conformity Assessment
- PNAC - Pakistan National Accreditation Council
- SLAB - Sri Lanka Accreditation Board for Conformity Assessment

Many of the accreditation bodies are the members of International Accreditation Forum (IAF) and these accreditation bodies agree to the IAF Multilateral Recognition Agreement (MLA) recognizing the equivalence of other embers' accreditation to their own.

There are more than fifty certification bodies operating in India, which have been granted accreditation either from NABCB or from any other foreign accreditation body. In such a situation, first you should collect information about the certification bodies operating in your country and then you should contact the certification bodies with brief description about your organization, nature of your business and your assessment requirements. You should also find out whether the certification body is accredited to provide certification in your area of business. In this connection, it is important to check that its accreditation scope includes the technical sector of your organization. The certification bodies are accredited scope wise. There are 39 scope sectors as mentioned by IAF, a few of them are as under:
- Agriculture, forestry and fishing,
- Mining and quarrying,
- Food products, beverages and tobacco,
- Nuclear fuel,
- Chemicals, chemical products and fibres,
- Pharmaceuticals,
- Transportation, storage and communication,
- Information technology,
- Engineering services,
- Education, etc.

Selection of a certification body

Since there are too many certification bodies operating in our country, you need to select a accredited certification body, for which you should know the details of accreditation, certification services and cost of certification. Therefore it is better to write letters or send emails to several certification bodies asking their accreditation, certification services and cost of certification. Upon receipt of your letter/email, the certification body will advise you the certification process and a quotation for the costs including the certification fee. Accordingly, you will have quotations from several certification bodies and you will be in a position to decide a certification body by which you will obtain ISO 9001:2015 QMS certification. Quotation will normally include a one-time certification fee (covering a period of three years), costs per day of auditing work (before, during and after certification), travel and other expenses. The number of workdays required for each audit will depend on the size of operation and the location of the organization to be audited. Please note that while deciding a certification body, don't just go for a cheap or non-accredited certification. You need to make a wise choice to get maximum benefits out of certification.

Best wishes,

Keshav Ram Singhal

Short Note - Addressing risks and opportunities

Short Note - Addressing risks and opportunities

Please refer to clause 4.4.1(f) and clause 6.1 of ISO 9001:2015 QMS standard.

The organization needs to
(i) address determined risks and opportunities, and
(ii) ensure take and implement any actions needed to address determined risks and opportunities.

Relevant articles in this connection, please refer to:
- Determining and addressing risks and opportunities - CLICK HERE.
- Risk Matrix - CLICK HERE.
- Risks and opportunities in ISO 9001:2015 QMS - Process-diagram - CLICK HERE.
- Why we need a risk-based thinking? - CLICK HERE.
- A simple method to determine risks and opportunities - CLICK HERE.

Best wishes,

Keshav Ram Singhal

Short Note - Assigning responsibilities and authorities for processes

Short Note - Assigning responsibilities and authorities for processes

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

The organization needs to assign the responsibilities and authorities of its (organization's) processes, for which following should be considered and determined:
- What are the activities of each process?
- Who will perform the activity/activities?
- What will be the responsibilities and authorities of the person performing the activity/activities?

Considering the above, steps should be taken to assign the responsibilities authorities in a documented information. Documented information may be organization chart, documented procedure, operational policies, job descriptions, or instructions.

Best wishes,

Keshav Ram Singhal

Short Note - Determining resources and their availability

Short Note - Determining resources and their availability

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

The organization needs to determine the resources needed for its (organization's) processes and ensure availability of determined resources. Resources include people, infrastructure, environment for the operation of processes, monitoring and measurement resources, and organizational knowledge. In this connection requirements of clause 7.1 is relevant that require consideration of (i) the capabilities of existing internal resources, (ii) constraints on existing internal resources, and (iii) what the organization will obtain from external providers.

Infrastructure includes buildings and associated utilities, equipment (hardware and software), transportation resources, information and communication technology.

People needs to be competent for the operation of relevant process (related to their work) and aware of quality policy, relevant quality objectives (related to their work), their contribution to the effectiveness of the quality management system, benefits of improved performance, and the implications of nonconforming requirements.

In addition to the above resources, the organization needs to determine documented information as being necessary for the effectiveness of the quality management system. In this connection, please refer to clause 7.5 of the standard.

Best wishes,

Keshav Ram Singhal

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