Articles for Enews May 2015

ARTICLES FOR ENEWS MAY 2015

1. A Critical Analysis of ISO 9001:2015 (part 1)
2. ISO 9001:2015 – A new Roadmap towards Implementing Quality Management Systems (Part 2)
3. Occupational Health and Safety Management Systems ISO 45001
4. L,entrevue de Mme Rashida Nanhuck, directrice par interim du Mauritius Standards Bureau
5. Standards Approved
6. Photo News

A CRITICAL ANALYSIS OF ISO 9001:2015
MRS R NANHUCK (Part 1)
In 1987, when the first Quality Management Standards elaborated by the International Organization for Standardizations (ISO) were published, no one could have predicted that a silent revolution had been initiated in the field of Quality. Since then a lot of water has flowed down the ISO bridge. The success of ISO 9001:1987 has paved the way for other breeds of ISO Management Standards to spawn.
Even the Quality Management Standard (ISO 9001:1987) has been revised three times, that is, in 1994, 2000 and 2008 and is nowadays again under revision with an updated version expected to be out by September 2015.
The revised DIS version of ISO 9001:2015 has been prepared using the common “high structure” which allows the alignment of management system standards with common definitions and common text. This structure is termed as Annex SL.
DIS ISO 9001:2015 consists of 10 clauses and three Annexes and is anchored on seven quality management principles which are given in Annex B of the Standard. These principles are:
Customer focus, leadership, engagement of people, process approach, improvement, evidence-based management and relationship management.
The Draft International Standards DIS ISO 9001:2005 remains a systems and process-based model.
In the introduction of DIS ISO 9001:2015, it is emphasized that “this International Standards promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system.
Clause 4.4 also explicits that “the organization shall establish, implement, maintain and continually improve a quality management system including the processes needed and their interactions in accordance with the requirements of this International Standard”.
In additition the organization ……………… shall determine:
a) / The inputs required and the outputs expected from these processes.
h) / The opportunities for improvement of the processes and the quality management system.
Several fundamental concepts have been introduced in the revised version of ISO 9001. First and foremost, “Leadership” (Clause 5) has at last found its rightful place in the document and elbows out “Management Responsibility”.
In many Management and Quality models, leadership plays a prominent role in driving changes in an organization. Although the concept of leadership as such is not fully elaborated in ISO 9001:2015 as in other models, yet it occupies a central position as evidenced in Figure 1- Model of a process-based quality management system of the standard. Special emphasis is also placed on leadership in respect with the quality management (clause 5.1.1) system and customer focus(clause 5.1.2).
Another appealing concept brought into the new standard is “Context of theOrganization” (Clause 4) and the attendant sub-clauses 4.1 – Understanding theorganization and its context and 4.2 – Understanding the needs and expectations ofinterested parties.
In ISO 9001:2008, clause 4 referred to the Quality management systems and sub-clause 4.1 to the General requirements of the Quality management systems.
In fact Clauses 4.1 and 4.2 as further explained in Note 1 and Note 2 of the revised version makes it a requirement for the organization to undertake an environmental analysis by using tools such as PESTLE (Political, Economic, Social , Technological innovation, Legal and the Environmental factors) as well as an internal analysis of the organization and taking into consideration factors such as values, culture and knowledge. The processes recommended under this clause are similar to those in strategic management whereby the focus is placed on the interior as well as the exterior of the organization to maintain its sustainability. In other words we find that Strategy as a concept is gradually creeping in the new ISO 9001 QMS model.
Another far-reaching concept proposed in the revised standard is Risk Management (Clause 6.1) and Risked-Based Thinking (Clause 0.5). Risks and risk management have emerged as the latest managerial innovation that can create value for the organization and it is not surprising that these ideas have come to occupy a legitimate place in the new version of ISO 9001 standard. Although a full scale risk analysis and risk management are not recommended in the standard we can safely say that these management concepts are the real game-changers.
In short, the new standard has adopted key management concepts such as leadership,strategic management and risk management which were missing in the earlier version. The other changes brought to the standard will be described and explained in another article.
It is worth mentioning that the Final Standard ISO 9001:2015 is expected to be published in September 2015 as per the indicative calendar of works.

Revision timeline

September 2015 –

ISO 9001:2015

January 2015
FDIS for ballot
November 2014
Draft FDIS to be issued
July 2014
DIS for ballot
ISO 9001:2015 – A NEW ROADMAP TOWARDS IMPLEMENTING QUALITY MANAGEMENT SYSTEMS

MRS R NANHUCK (Part 2)

In my last article on the revised draft version of ISO 9001-2015, I provided an overarching view on the changes brought to ISO 9001: 2015. The Standard has witnessed changes both in form and content. More particularly, I highlighted upon:
i)the adoption of the High Level Structure which standardize the titles of the sub- clauses, clause numbering, core text, common terms and core definitions to ensure compatibility and adjustment with other ISO management systems standards.
ii)an increased emphasis on leadership management requirements,
iii)an explicit requirement for risk-based management, and
iv)an increased emphasis on organizational context.
I drew the attention of the readers that the new standard will promote the need to demonstrate system effectiveness and the application of risk-based thinking through all the processes. Eventually the standard will call for new auditing techniques to ensure that the intended outcomes are achieved.
As a reminder, the main objectives of the ISO 9001 standard have remained the same, that is, to
i)provide confidence in the organization’s ability to constantly offer customers with conforming goods and services; and
ii)to enhance customer satisfaction
In this article I will elaborate on three major changes that will be brought to the standards viz:-
i)documented procedures and quality manual
ii)management representative; and
iii)preventive measures.
The DIS ISO 9001:2005 does not require documented procedures or a quality manual. It does not suggest any specific procedure to be developed and has left it open for organizations to decide. This gives flexibility to organizations. It does, however, require specific documented information to be retained or maintained. The two terms used in the standard are
i)maintain documented information
ii)retain documented information
The definition of “documented information” in accordance with Clause 3 (3.11) is;
“information required to be controlled and maintained by an organization and the medium on which it is contained”.
The informative notes- Note 2- explicitly refer to documented information as the quality management system including related procedures and information created in order for the organization to operate (documentation) and evidence of results achieved (records).
It is argued that in the new version of ISO 9001, maintaining documented information may be considered as documents while retaining documented information may be taken as records.
The requirements that were included under Control of documents and Control of records in ISO 9001:2008 are incorporated under Clause 7.5- Documented information of the new standard. Documented information shall be provided as evidence to auditors and include, among others:
i)the scope (4.3)
ii)the processes (4.4)
iii)the quality policy (5.2.2)
iv)the quality objective (6.2.11)
v)evidence of fitness and purpose of monitoring and measurement resources (7.1.5)
vi)evidence of competence (7.2)
As mentioned earlier, it is not a requirement in the new standard to establish and maintain a quality manual. It is worth noting the Clause 4.2.2 of ISO 9001:2008 made it an obligation for organization to have a quality manual that includes:-
a) the scope of the quality management system including details and justification for any exclusives
b) the documented procedures established for the quality management system, or reference to them, and
c)description of the interaction between the processes of the quality management system.
The information earlier included in the quality manual more particularly the scope “shall be available and be maintained as documented information” as specified at Clause 4.3 of the new version of ISO 9001.
Another notable change in the new version of ISO 9001 is that a designated management representative is no more a requirement. The attention of readers is drawn to the fact that in ISO 9001:2008, Clause 5.5.2 provides for top management to appoint a member of the organization’s management as management representative. The rational for appointing a member of management as the management representative is to invest one individual with sufficient authority to effectively carry out the quality management responsibilities.
Nevertheless, in the new version of ISO 9001, the requirements for assigning responsibilities, and authorities are mentioned at Clause 5.3 – Organizational roles, responsibilities and authorities and which reads as follows:-
“Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization”.
As a result, top management will have a direct responsibility and commitment in implementing the quality management system. It is assumed that auditors will have to interact directly with top management to obtain evidence of the effectiveness of the quality management system.
Another major change is that preventive actions have been deleted in the new version of ISO 9001 standard. In Clause 8.5.3 of ISO 9001:2008, there was a requirement for formalized preventive measures but its applicability and auditability was a matter of concern to auditors. Preventive action was not really about preventing the recurrence of non conformity but more about preventing occurrence of potential non conformity. It is believed that preventive actions are integrated within the requirements for risk management as defined in Clause 6.1 of ISO 9001; 2015.-Action to address risks and opportunities. The purpose of Clause 6.1 is to identify and eliminate any risk that might lead for non conformities in the organization.
In the next article, on the draft version of ISO 9001:2008 I will elaborate on the auditing techniques required to ensuring effective quality management system.
Occupational Health and Safety Management Systems ISO 45001

MRS R NANHUCK

Accidents at worksites are becoming a major issue for management all over the world. Several standards have been developed to assist organizations in implementing a framework that identifies and controls health and safety rules and reduce worksites accidents. Prior to 1995 there was no common single standard to address the issue of health and safety at the workplaces. Private standards and proprietary certification schemes were commonly used to promote occupational health and safety.
In 1999, the OHSAS Project Group with the British Standards Institution as the Secretariat, published the OSHAS 18000 series of Standards. The OHSAS 18001 focused on the requirement for an effective Occupational Health and Safety Management System while OHSAS 18002 provided guidelines for implementing OHSAS 18001. In 2007, the OHSAS 18001 standard was updated and aligned with ISO management system standards.
The need has been felt for the harmonization of the health and safety management systems using an international standard and international best practices among stakeholders. The objectives of developing an international standard on occupational health and safety are, firstly to set up an international benchmark for the health and safety governance and a common certification scheme accepted worldwide.
To this end, the International Organization for Standardization set up a Project Committee, ISO PC 283, in October 2013 to create the first working draft of ISO 45001. The new international standard on occupational health and safety will be based on BS OHSAS 18001. It is expected that ISO 45001 will have a direct impact on organizational life. It will promote health and safety governance, decrease accidents and disruptions at workplaces. Furthermore, it will enable companies to demonstrate compliance with health and safety requirements through third-party certification.
The new standard lays emphasis on the context of the organization. The organization does not operate in a vacuum and consequently it has to take into consideration the needs, demands and expectations of the society. The conditions of internal employees are safeguarded alongside with the quality of life of the contractors and suppliers. The standard is thus fully integrated in the management system of the organization.
The timeline for the development of ISO 45001 has been decided by the Project Committee. The first Committee draft was published in May 2014. The First Draft International Standard could not be published by February 2015 as the first Committee Draft failed to secure the necessary two-third vote. The Final Draft International Standard is expected to be published by March 2016.

L’entrevue de Mme Rashida Nanhuck, directrice par intérim du Mauritius Standards Bureau

Dans l’entretien qu’elle a récemment donne à la newsletter des industriels mauriciens (AMM), Mme Rashida Nanhuck, directrice par intérim, parle de sa vision stratégique, les défis et les enjeux dont fait face le Mauritius Standards Bureau et l’avenir de l’organisation.

E-News vous présente les grandes lignes de cette entrevue.

Tout d’abord, Mme Rashida Nanhuck élabore la stratégie du MSB qui est axée sur quatre dimensions notamment:

(i)améliorer l’infrastructure qualité pour faciliter les échanges commerciaux;

(ii)soutenir la politique nationale de qualité;

(iii)valoriser les normes et l’évaluation de conformité comme outils stratégiques; et

(iv)promouvoir le MSB comme une institution excellente et financièrement autonome.

Ensuite, elle parle de nouvelles orientations du MSB:

«Le MSB a depuis sa création prône une stratégie dite «development oriented». Le but principal de l’organisation a été de renforcer sa capacité technique dans les domaines d’activités commel’élaboration des normes et l’évaluation de conformité des entreprises. La nouvelle piste de réflexion qui fait surface durant cette moitié de la décennie est de considérer le MSB comme une entreprise commerciale qui vend ses services marchandes.

Le Bureau doit donc devenir «commercially oriented». En outre, le MSB est fondé sur un «management model» avec l’accent sur les procédures administratives et financières et une gestion des ressources calquée sur celle du secteur public. Or, ceci doit évoluer vers un «business model» ayant au centre des discours les clients, les marchés, la performance et les résultats.

Pour terminer, elle nous parle des défis et des enjeux.

«D’une part, des thématiques stratégiques prennent forme commel’économie verte, l’économie bleue, l’économie silver (économie liée a nos seniors), le développement durable, l’efficacité, énergétique, l’empreinte carbone, les bâtiments verts, la sécurité alimentaire ou encore la sécurité routière. Tous ces secteurs exigent un support normatif afin d’assurer un développement sain. Donc, il incombe au Mauritius Standards Bureau de s’adapter sans cesse à l’environnement national et international, de revoir son cadre institutionnel pour mieux appuyer ses activités, de rehausser son profil et de renforcer ses capacités techniques.

STANDARDS DEVELOPED AS FROM JANUARY 2015 UP TO 30 APRIL 2015

Mauritian Standard

/ Title
1 /

MS ISO 50004:2014

/ Energy management systems – Guidance for the implementation, maintenance and improvement of an energy management system
2 / MS ISO 50006:2014 / Energy management systems – Measuring energy performance using energy baselines (EnB) and energy performance indicators (EnPI) – General principles and guidance
3 / MS ISO 50015:2014 / Energy management systems – Measurement and verification of energy performance of organizations – General principles and guidance
4 / MS 10:2015
(BS 4449:2005) / Steel for the reinforcement of concrete – Weldable reinforcing steel – Bar, coil and decoiled product - Specification
5 / MS 34:2015
(BS 4482:2005 + A1) / Steel wire for reinforcement of concrete products - Specification
6 / MS 35:2015
(BS 4483:2005 + A1) / Steel fabric for the reinforcement of concrete - Specification
7 / MS ISO/IEC TS
17021-5:2014 / Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 5: Competence requirements for auditing and certification of asset management systems
8 / MS ISO/TS 22003:2013 / Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems
9 /

MS ISO/TS 22002-4:2013

/

Prerequisite programmes on food safety — Part 4: Food packaging manufacturing

10 / MS ISO 463:2006
+ Cor 1:2007 + Cor 2:2009 / Geometrical Product Specifications (GPS) – Dimensional measuring equipment – Design and metrological characteristics of mechanical dial gauges
11 /

MS ISO 14978:2006

+ Cor 1:2008

/

Geometrical product specifications (GPS) – General concepts and requirements for GPS measuring equipment

12 / MS 190-1:2015 (OIML R 35-1Edition 2007 (E)) / Material measures of length for general use. Part 1: Metrological and technical requirements
13 / MS190-2:2015 (OIML R35-2 Edition 2011 (E) / Material measures of length for general use. Part 2: Test methods
14 /

MS 190-3:2015 (OIML

R 35-3:2011)

/

Material measures of length for general use. Part 3:Test report format

15 / MS 204:2015 / Energy efficiency and labelling requirements – Domestic ovens and range hoods
16 / MS ISO 17742:2015 / Energy efficiency and savings calculation for countries, regions and cities
17 / MS 10002:2014 / Quality management – Customer satisfaction – Guidelines for complaints handling in organizations
18 / MS ISO 17582:2014 / QMS – Particular requirements for the application of ISO 9001:2008 for electoral organizations at all levels of government
19 / MS ISO 18091:2014 / QMS – Guidelines for the application of ISO 9001:2008 in local government

PHOTO NEWS

ISO 9001: 2015 Training conducted by Dr R N Bosu (Global Training and Certification Services) at Mauritius Standards Bureau

PHOTO NEWS

ISO 9001: 2015 Training conducted by Dr R N Bosu (Global Training and Certification Services) at Mauritius Standards Bureau