Organizational Context Issues..

Example of an issues..

A residence area located near-by with a construction company that has been certified by ISO 9001: 2015. The construction company was found to be ignoring the environment even several times a memo of protest were sent by residents' associations.

There has been a lot of problems in residential areas such as clogged drains, flash floods and dust pollution are thought to stem from the operations committed without control measures. The highlight of this problem, a picket organized by residents' associations to voice their grievances. More prolong the situation, the media are also invited to show their concern to the public.

Impressed of the strike, the local council and several government agencies have 'ground' and carry out their responsibilities. As a result, the project had to be stopped temporarily on the instruction of the authorities until the problem is resolved;

There are some issues that may be taken lightly by the top management according to the requirements contained in ISO 9001: 2015;

1. In all likelihood, the top management failed to understand the external issues that may affect their intrinsic events (clause 4.1 of the ISO 9001: 2015).
2. They also may not be aware of the impact of stakeholders who have an indirect effect on the company's operations (Clause 4.2 of ISO 9001: 2015).
3. Still unable deepen the understanding of the risk-based thinking (clause 5.1.1 of ISO 9001: 2015).
4. Less of regard to the issues raised by external parties that lead to more complicated problems (clause 6.1.1 of ISO 9001: 2015).
5. No action for settlement at a time when growing problem (clause 6.1.2 of ISO 9001: 2015)
6.  Perhaps there is no internal discussion on how to find common solutions to the conflicts that existed then. (Clause 9.3.1 of ISO 9001: 2015)

In short, the elements of ISO 9001: 2015 which has been released shows the need for the involvement of top management in ensuring a smooth management systems. NOT SOLELY TO LOOK FOR CUSTOMER SATISFACTION ONLY.

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Risk and opportunities

New aspects in ISO 9001:2015 which does not specifically required in ISO 9001:2008

Risks and Opportunities

1. Clause 4.4.1 (f) of ISO 9001:2015: address the risks and opportunities as determined
2. Clause 5.1.2 of ISO 9001:2015: Top management to demonstrate leadership to ensure focusing on customer through determining the risk and opportunity
3. Clause 6.1.1 & 6.1.2 of ISO 9001:2015: Action to address risk and opportunities
4. Clause 9.1.3 (e )  of ISO 9001:2015: Analysis and evaluation of effectiveness of action addressing risks and opportunities
5. Clause 9.3.2 of ISO 9001:2015: Input of management review on effectiveness of action on risks and opportunities.
6. Clause 10.2.1 of ISO 9001:2015: to update risks and opportunities when there is an occurrence of nonconformity

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Transition Period

Certification Transfer process for ISO 9001:2008 certified company

According to ISO

Recommendation for process steps.

1. Company to determine suitable date (current certificate will only valid until Sep 2018)
2. Readiness review
3. Liaise with certification body
4. Transfer audit (re-certification) based from IAF table
5. New full certificate with 3 years validity

We able to assist you for step 2, 3 and 4. Contact us now at HERE or email us at admin@osh-isis.com

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Package

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Main Changes of ISO 9001:2015

The transition of ISO 9001:2008 to ISO 9001:2015 is mainly to emphasize on the following subjects;
 

High level structure and core text from „annex SL“

The new format of ISO 9001 standard is providing identical structure, text and common terms to be applied to the system user. It consist 10 elements of the requirement to simplify and to be easily understood by the system implementer (see details of ISO 9001:2015 Standard Requirement)

There is also explanatory item to clarify the new structure, terminology and concepts of this ISO 9001. It addressed as per Annex A of the standard.

Besides, ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed. It provides the answer of the term that repeatedly being used in ISO 9001:2015 Standard Requirement and Annex A.
 

Increased requirements for top management commitment and involvement.

It has been defined specifically in the section 5 of the standard. This requires involvement of top management to ensure maintenance of the QMS. It can be realized through demonstrates of leadership and commitment (clause 5.1.1),  lead to the team in focusing on customer requirement (clause 5.1.2), Generation of Quality Policy (clause 5.2.1) and assigning the right person to manage the organization's QMS (clause 5.3).
Top management also must take part in reviewing and evaluating the effectiveness of their QMS through Management Review process (clause 9.3)

Emphasis on risk-based thinking

Details explanation of risk based thinking has been elaborated in A.4 of Annex A.
The concept of risk based thinking is also being part of responsibility of top management for promoting them in the operation (see clause 5.1.1 of ISO 9001:2015)

Increased emphasis on achieving value for the organization and its customers (“output matters”)

'Internal customer' requirement should be respected for assuring good output to be produced. It has been explained in clause 4.4.1 of the standard.
Proactive measures can be seen in the new version of standard where the control of nonconforming products is now used the phrase of controlling the nonconforming output to emphasize effective implementation and preventing the defect to be generated in the operation (see clause 8.7.1 of the standard)

Need to understand the context of the organization and the needs and expectations of interested parties

The new standard emphasizes for organization to look potential issues that may effected to product conformity besides it hall meet with customer requirement. That is including legal requirement aspect, internal and external issue that may influence the smoothness of company's activities.
Broader views has put into the attention for company to identify, manage and maintain as it was addressed in the standard requirement in clause 4.1, 4.2, 6.1.1 and 6.1.2.
Most of the system users interpret this new requirement are replacing the clause of preventive action in ISO 9001:2008. However, the scope and coverage of the risk management in new standard are comprehensively described in wider range than focusing on product quality only.

Increased flexibility on the use of documentation

The used of documented information to integrate the terminology of procedure, document and record under one application without significant change being shown. This aspect has been specifically explain in A.6 of Annex A.

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